Introduction to Research Ethics Africa RWG Workshop 21 May 2003 Stella Kirkendale Wayne Wilson.
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Transcript of Introduction to Research Ethics Africa RWG Workshop 21 May 2003 Stella Kirkendale Wayne Wilson.
Introduction to Research EthicsIntroduction to Research Ethics
Africa RWG Workshop
21 May 2003
Stella Kirkendale
Wayne Wilson
Four Corners:Four Corners:Values Clarification ExerciseValues Clarification Exercise
What is “Ethics”? What is “Ethics”? What is “Bioethics”?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.
Fundamental Principles ofFundamental Principles ofHuman Research EthicsHuman Research Ethics
FHI / N. Herndon
• Respect for persons
• Beneficence
• Justice
• Vulnerable people or groups needing special protection. Who might this be?
– …
– …
– …
Respect for PersonsRespect for Persons
• Autonomy, self-determination
Respect for PersonsRespect 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
• 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
BeneficenceBeneficence
JusticeJustice
• Equal distribution of risk and benefit
• Equitable recruitment of research participants
• Special protection for vulnerable groups
What is “Ethical Obligation”?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
What is an “Ethical Dilemma”?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.
How are “Ethical Dilemmas” How are “Ethical Dilemmas” resolved?resolved?
• Consider whether obligations are being violated
• Examine all viewpoints carefully, critically and openly
• Respect legitimate diversity
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 Research Issues Important to EthicsImportant to Ethics
Necessary to understand connection of other key issues and ethics:
• Informed consent
• Standards of care
• Partnerships
Issues Important to EthicsIssues Important to Ethics continued
Informed ConsentInformed Consent
ChallengesChallenges– 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
Meaningful Informed ConsentMeaningful Informed Consent
Process – pre-enrollment, enrollment and study participation
Community and CAB involvementAdequate time for counselingLexicon of locally used terms Managing rumours – egs blood draws;
“Devil’s money” Diverse range of methods – drama,
quizzes, comics, role-play, focus groups
Standard of CareStandard 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
Partnerships in ResearchPartnerships 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
Responsible Conduct of ResearchResponsible Conduct of Research
Shared responsibilities in research process
• Well-designed research
• Adequately reviewed
• Ethically conducted
• Properly disseminated
Partnerships for ensuring Partnerships for ensuring research is “ethical” in the HPTNresearch 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)
Three Partners of ResearchThree Partners of Research
Community/CAB
Site Staff EC/IRB
Partner ResponsibilitiesPartner Responsibilities
Community/CAB
Site Staff EC/IRB
Site Staff ResponsibilitiesSite Staff Responsibilities
Protection of human participants
• Scientific correctness
• Appropriate informed consent
• Confidentiality protection
FHI / N. Herndon
Site Staff
Researcher’s ResponsibilitiesResearcher’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
Researcher’s Human QualitiesResearcher’s Human Qualities
• Integrity
• Respect
• Compassion
• Professionalism
• Courtesy
• SensitivityFHI / R. Kohler
Sponsor’s ResponsibilitiesSponsor’s Responsibilities
• Select qualified researchers
• Ensure appropriate review, approval and supervision by an Ethics Committee
• Provide policies and procedures
• Monitor the research
Sponsor’s Responsibilities in Sponsor’s Responsibilities in International ResearchInternational 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
Ethics Committees:Ethics Committees:Research Supervision Research Supervision
• Required by ethical guidelines
• Names of committees vary by location
• Primary purpose is to protect human research participants
EC/IRB
Ethics Committee MembershipEthics 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
• 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:CAB Members:Connections to the CommunityConnections to the Community
Community/CAB
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 ResearchCommunity Partnership in Research
• 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
StakeholdersStakeholders
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.)
StakeholdersStakeholders (continued)
Indirect
Direct Two types of stakeholders:
• 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 MembersResponsibilities of CAB Members
Participants’ Rights Participants’ Rights
• Information• Access• Choice• Safety• Privacy• Respect• Referrals / follow-up care
CABs should be involved: 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
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 isCommunity Participation is
Ethics In Action!”Ethics In Action!”