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
Ethical Issues in the Planning Phase of Implementation Research
Slide 2
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 3
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 4
Quickly review the rationale for IR highlighting the fact that interventions may not be effective, although they may be known to work. List the many potentials for weak links along the chain between having a good intervention and implementing it successfully, linking to the fact that engagement with relevant stakeholders at each link of the chain is critical.
Slide 4
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
• 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
Ethical Issues in the Planning Phase of Implementation Research
Slide 5
Special Note to facilitator: Also mention policy-makers’ motivation to reach Sustainable Development Goals (SDGs) rather than focusing on the issue of whether malaria is an actual priority in that particular district.
Present case study example – suboptimal uptake of ITNs for malaria prevention.
Slide 5
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 6
Special Note to facilitator: Questions to ask during the planning stage:
Is research question demand-driven?
Is there an idea why uptake is not optimal?
What is the intervention type?
Who/what will be the research subjects?
Who/what will be the units of intervention?
Who/what will be the units of observation?
Who needs to give informed consent and how?
Who/what bears risks?
Who/what gains benefits?
Are vulnerable group included fairly?
Is this research vs. practice?
Is there awareness of cultural sensitivity?
What is the potential for ancillary care needs and follow up?
What are acceptable standards of care?
Who/what will be in the control groups, are they required
and ethically justifiable?
Who will have responsibility for data management
and data ownership?
Who will have responsibility post-study?
Does the research strengthen the local health system?
Slide 6
Make it interactive, before going through the slides, by asking participants how they might approach the study to improve uptake of ITNs in the community; brainstorm all aspects that should be considered. Summarize the participants’ responses and quickly take them through the questions in slides 6 and 7 – spending less time on points already discussed and more time on entities that were missed.
In planning IR, think of all components from start to finish that are to be considered and taken into account (identify early on the potential challenges and barriers, all the appropriate actors/stakeholders and generate plans to best engage them for optimal collaboration).
Slides 6 & 7 Early Thoughts on an Implementation Research Study 2: How to Increase The Appropriate Use of ITNS?
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 7
Special Note to facilitator: Questions to ask during the planning stage:
Is research question demand-driven?
Is there an idea why uptake is not optimal?
What is the intervention type?
Who/what will be the research subjects?
Who/what will be the units of intervention?
Who/what will be the units of observation?
Who needs to give informed consent and how?
Who/what bears risks?
Who/what gains benefits?
Are vulnerable group included fairly?
Is this research vs. practice?
Is there awareness of cultural sensitivity?
What is the potential for ancillary care needs and follow up?
What are acceptable standards of care?
Who/what will be in the control groups, are they required
and ethically justifiable?
Who will have responsibility for data management
and data ownership?
Who will have responsibility post-study?
Does the research strengthen the local health system?
Slide 7
Make it interactive, before going through the slides, by asking participants how they might approach the study to improve uptake of ITNs in the community; brainstorm all aspects that should be considered. Summarize the participants’ responses and quickly take them through the questions in slides 6 and 7 – spending less time on points already discussed and more time on entities that were missed.
In planning IR, think of all components from start to finish that are to be considered and taken into account (identify early on the potential challenges and barriers, all the appropriate actors/stakeholders and generate plans to best engage them for optimal collaboration).
Slides 6 & 7 Early Thoughts on an Implementation Research Study 2: How to Increase The Appropriate 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
Ethical Issues in the Planning Phase of Implementation Research
Slide 8
Characteristics of IR. All IR should originate from the identification of a relevant problem that is a local priority. To have maximum impact, the IR must be ‘systematic’ and strive to achieve the best possible scientific results within realistic circumstances. It should be multidisciplinary as there are many stakeholders who should be involved at all stages. It must be relevant to the local context and should have inherent flexibility to respond to changes in local circumstances, or adapt fast and respond to feedback in a timely and effective manner.
Slide 8
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 9
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 10
Summary of main steps/considerations in planning IR which will be discussed individually more fully in the rest of the module:
• Responsiveness to a community’s needs
• Scientific rationale
• Study design
• contextual factors
• Selection of research participants
• Weigh risks and benefits
• Community and stakeholder engagement
• Iterative process
Slide 10
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 11
Emphasize that the main purpose of IR is to be responsive to the community’s needs and NOT to be driven purely by external actors with diverse agendas. The ethical obligation is to conduct studies that are relevant and responsive, and to address the local problems as effectively as possible.
How does one determine that a study is indeed responsive to the needs of the community? Ideally this requires some data, as the existing data may not always be reliable. The best efforts should be made to use the best available data, which is often generated by the health system and in the hands of policy-makers, thereby having enough information to permit engagement with policy-makers and determine the relative priority of the particular problem. Ethical consideration should be given to conducting IR on issues of high priority where the impact could be expected to be highest, or possibly those that are highly cost-effective. This engagement with the policy-makers ensures that they have identified the same health issues that need to be addressed and, therefore, should be motivated to participate and support the IR. If the IR is successful, the policy-makers should commit to ensuring the financing and sustainability of the intervention. This step requires a certain robustness of the health system; weaknesses in the health system functioning could be identified and highlighted as subjects for future IR studies.
Slide 11
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 12
Once the problem is identified and study is planned, the rationale for the study and consideration to intervene should be reviewed. Is the study worth doing, what are the available tools to address the question, how reliable are the tools? Bear in mind the important obligation not to do harm. Has something similar been done elsewhere, what similarities or differences may impact on the new study? This leads to the ethical concept of equipoise, for example, if true uncertainty exists for generalizability of prior studies to current context to justify study.
See more detail in the next slide.
Slide 12
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
Ethical Issues in the Planning Phase of Implementation Research
Slide 13
The ethical concept of equipoise (meaning there is genuine uncertainty whether an intervention is beneficial or not) is fundamental to any study otherwise it would be unethical to include a control/untreated group if the treatment were already known to be beneficial. In IR, the equipoise may no longer lie in the clinical effectiveness of a known intervention (e.g. ITNs do reduce malaria transmission and proof of concept that an effective intervention does exist), but in how to achieve the target ITN distribution and appropriate use in the new context in which the
study will be conducted. The equipoise may, therefore, be contextual and the study worth doing ethically.
Equipoise is necessary to justify any study, especially as some subjects may be exposed to harm and this would only be potentially justifiable if true equipoise exists.
Slide 13
Ethical Issues in the Planning Phase of Implementation Research
Slide 13
Notes
