Transcript REB Review Process Initial Review

REB Composition
Comparison Chart
TCPS
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5 members of both sexes
 2 broad research expertise
 1 knowledgeable in ethics
 Biomedical research – 1
knowledgeable in law
 1 community member
 Membership should be broad enough
to reflect the composition of the
community the REB serves
www.pre.ethics.gc.ca/english/policystatement/sectio
n1.cfm#1B2
GCP
PHIPA
 5 Members
 Reasonable no. of members with
collective qualifications/experience
to review types of research seen by
the institution
 1 non-scientific
 1 independent
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5 Members (1 with no affiliation)
 1 knowledgeable in research ethics
 2 with expertise in methods or
areas
of research
 1 Professional with expertise in
privacy and PHI issues
www.elaws.gov.on.ca/DBLaws/Regs/English/040329_e.
htm#BK16
www.hc-sc.gc.ca/dhp-mps/prodpharma/applicdemande/guide-ld/ich/efficac/e6_e.html#3.0
Food & Drug Regs
45 CFR 46
 5 Members of varying expertise
 5 Members (majority Canadian
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Citizens or Residents)
Both male and female
2 with scientific expertise
1 knowledgeable in ethics
1 knowledgeable in biomedical
research
1 community member
1 non-scientific discipline
www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/pdf/compli-conform/1024_e.pdf
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sufficient to complete adequate
review of the research commonly
conducted by the institution
Diversity of members possessing
professional competence
suitable to an IRB
REB may not be drawn entirely
from 1 profession
1 non-affiliated member (no family
connections, either)
1 scientific member
1 non-scientific member
www.hhs.gov/ohrp/humansubjects/guidance/45
cfr46.htm