REB Review Process
REB Review Process
|Department||Applied Educational Research|
|Creation Date||May 17, 2011|
|Approval Date||May 17, 2011|
|Effective Date||May 17, 2011|
This policy pertains to all staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute.
The purpose of this policy is to describe what type of research requires ethics review and the review process at the Michener Institute.
All research involving “human participants” will require ethics review including:
- Research involving living human participants; and,
- Research involving human biological materials derived from living and/or deceased individuals (human embryos, foetuses, foetal tissue, reproductive material and stem cells.)
This policy applies to the Chair, members of the Research Office and/or administration, and REB.
2.1 Review Process
2.1.1 The Chair of the REB will determine if a research submission meets the definition of ‘human participant’ research;
2.1.2 Investigators will be notified immediately for submissions that do not meet the definition of ‘human participant’ research (see Procedure section 3.2.1 of Policy: Activities requiring REB review);
2.1.3 Submissions that meet the definition of ‘human participant’ research will be processed appropriately (see Policy: REB Submission Requirements and Administrative Review), assessed for delegated or full-board review, and distributed to reviewer(s);
2.1.4 The reviewer(s) will review research submissions for scientific and ethical merit applying a ‘minimal criteria for approval of research’ (see Procedure section 2.1of Policy: REB Initial Review) in making their decision determinations (see Policy: REB Decision Determinations);
2.1.5 For Delegated Reviews see Policy REB Delegated Review;
2.1.6 For Full Board Reviews see Policy REB Initial Review;
2.1.7 Investigators will be notified of the REB’s decision within as practicably as possible a time period. (see Policy: REB Communication with Investigators).
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Chapter 2.
- ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996.
- World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011. http://www.who.int/ethics/publications/research_standards_9789241502948/en/index.html
- Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT)