Annexes

Annexes,

Case Studies and Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 1

Module 2, Case Study 1

An mhealth application was developed by a German technological organization for use by frontline community health workers in Bangladesh. The application would guide the health worker in delivering maternal and child health–care services such as:

• Registration of pregnancy

• Reminders for antenatal care visits

• Alerting for birth preparedness

• Motivation for institutional delivery

• Post–natal visits

• Immunization of the child

• Infant and young child feeding practices

• Growth monitoring.

The application was developed entirely in Germany with local input from experts in Bangladesh. The application was developed in Bengali, the local language. It was field tested among 10 health workers who knew the Bengali language in Germany and found to be useful. An implementation study was designed to study the use, acceptability of the application by frontline health workers, ease of its use, perceptions of the frontline workers and the community of the application and its effectiveness in improving quality of maternal and child health–care delivery in a district in Bangladesh.

The study revealed that the frontline workers found the application extremely useful. They felt empowered by the use of the handheld device with the application. Some questions and data formats in the application needed to be changed based on the feedback given by the health workers. The data were captured accurately and in a timely manner. This improved data driven public health decision–making at the district level. There were practical issues with maintenance of the handheld device in some of the remote villages. In some villages where there was no electricity, so charging the devices was a problem.

Discuss the findings of this study. If the country plans to adopt and implement the strategy on a wider scale, how will these findings influence this decision?

Ethical principles of health systems and implementation research (IR)

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 2

Module 3, Activity Table 1 – Facilitator's copy

Research designs – types of implementation research (IR)

Cluster randomized trials (group randomized, place–based, community intervention trials

Effectiveness–implementation hybrid trials

Mixed–methods research

Participatory action research

Pragmatic trials

Quasi–experimental study

Realist view

Cluster randomized trials (group randomized, place–based, community intervention trials

Assess both effectiveness and implementation strategy simultaneously Identify intervention – implementation interactions

Use of both qualitative and quantitative methods

Understands various perspectives

Rationales: ‘participant enrichment’, ‘instrument validity’, ‘implementation validity’, ‘meaning enhancement’

Control of research held by research subjects

Bottom–up approach

Effects of intervention in routine practice

Maximize variability of settings, practitioners, patients

Real–life conditions

No control group

Explanatory analysis on how and why an intervention works in a specific context relative to a priori theoretical presumptions

Combines theory and empirical evidence

Randomization of clusters of obstetrics unit staff to education on hand washing or usual practice, measurement of rates of puerperal sepsis in women delivering at study clinics.

Evaluate the impact of sleeping under insecticide treated nets (ITNs) on reduction of malaria infection compared to historical controls (quantitative), and assess costs, consistent availability of nets, affordability and uptake of ITNs in the community (quantitative and qualitative).

Integration of HIV and TB management in single clinics to enhance quality of care. Patient experience (qualitative), adherence, clinical outcomes and cost (quantitative) will be studied over a 1 year period to determine the clinical impact and impact on quality of life in comparison to ‘usual care’ where patients attend HIV and TB clinics separately.

Community itself proposes a study to test whether peer support groups in local communities improve adherence to ARV in HIV + subjects. An iterative research process will engage in continuous programme evolution as challenges and successes become apparent. Adherence and incidence of new opportunistic infections in HIV + subjects over 1 year will be compared to that in a control community where peer support will not be introduced but their access to treatment remains as ‘usual’ care.

Introduction of community health workers (CHWs) for home–based management of malaria (HMM) into one district and another comparable district continues with current standard of care (patient presents to clinic for diagnosis and treatment). Outcomes of malaria infections in both districts over 1 year are evaluated. In addition, tracking of costs and acceptability of CHW in the community are also studied.

Open–label demonstration project of the effectiveness of self–reported use of pre–exposure prophylaxis for HIV.

Integration of traditional healers into HMM strategies based on theoretical assumptions of positive impact

An in–depth literature review of available empirical data on the topic from elsewhere is conducted to understand and identify factors that impact on implementation, and to apply this understanding to the local context as a step in policy development.

Different units of intervention and outcomes measurement

Unit of randomization

Consent before and after randomization, who gives consent? Unit of consent?

Choice of gatekeepers

No opt–out option within cluster

Risk: benefit balance

Ethics of randomization to known intervention, equipoise

Identification of vulnerable groups

Community engagement

Reaching most vulnerable

Informed consent

Inclusion of vulnerable groups

Informed consent

Stigmatization

Community engagement

Inclusion of vulnerable groups

Gatekeeper selection and representativeness

Stigmatization

Does study question represent a true health–care priority in the community?

How similar are the two study communities (scientific rigour)?

How to obtain/need for consent community?

Community engagement

Informed consent

Opt–out options?

Ancillary care responsibilities

Lack of control group reduces scientific rigour

Relevance of literature to local context

Accuracy/relevance of pre–study assumptions

Type of IR

Features

Example

Ethical concerns particularly relevant
to study design

Source: Adapted from Peters et al. (2013); Weijer et al. (2011).

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 3

Module 3, Activity Table 2 – Participant's copy

Ethical relevance of differences between biomedical/clinical research and implementation research

1. Subjects

2. Informed consent

3. Equipoise

4. Research question

5. Research conditions

6. Control groups

7. Anticipated outcomes

8. Risks assumed by

9. Benefits accrued by

Domain

Biomedical/clinical research

Implementation research

This table compares differences between clinical research and IR as an important step in understanding/illustrating how the ethical implications may be different between the two forms of research.

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 4

Module 3

Community engagement role play:

Researchers (there should be at least 2)

• Study background given for this case

• Plan community entry and engagement carefully before starting

• Ideally, you need to engage with all community members to understand their acceptability and willingness to engage in the research

• Be aware that multiple community members have differing points of view and personal situations and power relationships

• Plan according to last slide: When, Where, What, How, with Whom?

Community representative/s

• Male chief, 65 years old

• Tries to speak a lot, interrupts others frequently, very confident

• Married to third wife and 8 children, lost 2 children in childbirth and lost his first wife in childbirth

• Speaks Bengali and local dialect fluently

• Is fully literate, was previously a high school teacher

• Has large ego, wants to be recognized as the chief and respected and revered

• Wants a cell phone as well

• Wants better electricity delivery to the village to facilitate cell phone charging, has been approached
by a solar–panel company and tries to convince researchers to use this company to provide electricity

• Is concerned about the German company (a foreign company) entering their village and collecting their data. Is skeptical about how their information will be used.

• Some tension about community leadership with the imam (Islamic religious head)

Pregnant woman 1

• 24–year–old woman, second pregnancy (first pregnancy was uneventful besides low–birth weight infant)

• Shy and cautious to express her opinion

• Only speaks local dialect, cannot read well

• Went to school for 4 years

• Works in fields

• Husband works in the city 200 miles away and comes home every 6–8 weeks, main source of income is what the husband sends

• Family pressure, strong belief in traditional birth attendants

• Has never used a cell phone, has heard of them

• Worries that she may not be able to use the phone, feels ashamed

• (Only volunteer this information if asked in some way – problem not commonly acknowledged in the village.) Clean water is available for the village in a borehole constructed by an NGO, but women are afraid to walk the 1 km to get water as many have been harassed and raped along the way (husbands are away) The major preoccupation for women in this village is this violence which concerns them more than the risks of childbirth

Health–care worker(s)

• 50–year–old health worker, very senior, burned out, very interested in this study which she thinks will increase her prestige

• Thinks the study medically worth doing

• She wants a cell phone to keep up with other village nurses

• Has poor eyesight, worried she may not be able to read the phone, embarrassed about this

• Will likely move from her section – she is the head of polyclinic for hypertension (HT) and diabetes mellitus (DM management – and when she leaves there will be no senior nurses in that clinic

• Worried about her privacy that people will call her up at all times and expect her to solve other problems unrelated to the project

Traditional birth attendants

• Understand sometimes pregnancy ends badly but this is natural

• Cell phones are suspicious

• Speaks only local dialect, illiterate

• Not eager to speak out unless really coaxed

• Clinic is trying to steal her clients

• Might be interested in collaborating with the clinics and relaying information about home visits if the study provides a bicycle so she can get around for shopping and taking her child to school, etc.

• Worried about imam’s approval

Airtime (phone top–up) sellers

• Interested in the study because likely will increase sales of airtime

• If demand increases can increase his prices

• Worried that airtime will be provided by the study from a more centralized place and he would lose business

Female elder

• Supports traditional birth attendants

• Suspicious of cell phones

• Speaks only local dialect, illiterate

• (Do not volunteer this information too easily.) Is worried about violence against young women with absent migrant worker husbands in the village

• Worried about imam’s approval

Local Imam

• The whole village respects and reveres him as the intellectual of the village; they look to him for moral and religious advice

• Is a well–educated man and is fairly well informed about mHealth

• Has a feeling that there is a strong anti–Islamic sentiment in the western world and the innocent peace loving members of his village should not become victims of this paranoia

• Very confident in his views

Neighbourhood watch

• Concerned about violence and robberies of phones

• Worried the study will bring more crime to the area

Church leaders

• Potential conflict with imam

• Judgemental about unmarried mother

Fieldworkers

• Want the job and phones so very supportive

Pregnant woman 2

• 18–year–old woman, was raped on way to water source (others not aware of this unless they really engage well, you are humiliated and do not want to divulge this in public), HIV positive

• Is literate and speaks Bengali

• Went to school for 8 years, spent 1 year with relatives in the city before returning to the village for an arranged marriage

• Works as a seamstress

• Family pressure, strong belief in traditional birth attendants

• Is very eager to get a cell phone

• Worries about privacy of messaging and about the village knowing of her diagnosis and medical history

• Problems with vision and so find it difficult to constantly peer into the mobile phones (these workers are reluctant to use the application)

• Working in clinic with erratic supplies

• Worried about cell–phone initiative because it will bring more women and children to the clinic and will increase their workload

• If she leaves the adult polyclinic section there will be no experienced staff in that section, all are juniors

• Worried patients will call them at home when they are off duty and how to respond then?

Mother of an infant (5 months)

• Has so far not taken her infant for any vaccinations as the imam had advised against vaccination of male children

• Believes that anything foreign is suspicious

• Is also uneducated and is apprehensive of mobile phones

• Worried about imam’s approval

• Feels trapped between her allegiance to the imam and potentially doing something good for her child

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 5

Module 3

Stakeholder engagement role play

Researchers (there should be at least 2)

• Study background is given for this case

• Plan your entry and engagement with the stakeholders before starting

• Ideally, you need to engage with all stakeholders to understand acceptability and willingness to engage in the research

• Be aware that multiple stakeholders have differing points of view and personal situations, power relationships

• Plan according to last slide: When, Where, What, How, with Whom?

