Michelle P' Goldberg, Ph'D'

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Research Ethics andthe Ethical Review Protocol

• Michelle P. Goldberg, Ph.D.
• mgoldberg_at_oise.utoronto.ca
• November 22, 2008
• TSP Student Conference
• Adapted from the Office of Research Ethics and
  2004 TPS Student Conference
• http//www.research.utoronto.ca/ethics/eh_educatio
  n.html

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Outline

• Research ethics framework
• Review types/categories
• Research ethics issues
• The ethical review protocol
• The ethics review process FAQs
• Questions

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Ethics Review Required for all Research with
Human Participants

• Subject-centred perspective
• Research must have a favourable risks-benefits
  balance
• Just because research is not medically invasive
  does not mean it is low risk
• risk must be assessed in terms of a participants
  everyday life circumstances
• Potential benefits to science and knowledge do
  not automatically override the rights of
  participants
• Participants always have the right to say no

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Research Involving Human Subjects

• Obtaining data about a living individual
• through intervention or interaction (interview)
• obtaining of private personal information about
  the individual
• Secondary use of data (i.e. information collected
  for purposes other than the proposed research)
  with identifying information about a living
  individual, or data linkage through which living
  individuals may become identifiable.
• Naturalistic observation
• except the observation of individuals in contexts
  in which it can be expected that the participants
  are seeking public visibility.

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Key Ideas

• Key principles and issues
• Respect for human dignity, autonomy
• Balance distribution of harms/benefits
• Free informed consent
• Privacy confidentiality
• Conflict of Interest
• Inclusion/exclusion criteria
• System of research participant protection

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Research Ethics Boards

• Quorum
• 5 members, women men
• 2 broad knowledge of methods or areas
• 1 knowledgeable in ethics
• 1 no affiliation with the institution
• 1 knowledgeable in relevant law (biomed research)
• University of Toronto 3 boards
• Social Sciences Humanities ( mgmt, law,
  eng)
• Education
• Health Sciences

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Review

• All research involving humans is held to the same
  standard
• faculty member, graduate student or undergraduate
  student
• Research conducted by OISE/UT graduate students
  is reviewed at both the departmental and
  institutional levels
• Review type varies with the nature of the
  research

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Research Ethics Review

• Exempt
• educational testing, program evaluation, already
  has ethical approval
• Expeditable
• minimal risk on par with daily lifebut see
  risk matrix
• Non-expeditable
• full REBsee risk matrix
• Continuing review
• annual renewal, study completion, chance of site
  visit

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Risk Matrix

• Review Type by Group Vulnerability Research
  Risk
• Research Risk
• Group vulnerability Low Med High
• Low Exp. Exp. Full
• Med Exp. Full Full
• High Full Full Full

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RiskProbability Magnitude of Harm

• Vulnerability of group
• Physiological (e.g., health)
• Cognitive/emotional (e.g., impairment, trauma)
• Social (e.g., stigma, economic/legal status)
• Research risk
• Methods invasiveness data sensitivity
• Physiological (e.g., diagnoses, side effects)
• Cognitive/emotional (e.g., stress, anxiety)
• Social (e.g., identifiable harm as a result of
  breach dismissal, deportation duty to report,
  subpoena)

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Preparing a Protocol

• Thesis proposal should be approved by thesis
  committee
• Follow model protocols
• Work closely with your supervisor to decide on
  review type
• Check reviewer guide consent document guide
• Each section brief, clear, focused on ethics
• Download forms
• http//www.oise.utoronto.ca/depts/tps/ethics.html

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Submission Process

• Get signatures of supervisor and yourself
• Submit to Jane Goodlet
• Departmental Coordinator Michelle Goldberg
• Back to Jane
• Department Chair signature
• Sent to UofT
• Expedited weekly, Mondays by 5pm
• Full REB monthly (except August), check website
  for deadlines
• www.research.utoronto.ca/ethics/

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Deadlines

• Full Review (17 copies)
• 2 weeks before the meeting date.
• The Board meets monthly face-to-face
• Comments sent one week after meeting date
• Expedited Review (2 copies)
• Monday at 5 pm
• sent out in batches every week or 10 days
• 2-4 weeks turn around (can be 6)

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The Ethical Review ProtocolConflict of Interest

• Explain any pre-existing relationship with the
  researched in detail.
• Are you the teacher in the same board or
  potential school in which the research will be
  conducted?
• Typically role-based
• e.g., researcher instructor/minister/manager
• real or perceived, must disclose non-research
  aspects
• may have to managee.g., not recruit directly,
  blind to participation until after relationship
  ends

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Methods

• Logical sequence events Step by step is useful
• How you will gather data
• Add in what kinds of information will be asked in
  the interviews. Attach as Appendix A.
• How long will the interview/questionnaire/observat
  ion last?
• When and Where will it take place?
• How many interviews?
• Will the interviews be audiotaped and
  transcribed?
• Will participants have the opportunity to review
  the transcripts? If so, give details
• Is there a specific analysis method you will be
  using? What kinds of things will you be looking
  for in the analysis? Cite the author.

