Module-4

Specific Learning Objectives:

• To describe the ethical aspects of upholding research participants’ Tutonomy in implementation research (IR);

• To describe ethical issues related to promoting justice during the conduct of IR;

• To describe various ethical issues related to data collection and Tmanagement in IR

Learning Methodology:

Interactive lecture; case study discussion.

MODULE 4

Ethical Issues in the

Conduct 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 4

Ethical Issues in the

Conduct 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 Issues in the Conduct of Implementation Research

To describe:

• Ethical aspects of upholding participant autonomy in implementation research:

• Informed consent

• Ethical issues related to promoting justice during the conduct of implementation research:

• Standard of care in the Implementation research design

• Ancillary care

• Ethical aspects of data collection and management:

• Data ownership, data sharing, data dissemination

• Privacy and confidentiality

Learning Objectives

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Session Outline

• Informed consent

• Standard of care

• Ancillary care

• Data collection and management

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Informed Consent in Implementation Research

• Read the case study 1, part 1 (Annex 7).

• mHealth application was developed by a German technological organization for use by frontline community health workers in Bangladesh.

• An implementation research was designed to study the use, acceptability of the application by the frontline health workers, ease of use, perceptions of the frontline workers and the community about the application, and its effectiveness in improving quality of maternal and child health-care delivery in a district in Bangladesh.

• It was a cluster randomized controlled study with 10 villages randomized to intervention, and 10 villages to routine maternal and child health care by the community health workers.

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Informed Consent in Implementation Research

• Who are the participants of intervention?

• Who are the participants of outcome assessment?

• Who are considered as research participants?

• Who should provide informed consent?

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Who is the Research Participant in Implementation Research?

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Individual- and Group-Level Implementation Research Examples

Example 2

Example 1

Research on outdoor spraying of new insecticide in communities.

Research to test effectiveness, reach and acceptability of single dose mass drug administration (MDA) for lymphatic filariasis (LF).

Introduction to 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 Conduct of Implementation Research

Individual- and Group-Level Implementation Research

Individual-level implementation research

Group-level implementation research

No individual participant in the intervention or control clusters can meaningfully refuse to consent to participate as the spraying operation cannot be restricted

Non-excludable

It may not be feasible to obtain consent from each household in all the 20 villages before starting the intervention

Individual participants in the study can meaningfully refuse to consent and refuse to take the MDA

Excludable

It may be feasible to obtain consent as each individual taking the intervention will be approached by the research team

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Informed Consent in Individual- and Group-Level Implementation Research

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Informed Consent in Group-Level Studies Waiver
of Informed Consent

When randomization is at the group level, the individual informed consent may
be waived if following criteria are met:

• Intervention targeted at the group

• Individuals only indirectly impacted by intervention

• No identifiable private information collected from individuals

• No more than minimal risk

• Rights and welfare of participants not adversely affected

• Research could not be carried out if consent were to be obtained

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Informed Consent in Group-Level Studies gatekeeper Consent

Who is a community gatekeeper?

• A local leader concerned with welfare of the community

• A physician/health worker practicing in the community

• A representative of the community interested in its welfare

• A local government representative

Ethical concerns in selecting a community gatekeeper?

• Gender of the gatekeeper should be considered in the context of the study

• Justice considerations in gatekeeper selection – voice of the vulnerable

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Informed Consent in Individual-Level Studies

• Is individual consent required even after obtaining gatekeeper consent?

• Is it possible to obtain individual consent for randomization as cluster randomization happens a priori even in individual-level implementation research?

• Consent in research is for four different components – consent for randomization, consent for intervention, consent for sample collection and consent for data collection.

• In a cluster randomized trial, participants may not be able to give consent for randomization.

• If there is a control group without intervention, what amount of information should be provided to them?

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Informed Consent Model for Implementation Research

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Justice in the Conduct of Implementation Research

• Issues of fairness in participant selection

• Issues of appropriate standards of care

• Issues of ancillary care

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Justice in the Conduct of Implementation Research

Case study 1 – part 2 (Annex 7)

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

• An implementation research was designed to study the use, acceptability of the application by the frontline health workers, ease of use, perceptions of the frontline workers and the community about the application, and its effectiveness in improving quality of maternal and child health-care delivery in a district in Bangladesh.