German company

• Eager to test their product and create a market

• Have other apps ready to be marketed in developed countries for weight loss, need proof of principle

• Study cheaper to do in Bangladesh than in Germany or the United States

• Has collaboration with cell–phone company they plan to co–fund the study with, App at present only functions on specific cell–phone platforms

• Know the local authorities are interested in their district being seen as pioneers

• Know ministry of health is under pressure to achieve heath-related targets

• Want ownership of the data

Ministry of health

• Pressure to reach targets for maternal mortality and child mortality

• Cell phone study is new and innovative

• Costs may be manageable over the longer term if prices not raised by company and participants have their own cell phones

• Concern about diversion of staff from other clinic areas to this project

• Wants ownership of the data as most interesting data is the patient outcomes that will come form
the clinics

• Needs assurance of confidentiality

• Needs upgrading of existing computer systems in clinics for data capture, would require funding from study for this

Local authorities

• Pressure to reach targets for maternal mortality and child mortality

• Cell–phone study is new and innovative

• Concern about diversion of staff from other clinic areas to this project

• Concern clinics may be overwhelmed with clients and not have reliable enough stock and facilities to manage all the cases

• Feel a major priority before such a study would be to improve efficiency of stock tracking and deliveries

Cell-phone companies

• Has collaboration with App development company they plan to co–fund the study with, App at present only functions on specific cell–phone platforms

• Know the local authorities are interested in their district being seen as pioneers

• Want to broaden market for their specific cell–phone platform

• Bengali language is adequate on phone

• Batteries can be charged with electricity or via regular batteries through a small device (would need to be purchased by end–user or provided by the study)

• Solar charger device very slow, takes 8 hours to charge

Cell-phone service providers

• Can provide large numbers of SIM cards and airtime at a reduced price during the study?

Electrical company

• Eager for study to take place because they know the chief and have negotiated with him to use the study as potential leverage to improve electricity delivery to the district

Bengali translators

• Translations done by second generation Bengali’s who were born in Germany and are fluent in German

• Do not have any medical knowledge

• Did translation as best they could, some terms were culturally sensitive and awkward to translate
(e.g. last menstrual period)

• Translations ‘testers’ felt pressure from the company to perform well in the hope of future work and were, therefore, not very critical of the translation

Data handlers

• Explain how cell–phone data will remain confidential, how study participant identity will be protected, risks of hacking of phones, risk of loss of phone and, therefore, loss of confidentiality

• Paid for my German company

• Need to get access to clinic records in order to record patient outcomes if deliveries are at the clinics, follow ups, etc.

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 6

Module 3, Facilitator's notes – Case Study 1 continued

Implementation research study aim

To study the use, acceptability and effectiveness of an mhealth intervention to improve the quality of maternal and child health–care delivery in a district in Bangladesh

About the study design and goal

• The mHealth application for use on mobile phones was developed by a German technological organization for use by frontline community health workers in Bangladesh

• The application would guide the health worker in delivering maternal services, such as:

• registration of pregnancy

• reminders for antenatal care visits

• alerting for birth preparedness

• motivation for institutional delivery

• post–natal visits

• immunization of the child

• infant and young child feeding practices

• growth monitoring.

• Application was developed entirely in Germany with local input from experts in Bangladesh.

• The application was developed in the Bengali language.

• It was field tested among some people who knew Bengali language in Germany and found to be useful.

Important considerations in community and stakeholder engagement

1. What are the core imperatives of stakeholder engagement?

• Identify and manage non–obvious risks and benefits.

• Expand respect beyond individual to stakeholder community.

• Build legitimacy for research project.

2. Does the study meet the community’s needs?

• This is the first crucial step in determining whether it is ethically justifiable to conduct the study at all. This must therefore be ascertained in the earliest stages of study conception. Potential sources of this information include the public health officials and the health ministry. But the community itself must also be consulted to determine whether even though this study may address a prevalent need, it may not be a top priority for the community members who may wish to address another competing need first.

3. How should community or stakeholder engagement occur?

• When? Timeline? Stakeholder engagement should occur as early as possible.

• Where? State facility? Town/community hall? Traditional venues? The location must be accessible to all relevant stakeholders and not be threatening or impose discomfort or re–enforce inequalities.

• With whom? Identify all the stakeholders.

• Why? To listen to the community first, understand needs, desires and similar with all other stakeholders.

• How? What method/medium, e.g. posters, group meetings, media, pamphlets, face–to–face meetings, in town halls or at village meetings? Pay attention to literacy and most vulnerable stakeholders’ access to means of communication and ensure appropriate means of communication for each group.

• How long should it take, should it be before, during or after the study? Ideally ongoing to gain feedback and adjust if required.

4. Who are the stakeholders in this study?

• Communities

i. Selection of research participants/location/inclusion of vulnerable groups is crucial to ethical considerations, which assist in identification of appropriate stakeholders.

1. Frontline health–care workers will need to accept the mhealth intervention be confident enough to use it.

2. Pregnant women and mothers will need to accept their health–care worker using mhealth.

3. Will all health centres have access to mhealth, e.g. wireless availability, electricity? Need to ensure more vulnerable/remote centres and women are not excluded.

4. The German Bengali translation should be checked and determination should be made if Bengali is indeed the predominant language, and how the study will benefit those who do not speak/understand/read Bengali.

5. Is literacy a study participation requirement? How literate is the local community?

• Researchers: German organization; any other partners; for–profit or NGOs or universities, etc.? All may be ethically relevant.

• Funders.

• Sponsors, institutions.

• Collaborators.

• Government: need to engage with health ministry to investigate sustainability of mhealth long term in the region where study will take place and plans/potential for scale–up countrywide if intervention is successful.

• Local authorities: need their buy–in and ownership of the project.

• Health–care workers (HCWs), community health workers, volunteers, traditional healers: need to ensure local traditional birth attendants do not feel threatened or marginalized; consider ways of including them in the project. Need to understand any unforeseen barriers to mhelath among HCWs.

• Handheld device manufacturers, distributors: need to engage with them to assess potential market impact, commitment to affordable pricing over long term, maintenance of infrastructure, etc.

• Others impacted by study, e.g. cell phone service providers: need to engage to assess buy–in, negotiate fair pricing for their services, etc.

• Who is the research’s audience? Plans for publication in relevant journals/websites/nongovernmental organizations (NGOs), etc. to maximize reach of study results.

5. Who should represent the community?

• Consideration will need to be given to local customs and if local women can give their own consent or whether consent should be community–based. Who would be a legitimate representative, e.g. a female community elder, pregnant women or mothers? How should such individuals be identified and selected?

• Separate consideration must be given to who will represent the HCWs?

6. Risk assessment

i. Three sources of vulnerability

1. Inherent: pregnant women especially if from vulnerable populations may be willing to accept participation thinking they will receive better care or attention. They may be influenced by technological nature of the study. If a woman has a bad outcome or does not comply with all recommendations she may be subjected to shame. Not all pregnant women may have cellphones and be able to participate and therefore may attend clinic even less frequently from a feeling of inadequacy and shame. HCWs may experience shame if they struggle to use the hand–held devices if they forget to charge the devises or the devices malfunction. They may also be subjected to extra workload involved with the study, documentation, tracking of women, etc., as well as being potentially more ‘accessible’.Privacy and confidentiality in capturing and transmitting electronic data must be considered.

2. Situational: because of social, political, cultural milieu, e.g. socioeconomic status. Local poverty and perception that technology must be good may influence use and participation in the study and bias results because of a ‘novelty’ factor. Some communities may be intimidated by the technology? The technology would further undermine the role of traditional birth attendants, which may create stress and dissonance within the community.

3. Pathogenic: HCWs or mothers having study devices may by subject to theft and violence, they may be subject to over–spending if they have access to a SIM card and use of the device for personal communication. Thus, they may be made worse by attempts to reduce vulnerability.

• Social harms: the study may change the perception of traditional birth attendants or create distrust of other health services not supported by mhealth.

• Financial harms: women or HCWs may be subject to over–spending if they have access to a SIM card and use of the device for personal communication.

• Communal harms: new infrastructure may be built for the study to support mhealth devices, which could facilitate use of other devices by general community members. If the study is not sustained, services may stop.

• Harm to health system: if the study were successful but not rolled out or sustained, this could create disappointment and distrust in future studies and the health system. Trust in non–technology–based health care may decrease, HCWs/demand for services may be overwhelmed and divert attention/resources from other areas.

7. Risk levels

benefits and risks to each stakeholder group should be considered and if necessary weighed against each other to ensure fair distribution of risks and benefits especially if not accrued in the same individuals. Close follow–up and frequent feedback should continue throughout the study to identify any unforeseen harms/consequences of the intervention, e.g. the development of dependence on technology and a reduction in the use of other services,
or overuse of services, etc.

8. Commitment to scale up, if successful

important to have prior commitment from the government. Requires realistic estimation of costs, commitment from manufacturers, distributors, and service providers to ensure affordability.

Community and stakeholder engagement

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 7

Module 3, Case Study 1 continued

This case study uses the same case study as in the other modules. In this case study, some specific issues related to ethical considerations in the conduct of IR are explained.

Part 1.

The mhealth application was developed by a German technological organization for use by frontline community health workers in Bangladesh. An IR was designed to study the use, acceptability of the application by the frontline health workers, ease of use, perceptions of the frontline workers and the community about the application and its effectiveness in improving quality of maternal and child health–care delivery in a district in Bangladesh. It was a cluster randomized controlled study with 10 villages randomized to intervention and 10 villages to routine maternal and child health care by the community health workers.

Who is the focus of intervention in this study? On whom are the outcomes assessed? Who are considered as research participants? Who should give informed consent?

Can any woman in the intervention clusters refuse to have her data collected by the mHealth system? What are the implications of this refusal? Is individual informed consent meaningful in this context?

Part 2.

Issue 1. In the same case study described above it is known that data capture using the routine paper based system has a significant delay in being reported to the information system. Because of this delay there have been several instances of poor data based planning for maternal and child health care delivery services which have resulted in poor outcomes.

Given this knowledge of poor nature of the de facto care, can this be continued in the control clusters? What would be an acceptable standard of care for the control clusters?

Issue 2. During the conduct of the IR, it is found that there is an increase in the number of children with severe acute malnutrition in the age group of 6 months to 1 year.

Ethical considerations in the conduct of IR

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 8

Module 4, Case Study 2

The Ministry of Health of Country X has committed funds towards designing a successful implementation study to determine the optimal strategies to deliver childhood vaccinations to nomadic and remote communities in the country.

Special outreach teams (SOTs) will be deployed to a selected sample of known nomadic and remote communities. The teams will be supplied with all logistical requirements, i.e. vehicles, ice boxes, adequate vaccine stocks, translators, etc., and be trained to deliver the required vaccinations to all children under 5 years old in these communities and collect quantitative data on the existing level of vaccination coverage, numbers vaccinated, document feasibility challenges and tracking costs. The SOTs will work in coordination with the regular community health workers in the area delivering routine vaccination services in addition to other primary health–care services.

In addition to the SOTs’ intervention, in a selected subsample of communities, a key individual from each community will be identified to participate in a smart phone–based GPS tracking study, to assess the feasibility and utility of locating nomadic communities in real–time. Solar–powered battery packs will be supplied to these key individuals. Their location will be tracked in real–time and reported to the SOTs for more effective delivery of services.

Part 1. Data Collection

The implementation is rolled out in five nomadic groups in the area. Two of these groups are selected for the real–time GPS location study and key members of these groups are provided with the smart phones for GPS tracking of their location. The SOTs contact these groups and enumerate the names, family details, demographic characteristics, health details and vaccination status of all the children under 5 years old in the five groups. They administer the first dose of vaccine to all eligible children and conduct community meetings.

The SOTs will maintain an ongoing registry of new births, new entrants into the nomadic group, marriages, etc. They will follow–up the pattern of immunization coverage over the years using a time–series analysis. They will also work in close coordination with the local public health system and share the data with them for their health management information system records.

