Module-5

Specific Learning Objectives:

• To describe the ethical obligation to disseminate the findings of implementation research (IR);

• To describe the ethical implications of the sustainability of interventions studied in IR.

Learning Methodology:

Interactive lecture with illustrations.

Required Resources:

PowerPoint presentation.

MODULE 5

Ethical Issues in the

Post–Research Phase of

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 5

Ethical Issues in the

Post–Research Phase of

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 Considerations in the Post-Research Phase of Ir

To describe:

• The ethical obligation to disseminate findings of implementation research

• The ethical implications of sustainability of interventions studied in implementation research

Learning Objectives

Ethical Considerations in the Post-Research Phase of IR

Slide 2

Introduce the module and highlight the various ethical obligations of the implementation researcher in the post-research phase of IR. The key considerations are:

• Ethical obligations of researchers and donors to disseminate the findings from IR

• Role of IR in research capacity building and health system strengthening

• Post-IR access to interventions

• Ethical obligation to translate IR findings into policy and practice

Slides 2 & 3, Learning Objectives and Session Outline

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Session Outline

• Ethical obligations of implementation research to disseminate research findings

• Role of implementation research in research capacity building and health system strengthening

• Post- implementation research access to interventions

• Ethical obligation to translate implementation research findings into policy and practice

Ethical Considerations in the Post-Research Phase of IR

Slide 3

Introduce the module and highlight the various ethical obligations of the implementation researcher in the post-research phase of IR. The key considerations are:

• Ethical obligations of researchers and donors to disseminate the findings from IR

• Role of IR in research capacity building and health system strengthening

• Post-IR access to interventions

• Ethical obligation to translate IR findings into policy and practice

Slides 2 & 3, Learning Objectives and Session Outline

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Case Study

• A PI has just concluded an implementation research - study A; contrary to expectation, analysis revealed that the new service tested did not yield favourable results.

• He proposes to move forward with study B as he has recently won a big grant.

• Considering the outcome of study A was not favourable, he has decided neither to publish the findings nor feedback to the community.

• Instructed his team to devote their time instead to study B.

Concerns? Opinions?

Ethical Considerations in the Post-Research Phase of IR

Slide 4

The session opens with a case study in Slide 4 to demonstrate why results should be disseminated. The Declaration of Helsinki, one of the leading ethical codes for the conduct of research in human subjects, states that all researchers have an ethical obligation to publish and disseminate all results. It is recognized that negative results are often difficult to publish, but there are other options to traditional publication, e.g. abstracts at conferences. Sufficient time should be spent discussing this as non-publication could mean the likelihood of another investigator spending human, material and monetary resources redoing the same activity, when the answer has already been obtained. Introduce the possibility of publishing negative results in the Journal of Negative Results in Biomedicine.

Slides 4-9: Ethical Obligations of Researchers and Donors to Disseminate Findings from Implementation Research

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Ethical Obligation to Disseminate Implementation
Research Findings

• Implementation researchers have ethical obligation to disseminate research findings:

• The data emerged from the community

• Justice requirement to give back to community

• Empowerment of community with knowledge

Ethical Considerations in the Post-Research Phase of IR

Slide 5

Slide 5

Explain that implementation researchers have an ethical obligation to disseminate the IR findings. This ethical obligation is threefold:

• The data emerged from the community and it belongs to the community

• Justice requires that the IR should be given back to the community

• There is a need to empower communities with knowledge

Slides 4-9: Ethical Obligations of Researchers and Donors to Disseminate Findings from Implementation Research

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

To Whom Should Information be Disseminated?

• Health-system officials

• Local community health workers

• Local communities

• Larger communities

• Global community

• Other researchers

• Policy-makers

Ethical Considerations in the Post-Research Phase of IR

Slide 6

Slide 6

The information should be disseminated to all relevant stakeholders.

Slides 4-9: Ethical Obligations of Researchers and Donors to Disseminate Findings from Implementation Research

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

How Should Information be Disseminated?