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Justice in the Conduct of Implementation Research

• It was a cluster randomized controlled study with 10 villages randomized to intervention and 10 villages to routine maternal and child health care by the community health workers.

• It is known that data capture using the routine paper-based system has a significant delay in being reported to the information system. Because of this delay, there have been several instances of poor planning for maternal and child health-care delivery services, which have resulted in poor outcomes.

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

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Standard of Care in Implementation Research

• What care should be provided to the control group of the implementation research?

• ‘Usual care’ or existing standard

• Acceptable standard of care according to best available evidence

• Clinical equipoise condition

• Researchers should not take advantage of existing poor standard of care

• One way to overcome issue of standard of care is to apply the stepped wedge study design

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Ancillary Care

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

What should the implementation researchers do about this information?

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Ancillary Care

• Provision of care for incidentally detected health issues

• In implementation research, ancillary care may extend beyond medical care

• In implementation research, the ancillary care may pertain to groups and communities rather than to individuals

• It may include measures to address other social determinants of health

• It may also include creating some changes in the health system

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Why Collect Data?

• Why should we collect data?

• Enables public health research and practice to:

• Identify outbreaks

• Allocate resources

• Direct intervention

• By gathering information and translating those findings into interventions, public health is able to improve population health

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Sources of Data for Implementation Research

• Primary data is from people and communities

• Secondary data may be obtained from health information systems and programme management information systems

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Case Study for Discussion

• Read the case study 2, part 1 (Annex 8)

• Discuss part 1

• What specific data is collected in this implementation research?

• Who benefits from data collection? Who might be burdened? What are the risks?

• What will the data be used for?

• Can it be collected if no capacity/willingness to use?

• Is confidentiality required, how can it be maintained?

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Data Use in Implementation Research

• Once we have the data in hand, are there ways in which we must use them? Ways in which we cannot use them?

• Contact tracing

• Partner notification

• Quarantine

• Mandatory vaccination

• Mandatory treatment

• Others?

Ethical Issues in the Conduct 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 Conduct of Implementation Research

Data Sharing, Dissemination and Disclosure

• Read the case study 2, part 2 (Annex 8)

• Discuss part 2

• Groups 1, 2, 3 and 4 discuss the following 4 scenarios:

• Group 1 – can identifiable health information be shared with public health for purposes
of creating a registry? Can location information be shared?

• Group 2 – can data be shared with forest officials for other purposes?

• Group 3 – in the context of outbreaks, can the data be widely disseminated?

• Group 4 – should researchers disclose names of non-immunized children to the health officials?

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 Conduct of Implementation Research

Key Messages

Informed consent

Justice considerations

Data collection

• Full spectrum from waiver – gatekeeper permission – dual- level consent – individual consent

• Usually in Public health research and implementation research, informed consent does not take the primary position as in clinical research

• Standard of care – existing standards versus acceptable standards

• Ancillary care responsibilities

• Data collected only if ability and intention to use

• Ethical issues with data sharing, dissemination, disclosure to be considered

• Data protection, privacy and confidentiality

Ethical Issues in the Conduct 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 Conduct of Implementation Research

References and Reading Materials

• George AS, Mehra V, Scott K, Sriram V. Community participation in health systems research: a systematic review assessing the state of research, the nature of interventions involved and the features of engagement with communities. PLoS ONE. 2015;10:e0141091.

• Gupta S. Ethical review of health systems research in low- and middle-income countries: research-treatment distinction and intercultural issues. Am J Bioethics. 2014;14:44−6.

• Hutton J, Eccles M, Grimshaw J. Ethical issues in implementation research: a discussion of the problems in achieving. Implement Sci. 2008;3:52.

• Hyder AA, Dawson L. Defining standard of care in the developing world: the intersection of international research ethics and health systems analysis. Dev World Bioeth. 2005;5:142−52.

• 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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