Module-6

Specific Learning Objectives:

• To analyse in-depth the various ethical issues in the given case study;

• To apply the ethical considerations taught in this course.

Learning Methodology:

Group activity and plenary discussion (no power point presentations provided).

Two groups can be assigned one case study, two other groups another case study; this allows the opportunity for discussion on a wide range of ethical issues.

Required Resources:

Case studies 3-7: Choose one or two case studies provided in Annex 9 and related facilitators note in Annex 10, which are best suited to the participants’ needs, or the ones they are most comfortable with, to allow for meaningful discussion. If appropriate, make minor modifications/adaptation to them to suit the context/settings.

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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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 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

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

In-Depth Ethical Analysis of Implementation Research Using Case Studies

The ultimate goal of IR is to improve access to proven methods of care in communities where access had been lacking or suboptimal. As a prerequisite to the design of a successful implementation strategy:

• The clinical problem must be identified

• The epidemiology of the disease must be understood

• A situation analysis must be performed to identify why access is suboptimal

• The actual bottlenecks/gaps in care should be identified (not merely presumed), so that interventions can be targeted to reduce them

In the case of the adoption of a successful intervention from one country by another country, or the scaling up of interventions from a pilot phase, a situation analysis should also be carried out to determine the similarities and differences between the communities where the intervention has been successfully implemented and the communities in which it is planned to test the intervention. When the analysis justifies the full-scale implementation of the intervention, then the research is IR (which is designed to find out whether it will improve access to services).

The key components to be considered when designing an IR study are outlined as follows.

Identification of the public health concern/problem disease and the concern/problem/disease burden.

1. Determine the current standard of care (established treatment, guideline, protocol, evidence-based treatment for the condition) that is known to be effective.

2. Determine the implementation status/current performance data/quality gap. How widely is the standard of care currently implemented?

3. What is known about the implementation challenges? Why is implementation low?

4. What implementation strategies (approaches) will be tested for their ability to increase implementation of the standard of care?

5. In whom will the intervention be tested? How many groups? Similarity? Differences?

6. What is the major goal of the intervention study? What is the project trying to accomplish in terms of implementation outcomes? Broader spread? Acceptability? Sustainability?

Point 1 is important as an aid in prioritizing the health problem within a country, to determine if a study is indeed necessary (i.e. the problem is an important health burden for the country). Ethical considerations here involve equity and justice, addressing the needs of the most vulnerable (Health Capability Paradigm, Accountability for Reasonableness, Benchmarks for Fairness, etc.).

Points 2–4 relate to the need for a thorough and appropriate situational analysis, to engage with the community, to identify real needs and barriers on the ground, as a prerequisite to beginning to develop a strategy to tackle the barriers.

Ethical challenges here include those related to community engagement inclusion of the most vulnerable; avoiding shaming; understanding if an intervention would be acceptable locally; realistic understanding of the capacity of the local health system/health-care workers; identifying potential ancillary care issues that may arise; consideration of the potential sustainability and scale-up challenges, if the intervention were to be successful, etc.

Points 5–7 relate to the design of the implementation to be tested. Ethical challenges here relate to equipoise, scientific rigour, quality of care or access to care for control groups, issues around informed consent, confidentiality, stigmatization, identification of appropriate community representatives, community engagement etc.

The cases presented in this module have been designed following this template, but, in some cases, some steps have intentionally been omitted or have not been appropriately addressed, in order to highlight the ethical challenges that are associated with interventional research.

In-Depth Ethical Analysis of Implementation Research Using Case Studies

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

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

In-Depth Ethical Analysis of Implementation Research Using Case Studies

Table 3. Case Studies

Ethical challenges

Sustainability

Scalability

Vouchers

Quality control

“cherry picking”

Group consent

Adequacy of follow up

Opt–out possibilities

Subject confidentiality

Possibility for fraud/theft

Vertical vs. horizontal programmes

Incentives/gifts/inducements

Induce over–treatment or over– use of services

Selection of community representatives

Ancillary findings/care responsibility

Consent in illiterate subjects

Blurred line between research and clinical care

Excluding vulnerable populations?

Competing interests/duties of clinic staff, overwhelm clinic staff with extra work – decrease quality in other areas

Create need that cannot
be met by health system/clinics

Collateral impact (not on study subjects), e.g. taxi drivers, drug sellers

Stigmatization through subject identification/participation

Case 3Antenatal syphilis screening

Case 4Vouchers for delivery

Case 5HMM
malaria

Case 6PMCT
clinics

Case 7Nomadic population

Study design

Equipoise

Scientific rigour

Study context/relevance

Acceptability of intervention

Treatment obligations
in control group

Confidentiality/safety
of contact tracing

False positive/negative test implications

Decentralization of
laboratory testing

Information given to control group/false information

Transfer of a test/policy/procedure from one country to another

Who bears cost of study medication if standard
of care?

