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
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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 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