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Research Involving Human Participants

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... accurate and informed research concerning their heritage, customs and community. ... Conduct research with the group as a partnership ... – PowerPoint PPT presentation

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Title: Research Involving Human Participants


1
Research Involving Human Participants
  • Challenges and Opportunities in Field Research
    Lessons from Faculty and Graduate Research in
    Cross-Cultural Contexts

November 13, 2006
2
Need for Ethics Review
  • Respect for human dignity
  • Respect for Free and Informed Consent
  • Respect for Vulnerable Persons
  • Respect for Privacy and Confidentiality
  • Respect for Justice and Inclusiveness
  • Balancing Harms and Benefits
  • Minimizing Harm

3
When is it necessary to submit a review for
ethics approval?
  • If you are collecting information from people
    (participants) using
  • Surveys, questionnaires, interviews, focus
    groups
  • Participant or naturalistic observation
  • Experimental methods
  • Secondary data with identifying information
  • then ethics approval must be obtained prior to
    starting the research.

4
Minimal Risk
  • Tri-Council Policy Statement Ethical Conduct
    for Research Involving Humans1 (TCPS) establishes
    procedures and standards for ethics review
  • Minimal Risk (as defined by TCPS)
  • the probability and magnitude of possible harm
    implied by participation in the research is not
    greater than that encountered by the subject in
    those aspects of his or her everyday life
  • 1TCPS www.pre.ethics.gc.ca

5
University Research Ethics Board (REB)
  • The REB is mandated to approve, reject, review or
    terminate research involving human participants
    conducted within, or by members of, the WLU
    community based on the TCPS. The composition of
    the REB includes
  • Chair, Dr. Bill Marr
  • at least seven faculty members from different
    departments/faculties
  • a community representative
  • a staff member from Psychology who is responsible
    for coordinating their reviews
  • ex-officio, non-voting members from the Office of
    Research Services

6
Proposals reviewed by the University Research
Ethics Board
  • Faculty and staff research
  • Graduate student research
  • Undergraduate student research if the project
    will become part of a faculty members own
    research program or if the participants are at a
    greater than minimal risk by participating

7
Special Circumstances
  • Undergraduate student research with minimal
    risk to participants is reviewed by the
    Departmental Ethics Review Committee.
  • Research about a living individual in a public
    arena, or an artist, based exclusively on
    publicly available data does not need REB
    approval.
  • Quality assurance studies, performance review, or
    testing within normal educational requirements
    are reviewed by the Administrative Ethics Review
    Board.
  • Research undertaken by students on co-op work
    terms outside the auspices of WLU that does not
    require WLU resources and is not directly
    supervised by WLU faculty or staff does not need
    WLU REB approval (check guidelines at place of
    employment). Subsequent use of any data acquired
    may need REB approval.

8
Full Review vs. Expedited Review
  • Full Review
  • Requires face-to-face review before the REB if
    research involves greater than minimal risk, or
    if Chair requests full Board review
  • Expedited Review
  • Proposal will be reviewed by Chair of the REB as
    well as at least one other additional REB member

9
The Review Process at WLU
  • Before starting your submission to the REB,
    review the WLU Research Ethics Policy
    (http//www.wlu.ca/page.php?grp_id1430p5470)
  • TCPS policy statement and tutorial
    (http//www.pre.ethics.gc.ca/english)

10
The Review Process at WLU
  • Submit the Request for Ethics Review form and
    associated documents to the Office of Research
    Services.
  • Associated documents could include
  • Information letter/informed consent statement
  • Surveys/questionnaires
  • Telephone script
  • Recruitment posters

11
The Review Process at WLU
  • For student research, a Confirmation of
    Supervisors or Instructors Review form must
    also be submitted which confirms your faculty
    advisor/course instructor has read your ethics
    application.
  • All forms can be found on Research Office
    website, Research Involving Humans
    (http//www.wlu.ca/homepage.php?grp_id1430).

12
The Review Process at WLU
  • Application is forwarded to the Chair and at
    least one other REB member for review.
  • Comments from the reviewers are sent to the
    Research Grants Officer (RGO) and a memo
    reflecting reviewers comments is prepared.
  • The memo is sent to the researcher by internal
    mail and e-mail.

