Module-3

Specific Learning Objectives:

• Be able to recognize the value of and describe the following:

• Implementation research (IR) questions and ethical considerations;

• Responsiveness of IR to community needs;

• IR design and its ethical considerations;

• Ethical considerations in community and stakeholder engagement in IR.

Learning Methodology:

Interactive lecture with illustrations; case study 1 discussion; activity tables (Annex 2 and 3) and role-play (Annex 4, 5 and 6).

MODULE 3

Ethical Issues in Planning

Implementation 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
Slide Instructions

Keyboard Controls

Make a Note

Enter/Exit Fullscreen Mode

Download Content

Print Page

Zoom In/Out

Next Slide

Previous Slide

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 3

Ethical Issues in Planning

Implementation Research

Ethics in Implementation 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
Slide 2

Ethical Issues in the Planning Phase of Implementation Research

Be able to recognize the value of and describe the following:

• Implementation research questions and ethical considerations

• Responsiveness of the implementation research to community needs

• Implementation research design and its ethical considerations

• Ethical considerations in community and stakeholder engagement in implementation research

Learning Objectives

Ethical Issues in the Planning Phase of Implementation Research

Slide 2

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
Slide 3

Ethical Issues in the Planning Phase of Implementation Research

Session Outline

• Rationale for implementation research

• Importance of responsiveness of implementation research to community needs

• implementation research design and its ethical considerations

• What is community engagement?

• Ethical considerations in community and stakeholder engagement in implementation research

Ethical Issues in the Planning Phase of Implementation Research

Slide 3

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
Slide 4

Ethical Issues in the Planning Phase of Implementation Research

Rationale for Implementation Research

• Many successful strategies exist to control disease

• Strategies are often not as effective as they could/should be

• Effectiveness is lost because of inadequate implementation, e.g.:

• Lack of political buy-in/policies in place

• Poor uptake of practice guidelines

• Inconsistent supplies

• Poverty limiting access

• Cultural differences when programmes transferred

Source: WHO/TDR (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 4

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
Slide 5

Ethical Issues in the Planning Phase of Implementation Research

Case Study Example

• The use of insecticide treated nets (ITNs) for Malaria in India was found to reduce the risk of malaria by 65%

• After these results were published, church groups began distributing ITNs free of charge in a rural district in Cameroon, but local health-care workers have not seen a reduction the incidence of clinical malaria

• On routine home visits, community workers noted that ITNs were present in only some homes, but were often not being used correctly

• The ministry of health is concerned that they will not meet the Sustainable Development Goal (SDG) targets, and wants to increase the use of ITNs

Source: Van Remoortel et al. (2015).

Ethical Issues in the Planning Phase of Implementation Research

Slide 5

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
Slide 6

Ethical Issues in the Planning Phase of Implementation Research

Early Thoughts on an Implementation Research Study 1:
How to Increase the Appropriate use of ITNS?

1. Is malaria transmission a big problem in this community?

2. Is there any idea why ITNs are not in homes? Why are they not being used appropriately?

3. Is there an understanding of any of the cultural barriers to the use of ITNs?

4. Is there a need for commitment from health policy-makers, funders for sustainability?

5. Does the study design allow for scientific rigour and is it ethically acceptable?

6. Is there a need to identify communities at risk for inclusion in the study, optimal time of year for study?

Ethical Issues in the Planning Phase of Implementation Research

Slide 6

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
Slide 7

Ethical Issues in the Planning Phase of Implementation Research

Early Thoughts on an Implementation Research Study 1:
How to Increase the Appropriate use of ITNS?

7. Which manufacturer should be engaged to ensure quality ITNs in adequate numbers?

8. How and by whom will reliable distribution of ITNs be done?

9. Is there a need to determine pricing of ITNs so that sellers (formal and informal sectors) have an incentive to sell them, but they are affordable?

10. How to distribute ITNs − voucher schemes, or free distribution?

11. Where and how to distribute the vouchers?

12. How to engage the community to educate them that ITNs are beneficial – radio, community meetings, health centres, schools, antenatal clinics, churches?