Part 2. Data sharing, dissemination and disclosure

For the following scenarios, assume that a group outside the formal public health system (perhaps an NGO or research organization) has already been collecting data.

Group 1. Sharing with public health

Keep in mind the information we added to the vaccine case above and consider the following development. Public health officials are interested in boosting vaccination rates in the country. They want to start a vaccine registry. Given the richness of these data, they are asking for name–based information.

They argue that it is important to ensure that all children receive all vaccinations, that resources are not wasted, and that children are not put at unnecessary risk by duplicating vaccinations.

Consider the questions below.

• Can identifiable health information be shared with public health for the purposes of creating a registry?

• Can the GPS location information be shared with the public health system?

Group 2. Sharing with forestry officials

It is not only public health officials who want your data. While this study is ongoing, the local forestry officials approach the research team. They complain that some of these nomadic groups are engaged in poaching wild animals for their hide and teeth in the forest area.

They know that GPS tracking is being done for these nomadic groups for research purposes. They want the research team to share the data so that they can keep them under surveillance.

Group 3. Dissemination in an outbreak

The researchers regularly report vaccination levels back to the nomadic populations that they are tracking. Imagine an instance in which nomadic populations have particularly low levels of vaccination for polio.

Consider the questions below.

• In the context of an outbreak in the broader population, can they, should they, and must they also disseminate information about vaccination rates in nomadic communities more broadly?

• In the context of an outbreak in the nomadic community, should researchers disseminate the information to neighbouring communities and those that the outbreak has the potential to reach?

• What risks are associated with this decision to release this information?

Group 4. Disclosure

Imagine that our researchers find a case where two children under 5 years old have congenital syphilis.

The mother is pregnant with a third child.

Consider the questions below.

• Should the researchers disclose the name of the children and parents to health officials so that they can offer testing and treatment?

• Could the involvement of health officials and their subsequent interaction with the family effectively amount to public disclosure? If so, is disclosure still warranted?

• Are there ever circumstances when the names of individuals with disease should be disclosed to the public?

Source: Adapted from Gidado SO, Ohuabunwo C, Nguku PM, Ogbuanu IU, Waziri NE, Biya O et al. Outreach to underserved communities in northern Nigeria 2012–2013. J Infect Dis. 2014;210(Suppl 1):S118–24.

Ethical considerations in the conduct of IR

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 9

Case Study 3

Congenital syphilis is a highly preventable condition that is associated with significant morbidity. A full course of penicillin completed prior to 30 days before delivery in pregnant women testing positive for syphilis will prevent congenital syphilis in her child. Syphilis screening is recommended at the first antenatal clinic (ANC) visit and in the 3rd trimester of pregnancy. The ANC syphilis screening guideline includes pre–test counseling and after obtaining consent, a vial of blood is sent to a reference laboratory for diagnosis (RPR, rapid plasma reagin and TPHA, Treponema pallidum hemaglutination). The pregnant woman is then requested to return to clinic for the result, post–test counseling and if the test is positive, she is referred to a specialty clinic for treatment with 3 weekly doses of intramuscular Penicillin G (if not allergic). The woman is also invited to inform her partner who would also be tested and treated similarly for free. Testing and treatment has been freely available in ANC in country A (Central Asia). Despite 98% of women attending ANC however, the frequency of syphilis testing was low and the incidence of congenital syphilis rose over 20 fold between 1995 and 2006. To address this problem, a cluster–randomized trial of a “one–stop” syphilis screening and treatment protocol was carried out in country A. The screening test involved a previously validated point–of–care finger prick syphilis test where a result was obtained in 15 minutes. If a woman tested positive, blood was drawn to be sent to the lab for confirmation; she however received a first dose of Penicillin G at the same visit. She was asked to return weekly for 2 more doses of Penicillin, unless the confirmatory test was negative in which case Penicillin was discontinued. She was also invited to inform her partner who would be screened in the same way. This one–stop screening/treating policy resulted in a significant rise in testing and treatment of syphilis in pregnant women and their partners and a significant decline in the incidence of congenital syphilis.

As the head of preventive services in the Ministry of Health in country B (Central Africa), you have been approached by a company that manufactures the point–of–care syphilis diagnostic test, which is offering to fund an implementation study in your country. Congenital syphilis is a problem in country B and at present antenatal syphilis screening is carried out according to a standard guideline as in country A, with suboptimal uptake. Currently in the country only 60% of the antenatal women undergo syphilis testing and among those who screen positive only 40% complete treatment. The rest are lost to follow up. The antenatal clinic is overburdened and so does not have enough manpower to follow up and ensure adherence to treatment. You are impressed with the outcomes of the one–stop syphilis screening study reported in country A. The advantages you see are the following: a) obtaining a result within minutes avoids delay in diagnosis, b) women who test negative do not need to return to clinic for results, c) case detection rate increases, d) treatment can start immediately, e) partners can be screened with the one–stop protocol, f) rates of congenital syphilis will be reduced. You wish to implement the one–stop syphilis screening protocol in your country, but realize there are many issues that you will need to consider before designing your implementation study to test the feasibility.

In order to design and conduct the implementation research in your country, you set up a consultation group comprised of public health specialists, policy makers, members of the local governance body of the districts, and representatives of local women’s self–help groups. This consultation group decides to implement the one stop antenatal syphilis testing protocol in all the antenatal clinics in ten districts in the country. The rest of the country will continue with the routine syphilis testing protocol. The data of congenital syphilis in the various districts was analyzed and the districts with the highest burden of congenital syphilis were selected for the implementation. Representatives of women’s groups and local governance bodies of these ten districts were organized into a task force to closely monitor and follow up the process of the implementation research. These representatives were also encouraged to go to their respective districts and spread the message about the implementation research project.

In order to measure the impact of the implementation, the consultation committee plans to collect data on the following characteristics:

• Name, age, marital status, education, occupation, income and social status of the pregnant women.

• Details of the partner’s education, occupation, income

• One stop syphilis testing rates

• Syphilis screen positive rates

• First treatment acceptance rates

• Complete treatment rates

• Rate of confirmatory test negative among those who screened positive

• Reduction in congenital syphilis

• Partner notification and screening

• Experiences of pregnant women in participating to the implementation

After 6 months of implementation the monitoring team reported an increase in cases of domestic violence in the households of pregnant women who screened positive. On enquiry it was found that the health worker in the antenatal clinics were making phone calls to schedule screening tests for the partners without confirming with the women whether they had already informed their partners and invited them for screening. Interviews with some of these pregnant women revealed the truth that they had not notified their partners fearing the violent consequences.

Reflect on the following questions

1. What is the most appropriate study design for this implementation research? Discuss the ethical issues of the design.

2. Is there a need for control group?

3. Discuss why there is an ethical imperative to engage with the communities in this case.

4. What is the nature of community engagement described in this study? Is it appropriate for this implementation research?

5. Are the community representatives selected for the engagement appropriate? Will they truly represent the community interests?

6. List the potential stakeholders in this study.

7. What are the possible competing interests among the stakeholders? How can this affect the study and future adoption of the intervention?

8. Who are the research participants? Pregnant women? Their partners? The health workers?
The health system?

9. Is there a need for informed consent?
If yes, who should give informed consent?

10. Why do you need identifiable patient information
in this case? How can the data confidentiality
be protected?

11. The health workers in the clinic who had access to the contact details of the screen positive patients and their partner’s contact details, made phone calls to schedule tests for the partners.
Is it ethically right for the health workers to have access to the data of the partners who are not actually the study participants? Is it right for them to contact them without the knowledge
of the participants?

12 . After the completion of the study what is the obligation of the research team regarding the
data sharing and data driven action?

13. In case the same study is conducted as a cluster randomized controlled trial with 10 clusters randomized to intervention with the one stop syphilis protocol and 10 clusters to control, in the control group which of the following care should be provided:

a. Existing standard of care

b. A syphilis education intervention

c. A voucher scheme for transport of antenatal mothers who screened positive in order to travel to the health facility and complete their treatment

14. During the conduct of the study it is found that a particular ethnic tribe in the intervention clusters have very high prevalence of anemia during pregnancy. It is noticed that they are very poor and subsist on meagre cereal based diets. What is the responsibility of the researchers towards this ethnic tribe?

Source: Adapted from Munkhuu et al., Sex Transm Dis, 2009; 39 (11): 714-720 and Munkhuu et al., South Asian J Trop Med Publ Health, 2009; 24(4): 861-870

One–stop service for Antenatal Syphilis Screening

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 9

Case Study 4

The latest results from a demographic health survey show that Country C is not on track to meet its target to reduce maternal mortality, although it is well recognized that it can be reduced by the presence of skilled birth attendants at delivery. Safe delivery in a health centre is strongly encouraged to maximize the detection of complications early on and appropriately manage or refer women to a higher level of care promptly. Despite improvements in the standard of care for delivery – training midwives in delivery techniques and infant resuscitation, expanding facilities for Caesarean sections, and running community education campaigns to encourage women to deliver in health facilities – the overall maternal mortality rate in Country C has only fallen by 42% over the past decade, far from the target of 75%. Maternal mortality is especially high in rural areas where teenage pregnancy rates are high. This is because health centres are not necessarily within comfortable walking distance from villages, men are often away from home working as migrants and are unable to provide their consent for a woman to go to the centre or assist her in getting there. Also, there is a strong tradition of using traditional birth attendants (TBAs) during home delivery.

Based on success reported from other parts of the world, a voucher incentive scheme will be piloted as a strategy to increase deliveries in health centres. Using a quasi–experimental study design, maternal outcomes before and after the introduction of the voucher scheme were compared in one health district and in a highly similar control district where there was no voucher scheme. The two districts were chosen because they served rural populations and included a variety of health facilities, i.e. public, not–for–profit private and for–profit private. Further, they were far enough apart that it was thought unlikely that clients would travel from one district to the other. In the intervention district, pregnant women, identified during the first antenatal clinic (ANC) visit, received 1–4 vouchers to attend the ANC (the number of vouchers depended on the stage of gestation), a voucher for a health–care facility delivery, and vouchers for transportation to the ANC and for delivery/referral to higher level of care, if required. The women could choose to receive their health services at any public or private health–care facility in the district. The fixed redeemable value (for the health–care provider/facility) of the voucher was higher for the private facility than for the public service to encourage private health–care providers’ participation. Taxi vouchers were reimbursed according to distance travelled to motivate taxi providers. To minimize the fraudulent use of vouchers, each voucher was usable only once during a specified time period, and the pregnant woman’s name, village and estimated date of delivery were written on the vouchers for identification purposes. No intervention was carried out in the control districts. Data were collected by the midwives during the clinical care visits at both intervention and control clinics.

To assess the feasibility of implementation and scale–up of the voucher scheme, in randomly selected subsets of private and public health centres within the voucher intervention group, further qualitative studies were conducted to investigate the practicalities of operating the voucher scheme, perceptions of the scheme among various stakeholders (clinic staff, patients, husbands/family members, taxi drivers, and private and public facilities), and the contexts in which the scheme was implemented. Costs and charges were also tracked.

