Framework for Research Ethics Guidelines and Researcher’s Handbook

 

For Review of Non-Medical Reseearch Involving Human Subjects

A. THE ROLES AND RESPONSIBILITIES OF THE RESEARCHER AND THE RESEARCH
ETHICS BOARD


1. McMaster’s Policy and Mandate

2. McMaster Reserch Ethics Board

3. Responsibilities for Protecting Human Subjects

3.1 The Principle Investigator
3.2 The McMaster Research Ethics Board
3.3 The University Administration

4. Types of Research that Require Review

5. Exemptions to the Review Process

6. Criteria Used by the Board for Review

7. Levels of Review

7.1 The Principle of Proportionate Review
7.2 Full Board Review
7.3 More Than Minimal Risk
7.4 Expedited Review
7.5 Review by a Student Research Ethics Committee
7.6 Course-Based Research
7.7 Executive Review

8. Decision Making by the McMaster Research Ethics Board

9. Appeals

9.1 Appeals from Student Research Ethics Committee decisions

10. Multi-Centred and Inter-Institutional Review

10.1 Research that requires revew
10.2 Research in other jurisdictions or off of University premises
10.3 Approval by other research boards
10.4 Multi-Institutional research

11. Monitoring and Completion

12. Adverse Events

13. Non-Compliance

B. THE PRINCIPLES OF REVIEW


14. Risks and Benefits

14.1 Risks
14.2 Benefits
14.3 Assessment of Risks and Benefits
14.4 Guidelines for the Use of High Risk Test Instruments

15. Informed Consent

15.1 Elements of informed consent
15.2 Competence
15.3 Disclosure of information
15.4 Voluntariness
15.5 When to discuss participation
15.6 Consent in writing
15.7 Alternatives to individual written consent
15.8 Exceptions
15.9 Feedback to participants

16. Special Research Circumstances and Vulnerable Populations

16.1 Individuals who are not legally competent to consent
16.2 Research involving children
16.3 Research involving persons who are mentally incompetent
16.4 Authorized legal representative and legal age of consent
16.5 Research involving “captive” groups
16.6 Research involving Aboriginal Peoples

17. Participant Recruitment

17.1 Recruitement of students, employees, colleagues and subordinates

18. Privacy and Confidentiality

19. Conflict of Interest

19.1 Conflicts of interest involving researchers
19.2 Criteria for assessing the likeliehood of a conflict of interest
19.3 Conflicts of interest by REB members
19.4 Institutional conflict of interest

20. Deception

21. Naturalistic Observation

22. Secondary Use of Data

C. SUBMITTING RESEARCH FOR REVIEW: THE APPLICATION PROCESS


23.0 What to submit

23.1 Faculty and Graduates
23.2 Undergraduates
23.3 Course-Based Research Projects
23.4 What else to include with the Application Form

24. Where to submit the application forms

25. Completion of the application form

25.1 Title of the project
25.2 Other research ethics board approvals
25.3 Conflict of interest
25.4 Experience
25.5 Number and characteristics of participants
25.6 Compensation of participants
25.7 Risks and benefits
25.8 Informed consent
25.9 Additional information