• In a language and manner understandable to the intended target audience

• Use of different media to target lay people as well as technical

• Persuasive language of activism vs. honesty

Ethical Considerations in the Post-Research Phase of IR

Slide 7

Slide 7

The dissemination of the research findings to the community requires a delicate balance between the persuasive language of activism and that of honesty. The researcher should disseminate information with the intent of increasing knowledge and empowering the community.

Slides 4-9: Ethical Obligations of Researchers and Donors to Disseminate Findings from Implementation Research

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Data Ownership and Dissemination

• In donor-initiated research, the donors determine nature and method of dissemination of findings and regulate the process.

• Whether donors disseminate the data or not may depend on the findings and whether it is favourable to the donor.

• Irrespective of donor preferences and irrespective of study results, all implementation research findings should be disseminated – good governance is required.

Ethical Considerations in the Post-Research Phase of IR

Slide 8

Slide 8

Initiate a discussion on data ownership. In donor-initiated research, the donors are the primary users of the data and so they often determine the nature and method of disseminating the findings.

Slides 4-9: Ethical Obligations of Researchers and Donors to Disseminate Findings from Implementation Research

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Donor Influences on Dissemination of Implementation Research Findings

• An implementation research project done by a group of researchers in a low- and medium-income country (LMIC) was sponsored by an international donor.

• The implementation research assessed a particular guideline for treatment of an infectious disease of importance in the country.

• The implementation research concluded that the recommended treatment was innefective and not practical in the local context

• However, when an attempt was made to publish this research the donor raised serious concerns.

Ethical Considerations in the Post-Research Phase of IR

Slide 9

Slide 9

Describe a real-life example of how a donor influenced the publication of a negative research finding.

Often, researchers may incidentally stumble upon findings of systemic inefficiencies during their research and it is their moral obligation to report it or take corrective action, if possible. This is part of the post-research dissemination of information to those who need to know.

Slides 4-9: Ethical Obligations of Researchers and Donors to Disseminate Findings from Implementation Research

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Role of Implementation Research in Research Capacity Building & Health System Strengthening

• Usually funding of implementation research does not support long-term interventions

• Long-term and system-level interventions will build implementation research capacity as well as strengthen the system

• Vertical programmes tend to weaken the health system

• Apart from strengthening the health system, implementation research should also strengthen the local capacity to conduct, monitor and evaluate research

Ethical Considerations in the Post-Research Phase of IR

Slide 10

Describe the ethical obligations to empower the local research capacity and to strengthen the health system. IR may lead to a vertical system within the larger health system and this tends to drive substantial funding away from other important interventions. Therefore, there is a need to strengthen the health system by creating horizontal and integrated interventions. Horizontal health-care delivery refers to delivery of services through publicly financed health systems comprised of a comprehensive package of services. On the other hand, if a selective intervention to control a specific disease or condition is delivered without integrating it into other essential services, it is referred to as vertical service delivery. Horizontal and integrated services strengthen the overall health system.

Slide 10

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Post- Implementation Research Access to Interventions

• The interventions in implementation research are usually system wide

• Ensuring post-research access to the intervention can be challenging

• Post-research access may involve cost-intensive system-wide changes

• The researchers may not by themselves be able to bring about policy change, but should engage with political stakeholders at the beginning of the implementation research

• There is an ethical obligation to ensure the research participants benefit because of the intervention

Ethical Considerations in the Post-Research Phase of IR

Slide 11

In IR, the interventions are usually system wide and ensuring post-trial access to them is an ethical obligation. Another important obligation is engaging with policy-makers and the health system to adopt and scale-up the successful intervention. Involving the health system at the design phase of the mhealth study and obtaining, from the beginning, a commitment to its sustained use and scale-up is a good strategy in ensuring its post-trial access.

Use Slide 11 to highlight this aspect of the post-research consideration in IR.

Slide 11

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Ethical Obligation to Translate Implementation Research Findings into Policy and Practice

• There is a documented delay in translation of research to practice

• However implementation research is a special form of research which is done to study the best method of delivering intervention

• There is an ethical obligation to adopt implementation research into practice

• Having a policy adoption plan at the beginning of implementation research is very important and therefore stakeholder engagement is useful

Ethical Considerations in the Post-Research Phase of IR

Slide 12

Usually, there is a delay in translating research findings into practice. In IR, there is an ethical obligation to convert the research findings into practice. Having a policy adoption plan at the beginning of IR is very important and stakeholder engagement is, therefore, useful.