Reflect on the following questions

What are the ethical challenges arising in this case? Specifically focus on the following:

1. Ethical issues in study design – how could these ethical challenges have been avoided by better study design?

2. What are the risks and benefits?

3. What are the potential implementation challenges to be considered in the design stage?

4. Are there general ethical concerns with vouchers and cash inducements?

5. How could this affect scale–up and sustainability?

Source: Based on Ekirapa–Kiracho E, Waiswa P, Hafizur Rahman M, Makumbi F, Kiwanuka N, Okui O et al. Increasing access to institutional deliveries using demand and supply side incentives: early results from a quasi–experimental study. BMC Int Health Human Rights. 2011;11(Suppl. 1):511.

Voucher scheme to increase deliveries in health centres and reduce maternal mortality

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 9

Case Study 5

Despite global successes in reducing the burden of malaria, according to the 2014 World Malaria Report, only 26% of children with malaria in Africa received the appropriate recommended treatment in the past year. An important reason for this alarming statistic is that many children with fevers are not brought to health–care centres. Most childhood deaths resulting from malaria occur within the first 48 hours of symptom onset. Rapid, appropriate treatment may, therefore, be life–saving.

Over the past decade, implementation research (IR) projects have been conducted in several African countries with the goal of ensuring that children receive prompt access to appropriate anti–malarial therapy. A HMM strategy was tested to assess the acceptability and efficacy of the administration of pre–emptive anti–malarial therapy with pre–packaged medication to children under 5 years of age with fever, at home, in rural communities. Communities were selected by size (>10 000 population) and homogeneity (same languages/dialects). Mothers were educated to recognize the signs of malaria in children with fever and obtain medication within 24 hours from trained local community care workers. The underlying rationale for these studies was based on the knowledge that because of the lack of access to, or mistrust of the formal health services, most malaria episodes in rural Africa were being treated inappropriately at home with herbs, incorrect medication or incomplete courses of therapy. The results of these implementation studies showed that HMM was feasible, the community was largely receptive, rates of febrile children receiving appropriate treatment increased, episodes of severe malaria were reduced and mortality declined.
Based on these studies, many African countries have included HMM in their national malaria strategies.

Feedback from mothers engaged in the initial studies was generally very positive. They appreciated the dedication of the community care workers, they witnessed the effectiveness of the medication in most cases, and were usually appropriately referred to the health centre, if the child was too sick for HMM or the community care worker suspected another illness.
Over the years, the community developed trust in the process because they could identify the medication packages and consequently most completed the required three–day therapy.

A major drawback of these IR studies was that the diagnosis of malaria was presumptive; no confirmatory tests were performed unless a child was referred to a health centre. Therefore, many children may have been treated for malaria unnecessarily, whilst other causes of fever, for example, pneumonia, may have remained untreated.

Two major developments in the treatment and diagnosis of malaria have occurred in recent years:

1. Artemisin combination therapy (ACT) became the first–line treatment regimen (most often twice daily for 3 days), replacing chloroquine, (one tablet daily for 3 days) in most regions of the world because of emerging drug resistance. Chloroquine was the drug used in the implementation studies.

2. A point of care rapid diagnostic test (RDT) has been developed for malaria, which involves a finger– or heel–prick for blood with results being obtained within minutes. To improve the accuracy of diagnosis and appropriateness of therapy, WHO recommendations now include testing with RDT prior to pre–emptive HMM in children with fever.

You work for the health ministry in Country X, where HMM has been implemented in multiple rural communities in province Y with some success. The latest results show that around 60% of mothers seek care within 24 hours of a child developing fever. Of those, 80% are compliant with the pre–packaged medication use. Given your success, you have obtained a large grant to scale up the HMM programme in your region and expand to the neighbouring province Z where civil unrest has now subsided. In the communities familiar with the current HMM in province Y, you anticipate that there may be some scepticism to the implementation of RDT prior to initiation of therapy, and to the change in the medication’s appearance and dosing (ACT versus chloroquine). You wish to design a cluster randomized intervention to test the acceptability of ACT and RDT in 15 communities in province Y (clusters A and B) to assess any unexpected changes in health–seeking behaviour and medication use, and to compare uptake and outcomes with people in 10 communities in province Z where HMM will be implemented for the first time (Cluster C). Cluster A will be randomized to continue existing HMM strategy but switching from chloroquine to ACT, without RDT (five communities). Clusters B and C will be randomized to RDT + ACT (10 communities each).

In order to facilitate the seamless implementation of the intervention in all three clusters, community engagement is planned. Information about HMM for children is presented in all local newspapers, television channels and radio broadcasts. The changes in the original home–based management, the need for the changes and improvement in outcomes are explained in a way that is easy for the community to understand. In addition, the village headmen of all the selected villages in the three clusters are contacted and the details of the IR project explained in detail.

After finalizing the research design and initiating active community engagement the implementation is rolled out in the three clusters. Country X has an ongoing fever surveillance that is carried out through community health workers. This is a syndromic– and laboratory–based surveillance. Whenever a person presents to a health worker or a clinic with fever, the details are reported to a central surveillance unit. In addition, all laboratories also report cases of fever where positive blood smears for malaria are reported. The reporting is done along with the name and the address of the person with fever/blood smear positivity. The community health workers involved in syndromic surveillance are trained and enrolled into the IR project. They are instructed to actively look for children with fever and report the case to the project investigator in the field, who will then visit the family and collect information on the characteristics of the child and the family, utilization of HMM intervention, and clinical outcomes. In addition, in–depth interviews are also conducted among the mothers to understand their experiences and opinion about the HMM system.

Reflect on the following questions

With respect to community engagement:

1. Why should you engage with the communities in provinces Y and Z?

2. In this case, the community engagement was started after the design of the study had been finalized. When should it ideally begin? What aspects of the IR project should the community be engaged with?

3. What should be the terms of the engagement with the community?

4. Village headmen have been selected as community representatives for the community engagement process. Who is an ideal representative? Who should decide on representation?

5. What do you think about the community engagement strategy used in this study? Will newspaper, television and radio broadcasts effectively reach women in the households, who are the true implementers of the intervention?

With respect to ethics of data collection in IR:

6. What is the nature and type of data that are required in order to understand the effectiveness, acceptability, reach and utilization of the HMM? Is surveillance necessary? If yes, is name–based reporting necessary?

7. Given that the surveillance activity is name–based case reporting and given that identifiable patient information (characteristics of the child and the family) will be available to the researchers, what data confidentiality issues should be considered? How should confidentiality of patient data be protected?

8. Who owns the data collected as part of the surveillance? Who owns the data collected by the researcher for the IR?

9. When the people of provinces Y and Z provide information for the public health surveillance for fever, does it imply that they give their consent to it being shared with researchers? Should specific consent be required before data are shared with the researchers?

10. Is there an ethical obligation to share the data obtained from the IR with the community? Is there an ethical obligation to share the data with the scientific world?

With respect to study design:

11. In designing implementation studies, implementation researchers must take a structured and holistic approach to maximize the chances of success. The crucial components in designing an IR study include the following:

• selection of study sites;

• engagement with the community;

• identification of relevant stakeholders;

• conduct a situation analysis;

• select medication manufacturer and supplier;

• need for special medication packaging;

• decide on drug pricing;

• select community care workers who will distribute the medication when indicated;

• training of study staff/volunteers at all levels, development of training materials;

• training of mothers/child carers on how to identify possible malaria and seek care;

• ongoing tracking of medication use and outcomes as well as feedback from the community and refining of the processes;

• consideration of scalability and sustainability.

What are the ethical implications of each of these components that may have an impact on this study?

Sources: Based on: Gyapong M, Garshong B. Lessons learned in home management of malaria: implementation research in four African countries. Geneva: World Health Organization; 2007; WHO. Early appropriate home management of fevers in children aged 6 months to 6 years in Ghana: study protocol May 2000: World Malaria Report 2014. Geneva: World Health Organization; 2014b; Chinbuah MA, Kager PA, Abbey M, Gyapong M, Awini E, Nonvignon J et al. Impact of community management of fever (using antimalarials with or without antibiotics) on childhood mortality: a cluster–randomized controlled trial in Ghana. Am J Trop Med Hyg. 2012;87(Suppl. 5):11–20.

Home–based management of malaria (HMM)

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 9

Case Study 6

Mother–to–child transmission of HIV is reduced by treating the HIV positive mother with antiretroviral therapy (ART) during pregnancy and lactation. In the guideline, option B is recommended to treat all HIV positive women with ART during pregnancy, but to stop therapy six weeks post–partum or at cessation of breastfeeding if the mother’s CD4 cell count is above 500 cells/mm3 and she has asymptomatic HIV infection. Future care would occur through referral for follow–up to a HIV clinic. In countries where access to CD4 cell count testing at diagnosis of HIV is limited (i.e. HIV infection cannot be accurately staged), Option B+, continuing all pregnant women with positive HIV tests for life on a fixed–dose triple drug ART combination tablet, has been shown to be pragmatic and successful. Anticipated benefits of Option B+, in addition to PMTCT, are that mothers on life–long HIV treatment would be more likely to survive to look after their children and less likely to transmit HIV to their sexual partners or subsequent children. However, the drawbacks of such a policy are the increased cost of treating many women earlier than they would otherwise have been eligible for ART. Logistically, there are questions on whether or not the ART in Option B+ should continue to be administered through the antenatal clinics (ANCs) and, if so, for how long, and the optimal timing for transitioning care to specialized ART clinics. These factors may all have an impact on the long–term success of the policy.

To test the transferability of Option B+ to Country E, a pilot roll–out of Option B+ was carried out over three years in 100 clinics across the country with a plan for rapid scale up, if effective. As part of the evaluation of the pilot implementation in Country E, it was noted that outcomes of Option B+ from individual ANCs were quite different. Even within similar socioeconomic and geographical health districts, where patient populations are considered highly similar, some clinics had excellent retention and follow–up of HIV positive women receiving ART (>95%), whereas others had very high dropout rates (>50%). The standard operating procedures (SOPs) were the same for all clinics. Prior to initiating countrywide roll out of Option B+, a further pre–implementation study must be carried out to identify barriers to successful implementation.

Using mixed–methods, a situation analysis (SA) will be conducted in two groups of clinics that had been identified previously as the 20 best and the 20 worst performers. Pairs of best and worse performing clinics will be matched for similarity of socioeconomic and geographic factors. The outcomes will be used to assess the clinics’ performance and effectiveness and will include the number of women: (a) tested for HIV; (b) initiated on ART; (c) returning for follow–up; and (d) taking treatment appropriately. In addition, it is proposed to assess through a qualitative study the comprehension of the rationale and acceptability of Option B+ among the clinics’ workers and HIV–positive women, and potential additional barriers (e.g. inadequate supplies, overwhelming of clinic staff, diversion of clinic staff to other ongoing research projects or vertical programmes, and local acceptability/barriers within the community).

The Ministry of Health has consented to the enrolment of the selected clinic sites. Staff from all selected clinics will attend a mandatory information session on the study that will take place in their clinics and will help them “understand the emotional reactions of pregnant women receiving a diagnosis of HIV”. The clinic staff will intentionally not be informed about the true nature of the study as it is believed that the behaviour of health–care workers may change if they are aware that their daily operations are being observed. Clinic staff will participate in data collection (as they had done in the pilot study) and inform patients that researchers may approach them after their clinic visit. Quantitative data will be collected on how many women are diagnosed with HIV, started on and continued on Option B+ during the study period. Qualitative data will be collected on all processes carried out relating to HIV diagnosis and Option B+ treatment enrolment, including: what is done, by whom, how, when and where; the adequacy of follow–up; medication availability; the triggering of screening of family members; and transition of care. All HIV positive women attending ANC will be approached as they leave the clinic to give consent for participation (signature or thumb print) and will be asked to complete an exit survey in return for a clinic voucher. A random group of women from each clinic will be selected for in–depth interviews about their clinic experiences and receive a bag of food to thank them for participating.