13. How best to monitor use of ITNs?

Ethical Issues in the Planning Phase of Implementation Research

Slide 7

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
Slide 8

Ethical Issues in the Planning Phase of Implementation Research

Characteristics of Implementation Research

Systematic

Balances ‘real life’ with scientific rigour

Multidisciplinary

Collaborative, researchers, stakeholders

Contextual

Relevant locally but ideally generalizable

Complex

Dynamic and evolving, cyclical iterative activity

Source: WHO/TDR (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 8

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
Slide 9

Ethical Issues in the Planning Phase of Implementation Research

Interacting Domains in Implementation Research

Source: WHO/TDR (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 9

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
Slide 10

Ethical Issues in the Planning Phase of Implementation Research

Main Steps / Considerations in Planning Implementation Research

1. Responsiveness to the community’s needs

2. Scientific rationale

3. Study design

4. Contextual factors

5. Selection of research participants

6. Weigh risks and benefits

7. Community and stakeholder engagement

8. Iterative process

Ethical Issues in the Planning Phase of Implementation Research

Slide 10

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
Slide 11

Ethical Issues in the Planning Phase of Implementation Research

1. Responsiveness of Implementation Research to the Comminity’s Needs

• Reliable data on needs within a community will permit appropriate identification of need

• Whose agenda is driving research?

• Prioritization of needs within the health system

• Potentially scalable and sustainable intervention over the long term

• Will intervention reach those who need it?

• Avoid researching questions to benefit more advantaged communities

Ethical Issues in the Planning Phase of Implementation Research

Slide 11

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
Slide 12

Ethical Issues in the Planning Phase of Implementation Research

2. Good Scientific Rationale?

• Is it worth doing?

• Are technologies available, reliable and affordable?

• Obligation not to do harm

• Does proof of concept exist?

• Is there equipoise?

Ethical Issues in the Planning Phase of Implementation Research

Slide 12

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
Slide 13

Ethical Issues in the Planning Phase of Implementation Research

Is There Equipoise?

Genuine uncertainty about the effectiveness of an intervention

Clinical equipoise often no longer exists in implementation research

e.g. Vaccination against rotavirus reduces childhood mortality from diarrhoeal illness

Situation/contextual equipoise is usually present in implementation research

e.g. In a rural religious community, vaccination may not be easily acceptable

Ethical Issues in the Planning Phase of Implementation Research

Slide 13

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
Slide 14

Ethical Issues in the Planning Phase of Implementation Research

3. Approaches and Study Designs

Examples

• Cluster-randomized trials

• Effectiveness-implementation hybrid trials

• Pragmatic trials

• Participatory action research

• Mixed-methods

• Open label demonstration projects

Each may have specific ethical implications

Ethical Issues in the Planning Phase of Implementation Research

Slide 14

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
Slide 15

Ethical Issues in the Planning Phase of Implementation Research

3. Approaches and Study Designs

• Distinction between implementation research, quality improvement and public health practice may be blurred

• Service delivery?

• Standard of care?

• Control groups?

Ethical Issues in the Planning Phase of Implementation Research

Slide 15

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
Slide 16

Ethical Issues in the Planning Phase of Implementation Research

4. Contextual Factors to Consider in Planning Implementation Research

Source: WHO/TDR (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 16

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
Slide 17

Ethical Issues in the Planning Phase of Implementation Research

5. Selection of Research Participants

• Institutions, locations

• Individuals, groups

• Inclusion of vulnerable groups

• Identify those experiencing risk vs. those gaining benefit

Justice implications

Informed consent implications

Ethical Issues in the Planning Phase of Implementation Research

Slide 17

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
Slide 18

Ethical Issues in the Planning Phase of Implementation Research

Vulnerability

Vulnerable to “exploitation and overrepresentation in research”

• Need extra protection

• Traditionally understood as:

• Dependent

• No capacity to give informed consent

• Other features?

Source: Rogers & Lange (2013).

