MODULE 2
Ethical Considerations 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
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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 2
Ethical Considerations in
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
• To describe the existing frameworks of ethical reasoning in medical, research, public health and bioethics
• To differentiate medical and public health ethics
• To describe the key ethical considerations in public health as a background for ethics of health systems research and implementation research
• To describe the ethical considerations of health systems research and implementation research
• To apply the ethical considerations to health systems research addressing various building blocks of the health system
• To apply ethical principles of health systems research and implementation research to practical situations
Slide 2
Ethical Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 2
Slide 2
This module will cover the important aspects of health systems’ ethical principles and IR.
The following aspects will be covered:
1. The key ethical frameworks of medical, research, public health ethics, bioethics as an overarching framework;
2. Differences between medical and public health ethics;
3. Key characteristics of public health ethics;
4. Key ethical principles of health systems and IR;
5. Ethical justification for IR.
Introduce these concepts to the participants.
Slide 2 & 3, Learning Objectives and Session Outline
Ethical Considerations in 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 Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 3
Slide 3
This module will cover the important aspects of health systems’ ethical principles and IR.
The following aspects will be covered:
1. The key ethical frameworks of medical, research, public health ethics, bioethics as an overarching framework;
2. Differences between medical and public health ethics;
3. Key characteristics of public health ethics;
4. Key ethical principles of health systems and IR;
5. Ethical justification for IR.
Introduce these concepts to the participants.
Slide 2 & 3, Learning Objectives and Session Outline
Ethical Considerations in 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 Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 4
Slide 4
Draw attention to the fact that health systems and IR is an emerging field, and ethical reflection in this area is also fairly recent. It draws upon the various existing frameworks, which are:
• Medical ethics
• Research ethics
• Bioethics
• Public health ethics
Slide 4 & 5, Ethics of Health Systems Research and Implementation Research
Ethical Considerations in 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 Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 5
Slide 5
Draw attention to the fact that health systems and IR is an emerging field, and ethical reflection in this area is also fairly recent. It draws upon the various existing frameworks, which are:
• Medical ethics
• Research ethics
• Bioethics
• Public health ethics
Slide 4 & 5, Ethics of Health Systems Research and Implementation Research
Ethical Considerations in 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 Considerations in Implementation Research
Public health ethics focuses on:
• Population health
• Health programmes and policy issues
• Scientific evidence
• Public participation
• Preventive measures
Medical ethics focuses on:
• Individual patients
• Doctor-patient relationship
• Duties of doctors/nurses
Research ethics focuses on:
• Protection of study participants
• Informed consent
• Risk-benefit analysis
• Equitable selection & access etc.
Ethical Considerations in Implementation Research
Slide 6
Among all these existing frameworks the most recent is the public health ethics framework, which is highly relevant to IR. This framework is unique and has its characteristic differences from the older medical ethics framework.
Slide 6
Use Slide 6 to describe the differences between medical, research and public health ethics. While medical and research ethics deal with individual patients and study participants, public health ethics considers the welfare and risks to populations.
Slide 6-10, Medical Ethics, Research Ethics,
Public Health Ethics
Ethical Considerations in 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 Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 7
Slide 7
In this context, present Slide 7 to raise some of the most important questions and ethical considerations in public health ethics.
• What level of risk is acceptable?
• How much coercion is justifiable?
• How to weigh individual interest vs. the common (public) good?
• Health promotion: how much should the government interfere with personal choices on health?
• How to ensure fair participation in decision-making?
Priority-setting and rationing: who will get what if resources are short?
From these considerations emerge a unique set of ethical principles as discussed below.
Slide 6-10, Medical Ethics, Research Ethics,
Public Health Ethics
Ethical Considerations in 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 Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 8
Slide 8
1. Substantive principles – they establish the rules for what is right and wrong, and the right and wrong actions in public health.
2. These principles facilitate ethical conduct in public health, producing benefits and minimizing harms.
• Discuss the potential benefits of the herpes simplex virus (HSV) screening strategy – detection of asymptomatic carriers, prevention of neonatal HSV infections, and improvement in child health.
• Discuss the potential harms – stigmatization of men and women detected to have a sexually transmitted infection (STI) – problems of marital discord and infidelity problems when screening positive.
• Infringement of individual autonomy and compromises that individuals make should be proportional to the benefits to the community. Is being detected as having an asymptomatic sexually transmitted affliction proportional to the reduction in burden of newborn deaths in this community?
• n support of the compromises that individuals make for the sake of common good, the community should reciprocate the gesture by upholding their interests. How can the community uphold the interests of people who reveal their HSV status for the sake of common good? Can efforts be made to protect their confidentiality? Can treatments be offered in an affordable and respectful manner?
• Equity – justice, fairness – is the programme likely to benefit/harm all sections of the community in a similar manner? Do women bear a greater burden of stigma and domestic violence after having been detected as having HSV?
