1
WHAT IS A RESEARCH
ETHICS BOARD?
Karen Szala-Meneok, PhD
Senior Ethics Advisor, McMaster
University
November 3, 2011
Mandate of the REBs
2
 To protect the rights, safety and well-being of any
participant who takes part in research conducted
by a faculty member post doctoral fellow, graduate
student, undergraduate or staff member at or
under the auspices of McMaster University.
 No research involving humans may begin without
written REB approval.
November 3, 2011
How many REBs does McMaster have?
3
 1. McMaster Research Ethics Board: reviews
human participant research conducted by McMaster
Researchers from Business, Engineering,
Humanities, Science, Social Science, Divinity College
and other programs including certain MohawkMcMaster hybrid programs
 2. Hamilton Health Sciences/Faculty of
Health Sciences Research Ethics Board: A
joint board that reviews research conducted by
researchers affiliated with these two entities or
research conducted at these sites.
November 3, 2011
Establishment of McMaster’s REBs
4
 The Research Ethics Boards (REBs) at McMaster are
bodies that have been established by the President
and report through the Office of the Vice President of
Research and International Affairs.
 In Addition, the Hamilton Health Sciences / Faculty
of Health Sciences REB reports to the highest level of
senior management at the Hamilton Health Sciences
Corporation.
November 3, 2011
Establishment of McMaster’s REBs
5
The Tri-Council Policy Statement, Article 6.3
States:
The institution grants the REB the mandate to
review the ethical acceptability of research on behalf
of the institution, including approving, rejecting,
proposing modifications to, or terminating any
proposed or ongoing research involving humans.
November 3, 2011
But, why the “Tri-Council” Policy Statement?
6
OR
“Why do I have to follow the TCPS if:
a) my research is unfunded or
b) is funded by a source other than the TriCouncils (i.e. SSHRC, NSERC or CIHR)?”
November 3, 2011
McMaster Policy Statement for Research Involving
Human Participants
7
 McMaster University “endorses the ethical
principles cited in the Tri-Council Policy
Statement: Ethical Conduct for Research Involving
Humans (1998), and any subsequent revisions
thereto, and has mandated its Research Ethics
Boards (REBs) to ensure that all research
investigations involving human participants are in
compliance with the Statement.”
Excerpted from: McMaster Policy Statement for Research Involving
Human Participants http://www.mcmaster.ca/ors/policies/humans.htm
November 3, 2011
McMaster’s Policy
continued…
8
 “The University is committed, through its Research
Ethics Boards, to assisting the research
community in identifying and addressing ethical
issues inherent in its research, recognizing that all
members of the University share a commitment to
maintaining the highest possible standards in
research involving humans.”
 TCPS stipulates that “institutions must respect the
authority delegated to the REB.” TCPS Article 6.2
November 3, 2011
REB Guidance Documents & Regulations
9
 Across Canada, REBs at universities, colleges,
hospitals and other REBs have mandated the TCPS
as the primary research ethics guidance document.
 In addition, biomedical REBs have additional
requirements to follow, such as Health Canada, Food
and Drugs Act and Good Clinical Practice.
 REBs (both behavioral and biomedical) must also be
aware of federal, provincial and territorial privacy
legislation regarding personal information.
November 3, 2011
REB Composition & Structure Mandated by TCPS
10
 Minimally….
 A member knowledgeable
 At least 5 female & male
in ethics.
 For biomedical REBS a
member with knowledge
of the relevant law.
members.
 At least 2 members from a
broad range of
McMaster’s research
community who have
experience with the type
of research the particular
REB reviews.
 A community member
with no affiliation to the
institution.
November 3, 2011

REB Membership
expands as:


the types of research
broaden
as the number of
applications increase
Composition and Structure of McMaster’s REBs
11
McMaster Research Ethics
Board
 Chair model
 20+ members
 Member knowledgeable in




Ethics
Member knowledgeable in the
law (additional)
Community members
Members with relevant
research knowledge
Aboriginal community
member
November 3, 2011
Hamilton Health Sciences /
Faculty of Health Sciences
REB
 Chair & vice chair model
 20+ members
 Member knowledgeable in
Ethics
 Member knowledgeable in the
law (required)
 Community members
Members with relevant research
knowledge
Member with statistics
background
REB Subcommittees
12
Two examples of types of subcommittees McMaster’s
REBs established to deal with the work of their
boards in light of the notion of proportional review.
 HHS/FHS has a Student Research Ethics Committee
(SREC) for undergraduate and graduate research.
 MREB has department/discipline specific SRECs to
review minimal risk undergraduate research &
course-based research (i.e. projects created to help
students develop familiarity with methods).
 HHS/FHS: Also has a Human Tissue Committee
November 3, 2011
REB Workload
13
 Each of McMaster’s REBs have hundreds of new
applications submitted every year. Their numbers
are growing.
 Both REBs deal with thousands of pages of study
documentation every year
 Meet monthly or more frequently as required to review &
clear protocols and conduct the work of the boards.
 In addition to clearing these new studies they process,
change requests, protocol deviations, and reports of serious
adverse events for studies already in progress.
November 3, 2011
REB WORKLOAD
14
 Members read applications they are assigned &
write reviews then go to the chairs.
 Chairs lead monthly meetings (or more frequently
for sub-committees), coordinate and communicate
the initial results of the reviews to researchers and
deal with subsequent communication to clear any
remaining questions before clearance is granted.
 Members & chairs work to stay current with trends
and issues in research and research ethics and
engage in continuing research ethics education.
November 3, 2011
Key Roles and Responsibilities of the REB
15
 To provide education to the McMaster
research community about the ethical
conduct of research with human
participants.
 To provide advice and guidance to
researchers in the initial preparation of their
protocols as well as after clearance has been
obtained, should questions arise.
November 3, 2011
Key Roles and Responsibilities of the REB
16
 To provide initial ethical review of all
research proposals prior to implementation.
 To provide continuing ethical review of all
cleared research over the life of the study.
 To suspend or withdraw approval of any
study which does not continue to meet
ethical standards.
November 3, 2011
Where does the work of the REB occur?
17
 In face-to-face REB, SREC and other subcommittee
meetings (meeting monthly or more frequently).
 In one-on-one meetings/consultations with
researchers, in monthly ethics drop-ins, by email &
by telephone.
 In education workshops, “Lunch & Learn” events, &
during guest lectures in classrooms & other events.
 In the administrative offices of the board that deals
with the day to day work of the REBs.
November 3, 2011
What about the “How” of Ethics Review…?
18
I’ve taken you through the who, what, when, where,
why of REBs.
You’ll get to hear about the “how” at lunch time when
you “Dine with the Chairs” . They’ll be able to answer
that burning question…..
“How does the research ethics board know my
research is ethical?”
November 3, 2011
The End… or is it just the beginning?
19
Thank you for your kind
attention…
Dr. Karen Szala-Meneok
Senior Ethics Advisor
[email protected] Ext. 26117
November 3, 2011
Download

Karen Szala-Meneok - McMaster University