Ethical Issues in the Planning Phase of Implementation Research

Slide 18

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
Slide 19

Ethical Issues in the Planning Phase of Implementation Research

6. Risk Assessment in Implementation Research
– Potential Harms?

Individual harms

• Risks of intervention

• Control groups or standards of care

• Ancillary-care responsibilities

Social harms

• Stigmatization of groups of subjects involved

• Potential excess burden experienced by marginalized groups, especially if not consulted

Financial harms

• Incentives or vouchers may destabilize local economy

Communal harms

• Cultural insensitivity of an intervention, distortion of health promotion messages leading to misinformation

Harm to health system

• Overworking/overwhelming health-care workers, diversion of resources towards research area

Source: Hyder et al. (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 19

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
Slide 20

Ethical Issues in the Planning Phase of Implementation Research

Examples of Potential Harms in Vaccine Trials

HIV

Selection of ‘high risk’ participants to test HIV vaccines may lead to stigmatization

Malaria

Transmission-blocking vaccines do not protect the individual but prevent transmission to others

Rotavirus

Is administering a pneumococcal vaccine in a control arm ethical for a rotavirus vaccine study?

Source: Mamotte et al. (2010).

Ethical Issues in the Planning Phase of Implementation Research

Slide 20

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
Slide 21

Ethical Issues in the Planning Phase of Implementation Research

6. Identifying Non-Obvious Risks or Benefits in Implementation Research

Requires meaningful engagement with the community

• Non-obvious harms e.g.:

• Cultural norms

• Gender roles

• Beliefs about blood samples

• Pregnancy, etc.

• Consider undue benefits to certain groups

Source: King et al. (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 21

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
Slide 22

Ethical Issues in the Planning Phase of Implementation Research

Activity

What are the features of biomedical/clinical research and implementation research that are different, requiring different application of ethical principles?

Ethical Issues in the Planning Phase of Implementation Research

Slide 22

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
Slide 23

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

5. Research conditions

4. Research question

3. Equipoise

2. Informed consent

1. Subjects

Ethical Issues in the Planning Phase of Implementation Research

Slide 23

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
Slide 24

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

5. Research conditions

4. Research question

3. Equipoise

2. Informed consent

1. Subjects

• Countries

• Institutions

• Individuals

• Communities

• Individuals

Ethical Issues in the Planning Phase of Implementation Research

Slide 24

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
Slide 25

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

5. Research conditions

4. Research question

3. Equipoise

2. Informed consent

• Countries

• Institutions

• Individuals

• Communities

• Individuals

1. Subjects

• Individual

• Group/gatekeeper permission

• Waived

• Individual

• Assent (in minors/those unable to consent after consent given by guardian)

Ethical Issues in the Planning Phase of Implementation Research

Slide 25

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
Slide 26

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

5. Research conditions

4. Research question

3. Equipoise

• Individual

• Group/gatekeeper permission

• Waived

• Individual

• Assent (in minors/those unable to consent after consent given by guardian)

2. Informed consent

• Countries

• Institutions

• Individuals

• Communities

• Individuals

1. Subjects

• Contextual

• Clinical

Ethical Issues in the Planning Phase of Implementation Research

Slide 26

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
Slide 27

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

5. Research conditions

4. Research question

• Contextual

• Clinical

3. Equipoise

• Individual

• Group/gatekeeper permission

• Waived

• Individual

• Assent (in minors/those unable to consent after consent given by guardian)

2. Informed consent

• Countries

• Institutions

• Individuals

• Communities

• Individuals

1. Subjects

• Testing implementation of a proven intervention or process in a new context/country

• Goal to scale up successful interventions

• Testing efficacy, safety of a new intervention targeting a specific condition

Ethical Issues in the Planning Phase of Implementation Research

Slide 27

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
Slide 28

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

5. Research conditions

• Testing implementation of a proven intervention or process in a new context/country

• Goal to scale up successful interventions

• Testing efficacy, safety of a new intervention targeting a specific condition

4. Research question

• Contextual

• Clinical

3. Equipoise

• Individual

• Group/gatekeeper permission

• Waived

• Individual

• Assent (in minors/those unable to consent after consent given by guardian)

2. Informed consent

• Countries

• Institutions

• Individuals

• Communities

• Individuals

1. Subjects

• Real-life’

