1. Introduction to Research Ethics Africa RWG Workshop 21 May 2003 Stella Kirkendale Wayne Wilson

2. Four Corners: Values Clarification Exercise

3. What is “Ethics”? What is “Bioethics”? Ethics are ways of understanding and examining the moral life, or right and wrong human conduct. Bioethics is a way of understanding and examining the moral aspects of biomedical research and practice.

4. Fundamental Principles of Human Research Ethics FHI / N. Herndon Respect for persons Beneficence Justice

5. Vulnerable people or groups needing special protection. Who might this be? –… Respect for Persons Autonomy, self-determination

6. Respect for Persons Respect for Persons (continued) — those with limited education — the poor — those with out easy access to health services — women — people in prison — sex workers — gay or lesbian people Informed consent Autonomy, self-determination Vulnerable people or groups needing special protection

7. Physical, mental and social well-being Risks reduced to a minimum Protection of the participant is the most important responsibility of the researcher FHI / N. Herndon Beneficence

8. Justice Equal distribution of risk and benefit Equitable recruitment of research participants Special protection for vulnerable groups

9. What is “Ethical Obligation”? An ethical obligation is a required action that must be met “all things considered.” Obligations may be strong or weak, or vary from one person to another

10. What is an “Ethical Dilemma”? When two or more obligations require mutually exclusive actions When some evidence suggests that an act is right but other evidence suggests it is wrong.

11. How are “Ethical Dilemmas” resolved? Consider whether obligations are being violated Examine all viewpoints carefully, critically and openly Respect legitimate diversity

12. Two important ideas to know about: Genuine uncertainty about the effectiveness of what is being researched (Equipoise) Research being confused with care (Therapeutic misconception) Research Issues Important to Ethics

13. Necessary to understand connection of other key issues and ethics: Informed consent Standards of care Partnerships Issues Important to Ethics Issues Important to Ethics continued

14. Informed Consent  Challenges –cross-cultural variability in decision-making –understanding and exposure to to the scientific research model –beliefs about disease causality –language and literacy levels –undue inducement –social harms – gender or HIV status related

15. Meaningful Informed Consent  Process – pre-enrollment, enrollment and study participation  Community and CAB involvement  Adequate time for counseling  Lexicon of locally used terms  Managing rumours – egs blood draws; “Devil’s money”  Diverse range of methods – drama, quizzes, comics, role-play, focus groups

16. Standard of Care  Prevailing standards so minimal – upgrading of services essential to conducting research  Goal – implement reasonable overall improvements through progressively “ratcheting- up”  Benefit all research participants; local health care system, community; ongoing and future research – avoid two-tier system

17. Partnerships in Research An important aspect of conducting research is ensuring the research partners have a role in the research process. Often the discussion comes down to: Are they …. Advisors/ Partners/ Consultants Collaborators

18. Responsible Conduct of Research Shared responsibilities in research process Well-designed research Adequately reviewed Ethically conducted Properly disseminated

19. Partnerships for ensuring research is “ethical” in the HPTN Protocol teams HPTN Review Committees (including DAIDS as a member) Investigators Institutional Review Boards/Ethics Committees Community Advisory Processes ( for example, CABs)

20. Three Partners of Research Community/ CAB Site StaffEC/IRB

21. Partner Responsibilities Community/ CAB Site StaffEC/IRB

22. Site Staff Responsibilities Protection of human participants Scientific correctness Appropriate informed consent Confidentiality protection FHI / N. Herndon Site Staff

23. Researcher’s Responsibilities Researcher’s Responsibilities (continued) Conduct research according to protocol Compliance with Ethics Committee requirements — Report adverse experiences, protocol violations, participant complaints Post-study — Long-term interests of participants

24. Researcher’s Human Qualities Integrity Respect Compassion Professionalism Courtesy Sensitivity FHI / R. Kohler

25. Sponsor’s Responsibilities Select qualified researchers Ensure appropriate review, approval and supervision by an Ethics Committee Provide policies and procedures Monitor the research

26. Sponsor’s Responsibilities in International Research Comply with the local ethical, regulatory and legal requirements Ensure the local relevance of the research while involving local partners in the development stages Promote research integrity

27. Ethics Committees: Research Supervision Required by ethical guidelines Names of committees vary by location Primary purpose is to protect human research participants EC/IRB

28. Ethics Committee Membership Qualified Area of expertise aligned with type of research Local community representatives Clergy or other community leaders Former study participants Diverse Sex Age Cultural Background

29. Initiate and provide feedback on research specific issues Voice concerns from the community and study participants Take the initiative to understand research and community issues CAB Members: Connections to the Community Community/ CAB

30. Ensuring community input is based mainly on the role community has in the process, particularly the role of the CAB. Are they advisors or partners? Advisors/ Partners/ Consultants Collaborators Community Partnership in Research

31. Potentially, there are many different people and organizations who will be affected by research in the community have an investment in what happens to in their community. All these people and organizations are called: Stakeholders Stakeholders

32. stakeholders who are directly affected and invested in an outcome of the research (Women in prenatal clinics, actual IV Drug Users) people or organizations that are interested in the outcomes but are not directly affected by it (Family members of substance users, NGOS providing services, politicians, religious institutions, government, PSB, the Researchers, etc.) Stakeholders Stakeholders (continued)  Indirect  Direct Two types of stakeholders:

33. Inform the research team of local issues and concerns that might affect the research Advise research team on the development and implementation of recruitment and retention plans and other study documents Review and advise protocol team and site staff on the development of the Informed Consent processes to improve informed decision making. Ensuring participants’ rights are considered. Responsibilities of CAB Members

34. Participants’ Rights Information Access Choice Safety Privacy Respect Referrals / follow-up care

35. CABs should be involved: At a minimum:  At the FRONT END of a study in formulating research questions and approaching the community  IN THE MIDDLE serving as a check point for how things are going.  At the BACK END in interpreting and applying the findings

36.  Community participation is a component of larger Network ethics agenda  Community partnerships must occur at all levels of the research process  Community processes are key to ethical conduct of research “Community Participation is Ethics In Action!”