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

SCERIHSSenate Committee on the Ethics of Research Involving Human

Subjects

Fort Garry Campus Bannatyne Campus

Psychology/Sociology REB Health REB

Education/Nursing REB Biomedical 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