• Generally controlled research environment

Ethical Issues in the Planning Phase of Implementation Research

Slide 28

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
Slide 29

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

9. Research question

8. Risks assumed by

7. Anticipated outcomes

6. Control groups

Ethical Issues in the Planning Phase of Implementation Research

Slide 29

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
Slide 30

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

9. Research question

8. Risks assumed by

7. Anticipated outcomes

6. Control groups

• May be ethically questionable because testing a proven intervention

• Usually required especially for RCTs may not be required for phase 1 and 2 clinical trials

Ethical Issues in the Planning Phase of Implementation Research

Slide 30

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
Slide 31

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

• May be ethically questionable because testing a proven intervention

• Usually required especially for RCTs may not be required for phase 1 and 2 clinical trials

9. Research question

8. Risks assumed by

7. Anticipated outcomes

6. Control groups

• Multi-faceted holistic impact on the functioning of health systems with regard to intervention tested

• Pre-specified, most often disease-specific

Ethical Issues in the Planning Phase of Implementation Research

Slide 31

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
Slide 32

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

• May be ethically questionable because testing a proven intervention

• Usually required especially for RCTs may not be required for phase 1 and 2 clinical trials

9. Research question

8. Risks assumed by

• Multi-faceted holistic impact on the functioning of health systems with regard to intervention tested

• Pre-specified, most often disease-specific

7. Anticipated outcomes

6. Control groups

• Individuals

• Groups

• Communities

Ethical Issues in the Planning Phase of Implementation Research

Slide 32

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
Slide 33

Ethical Issues in the Planning Phase of Implementation Research

Differences Between Biomedical/Clinical Research and Implementation Research That May Have Ethical Implications

Domain

Biomedical/clinical research

Implementation research

• May be ethically questionable because testing a proven intervention

• Usually required especially for RCTs may not be required for phase 1 and 2 clinical trials

9. Research question

• Individuals

• Groups

• Communities

• Institutions

• Health systems

• Individual research subject

8. Risks assumed by

• Multi-faceted holistic impact on the functioning of health systems with regard to intervention tested

• Pre-specified, most often disease-specific

7. Anticipated outcomes

6. Control groups

• Individuals

• Communities

• Institutions

• Health-system functioning

• Benefits may be gained by individuals/groups different from those experiencing risks

• Common good

• Same individual research subject experiencing risk

• Future potential users of research outcome

• Common good

Ethical Issues in the Planning Phase of Implementation Research

Slide 33

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
Slide 34

Ethical Issues in the Planning Phase of Implementation Research

Contributors to Success of an Intervention example: Immunization

Source: WHO/TDR (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 34

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
Slide 35

Ethical Issues in the Planning Phase of Implementation Research

7. Stakeholder and Community Engagement

Case study: mhealth in Bangladesh

• The 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 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

Ethical Issues in the Planning Phase of Implementation Research

Slide 35

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
Slide 36

Ethical Issues in the Planning Phase of Implementation Research

Case Study: mHealth in Bangladesh

Case study: mhealth in Bangladesh

• 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 people who knew Bengali language in Germany and found to be useful

Who would all the relevant stakeholders be in this case?

Ethical Issues in the Planning Phase of Implementation Research

Slide 36

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
Slide 37

Ethical Issues in the Planning Phase of Implementation Research

Stakeholders – mHealth in Bangladesh

Community

• Community as a whole

• Community representative/s

• Pregnant women

• Health-care workers

• Traditional birth attendants

• Cell-phone air-time sellers

• Health clinics

• Families of women and children

• Others?

Other Stakeholders

• German company

• Ministry of health

• Local authorities

• Cell-phone companies

• Cell-phone service providers

• Electrical company

• Bengali translators

• Data handlers

• Others?

Ethical Issues in the Planning Phase of Implementation Research

Slide 37

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
Slide 38

Ethical Issues in the Planning Phase of Implementation Research

Importance of Stakeholder Engagement

• Democratic process, power sharing

• Identify the full range of stakeholders up front

• Engagement early in the process

• Agreements and disagreements are acknowledged and discussed

• Stakeholders’ perspectives must be considered

• Determination who/which bodies may legitimately consent to the research process at various levels

• Channels of accountability are agreed upon

• Stakeholders feel empowered, respected

• Researchers are seen as partners, not dominant

• Overriding obligation is to avoid harm potential benefit

Source: King et al. (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 38

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
Slide 39

Ethical Issues in the Planning Phase of Implementation Research

What is Community Engagement?