In-Depth Ethical Analysis of Implementation Research Using Case Studies

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

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

In-Depth Ethical Analysis of Implementation Research Using Case Studies

10. Presentation and Facilitation Skills: General Tips

10.1 Skills Required to be an Effective Trainer/Facilitator

• Technical expertise in the subject matter

• Understand background and material

• Able to facilitate the discussions and provide inputs to participants on the various case studies

• Good presentation skills

10.2 Presentation Skills

• Project your voice if microphones are not used

• Listen to participants:

• Reply to questions in a concise manner

• Respond to comments

• Stay calm under pressure:

• Deep breathing exercises may help

• Be organised

• Although an expert, always be open to learning
new things!

• Act as a good facilitator for discussions

• Practice and rehearse the material beforehand

• Avoid jargon, slang and colloquialisms:

• For example, in South Africa, people often say “shame” to show that they are feeling sad for you, or to express solidarity when an event has gone wrong; however, in other cultures, shame is used to project a negative feeling onto someone, to actively shame them

• Ask questions to keep the participants engaged:

• At the beginning of the course, participants might be shy and reluctant to speak up,
so when you ask a question, provide them with silence so that they will feel the need
to fill it; count to 10, if after that time no one has replied, provide them with a hint – this should hopefully prompt them to start responding

• Define abbreviations

• Keep in mind the non–verbal cues:

• Appearance – be culturally sensitive, and dress as you would for a business meeting; after the first day, you may dress more business casual, depending on the audience

• Do not cross your arms too much, stay relaxed

• Do not jingle the keys or change in your pockets, it might be distracting

• Maintain eye contact

• Keep a bottle of water close by in case your throat becomes dry. Try to avoid iced water as that can cause the throat to constrict

• Vary your voice through pitch, volume, pauses and speed

• Remember that humour is not universal! What is funny in one setting might not be in another. This is particularly true when using simultaneous translation as the joke might not translate:

• Use humour with caution – if you know your audience, then it will elevate the presentations, relax participants, and create a friendly atmosphere ripe for learning

• If you are in a new setting, use humour with caution – get to know the group, the culture, the setting

10.3 How to answer questions from the participants

• Wait before immediately responding

• Ask the other participants if anyone has ideas, or wants to contribute

• Avoid making judgements – participants are here to learn

10.4 Facilitation skills

Facilitation skills may be described as the process of making something easier; the role may vary from doing nothing to actively directing the activities. In guiding the participants, a facilitator helps them: interact with each other; gain new information; build upon their experience; and reach the stated goals and objectives within the allotted time.

10.5 The roles of a facilitator

• Main focus is on making content meaningful to learners

• Basic approach is ‘How can I help you learn what you want to learn?’

• Usually help learners deal with content using a wide variety of approaches

• Use a lecture to obtain something else from the learner, e.g. application of content to personal experience

• Usually asks the learners many questions.

• Encourages learners to develop their own view of reality by using the subject matter. Do these objectives reflect all what you want to achieve? Do you have a way to measure that you have achieved them?

• Commit to sharing the responsibility for the learning situation with learners

• Involve the learners in participating in every aspect of the course

10.6 A good facilitator

• Keeps the group focused on task and process

• Remains as objective as possible

• Is an informed guide, helping the group to accomplish its objectives

• Listens more than talks

• Adopts various learning styles

• Encourages everyone to participate while remembering that individuals participate in different ways; some may talk only in small groups, still be participating, while others may talk constantly but be contributing little

• Protects members of the group from attack by others

• Is sensitive to gender and cultural issues

• Energizes a group or slows it down as appropriate

• Recaps occasionally on what has happened in the course and helps groups to make connections between sessions

10.7 General tips for the trainers

The delivery of the material can be adapted to the local context, as long as the slides are not altered or deleted. This guide is to familiarize the facilitator with the contents of the training material and not to be used verbatim in the teaching. As the trainers/facilitators will have been working in research and ethics for a number of years, they are likely to have experienced many situations, which would make great examples during the sessions. Although the course has been developed to ensure consistency in the teaching, if a trainer has a great example that will clarify a teaching point, they should feel free to use it!

Participants will be asked to come to the course as a team. Over the two and a half days of the course, they will have the opportunity to learn from and exchange ideas with their peers. The exercises provide the opportunity to apply their learning. During the exercises, facilitators should walk around the groups and spend time with each group so participants can ask specific questions. As the trainers are ‘experts’ in the field, they should be able to help each team with any issues that might come up.

Summary and recapitulation: Each day could end with a quick summary of what was learnt during the day; every morning can begin with a re-cap of the previous day. This has two purposes: (1) it wakes up the participants; and (2) it provides a useful summary so the material is fresh in everyone’s minds. The participants should do the re-cap with small prompts from the trainer as required.

10.8 Evaluation

• Following each course, review what did and what did not work.

• Make notes for the next course while it is fresh in the minds of all the trainers.

• Ask for feedback from all the participants using either a structured questionnaire or qualitative interview. Analyse the data and modify training materials/methods as appropriate.

In-Depth Ethical Analysis of Implementation Research Using Case Studies

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

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