A researcher on the study team is not comfortable with the decision to not inform the clinic staff and has approached you as a member of the local university ethics committee to review this study protocol.

Reflect on the following questions

From clinic staff perspective:

1. Discuss the issues around informed consent in this study.

2. Discuss the implications of the decision that the clinic staff should not be fully informed of the research goals. Are there potential reasons why this might or might not be acceptable? How might this impact on the validity of the research findings?

3. Are there any conflicts of interest in this study?

From the patient perspective:

4. When should patients be eligible to enter the study? Are the challenges relating to patient confidentiality with different approaches to patient consent? How would scientific validity be affected by varying approaches to gaining patient consent?

5. Is use of inducements ethical? Ever? Sometimes? Justify the response.

6. Are there any unanticipated potential risks to patients from this study?

What are the obligations for the future?

Source: based on study protocol.

Identification of barriers to scaling up the successful “test and treat” option for prevention of mother–to–child transmission (PMTCT) of HIV (Option B+)

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 9

Case Study 7

A recent outreach activity in Country X identified that up to 70% of children in nomadic populations and remote communities had not been vaccinated. Childhood vaccination is important in improving children’s health and reducing mortality. It is also a key public health mechanism for the successful eradication of diseases such as poliomyelitis. Unvaccinated communities can become reservoirs of infection, which may then spread to the wider community. Factors that have been identified as barriers to reaching these communities include insufficient knowledge of their location, and the lack of logistical support and community engagement in developing successful strategies. The Ministry of Health of Country X has committed funds towards designing a successful implementation research (IR) study to determine the optimal strategies to deliver childhood vaccinations to these nomadic and
remote communities.

Special outreach teams (SOTs) will be deployed to a selected sample of known nomadic and remote communities. The teams will be supplied with all logistical requirements, i.e. vehicles, ice boxes, adequate vaccine stocks, translators, etc. They will be trained to deliver the required vaccinations to all children under 5 years of age in these communities and collect quantitative data on existing levels of vaccine coverage, numbers vaccinated, document feasibility challenges and track costs. The SOTs will work in coordination with the regular community health workers in the area delivering routine vaccination services in addition to other primary
health–care services.

In addition to the SOT intervention, in a selected subsample of communities, a key individual from each community will be identified to participate in a smart–phone–based Global Positioning System (GPS) tracking study, to assess the feasibility and utility of locating nomadic communities in real–time. Solar powered battery packs will be supplied to these key individuals. Their location will be tracked in real–time and reported to the SOTs for more effective delivery of services.

In order to increase awareness of the need for immunization and facilitate the utilization of the immunization services among the nomadic and remote communities, notification of the date and location of each community outreach vaccination event will be posted in local schools and clinics that serve the nomadic and remote populations, starting one month before the planned event.
The SOT members will be trained to conduct community meetings immediately after the first vaccination event, through which to engage with the local population in developing strategies to ensure ongoing adherence to childhood vaccination programmes. They will gather all the women available in the village at the time of their field work and deliver messages emphasizing the need for immunization, the advantages of immunization and the risks to the children, and the community if they are not immunized.

The intervention is rolled out in five nomadic groups in the area. Two of these groups are selected for the real–time GPS location study and key members of these groups are provided with the smart phone for GPS tracking of their location. The SOTs contact these groups and enumerate the names, family details, demographic characteristics, health details and vaccination status of all the children under 5 years of age in the five groups. They administer the first dose of vaccine to all eligible children and conduct community meetings. The SOTs will maintain an ongoing registry of new births, new entrants into the nomadic groups, marriages, etc. They will follow up the pattern of immunization coverage over the years using a time–series analysis. They will also work in close coordination with the local public health system and share the data with them for their health management information system records. While this study is ongoing, local forestry officials approach the research team. They complain that some of the nomadic groups are engaged in poaching wild animals for their hide and teeth in the forest area. They have learned that GPS tracking is being carried out on these nomadic groups for research purposes. They want the research team to share the data so that they can keep them under surveillance.

Reflect on the following questions

With respect to community engagement:

1. Is there an ethical imperative to engage with the community in this case before implementation?

2. What is the type of community engagement planned for this study? Is it appropriate for
this research project?

3. What are the terms of engagement with the community? Does the community engagement plan in this study adequately cover these terms?

4. What do you think about the community engagement strategy used in this study?

With respect to data collection:

1. What is the type of data required to achieve the outcomes of this IR?

2. What is the obligation of the research team to share the data with the local public health system?

3. What are the implications of the GPS tracking data on the privacy of the nomadic community, especially the key informant?

4. Is the research team obliged to share the GPS location data of the nomadic communities with
the forestry officials who want to track them in case they are poaching wild animals?

Source: Adapted from Gidado SO, Ohuabunwo C, Nguku PM, Ogbuanu IU, Waziri NE, Biya O et al. Outreach to underserved communities in northern Nigeria 2012–2013. J Infect Dis. 2014;210(Suppl 1):S118–24.

Vaccination campaigns in nomadic populations

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 10

Case Study 3 – Facilitator's notes

1. What is the most appropriate study design for this implementation research (IR)? Discuss the ethical issues of the design.

There are various interesting study designs in IR, namely, effectiveness–implementation hybrid, quasi–experimental study, pragmatic design and cluster randomized controlled trials (RCTs), etc. Since the one–stop testing protocol is of established efficacy and safety, a quasi–experimental study without a control group would be sufficient to understand implementation issues. However, this may have questionable scientific rigour. So a pragmatic trial design or a CRT may be performed. The ethical issues of importance to be discussed here is the balance between denying the control group of a proven intervention
and the need for scientific rigour that is achieved by
a control group.

Consideration should be made for a 3–phase IR study
as follows.

Phase 1 – Formative study to develop a theory of change about the main implementation problem in Country B.

Study design for this could include qualitative,
or participatory action research (PAR).

We do not know why uptake is low in Country B. One would need to first establish where the barrier lies. As written in the case, it seems the main barrier in the past in Country A has been the need to return to the clinic for results and referral for further treatment, which was largely overcome with the ‘one–stop’ model. Other barriers could exist, such as women declining tests (would need to asses why) or women being tested, but maybe not returning for follow up for some reason and not completing the required therapy. It is important to assess prior to launching the study whether the barriers/acceptability of the strategy would be similar in countries A and B. If different in Country B, the one–step model may not solve the problem. Transfer of implementation from one country/culture to another (one size fits all?)

2. Is there a need for control group? Why?

The presence of a control group is required to ensure the scientific rigour of findings. However, designs without control groups can also provide the required information for IR.

3. Discuss why there is an ethical imperative to engage with the communities in this case.

Syphilis is a sexually transmitted infection (STI) and it has a strong stigma associated with it. Therefore, there is a social risk of stigmatization and discrimination associated with a diagnosis of syphilis in an asymptomatic antenatal woman. In this situation, it is essential to engage with communities in advance of the implementation in order to gain their support, and buy–in to the project and acceptance. The community engagement will also help in identifying the potential problems that could arise in the community because of the implementation of the testing protocol.

4. What is the nature of community engagement described in this study? Is it appropriate for this IR?

In this study, the research itself is designed by a consultation committee of stakeholders, which includes community members. The community members are also involved in the process of identifying districts with high a burden of congenital syphilis and including them into the research. Further, the sub–committee of community representatives has also been formed to monitor the research project. It has also been encouraged to increase awareness about the protocol in the community. All these community engagement activities will increase trust, acceptance and reach.

5. Are the community representatives selected for the engagement appropriate? Will they truly represent the community interests?

The community members who are selected for representation in the engagement process are the members of the women’s self–help groups and a member of the local governance body of the district. These members are likely to be representing the true experiences of the community. Is there a need to have male representatives? Is there a need to have representation from health workers in the local community?

6. List the potential stakeholders in this study.

The potential stakeholders in this study are:

• the health system, programme managers;

• the health–care providers, doctors, nurses, community health workers;

• the community – pregnant women, their partners, the general community;

• the one–stop syphilis testing kit manufacturer;

• policy–makers.

7. What are the possible competing interests among the stakeholders? How can these affect the study and future adoption of the intervention?

Financial conflicts of interests are to be considered. The policy–makers and the syphilis kit manufacturers have to declare their conflicts of interest. For example, some of the policy–makers may hold stocks in the kit manufacturing company. These kinds of conflicts of interest may influence the way the findings of the research are interpreted and reported.

8. Who are the research participants? Pregnant women? Their partners? The health workers?
The health system?

Is there a need for informed consent? If yes, who should give informed consent?

All of the above can be said to be research participants. Informed consent may be obtained from them all. However, the primary research participants are the pregnant women and getting their consent is mandatory. The discussion may also lead to the spouses of the research participants being indirectly included in the study. Do they need informed consent too? Is the health system a research participant? Are the staff who provide the one–stop syphilis testing service research participants? Is their consent warranted?

9. Why do you need identifiable patient information in this case?

Identifiable patient information may be necessary for the delivery of the implementation, for follow up of patients who screened positive and for completion of treatment. However, this information may not be necessary for the research team whose objective is to study acceptance and utilization of the testing and treatment.

10. Is there a need for data confidentiality in this research? How can data confidentiality be protected?

This research is specifically looking at the detection of a sexually transmitted disease, which is stigmatizing. In such conditions data confidentiality is of utmost importance.

11. The health workers in the clinics who had access to the contact details of the patients who screened positive and their partners, and made phone calls to schedule tests for the partners. Is it ethically right for the health workers to have access to the partners’ data as they are not actually the study participants? Is it right for them to contact them without the knowledge of the participants?

If proper community engagement has been done and the spouses are also informed about the participation of pregnant women in such a study, these ethical issues could have been averted. However, despite CE and active engagement with the spouses, there should be checkpoints in place to confirm or inform the pregnant women about contacting their spouses. It was not right for the researchers to have contacted the spouses without the prior knowledge and permission of the women.

12. After the completion of the study, what is the obligation of the research team regarding the data sharing and data–driven action?

It is the ethical obligation of the research team to use the data appropriately for public health action.

13. In case the same study is conducted as a cluster RCT with 10 clusters randomized to intervention with the one–stop syphilis protocol and 10 clusters to control, in the control group which
of the following care should be provided:

a. existing standard of care

b. syphilis education intervention

c. a voucher scheme for transporting antenatal mothers who screened positive in order to travel to the health facility and complete their treatment.

The existing standard of care is very poor as the uptake and utilization of syphilis screening is not acceptable. Therefore, something else needs to be done in the community. There are pros and cons for the voucher system. It may not be able to sustain a voucher system in the long term. Moreover, it may not produce a sustained change in behaviour. The syphilis education intervention should be well planned and should induce behaviour change. Such an education system may be an acceptable standard of care.

14. During the conduct of the study, it is found that a particular ethnic tribe in the intervention clusters has very high prevalence of anaemia during pregnancy. It is noticed that they are very poor and subsist on meagre cereal–based diets. What is the responsibility of the researchers towards this ethnic tribe?