A process of working collaboratively with and
through groups of people affiliated by geographical proximity, special interest or similar situations
to address issues affecting the well-being
of those people.”

Source: CDC (2013).

Ethical Issues in the Planning Phase of Implementation Research

Slide 39

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
Slide 40

Ethical Issues in the Planning Phase of Implementation Research

What Constitutes a ‘Community’ and Who Makes This Determination?

What constitutes a ‘community’?

• Group of people who are linked by social ties, share common perspectives and engage in joint action in geographical locations or settings

• In the context of research, community can also be defined by ethnicity/the disease/illness under investigation

• Common identity shared by its members, a commitment to a shared CULTURE.

Who makes or should make this determination?

• Community self-characterization?

• Classification by others, such as authorities, civil society, industry, academics, scientists, sponsors?

Ethical Issues in the Planning Phase of Implementation Research

Slide 40

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
Slide 41

Ethical Issues in the Planning Phase of Implementation Research

What Constitutes ‘Representation’?

• Election?

• Nomination (by whom)?

• Self-appointed?

• Appointed?

• State official?

• Traditional official?

• Community elder?

• Political figure?

• A member of the proposed target group of the intervention (for example, an adolescent)?

Ethical Issues in the Planning Phase of Implementation Research

Slide 41

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
Slide 42

Ethical Issues in the Planning Phase of Implementation Research

What Constitutes ‘Representation

Consider the impact of, amongst other factors:

• Patriarchal norms;

• Sexism;

• Institutional and systemic oppression (for example, repressive state policies and practices);

• Economic power;

• Conflicts of interest;

• Cultural norms and beliefs on legitimacy and authenticity of a community representative.

Ethical Issues in the Planning Phase of Implementation Research

Slide 42

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
Slide 43

Ethical Issues in the Planning Phase of Implementation Research

Community VS. Public Engagement?

• Same principles and similar goals

• Largely depends on the research context

• Community engagement targets communities that are directly affected by or involved in research

• Public engagement targets a broader audience and uses different (less targeted) means of engagement such as:

• Public meetings or meetings with policy-makers

• Science cafes

• radio or television programmes or newspaper articles.

Source: H3Africa (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 43

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
Slide 44

Ethical Issues in the Planning Phase of Implementation Research

The Community Engagement Continuum

Sharing information: two-way communication

• Creating awareness and improving understanding about research and local culture and traditions that might have implications for the conduct of research

• Opportunity for co-learning

Consulting the community on key aspects of research

• Community as consultants

• What is locally and culturally relevant and acceptable/permissible?

Community as consultants

• All aspects of the research: from inception to dissemination

Empowering the community to improve health outcomes

Ethical Issues in the Planning Phase of Implementation Research

Slide 44

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
Slide 45

Ethical Issues in the Planning Phase of Implementation Research

Value of Community Engagement

Intrinsic Value

• Extending the principle of respect to the community’s values, culture, traditions, and social practices

• Ensuring the relevance of research

• Establishing relationships and building trust

• Protective measure to limit harm to individuals

Instrumental value

• Support consent process

• Provide ongoing channels of communication

• Address local fears, anxieties and rumours about research, i.e. blood sampling

• Feedback of research findings

Source: Participants at the Community Engagement and Consent Workshop (2013).

Ethical Issues in the Planning Phase of Implementation Research

Slide 45

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
Slide 46

Ethical Issues in the Planning Phase of Implementation Research

Some Strategies/Models for Community Engagement in Africa

• Community ENTRY is sensitive and crucial and must, therefore, be planned and conducted carefully

• Direct community engagement models

• Community meetings/durbars

• Town hall meetings

• Focus group discussions

• Engagement through representatives

• Community advisory boards/groups

Example: The Navrongo Model of community engagement

Community
Entry

Community Durbars

Compond,
household
meetings

Individual
Consent

Sources: Tindana et al. (2011); Tindana et al. (2015).