13
The Review Process at WLU
  • Researcher submits any clarifications or
    corrections to the RGO.
  • Chair reviews the changes.
  • If all comments addressed, approval letter sent
    to researcher.
  • Initial response from the REB should be received
    within two weeks of submission please contact
    RGO if you do not hear from the REB within two
    weeks.

14
Changes to Research Program
  • Should the research program change, a Request for
    Ethics Clearance of a Revision or Modification
    form must be completed and submitted to the REB
    for approval.

15
Other Reports
  • Annual reviews for on-going projects must be
    submitted to the Research Office.
  • Students must submit Final Report on Human
    Research Projects prior to graduation.

16
Other Reports
  • Should a participant be adversely affected
    (emotional, psychological or physiological in
    nature) as a result of their involvement in the
    research, the REB Chair must be notified
    immediately and an Adverse Events Report must be
    submitted. Note that lost or stolen data
    represents an adverse event because of possible
    loss of confidentiality and/or anonymity of
    participants.

17
Research Involving Aboriginal Peoples
  • Guidelines do not replace ethical standards for
    research involving human participants but rather
    ensure that the rights and interests of the
    community as a whole are respected.

18
Research Involving Aboriginal Peoples
  • Research involving Aboriginal groups gives rise
    to both special considerations and to basic
    ethical duties regarding ethics review, informed
    consent, confidentiality, conflict of interest
    and inclusion.
  • Aboriginal Peoples have a unique interest in
    ensuring accurate and informed research
    concerning their heritage, customs and community.

19
Research Involving Aboriginal Peoples
  • Why special guidelines for research involving
    Aboriginal Peoples?
  • they have been treated as a source of data
  • cultural property has been expropriated by
    researchers
  • inaccurate or insensitive research has caused
    stigmatization
  • Respect for human dignity must be maintained.

20
Research Involving Aboriginal Peoples
  • Researcher must be aware of the different culture
    (customs, rituals, etc.).
  • Language differences may impede clear
    communication when obtaining informed consent.
  • Community consent as well as individual consent
    may be needed.
  • Consent may build gradually over the course of
    the research project.

21
Research Involving Aboriginal Peoples - Special
Considerations
  • Will property/private information belonging to
    the group as whole be studied or used?
  • Will the leaders of the group be involved in
    identifying potential participants?
  • Will the research analyze or describe
    characteristics of the group?
  • Will individuals be selected to speak on behalf
    of, or otherwise represent, the group?

22
Research Involving Aboriginal Peoples Good
Practices
  • Respect the culture, traditions and knowledge of
    the Aboriginal People
  • Conduct research with the group as a partnership
  • Consult members of the group who have relevant
    expertise
  • Involve the group in the design of the project

23
Research Involving Aboriginal Peoples Good
Practices
  • Allow the community an opportunity to review,
    respond and react to the research findings before
    completing final report
  • If available, provide the REB with documentation
    regarding best practices or cultural norms for
    the community you are studying.

24
Research Involving Aboriginal Peoples Good
Practices
  • Refer to Section 6 of the TCPS (http//www.pre.eth
    ics.gc.ca/english/policystatement/section6.cfm)
    for a complete list of Good Practices and more
    details regarding Research Involving Aboriginal
    Peoples
  • CIHR Guidelines for Health Research Involving
    Aboriginal Peoples - Draft for consultation
    (http//www.cihr.ca/e/29134.html)

25
Research Involving Aboriginal Peoples Case
History
  • For an account of the Nuu-chah-nulth blood study,
    see
  • http//www.caj.ca/mediamag/awards2005/Pages/Commu
    nity20Newspaper.htm.

26
Guidelines and Flexibility
  • The TCPS and REBs in general have come under fire
    at many universities because of perceived
    inflexibility and adherence to rules that were
    based on medical research practices. Lauriers
    REB is willing to work with researchers to ensure
    that the guiding principles of the TCPS are
    adhered to within the context of the research
    proposal.

27
Guidelines and Flexibility (cont.)
  • Do not hesitate to contact the RGO if you have
    any questions about the REBs suggestions, or if
    you feel those suggestions are not a viable
    option for your research.

28
WLU Contacts
Rosemary Springett Research Grants
Officer Extension 3131
Sally Gray Manager of Research Services Extension
3528
Bill Marr Chair, University Research Ethics
Board Extension 2468
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