It may not be possible for the implementation researcher to manage the severe anaemia of the population on a long–term basis. Therefore, there is a need for community engagement and stakeholder engagement. Appropriate referral to anaemia treatment facilities may be required.

Facilitator's Notes – One–stop service for Antenatal Syphilis Screening

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 10

Case Study 4 – Facilitator's notes

1. Study design

The case study states the health problem (high maternal mortality), the standard of care, implementation problem (women are not using the clinics, i.e. demand–side problem), and an implementation strategy to address the demand–side problem (vouchers).

• Context: Prior to embarking on the study in Country C, there is a need to understand the context before any implementation of a new strategy. Why are the women not using the health system appropriately? This may require preliminary anthropological observation (situation analysis) to understand the main barriers. Is transport a major barrier? How similar is Country C to the countries where this strategy has been implemented successfully? (Point 6 on template.)
The investigators have an obligation to ensure they truly understand the relevant issues before attempting to embark on changes.

• Community engagement: The proposed changes also need to be acceptable to the community, e.g. men who are away at work may not agree to their wives can be taken unaccompanied to the clinic in a taxi driven by another man. The funding of chaperones or female taxi drivers may need consideration. Addressing the transportation hurdle does not address the belief in the use of traditional birth attendants (TBA), for example. An additional, ideally complementary strategy may be considered, which somehow incorporates TBA into the health centres, or provides intensive training to health workers to detect and refer complications early with a fast track to the taxi system, or could the clinics distribute the vouchers in addition to providing the antenatal clinics (ANCs)?

• Ethical issues relating to study design: There is a control group here. Is there a need for a control group? Why not just do a comparison study before and after in the implementation group? Could discuss that contextual equipoise exists (justifying a control group) despite the fact it is well recognized that from a clinical point of view health–centre deliveries have improved outcomes.

• Alternative study designs for IR?

• Should discuss who are the actual research participants: Here there is a distinct difference between implementation participants (health system, taxi drivers) and those who have the outcomes (mother and their babies). Research is conducted among both. This leads to issues with informed consent. Who gives consent? How is it obtained? Also the issue of the implementation on one party and outcomes measured in another party, which is a characteristic of implementation research (IR) (as opposed to clinical research where intervention and measurement are generally on the same individual).

• Determining cost/use of vouchers:

• what if a neighbour has a car but is not a taxi, can they redeem a voucher;

• is it correct that the price of the voucher is different between public and private health centres – do patients know this?

2. Risks and benefits

Benefits:

• attendance likely to rise significantly

• taxi providers will probably encourage women to attend clinics

• increased revenue for health facilities – may permit improvement standards/services.

Risks:

• over–treating is likely as providers might carry out interventions not necessarily required in order to get paid for them;

• ‘cherry picking’ – providers choose the least complicated patients so they make most profit, leaving the sickest patients who would require more resources to care for less well attended;

• high administration and transaction costs – how to reimburse, with cash or cheque; if cash, where would it be safe; it may expose the health–care worker to robbery, physical harm, etc.;

• vouchers can be faked, sold;

• does the use of name and village in the vouchers to avoid fraud pose privacy concerns; explore possible mitigation measures applicable in the setting;

• taxi providers might start to expand in anticipation of ongoing business, and might lose a lot if the programme were withdrawn.

3. Potential Implementation challenges to consider at the design stage

• If the health system is not strengthened in parallel with implementation, does this make the implementation itself unethical?

• It might not be possible to reach those who did not attend an ANC at least once (ANC coverage is not 100%, so even if 5–10% never attend, a large number of women are left at risk) – issue of equity of participation.

• Initial flat fee for taxis did not work, as taxi drivers did not want to travel longer distances for the same fee, so they were later reimbursed for the longer distance (how to check?).

• Need to ensure that the health centres can cope with the increased numbers of women who may potentially use the voucher scheme.

• What if there were complications, but the taxi voucher only covered a ride to the referral hospital? If referral to a higher level hospital outside the district were required, would the voucher ’price’ be considered too low? Would the woman have to pay the difference?

• No control of quality of care delivered.

• Should be anticipated as part of the study design and also consider the possibility of diversion of clinic resources/staff to locations with increased deliveries, possibly leaving other sections less well served than previously (issues of equity, vertical versus horizontal programmes).

• Paperwork and tracking was extra work for midwives.

• When demand increases, need to be prepared with an increased supply of staff, equipment, drugs, etc. Otherwise, clients lose confidence, can undermine trust in the health system for other conditions and future projects.

Suggest ethical imperative for monitoring and evaluation to ensure the study is well done, data collection is rigorous, and the outcomes are reliable so the study is of maximum use. Discuss whether there is a moral and ethical imperative to convert research findings to policy and public health action.

4. General concerns with vouchers/cash inducements

• Positive if it empowers people to do what they would have done themselves had they had the money for the taxi/user fee, etc.

• Negative if it induced a change in behaviour that the person would otherwise not have done (impact on autonomy), e.g. if a pregnant woman chooses to travel further to a clinic where she will get a bigger voucher/cash than at her local clinic, she may put herself at increased risk.

• May create an expectation that it is not sustainable in the long term.

• May create expectations of rewards for other health–seeking behaviours, e.g. if TB patients were given inducements to come for therapy if they refused treatment, this could lead to more people refusing treatment in order to get the inducement, e.g. food, etc.

• How big should the inducement be?

• How to ensure cash/vouchers are administered properly and not given as bribes, sold or stolen, etc.

• Ethics of collateral benefit, e.g. taxi drivers getting paid. They may be advantaged in the community, and raise their prices for everyone else, etc.1

• Considerations:

• size of incentive, attractiveness

• what is being incentivized, is it in the best interest of the recipient?

• “degree of recipient familiarity with activity”

• distribution of risks and benefits

• fairness/justice concerns

• sustainability.

Incentives may:

• undermine autonomy

• hinder disclosure

• exacerbate social inequalities, make a person a target for robbery, etc.

• may misuse the system

• lead to exploitation/degradation of vulnerable populations

• help bring about a change the person’s wishes

• can be autonomy enhancing.

5. Scale up and sustainability

• How sustainable are the costs? Would redemption of vouchers go back to health centre as fee–for–service and enable for provision of better infrastructure?

• Can this be scaled–up countrywide?

• If such a scheme were taken up, would the health system have a responsibility to ensure the taxis are safe? Is the health system endorsing this mode of transport? Would it introduce a complex layer of regulation?

Facilitator's Notes – Voucher scheme to increase health–centre deliveries among pregnant women and reduce maternal mortality

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 10

Case Study 5 – Facilitator's notes

1. Why should you engage with the communities in provinces Y and Z?

There is an ethical obligation to engage with communities in provinces Y and Z before the implementation research (IR). It is clearly explained in the case study that there is going to be a change in the way HMM is delivered in Province Y where an older model is already being implemented. There is likely to be skepticism in the areas in Province Y, which are already familiar with the existing HMM implementation. Moreover, in Province Z there has been civil unrest, which has been resolved in the recent past. Therefore, it is likely that levels of trust are low in Province Z. Community engagement helps the people in the two provinces develop trust in HMM, especially in Province Z where it is going to be implemented for the first time. Community engagement also leads to a high level of self–determination, self–reliance, self–efficacy and empowerment of the communities in these provinces. In the absence of community engagement the skepticism about the change, introduction of a new invasive blood test and the overall distrust due to recent civil unrest, will lead to poor uptake of implementation.

2. In this case, the community engagement has began after the design of the study had been finalized. When should community engagement ideally begin? With what aspects of the IR project should the community be engaged?

Implementation of HMM is already ongoing in some areas in Province Y. Now this is going to be scaled–up throughout Province Y with some changes and be introduced afresh in Province Z. The engagement with community should begin before the design of the IR. Community engagement should ideally begin before the design stage of the study and community stakeholders should be part of the decision–making regarding the study design. In this case, it seems the study has been designed in advance of any form of community engagement. Community engagement should ideally begin before the design stage of the study.

3. What should be the terms of the engagement with the community?

Firstly, the community should decide whether HMM is an immediate priority for them. Although there is strong evidence to show improvement in malaria cure rates following early HMM, unless it is a priority for the community, both the research as well as the implementation will fail. The community should engage in finalizing and agreeing to the research design. In this case, is a cluster randomized controlled trial (RCT) ethically appropriate given that one cluster is going to receive only artemisin–based combination therapy (ACT) without rapid diagnostic tests (RDTs). Knowing from previous experience of IR that this leads to higher rates of unnecessary malaria treatment among children, will this be acceptable to the community? The community should be made aware of this ethical issue and should be empowered and encouraged to participate in decision–making regarding the study design. If the community agrees to such a design, it should be engaged in monitoring the safety of the participants during implementation. The community should also engage in efforts to recruit research participants, retain participants in the implementation and facilitate data management. However, there is no generic formula for community engagement. It has to be tailored to the social and cultural context of the IR project. After the IR project is complete community engagement should continue to disseminate the research findings back to the community.

4. Village headmen have been selected as community representatives for the community engagement process. Who is an ideal representative? Who should decide the representation?

In the case of HMM, it might be important to have representatives who are mothers and who will be actively implementing the intervention in the households. The representative should be selected by the community. They should be in a position to truly represent the opinions and ideas of the main participants in the implementation, in this case, the mothers.

5. What do you think about the community engagement strategy used in this study?

Will newspaper, television and radio messages effectively reach women in the households, who are the true implementers of the intervention? Given the poor social status of women, lower educational attainment, and lack of health literacy among these women, can we expect such methods of awareness generation to have their impact? Alternative approaches for community engagement, especially when targeting lower income, lower socioeconomic populations, such as street theatre, inter–personal communication, etc.

6. What is the nature and type of data that are required tor understand the effectiveness, acceptability, reach and utilization of the HMM?

Is surveillance necessary? If yes, is name–based reporting necessary?

Based on the design of the IR, a cluster randomized controlled trial, to understand the reach, effectiveness and acceptability of the HMM protocols, children with fever have to be identified and their caregivers interviewed to understand these aspects. Therefore, surveillance data will be useful to identify the children. Name–based reporting is necessary in this case in order for the research team to track the children with fever and collect data.

Surveillance is generally classified as a public health activity and not as a research. Even though the surveillance that is used for gathering the data on fever among children is a routine ongoing public health activity in Country X, the intent of this surveillance in the context of this IR is to identify specific participants for the research. Therefore, it may be considered as research. Moreover, the data that is collected is likely to identify children and their families. This leads to a whole set of data confidentiality issues.

7. Given that the surveillance activity undertakes name–based case reporting and given that identifiable patient information (characteristics of the child and the family) will be available to the researchers, what data confidentiality issues should be considered? How should confidentiality of patient data be protected?

The ongoing syndromic surveillance for fever in Country X is a public health activity that the government of Country X is performing in order to protect the health of the community. Therefore, it is a public good and hence the community may be willing to share the data (even in an identifiable manner) for the sake of the greater good. However, the surveillance data are being used here to identify participants for a research project. The participants are not obliged to do this as part of the public health surveillance mandate. So there is an ethical obligation to protect the confidentiality of the participants’ data. While the data may be made available for the researchers to contact participants and collect information, the surveillance data and research data can effectively be de–linked to protect the confidentiality of the participants’ research data. Some sensitive information regarding the child and his/her family may be collected during the data collection process. This should definitely be de–linked from the surveillance data and protected.