Ethical Issues in the Planning Phase of Implementation Research

Slide 46

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
Slide 47

Ethical Issues in the Planning Phase of Implementation Research

Ethical Norms That Underpin The Notion of Community Engagement

Respect for persons

Recognizing the community’s right to be involved in decisions that will affect them

Beneficence

Involving the community in creating common good for themselves and deciding what is good for them

Justice

Recognizing that the community is the best judge of fairness and justice

Accountability

The acknowledgement and assumption of responsibility for actions and decisions

Ethical Issues in the Planning Phase of Implementation Research

Slide 47

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
Slide 48

Ethical Issues in the Planning Phase of Implementation Research

Ethical Norms That Underpin The Notion of Community Engagement

Solidarity

Sense of shared responsibility and interests, concern for those who are less fortunate or vulnerable, and action to help such people

Transparency

Acting in such a way that it is easy for others to see what and why actions are performed, thus ensuring information disclosure, clarity, and accuracy

Sustainability

The ability to maintain something at a certain rate or level

Public justification

A proposed initiative should be acceptable to those who stand to be affected by the proposal

Other normative ethics principles?

Ethical Issues in the Planning Phase of Implementation Research

Slide 48

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
Slide 49

Ethical Issues in the Planning Phase of Implementation Research

Ethical Framework for Stakeholder and Community Engagement

Three core imperatives:

1. “Identify and manage non-obvious risks and benefits”

2. “Expand respect beyond individual to stakeholder community”

3. “Build legitimacy for research project”

Source: King et al. (2014).

Ethical Issues in the Planning Phase of Implementation Research

Slide 49

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
Slide 50

Ethical Issues in the Planning Phase of Implementation Research

Community Engagement Challenges

• Identifying relevant community representatives and legitimacy of representation

• Power imbalance between researchers and communities

• Power imbalances within or between communities

• Involving minority groups

• Voluntary consent if community agreed to participation?

• Finding appropriate methods of engagement

• Handling community expectations

• Time and resources, where is the budget?

• Little empirical evidence to support practice

Ethical Issues in the Planning Phase of Implementation Research

Slide 50

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
Slide 51

Ethical Issues in the Planning Phase of Implementation Research

Components of Community Engagement

• When? Timeline? How early?

• Where? State facility?

• Town hall/community hall? Traditional venues?

• What? Engage about what?

• How? What method/medium?

• Posters? Group meetings? Media? Pamphlets? Face-to-face meetings?

• Duration?

• Before study? During study? After study?

• With whom?

No one-size-fits-all

Ethical Issues in the Planning Phase of Implementation Research

Slide 51

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
Slide 52

Ethical Issues in the Planning Phase of Implementation Research

Case Study: mHealth in Bangladesh

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.

As the researchers, you now need to conduct community and stakeholder engagement during the planning phase of the study.

Ethical Issues in the Planning Phase of Implementation Research

Slide 52

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
Slide 53

Ethical Issues in the Planning Phase of Implementation Research

Role Play – mHealth in Bangladesh − Stakeholder Engagement

Community

• Community as a whole

• Community chief

• Pregnant women

• Woman with child of immunization age

• Health care workers

• Traditional birth attendants

• Cellphone air-time sellers

• Health clinic workers

• Field workers/volunteers

• Families of women and children

• Religious leaders

• Neighbourhood watch

Other Stakeholders

• German company

• Ministry of health

• Local authorities

• Cellphone companies

• Cellphone service providers

• Electrical company

• Bengali translators

• Data handlers

Ethical Issues in the Planning Phase of Implementation Research

Slide 53

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
Slide 54

Ethical Issues in the Planning Phase of Implementation Research

Role Play – mHealth in Bangladesh − Stakeholder Engagement

Separate participants into two large groups

• Group 1: Stakeholder engagement with all the stakeholders except the community

• Group 2: Community engagement

In each group there will be two researchers and the rest of the group will be assigned roles which will be outlined on a sheet of paper to be kept to themselves and information shared only if asked

Ethical Issues in the Planning Phase of Implementation Research

Slide 54

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
Slide 55

Ethical Issues in the Planning Phase of Implementation Research

Role Play – mHealth in Bangladesh − Stakeholder Engagement

• Participants will be given 5−10 minutes to familiarize themselves with their individual roles

• The researchers must plan their strategy beforehand along the lines of:

• When?

