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
Ethical Issues in the Conduct of Implementation Research
Slide 2
Slides 1 and 2: Introduce the session and list the various ethical considerations that will be discussed in the session:
• Ethical aspects of upholding participant autonomy in IR
• Informed consent
• Promoting justice during the conduct of IR
• Standard of care in the IR design
• Ancillary care
• Ethical aspects of data collection and management
• Data ownership, data sharing, data dissemination
• Privacy and confidentiality
Slide 2 & 3, Learning Objectives and Session Outline
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
Ethical Issues in the Conduct of Implementation Research
Slide 3
Slides 1 and 2: Introduce the session and list the various ethical considerations that will be discussed in the session:
• Ethical aspects of upholding participant autonomy in IR
• Informed consent
• Promoting justice during the conduct of IR
• Standard of care in the IR design
• Ancillary care
• Ethical aspects of data collection and management
• Data ownership, data sharing, data dissemination
• Privacy and confidentiality
Slide 2 & 3, Learning Objectives and Session Outline
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
Ethical Issues in the Conduct of Implementation Research
Slide 4
Using this slide, introduce the participants to further information in part 1 of case study 1 in Annex 7.
The participants discuss only part 1. After the participants discuss the questions in Slide 5 in the large group, use Slide 6 to discuss the issue of identifying the research participants in the study. In the case study, there are three groups of research participants, namely, the pregnant women, mothers and babies in the intervention, control villages, the community health workers, programme managers, policy-makers and district health officials. The data will be collected from the mothers and the babies.
Slide 4-6: Informed Consent in Implementation Research
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
Ethical Issues in the Conduct of Implementation Research
Slide 5
Using this slide, introduce the participants to further information in part 1 of case study 1 in Annex 7.
The participants discuss only part 1. After the participants discuss the questions in Slide 5 in the large group, use Slide 6 to discuss the issue of identifying the research participants in the study. In the case study, there are three groups of research participants, namely, the pregnant women, mothers and babies in the intervention, control villages, the community health workers, programme managers, policy-makers and district health officials. The data will be collected from the mothers and the babies.
Slide 4-6: Informed Consent in Implementation Research
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
Ethical Issues in the Conduct of Implementation Research
Slide 6
Using this slide, introduce the participants to further information in part 1 of case study 1 in Annex 7.
The participants discuss only part 1. After the participants discuss the questions in Slide 5 in the large group, use Slide 6 to discuss the issue of identifying the research participants in the study. In the case study, there are three groups of research participants, namely, the pregnant women, mothers and babies in the intervention, control villages, the community health workers, programme managers, policy-makers and district health officials. The data will be collected from the mothers and the babies.
Slide 4-6: Informed Consent 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
Example 2
Example 1
Ethical Issues in the Conduct of Implementation Research
Slide 7
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-level implementation research
Group-level implementation research
Ethical Issues in the Conduct of Implementation Research
Slide 8
Explain that in example 1 – the study of a new insecticide spray against mosquitoes – the study is at the level of the village and no individual household can be effectively prevented from being sprayed, thus the intervention is non-excludable. Thus, obtaining informed consent from each household may not be meaningful or feasible. However, in the case of MDA – administering a drug against LF to the entire population on the same day – individual participants can meaningfully refuse to take the medicines and it may not be difficult to explain and obtain informed consent from each individual before giving them the drug.
Slide 8
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
Ethical Issues in the Conduct of Implementation Research
Slide 9
Describe the various options for obtaining informed consent in IR. For community-level intervention, the options may be waiver of consent or community gatekeeper consent. For individual-level consent, the options may range from waiver of consent to individual-level consent up to dual-level consent from the gatekeeper and the individual.
Slide 9
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
Ethical Issues in the Conduct of Implementation Research
Slide 10
Explain that sometimes informed consent may be waived in group- level IR and defines the conditions under which this can be done. The decision to waive informed consent is made by the ethics committee after detailed deliberations.
Move on to discuss the alternative options for group-level or community-level IR.
Slide 10
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
Ethical Issues in the Conduct of Implementation Research
Slide 11
Discuss the concept of gatekeeper consent as an informed consent option for group-level IR. A community gatekeeper is a person who represents the interests of the community and has the community’s welfare in mind.
Highlight the ethical concerns in the selection of gatekeepers. The gender of the gatekeeper should be a consideration in the context of the study. Justice considerations and the representation of the most vulnerable people should be considered in gatekeeper selection.
In case of individual-level studies in IR, there are some unique ethical issues, especially in the cluster-randomized design as described in the case study. Use Slide 11 to highlight these issues.
Slide 11
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
Ethical Issues in the Conduct of Implementation Research
Slide 12
Individual consent questions
Is individual consent required even after obtaining gatekeeper consent?
Sometimes individual consent may also be required as a second-stage informed consent process when risks and benefits directly concern the individual. For example, in the MDA campaign, apart from community-level consent from a gatekeeper, individual-level consent may also be necessary because individual risks are definite.
Is it possible to obtain individual consent for randomization as cluster randomization happens a priori even in individual-level IR?
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 no-intervention control group, what amount of information should be provided to them?
Even to the no-intervention control group, full information should be provided. It is ethically appropriate that they know that they are part of a study in which the arm they belong to does not receive any intervention. Sometimes, providing information to the no-intervention control group may adversely affect their behaviours and their perceptions. This may distort the findings of the study.
Slide 12
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
Ethical Issues in the Conduct of Implementation Research
Slide 13
Following the above, summarize the discussions on informed consent in IR using the flow diagram in Slide 13.
The researcher asks whether there is a need for informed consent. If not, are the conditions for waiver of informed consent met? If there is need for informed consent, then is obtaining it at the individual level feasible? If obtaining individual consent is not feasible, the researcher considers gatekeeper consent. If the individual consent is feasible, then the researcher asks whether it is meaningful. Can an individual participant meaningfully refuse to participate in a study? In case of non-excludable public health interventions to which the individuals cannot refuse consent, gatekeeper consent is considered. Finally, the researcher has to also consider whether the local ethics committee approves the waiver of consent or the informed-consent process.
Slide 13
Ethical Issues in the Conduct of Implementation Research
Slide 13
Notes