8. Who owns the data collected as part of the surveillance? Who owns the data collected by the researchers for the IR?

Data ownership is a major ethical issue in research. Country X’s ongoing fever surveillance is collecting data on fevers. This is used by the public health system for public health action. These data are clearly owned by the public health system for the public health action. This implies that the data are publicly owned for the sake of public good. However, the research data which are collected by the researchers for the sake of the IR – relating to effectiveness, use of HMM, outcomes of treatment and opinions, and experiences of the users – is owned by the researchers.

9. When the people of provinces Y and Z give their data for the public health surveillance for fever, does it imply that they are consenting to the sharing of this data with researchers for IR? Is specific consent required for sharing the data about their fever with the researchers?

Data shared by people for the sake of a public health activity are intended for that purpose only. When these data are being shared for research purposes, then this raises the issue of whether consent is required from the participants before the information regarding their fever is shared with the researcher. Whether mandatory consent should be obtained from each mother whose child has fever to share her information with a researcher, or whether an opt–out option should be introduced is to be discussed and decided in consultation with the community. Provision of community–wide awareness about this form of data collection, and the possibility of opting out from participation in the IR is essential.

10. Is there an ethical obligation to share the data obtained from the IR with the community? Is there an ethical obligation to share the information understood from the data with the scientific world?

There is an ethical obligation to use the data collected in a scientifically rigorous analysis and interpret the information to guide public health action. This is an obligation to the participants as well as to the community at large.

11. Prior to designing your study you should consider the ethical implications of each of the following components that may have an impact on the study.

i. Selection of study site. In the source studies and grant application used to develop this case, only large communities were selected (> 10 000 people), where malaria was highly endemic, populations were chosen if homogeneous within regions and understood similar dialects:

• this design will continue to leave smaller underserved communities un–served, to discriminate against small communities/groups that may have their own language;

• need to justify the addition of Province Z. If an intervention is planned then baseline malaria prevalence data will be needed, etc.

ii. Identification of relevant stakeholders. Policy–makers, drug manufacturers and distributors, community members, local media:

• need to gain their interest, avoid corruption or ulterior motives especially with companies;

• ensure stakeholders represent all involved top to bottom, and that voices of all are heard and respected;

• need to consider all implications of study for health–care providers, will they feel undermined, or resist because of loss of authority/status, loss of income; similar issues for traditional healers;

• consideration of extra work for local health centre, e.g. pharmacy staff, if the are packaging drugs.

iii. Conduct a situation analysis. This is to determine baseline data, understand current concepts around malaria and its treatment, local health–care resources, understand the community, where medical care is sought, where medication is procured, engage with local health–care workers and stakeholders, etc.:

• there is an ethical imperative to conduct this kind of public health research before embarking on an intervention. In fact, such a situational analysis is a prerequisite even for the IR. The IR may not be justified if malaria is not a major problem and if HMM is already operating well in Province Z, then there is no point in conducting the IR;

• is the situation analysis a separate study in itself or is it part of the IR? This is an important practical ethical consideration. It has to be a separate study, because the conduct of the IR will depend on the findings of the situational analysis. This will have implications for ethical considerations such as for the institutional review board (IRB), informed consent, etc. In the studies and protocols this was done simultaneously which allowed the identification of stakeholders and other participants during the SA process to be more efficient;

• requires delicacy, should engender trust, understand current choices and why they are being made, must be careful not to show any judgement of current conditions or choices made, and avoid creating guilt or distrust;

• special care when interviewing mothers who may have lost children to malaria because of ‘inappropriate care’, these may fear the community’s judgement as education progresses and they realize they may have made incorrect choices.

iv. Select medication manufacturers and suppliers. It is likely that some competition exists, between the need for high–quality drugs, affordable prices and reliable supply:

• if the strategy is successful, it must be scalable and sustainable, it will need reliable drugs and manufacturers willing to produce them at low costs – should government subsidize or not; possibility of corruption; need for transparent tender process;

• may generate significant competition within the community, drug sellers face loss of business, especially threatens fake drug market; there may be intimidation of study drug distributors by existing drug vendors in community;

• should compensation be given to drug vendors who will lose business, or should them be engaged in drug distribution with an overhead; how would one control price rises if they did become drug distributors in the community (become community care workers); BUT, if an overhead were given to drug sellers, then the implications for giving incentives to other study workers/volunteers must be considered.

v. Select medication distributors within the community, i.e. community care workers. They may create unwanted competition, and pose a threat to existing providers. Therefore there is a need to consider incentives – if they are only volunteers, they may lose work time, be less available; they may need to track information as well:

• community care workers were often older mothers or respected community individuals, who had attained some status with the role; in studies, many were very committed and followed patients up, etc.; the community’s acceptability of these people, males and females; etc., needs to be assessed;

• a criterion in some studies was that a community care worker “must be trustworthy” – if someone were rejected for the position, this could create shame even if they were rejected on different grounds;

• must be literate, or at least one in each community had to be literate to fill in the tracking forms, etc., this discriminates against candidates who are not literate; a solution in one community was to have a literate care worker supervise a non–literate one; this creates difference in status and awkwardness;

• in Nigeria, the drop out of existing local drug vendors acting as community care workers was very high, their motives for participation were different from others; would it be ethical to judge someone’s motivation to participate;

• question of incentives or compensation – should these care workers receive money or items for participation; this may be effective, but may attract people who will not have the same dedication; how sustainable and scalable would the incentives be;

• issue of moral hazard incentivizing drug distribution;

• some studies allowed the care worker to charge 10% extra, thereby, making some money; would this affect their drug distribution practices, i.e. give medication when it was not really indicated, sell extra medication to adults, register fake patients in their tracking lists or maybe sell extra packets for people to keep at home.

vi. Medication packaging. Who would do this; would they cover their costs; medication packaging should be understandable; different doses should be easily distinguishable from each other and dosing instructions clear:

• explore acceptable colours, images on packages, consider low literacy instructions otherwise they may intimidate and confuse; ideally, in collaboration with community consultation, e.g. white represents milk so acceptable for a child, etc.

vii. Medication pricing. In some countries, care is free for children under 5 years and, therefore, should not be sold, whilst in others all medication is sold:

• consideration of cost is important; it is often a major reason why appropriate formal health care is not sought;

• the HMM strategy reduces the indirect costs of seeking health care by reducing travel to the clinics, and the need to lose days off work for travel, etc.; therefore, may not be unreasonable to charge for the medication as it still represents a saving;

• what is a reasonable and fair price; should the price be the same for all community members or scaled according to their ability to pay;

• how to control prices are not inflated at point of sale and mothers taken advantage of;

• some mothers may try to share the pills among more children or stop prematurely if the child improves and save a pill for another episode if considered too expensive;

• mass drug administration (MDA) drugs are often free, why charge for malaria;

• could the price force a choice between medication and a bednet.

viii. Training of participants at all levels, training materials. Trainers, supervisors, distributors require some literacy from all participants; if literacy rates were low in the community some chose one care worker who was more literate and this person supervised the other one. Training not one off but requires booster sessions. Training must be appropriate for the community, simple to understand, durable if left in place, varied, etc.:

• need to ensure material taught in a respectful way, not patronizing, intimidating or judgemental which will otherwise exclude more vulnerable groups within the community;

• respect for local beliefs and customs, consider where and how to do the training in collaboration with community representatives;

• should there be remuneration for time taken for trainings; if yes, then why not for other things.

ix. Training of mothers/child carers how to identify possible malaria and seek care.

• Can engender guilt if mothers realize their perceptions or actions in the past may have caused harm;

• strong feelings about traditional medicines, disease causality must be considered;

• may create tension within families if grandmother has different ideas, mothers may feel overrided;

• mothers may feel overwhelmed when being taught by other studies/groups about diarrhoea, pneumonia, use of bednets, etc., which may create confusion;

• ideally would like to check the ‘accuracy’ of a subset of the mothers’ judgement about fever/malaria, to test comprehension, may create stress/fear.

Participants could use the table below as a guide by filling in their concerns, and considering differences between implementation in provinces Y and Z.

Facilitator's Notes – Home–based management of malaria (HMM)

Table 4. Concerns and differences between provinces

Other Considerations

Selection study site

Medication packaging

Community engagement

Drug price

Identification of stakeholders

Selection of community care workers

Situation analysis

Training of staff/volunteers

Tracking of outcomes and feedback

Medication sources

Training of mothers/carers

Sustainability/scale up?

Practical concerns

Practical concerns

Practical concerns

Ethical concerns

Ethical concerns

Ethical concerns

Cluster A

Cluster B

Cluster C

1. Why is there no cluster randomized arm to continue chloroquine + RDT – continuation of chloroquine not appropriate (especially with emerging resistance) with better drug availability – could lead to actual harm.

2. Is Cluster A ethical with no RDT if it should be standard of care?

3. It is good to educate the mother about malaria? Is there also an obligation to educate them about other major child killers, i.e. pneumonia and diarrhoea? Even if not treated through the HMM, mothers should know to go to hospital or seek other medication.

• Ethical issue of vertical vs. horizontal programmes, i.e. good vertical approach to malaria but what is neglected, etc. It is an ethical imperative, especially in resource– poor settings to integrate the malaria programme into existing child health programmes. Efforts should be made to achieve an integrated strategy.

4. Could a study focused so strongly on malaria possibly dilute efforts of other education programmes, i.e. should it rather be packaged as a holistic child–care management programme? Would the mothers gain too much confidence in the malaria tablets and try to use them for alternative problems, if not appropriately educated?

5. The introduction of a new medication in Province Y may create suspicion of the prior study and may erode trust unless very well explained.

6. Use of RDT may be problematic in some communities, which do not like blood tests. May seem somewhat like ‘magic’. RDT costs money, need to consider who pays, ensure regular supplies, etc. What if false negative? Should there be criteria to ‘treat anyway’, how would this undermine goals?

7. Community care workers may be put in position of moral distress if a mother insists on medication when the care worker suggests she must go to hospital instead? Giving tablets would be under–treatment with small chance of success, but no tablets may mean higher chance of dying if the mother refuses?

• Need support system in place for care workers faced with ethical dilemmas.

8. Evolution of this strategy is to treat malaria and pneumonia together. Ethics of treating both simultaneously, because by definition it is very likely that one treatment would be unnecessary, but which one if there is no RDT? Would this also mean extra costs to a mother for the two drugs?

• There are some studies looking into this, which found a small trend towards improvement in outcomes with addition
of amoxicillin to malaria Rx.

• Ideally, one should differentiate between malaria and pneumonia and not gunshot treat both, especially with risk of allergies, e.g. amoxicillin, or issues with co–trimoxazole and G6PD deficiency, etc.

9. Care workers may become overwhelmed if many cases/additional diseases are added (e.g. pneumonia, diarrhoea). It may affect their ability to earn their livelihood but their sense of responsibility may be very strong together with the status their work affords them, etc. May be a reason for compensation. Is there a percentage threshold for the time donated to the study that might justify compensation? If one compensates at one study site (e.g. particularly poor communities), should one compensate at all study sites?

10. Care workers who visit patients for a follow up may note a lack of insect treated nets (ITNs) or other illnesses – what are the ancillary care obligations?