• Where?

• What?

• How?

• Duration?

• With whom?

• Researchers can divide the group up if they wish or communicate with individuals one-on-one if they feel it is necessary

Ethical Issues in the Planning Phase of Implementation Research

Slide 55

Allow the participants to refer to the contents of the mHealth case study; then introduce the role play on stakeholder engagement .

Separate participants into two large groups. Group 1: stakeholder engagement with all the stakeholders except the community, and Group 2: community engagement.

In each group, there will be two researchers and the rest of the group will be assigned roles . Their role is outlined on a sheet of paper to be kept to themselves and the information shared only if requested. Roles listed in Annex 4 and 5. Print, cut and distribute one role per participant.

In some cultures, participants are very shy and inhibited and it may not be helpful to do role-play spontaneously. It would be ideal to form the groups and assign roles a day prior to this activity. Share the document on the role each actor is expected to play in the ‘community engagement’ and ‘stakeholder engagement’, as this will allow participants to read and be prepared for their role.

Timing: 45 minutes.

10 minutes – instructions from the facilitator and planning by participants.

20 minutes – to do the activity (followed by a tea break).

15 minutes – debriefing.

Two researchers should be given 7 minutes to plan how they wish to engage (as per Slide 51).

Individual participants will each be given only the description of their character, some will have suggestions to be loud, others may be quiet and shy, and not volunteering information which is relevant or have other priorities (e.g. women being raped on their way to get water is more a problem for them than the study topic). Do not necessarily tell researchers there is hidden information, but let them know that they can engage with different groups separately, if they wish.

Slide 52–55: Case Study 1: mHealth In Bangladesh

Ethical Issues in the Planning Phase of Implementation Research

Slide 55

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
Slide 56

Ethical Issues in the Planning Phase of Implementation Research

Case Study: mHealth in Bangladesh

• Please discuss the case from the perspective of stakeholder engagement

• When?

• Where?

• What?

• How?

• Duration?

• With whom?

• Anticipate ethical challenges that may arise and how to plan to mitigate these through effective engagement

Ethical Issues in the Planning Phase of Implementation Research

Slide 56

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
Slide 57

Ethical Issues in the Planning Phase of Implementation Research

Case Study – mHealth in Bangladesh considerations in Stakeholder Engagement

• What are the core imperatives of stakeholder engagement?

• Does the study meet the community’s needs?

• How should stakeholder engagement occur?

• Who are the stakeholders in this study?

• Who should represent the community?

• Risk assessment:

• Individual harms

• Social harms

• Financial harms

• Communal harms

• Harm to health system

• Commitment to scale up if successful

Ethical Issues in the Planning Phase of Implementation Research

Slide 57

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
Slide 58

Ethical Issues in the Planning Phase of Implementation Research

8. Iterative Process

• Ongoing monitoring, evaluation and community and stakeholder engagement throughout the research process to detect and understand barriers and potential harms early on

• Channels for communication should remain open in all directions to obtain constructive feedback

• Protocols may require adjustment or adaptation once the project has begun to optimize success and minimize harms while maintaining scientific rigour

• Potential adjustments may require rethinking of ethical consequences and requirements at all stages

• It is important that the research remains responsive to the identified needs

Ethical Issues in the Planning Phase of Implementation Research

Slide 58

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
Slide 59

Ethical Issues in the Planning Phase of Implementation Research

Key Messages

• Effectiveness of successful strategies is often lost because of inadequate implementation

• Implementation research must be responsiveness to a community’s needs

• Study design must be flexible often requiring collaboration from multiple research disciplines

• Implementation research strategies must consider local contextual factors to avoid harm and optimize success

• Selection of research participants is crucial to ensure valid results and to include true target populations

• Risks and benefits may not accrue to the same individuals and communities and require diligent consideration

• Community and stakeholder engagement is key throughout

• Study adaptation through an iterative process is important to minimize unforeseen harms and optimize research outcomes

Ethical Issues in the Planning Phase of Implementation Research

Slide 59

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
Slide 60

Ethical Issues in the Planning Phase of Implementation Research

References and Reading Materials (1/2)

• CDC. Principles of community engagement. 2nd ed. Atlanta, GA: Centers for Disease Control and Prevention; 2013.

