Is Your Research Ethical? The application of Research Ethics Guidelines to Regional Health Authority Research Dr Alan Katz Need to Know: June 9, 2003

Role of Research Ethics Boards: Rights, Safety and Well-being of Research Participants Independent Review

Guiding Ethical Principles Respect for human dignity Respect for Free and Informed Consent Respect for Vulnerable Persons Respect for Privacy and Confidentiality Respect for Justice and Inclusiveness Source: TCP 1998

Requirement for Ethics Review All research involving human subjects: information collected through intervention or interaction with living individuals identifiable private information about individuals human organs, tissues, body fluids written/recorded information derived from identifiable individuals Pilot/Feasibility studies Secondary Use of data

Compliance with Ethical & Regulatory Guidelines Tri-Council Policy Statement (1998) ICH-GCP guideline (1997) Personal Health Information Act (1997) –University of Manitoba’s Policy 1406 (1999) –FDA Guidelines (1991)

1. Social value and Scientific Validity Scarce resources Rationale and Background (Protocol) Design –qualitative vs. quantitative –sample size calculations –can the proposed design answer the research question

2. Balancing Harms and Benefits Likelihood Not less than standard care Placebos Minimize Harm Maximize Benefit

3. Investigator Qualifications (CV) –Student, Faculty member or community based Conflict of Interest Relevant Experience

4. Subject Selection Societal distribution of risks and benefits –Randomization Advertisements Enrollment and Referral process (PHIA) Amount and method of payment Privacy and Confidentiality

5. Free and Informed Consent Competence Informed Potential for coercion: Payment or compensation Risks and Benefits Rights to refuse/withdraw Contact Information

6. Conflicts of Interest Researchers REB Members Sponsoring organizations

REB structure at The University of Manitoba SCERIHS Senate Committee on the Ethics of Research Involving Human Subjects Fort Garry CampusBannatyne Campus Psychology/Sociology REBHealth REB Education/Nursing REBBiomedical REB Joint Faculty REB

REB Review Procedures Monthly Scheduled Meetings Quorum Decisions via consensus –Approved as submitted –Approved pending revisions –Tabled –Not approved

Monitoring/Continuing Review Annual Status Reports & Re-approval Final Study Status Reports Full Board Re-review every 5 years Random audits by SCERIHS or REB –e.g. informed consent process –e.g. protection of privacy & confidentiality

Research Methodologies Quantitative –Database Research –Longitudinal studies –Needs assessment Qualitative –Focus Groups –Semi-structured interviews –Participatory action research –Participant Observation

Database Research Privacy & Confidentiality –Identifying information –Cell size –Security Database linkage HIPC (Clinical Databases)

Research involving communities Methodology –Participatory action research Cultural context –Potential for conflict between cultures of the researcher and the community –Language –Consent Competing interests of different sections of the community

Aboriginal communities Good practices (TCPS) –Respect culture and traditions and knowledge of the aboriginal group –Conceptualize and conduct research as a partnership –Consult members of the group who have relevant expertise

Aboriginal communities (cont.) –Involve group in design of the project –Examine how research may be shaped to address the needs of the group –Respect viewpoints of the various segments of the group –Opportunity to respond to research findings before completion of final report

Aboriginal communities (cont.) Sharing information with the community: –Protection of groups, property –Availability of preliminary report for comment –Potential employment of community members –Cooperation with community institutions –Deposit of data in agreed-upon repository