11. Province Y statistics show that only 60% of children seek care, this will not be addressed with the current study. Should alternatives be sought? Should a new situation analysis take place in Province Y first to understand why 40% do not use HMM?

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 10

Case Study 6 – Facilitator's notes

1. Study design

• This study has a complex design and uses multiple strategies. Participants should identify the study components and implications for research integrity. It also raises multiple ethical issues that are integral to the study design and planning, and must consider the perspectives of all affected groups, from which groups to gain consent, assent, opt–out options, as well as the potential for unanticipated harm to multiple parties for various reasons, including non–disclosure, inducements, and identification of potential subjects based on their HIV status prior to consent.

• The study describes the clinical problem, current standards of care, implementation status, what will be tested, group tests and the goal is testing what is known about implementation challenges?

• This study uses a mixed methods approach. The research outcomes for both qualitative and quantitative components must be pre–specified and ethical issues within each component identified. Quantitative data collected involves patient identification, issues of anonymity, accuracy of numbers, etc. Qualitative data accuracy may depend on trust developed between researchers and the study subjects, and community engagement. Both forms of research share many ethical pitfalls, as outlined below.

Ethical challenges from clinic staff’s perspective

• Is it correct for the ministry of health to consent to the clinics’ participation? Individual consent of the staff was not sought. How could a staff member opt out if they felt uncomfortable?

• Information given to clinic staff (study participants) was misleading, the actual aim was to observe all behaviours and processes around Option B+ in the clinic.

• Why did the researchers not disclose their true aim?

• Is such an approach ethical?

• It is possible that astute health–care workers will realize that more is going on, how will/should this be anticipated/addressed?

• Should nursing representatives have been informed of the true nature of the study? At what administrative level should consent be obtained/acceptability of the study be discussed beforehand, to ensure cooperation? How can clinic staff be protected from punitive action? Considering the study is very delicate, should those ‘representing’ the nurses and doctors at the clinic be informed ahead of time of the deception and the reasons why this may be justifiable?

• Is there consideration to later inform the clinic staff that they were actually observed; that this was for research purposes and that no punitive action would be taken

• Is there a conflict of interest for staff who both collect data and are study subjects/care providers?

Ethical challenges from the patient’s perspective

• Patients’ consent to the survey was sought when they left the clinic, therefore, their HIV status had already been disclosed to the research team. Should their consent be sought on entering the clinic instead? As noted above, there is a delicate balance between maintaining scientific rigour (so that results reflect reality), and honesty to patients and clinic staff. Would this exit consent lead to research bias anyway (probably not likely as all HIV + patients would be approached for participation).

• How to ensure participants are fully informed, are aware of opt–out possibilities – they will see others getting vouchers and or food after doing the survey so will most likely have an inducement to participate. Are inducements ethical? What if stakes were higher than a mere interview?

• There is no physical risk to the patients here, but a patient signing with a thumbprint is unlikely to be able to read the consent form, how to get around this? If there were some physical risk to the patient (e.g. further blood testing as a control for actual CD4 cell count purely for research purposes, with the results not being fed back to clinic), how would one guarantee that consent information had been understood, how would adequacy of comprehension be tested, and cultural sensitivity, and language be taken into account?

• Selection of HIV + patients leaving clinics may lead to stigmatization as their HIV status can be inferred.

• News of receipt of food for participation in in–depth interviews on site at the clinic will spread. Many women will want to be selected, may even result in violence/unrest? Is it ethical to give food even after the interview (on day 1 this may be a surprise, but it will not be on subsequent days, clinics may be inundated with clients because of this possibility. How to get around this? Provide food at the clinic to all mothers? How sustainable would this be? What expectations would there be during subsequent clinic visits or subsequent study participation?

• Can discuss the nature and size of the inducements. The ethical perspective mass contentious than if inducements were large. However, the size of the inducement must be determy change if inducements were very small – may be leined from the recipient’s perspective and not the researcher’s perspective, e.g. a bar of soap may seem negligible to the researcher but may be an exceptional luxury to a study participant, etc.

• Issue of standard of care for patients who opt out of the study.

• Issue of ancillary care responsibility for women on antiretroviral therapy (ART) for those who develop adverse events or for those who develop complications of HIV/AIDS.

Obligations for the future

• Obligation to use the data obtained from the IR for policy change.

• May need a second implementation pilot study to test validity/generalizability of observations identified in situation analysis.

Facilitator's Notes – Consent to prevention of mother–to–child transmission (PMTCT)

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Annex 10

Case Study 7 – Facilitator's notes

Reflect on the following questions with respect to community engagement.

1. Is there an ethical imperative to engage with the community in this case before implementation?

The nomadic communities have poor economic resources, are marginalized and lack the health literacy to actively engage with the health system to obtain their entitlements. Such communities tend to be apprehensive and distrustful of the health system. Therefore, community engagement is important from the start of the implementation research (IR) project in order to allay anxieties and promote community buy–in to the project.

2. What is the type of community engagement planned for this study? Is it appropriate for this research project?

One month before the planned events, the research team is posting notices in the schools and clinics to notify them about the intervention. This is a passive form of engagement. Ideally, this kind of intervention, especially in remote and nomadic groups, should be implemented only after active engagement with communities even before the design stage of the study. The problem with passive engagement with communities is that they do not foster the community’s sense of ownership of the project.
Apart from this, the special outreach team (SOT) members also engage with communities immediately following the first immunization event. This is planned in order to sustain the other doses of immunization. The participants in this community engagement activity are all women present in the community during the day of the field visit. It is important to see whether such representation is sufficient in this cultural context. Who are the key decision–makers regarding immunization? What is the
role of women in decision–making in these societies? These will influence the decision on who should participate in the community engagement.

3. What are the terms of engagement with the community? Does the community engagement plan in this study adequately cover these terms?

The community should be engaged in deciding whether immunization and this implementation are of priority to them. If their children are dying from more serious problems before complete immunization can be achieved, then immunization may not be a priority. Moreover, if there are other competing health problems, which are more serious and more common than vaccine–preventable diseases, then the priority may change. These have to be understood and planned after active community engagement before the start of the IR. The community should also be engaged in deciding the research design. In this case, the study is a before and after comparison of immunization coverage rates. Therefore, the ethical risks are less than a typical randomized controlled trial (RCT). However, the community should participate in making the decision regarding the design. The SOTs should be acceptable to the community. Ideally a community member can be recruited to play a role in the SOTs. This will increase the acceptability of the implementation.

4. What do you think about the community engagement strategy used in this study?

In this study, they have planned to put up notices in the schools and clinics about the date of the vaccination campaign. The appropriateness of this strategy should be assessed. Are all the nomadic people literate? Are the women literate? Can they seek, read and understand the notices put up in these places? Alternatively, should some kind of street theatre/interpersonal communication/media messaging be used?

Reflect on the following ethical dimensions of data collection based on the case study.

5. What the types of data are required to achieve the outcomes of this IR?

In order to understand the utilization of immunization among these nomadic groups and to identify the effectiveness of the SOTs and Global Position System (GPS) tracking intervention, the coverage of the immunization and trends in immunization of the children under 5 years of age is required. This can be obtained by immunization coverage tracking. Although the data on family details, demographic characteristics, etc., may be useful for the SOTs to identify and track the children, this information may not be necessary to understand the coverage and effectiveness of the intervention. Therefore, the essential ‘need to know’ data alone can be made available to the research team and the SOTs can protect the other identifiable participant information.

6. What is the research team’s obligation to share the data with the local public health system?

Dates of birth, deaths, marriages, migration and other demographic data from nomadic populations often elude routine census data because of the difficulty in accessing these populations. Therefore, it is important to consider the ethical imperative to share the data collected from these populations through research initiatives such as this with the local health system. This will help them plan better.

7. What are the implications of the GPS tracking data on the privacy of the nomadic community, especially the key informant?

The data gathered by GPS tracking have the potential to invade the privacy of the nomadic community, especially the key informant. The question remains whether such an invasion into the privacy of a person is warranted in order to ensure the community’s immunization. Are there less invasive alternatives? Rather than tracking the location using GPS, can the key informant/community member just be given a phone and asked to touch base with the SOT on a regular basis?

8. Is the research team obliged to share the GPS location data of the nomadic communities with forestry officials who want to track them because they suspect that they are poaching wild animals?

The use of research related data intended for the specific research purpose has certain protections. The participants give consent for the tracking of their location only for research purposes. However, sharing of these data for other purposes, such as for the protection of forest animals is questionable. If data collected for research purposes are made available for other purposes, which are not obviously related to the intended research activity, it grossly undermines the trust in the IR and the health system as a whole. Therefore, there should be some protection of participants’ data. Confidentiality of data should be ensured to retain trust, and ensure compliance with the IR.

Reflect on additional and specific ethical issues pertaining to this study.

1. Engagement with the community at the community meetings to understand perceptions, barriers, and pros and cons are important IR questions if framed properly. It would benefit from participatory action research design.

2. Study blurs the lines between research and clinical care. Is this SOT intervention a pure research activity or is it an intervention? This raises the issue of what differentiates research vs. practice in public health.

3. How to ensure their needs will be reliably met,
i.e. maintain trust?

4. Will services be linked to one clinic or multiple clinics along livestock routes?

5. How to identify key barriers to vaccination in
their communities?

6. What if vaccination is not perceived as an important issue in the community, or there is resistance in the community against vaccination?

• Do they need adequate background information on the concerned community?

• Are there religious reasons, political reasons, or are they suspicious of Western medicine? Perhaps they do not understand why the system gives them vaccinations but nothing else.

7. It is likely other health issues will come up during the community meeting, how will these be handled, e.g. with ancillary care?

• Would women have equal opportunity to raise issues, e.g. family planning/family violence if men are present?

8. Are the phones being imposed on the communities, is this acceptable, how realistic is it that they will work and be used? It may have been better to explore with the community what would be the best way to track them. They may know they will be in specific places at specific times of the year.

9. Need to evaluate satisfaction/comprehension, etc., after the meeting.

10. Need to set up feedback sessions to work on the community engagement process to ensure IR is following its intended path.

11. The obligation of the research team to empower the local health system and the communities.

Important ethical concepts/framework to consider:1

• identifying and managing non–obvious risks and benefits:

• cultural significance of blood/tissue samples (not truly relevant in this case but listed for completeness)

• minimize offence

• acceptability of research/protocol

• responsibility to avoid harm > obligation to benefit;

• expanding respect beyond the individual and stakeholder community:

• identify subjects as people, recognition

• identify range of stakeholders;

• building legitimacy for the research project:

• justification

• perceived social value, nature of risks, trust in researchers, funders, accountability

• formal ethics review, etc.

• informal discussion and listening, collaboration.

Ethical issues identified:2

• relational personhood

• social justice

• relational autonomy

• relational solidarity

• sustainability.

Facilitator's Notes – Vaccination campaigns in nomadic populations

1 King KF, Kolopack P, Merritt MW, Lavery JV. Community engagement and the human infrastructure of global health research. BMC Medical Ethics201415:84

2 Davison CM, Kahwa E, Atkinson U, Hepburn–Brown C, Aiken J et al. Ethical challenges and opportunities for nurses in HIV and AIDS community–based participatory research in Jamaica. J Empir Res Hum Res Ethics. 2013;8(1):55–67. doi: 10.1525/jer.2013.8.1.55.

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

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