Slide 12

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Scalability and Sustainability

• If implementation research introduces an intervention into a system there is an ethical obligation to scale up the intervention.

• There is also an ethical obligation to sustain the intervention.

• Community engagement at the beginning of the implementation research helps in ensuring sustainability.

• Stakeholder engagement in terms of the public health system helps in scalability and sustainability.

Ethical Considerations in the Post-Research Phase of IR

Slide 13

If IR introduces an intervention into a system, there is an ethical obligation to scale-up the intervention. There is also an ethical obligation to sustain the intervention. Community engagement at the beginning of the IR helps to ensure sustainability. Stakeholder engagement in terms of the public health system helps in scalability and sustainability. However, issues of sustainability and scalability are not free of challenges. Sometimes, donor-initiated research may not provide for long-term sustainability. The local health system may not be able to afford to take over and sustain the intervention. Such a situation begs the question should the research be undertaken? Is it ethically right to conduct IR where scale up and sustainability are challenging? Are there justice implications to conduct such IR in any case to generate knowledge? Will political priorities and policy circumstances change and make the IR knowledge usable at a later date? These are important ethical questions to be discussed.

Finally, summarize the various considerations in the post-trial phase of IR and stress that, in the post-trial phase, there is an ethical obligation to disseminate the data to all relevant stakeholders. There is also an obligation to ensure post-trial access to the successful intervention and to engage with the health system to ensure sustainability and scalability. In the post-trial phase, there is also an ethical obligation to empower the community, build research capacity in the local area, and strengthen the health system.

Slides 13 & 14: Scalability and Sustainability

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Challenges in Scalability and Sustainability

• Sometimes donor-initiated research may not have provision for long-term sustainability.

• Local health system may not be able to afford to take over and sustain the intervention.

• In such situations, should the research be done? Is it ethically right to conduct implementation research where scale up and sustainability is a challenge?

• Are there justice implications to anyway conduct such implementation research to generate knowledge?

• Will political priorities and policy circumstances change and make the implementation research knowledge usable at a later date?

Ethical Considerations in the Post-Research Phase of IR

Slide 14

If IR introduces an intervention into a system, there is an ethical obligation to scale-up the intervention. There is also an ethical obligation to sustain the intervention. Community engagement at the beginning of the IR helps to ensure sustainability. Stakeholder engagement in terms of the public health system helps in scalability and sustainability. However, issues of sustainability and scalability are not free of challenges. Sometimes, donor-initiated research may not provide for long-term sustainability. The local health system may not be able to afford to take over and sustain the intervention. Such a situation begs the question should the research be undertaken? Is it ethically right to conduct IR where scale up and sustainability are challenging? Are there justice implications to conduct such IR in any case to generate knowledge? Will political priorities and policy circumstances change and make the IR knowledge usable at a later date? These are important ethical questions to be discussed.

Finally, summarize the various considerations in the post-trial phase of IR and stress that, in the post-trial phase, there is an ethical obligation to disseminate the data to all relevant stakeholders. There is also an obligation to ensure post-trial access to the successful intervention and to engage with the health system to ensure sustainability and scalability. In the post-trial phase, there is also an ethical obligation to empower the community, build research capacity in the local area, and strengthen the health system.

Slides 13 & 14: Scalability and Sustainability

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

Key Messages

Ethical Considerations in the Post-Research Phase of IR

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 Considerations in the Post-Research Phase of Ir

References and Reading Materials

• Dowdy DW. Partnership as an ethical model for medical research in developing countries: the example of the "implementation trial". J Med Ethics. 2006;32:357−60.

• Hyder AA, Pratt B, Ali J, Kass N, Sewankambo N. The ethics of health systems research in low- and middle-income countries: a call to action. Global public health. 2014;9:1008−22.

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

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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