• Trust – belief that the public health intervention is intended for the common good – trustworthiness.
• Solidarity – the feeling of standing united for a common cause, willingness to stand up for the common good.
• Stewardship – the act of protecting the health of the community, accepting responsibility for the well-being of the community as a service and not as a control. For example, during an influenza outbreak, the state should act by increasing awareness and providing specific vaccinations. The state may also take measures to isolate infected patients. However, all this is done in a spirit of service and not as a controlling measure. This is called stewardship.
Slide 6-10, Medical Ethics, Research Ethics,
Public Health Ethics
Ethical Considerations in 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 Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 9
Slide 9
Introduce procedural ethical principles:
1. Procedural principles – they establish the rules by which public health should be practiced and decisions made. They are concerned with the process of delivery of public health services.
2. These principles lay down the following rules for due process in public health.
• Transparency – openness, honesty.
• Relevance – appropriateness – is the screening programme for HSV the most relevant in this community? Are there other more important causes of morbidity?
• Inclusivity – non-discrimination.
• Responsiveness – being able to adapt to community needs and respond to the requirements.
• Accountability – being answerable to the community.
• Participation – were stakeholders involved in deciding on the best strategy to screen men and women for HSV?
• Sustainability – being able to sustain public health action and public health impact.
Slide 6-10, Medical Ethics, Research Ethics,
Public Health Ethics
Ethical Considerations in 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 Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 10
Slide 10
Potential conflicts between substantive ethical principles.
The limitation of a principle-based approach to public health ethics is that substantive principles will sometimes be in conflict with one another. Some examples of the conflicts are listed below.
1. Quarantine during pandemics – autonomy versus common good, autonomy versus solidarity.
2. Targeted interventions – improves efficiency and produces common good, but not equitable.
3. Name-based reporting of sexually transmitted diseases and contact screening – confidentiality versus disclosure and common good.
4. State taking responsibility for public health interventions such as introducing a ban on smoking – autonomy versus stewardship.
Slide 6-10, Medical Ethics, Research Ethics,
Public Health Ethics
Ethical Considerations in 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
Medical ethics
Public
health ethics
Research
ethics
Slide 11
Ethical Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 11
Ethical Considerations in 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 Considerations in Implementation Research
Ethical Considerations in Implementation Research
Slide 12
Slide 12-13
Introduce examples in Slide 12 and then use Slide 13 to highlight important ethical considerations in HSR and IR.
In HSR, it is often challenging to identify who the beneficiaries are and who is bearing the risks. For example, during research to improve the performance of the community health-care provider, if a new method of information collection is introduced, and it is studied whether the health outcomes at the community level are improved, the beneficiaries are at two levels, both the community health workers as well as the communities. Likewise, the risks are also at both these levels. Therefore, identifying the beneficiaries and those at risk can be challenging.
Following from the same description, in ensuring autonomy, it is difficult to identify whether the health workers or the community should give informed consent.
While planning HSR it is also important to involve participants from vulnerable communities, as it is important for the health-system services to reach them.
Other important ethical considerations in HSR include: (a) the research should be responsive to the community and health-system needs; (b) the research intervention should be sustainable and scalable; and (c) appropriate standards of care and ancillary care responsibilities should be identified.
Slide 11-20, Ethics of Health Systems Research
and Implementation Research
Ethical Considerations in 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 Considerations in Implementation Research
Balancing benefits
and risks
• Who are the beneficiaries?
• Who are at risk?
• Is there balance between risks and benefits?
Upholding participants’ autonomy
• Levels of research participants
• Who should give consent?
• Is consent necessary, feasible, meaningful?
Justice
• Fairness in participant selection
• Need for health systems research among vulnerable populations
Other issues
• Responsiveness
• Sustainability
• Standard of care/ancillary care
• Empowerment
Ethical Considerations in Implementation Research
Slide 13
Slide 12-13
Introduce examples in Slide 12 and then use Slide 13 to highlight important ethical considerations in HSR and IR.
In HSR, it is often challenging to identify who the beneficiaries are and who is bearing the risks. For example, during research to improve the performance of the community health-care provider, if a new method of information collection is introduced, and it is studied whether the health outcomes at the community level are improved, the beneficiaries are at two levels, both the community health workers as well as the communities. Likewise, the risks are also at both these levels. Therefore, identifying the beneficiaries and those at risk can be challenging.
Following from the same description, in ensuring autonomy, it is difficult to identify whether the health workers or the community should give informed consent.
While planning HSR it is also important to involve participants from vulnerable communities, as it is important for the health-system services to reach them.
Other important ethical considerations in HSR include: (a) the research should be responsive to the community and health-system needs; (b) the research intervention should be sustainable and scalable; and (c) appropriate standards of care and ancillary care responsibilities should be identified.
Slide 11-20, Ethics of Health Systems Research
and Implementation Research
Ethical Considerations in Implementation Research
Slide 13
Notes