• Hyder A, Rattani A, Krubiner C, Bachani AM, Nhan TT. Ethical review of health systems research in low- and middle-income countries: a conceptual exploration. Am J Bioethics. 2014;14:28–37.

• H3Africa. Guidelines for community engagement. Bethesda, MD: Human Heredity and Health in Africa Consortium; 2014 (http://www.health.uct.ac.za/sites/default/files/image_tool/images/116/documents/research/H3Africa%20CE%20Guidelines_Final.pdf, accessed 12 January 2017).

• King KF, Kolopack P, Merritt MW, Lavery JV. Community engagement and the human infrastructure of global health research. BMC Medical Ethics. 2014;5:84.

• Implementation Research in Health. A practical guide. http://www.who.int/alliance-hpsr/resources/implementationresearchguide/en/

• Mamotte N, Wassenaar D, Koen J, Essack Z. Convergent ethical issues in HIV/AIDS, tuberculosis and malaria vaccine trials in Africa: report from the WHO/UNAIDS African AIDS Vaccine Programme’s Ethics, Law and Human Rights Collaborating Centre consultation, 10–11 February 2009, Durban, South Africa. BMC Medical Ethics. 2010;11:3.

• Participants in the Community Engagement and Consent Workshop, Kilifi, Kenya, March 2011. Consent and community engagement in diverse research contexts: reviewing and developing research and practice. J Empir Res Hum Res Ethics. 2013;8:1–18.

• Rogers W, Lange MM. Rethinking the vulnerability of minority populations in research. Am J Public Health. 2013;103:2141–6.

• Tindana P, Rozmovits L, Boulanger RF, Bandewar SVS, Aborigo RA, Hodgson AVO et al. Aligning community engagement with traditional authority structures in global health research: a case study from Northern Ghana. Am J Public Health. 2011;101:1857–67.

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
Slide 61

Ethical Issues in the Planning Phase of Implementation Research

References and Reading Materials (2/2)

• Tindana P, de Vries J, Campbell M, Littler K, Seeley J, Marshall P et al. Community engagement strategies for genomic studies in Africa. BMC Medical Ethics. 2015;16:24.

• Van Remoortel H, De Buck E, Singhal M, Vandekerckhove P, Agarwal SP. Effectiveness of insecticide-treated and untreated nets to prevent malaria in India. Trop Med Int Health. 2015;20:972–82.

• WHO/TDR. Implementation research toolkit. Geneva: World Health Organization; 2014a.

• WHO. Implementation research in health. A practical guide. Geneva: World Health Organization; 2014.

• Lavery JV, Tinadana P, Scott TW, Harrington LC, Ramsey JM et al. Towards a framework for community engagement in global health research. Trends in Parasitology. 2010; 26: 279–283.

• El Zahabi-Bekdash L, Lavery JV. Achieving precaution through effective community engagement in research with genetically modified mosquitoes. AsPac J. Mol. Biol. Biotechnol. 2010; 18 (2): 247-250.

• Boulanger RF, Seidel S, Lessem E, Pyne-Mercier L, Williams SD, Mingote LR, Scott C, Chou AY, Lavery JV et al. Engaging communities in tuberculosis research. Lancet, March 2013.

• Bandewar SVS, Kimani J, Lavery JV. The origins of a research community in the Majengo observational cohort study, Nairobi, Kenya. BMC Public Health 2010; 10:630.

• Tindana PO, Singh JA, Tracy CS, Upshur REG, Daar AS et al. Grand Challenges in Global Health: Community engagement in research in developing countries. PLoS Med. 2007; 4(9): e273.

• Kolopack PA, Parsons JA, Lavery JV. What Makes Community Engagement Effective?: Lessons from the Eliminate Dengue Program in Queensland Australia. PLoS Negl Trop Dis. 2015; 9(4): e0003713.

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

Built with In5.