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Participants

• Who are your participants? Organizations?
  Individuals?
• Why were they chosen for your study?
  (exclusion/inclusion criteria)
• How many are there?
• Justification of sample size
• Describe personal information how extracted,
  degree of identifiability

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Experience

• If risk, sensitive, vulnerable describe
  researchers experience
• Can be course, previous research experience, or
  job
• If student describe degree of supervision

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Recruitment

• Arms length
• Phone? Provide telephone script
• Email? Provide email script
• Letter?
• posting a recruitment flyer
• see Appendix x
• Minimize perceived or overt coercion
• Avoid pressure to participate based on power
  relationships

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The Consent ProcessFree Informed Consent

• Quality of researcher-participant relationship
  across all interactions, verbal or written
• emphasis on processnot just a signature on a
  page
• covers recruitment (verbal discussions, phone
  calls, letters, e-mail, ads), responses to
  questions, de-briefing
• Straight-forward explanation, warm invitational
  tone
• free not to participate, not to answer any
  question, to withdraw without consequence
• no undue influence (e.g., non-research roles) or
  inducement (e.g., financial)
• Experience and/or training with population

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Risks

• To manage the risks you can state that
  participants will
• be informed about the nature of the study and
  their participation including the assurance that
  they may withdraw at any time or not answer any
  question they are not comfortable with.
• at no time be judged or evaluated and at no time
  will be at risk of harm.
• be informed that no value judgments will be
  placed on their responses.
• That their information will be retained in a
  secure location and kept confidential as their
  names will not be used in the study in reports,
  publications and presentations

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Benefits

• Both to individual and scholarly community
• Add into consent /recruitment letters

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Consent

• To make it easy to read outline the process step
  by step.
• Add in your experience with this participant
  population and/or training you will receive.
• Do you need administrative consent from the
  university or school board to conduct this study
  first?
• If so, include the details of the approvals
  process
• Need ER first, then approach administrative
  consent
• Dont include the letter in the body of the text.
  
• You cannot just state see appendix A.

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Consent

• Prior to participating in the interview,
  participants will be given a letter outlining
  their participation See Appendix X. The letter
  will contain information that participants need
  to know in order to sign the consent form. The
  letter will contain the title of the project and
  my contact information and that of my supervisor.
  Participants will be informed that the project
  will state purpose. They will be told that the
  interview will take X minutes and will ask
  about add in the kinds of things that will be
  asked. They will be told that the session will
  be tape recorded and transcribed and they will
  sign for their specific approval of this point.
  They will be told their participation is
  completely voluntary and they will be free to
  withdraw at any time. Participants will be told
  that at no time will they be judged or evaluated
  and at no time will be at risk of harm and no
  value judgment will be placed on their responses.
  They will be informed that they may also refuse
  to answer any questions that they are not
  comfortable with. They will be informed that the
  information will be retained in a secure location
  where and kept confidential as their names will
  not be used in the study in reports, publications
  and presentations.

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Debriefing

• If deception is used be sure to debrief to allow
  real informed consent.
• Participant needs to reconsent after debriefing
• Allowed to withdraw data after debrief
• If giving participants the opportunity to request
  a copy of the summary of results of the study,
  state how they can request it and how you will
  get it to them.
• You can state See my consent letter where
  participants can tick off a box to request a copy
  of the summary of the project.

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Participant Withdrawal

• State that participants have the assurance that
  they may withdraw at any time without
  consequence, penalty and judgment, or that that
  can refuse to answer any question in the
  interview or questionnaire and choose to
  terminate the interview at any time.
• State that participants will be informed of their
  rights through the consent form, which you will
  review with them prior to their participation and
  they will keep for their records.

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Confidentiality

• Identity and personal information anonymity
• protect personal information
• Consider throughout project
• Recruitment (e.g., confidentiality/anonymity,
  snowball referrals, phone messages)
• Data collection (e.g., focus groups/interviews,
  notes/recordings)
• Data storage plan separate identifiers from
  content double lock password protect, retention
  
• Specific, home locked cabinet
• Destruction When How? 5 years
• Future publication pseudonyms, generics,
  aggregates
• Explain who has access to raw data e.g.,
  supervisor?

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Confidentiality

• Possible limits to confidentiality
• Key informants (specialized group, readership)
• Duty to report
• child abuse
• intent to harm self or other
• Subpoena
• may be possible to challenge
• What could happen if the participant is recognized

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Risk Matrix

• You need to justify why it is low risk in terms
  of research and group vulnerability.
• Low risk
• Add in that the data collected is not sensitive
  and the participants are highly educated
  professionals that can make rational/ informed
  decisions about participating.
• State there is no more risk involved than in
  everyday interactions.

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Appendices

• Telephone/email scripts
• Sample administrative consent letters
• Sample informed consent letters
• Observation guides
• Questionnaires including cover letters
• Interview or focus group questions
• Label A, B, C
• Include List

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Consent Letters

• Plain language, not legalistic, typically gr.6-8
  level
• OISE/UT letterhead
• name, position, contact, and supervisor
• At UofT
• study title, purpose, procedures, time
  involvement, risks/benefits, how data will be
  used (additional articles or presentations),
  limits to confidentiality
• Voluntary, include the assurance that they may
  withdraw at any time without consequence, no
  judgments, no risk
• Inclusion/exclusion criteria
• Sign off had study explained, questions
  answered, agree to begin, and be taped,
  transcribed
• please keep a copy of this letter for your
  records

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Consent Letters

• Variations
• Verbal if culturally more appropriate phone web
• Administrative consent (school)
• For children, written parental consent is
  required and student assent should be obtained

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Websites

• http//www.oise.utoronto.ca/depts/tps/ethics.html
• http//www.research.utoronto.ca/ethics/

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More Informationwww.research.utoronto.ca/ethics/

• Information Assistant, Office of Research Ethics
• ethics.review_at_utoronto.ca, 6-3273
• Coordinator, Undergraduate/Delegated Ethics
  Review
• rhain.louis_at_utoronto.ca, 6-0836
• Coordinator, Education REB
• bridgette.murphy_at_utoronto.ca, 6-5606
• Coordinator, Social Sciences and Humanities REB
• marianna.richardson_at_utoronto.ca, 8-3165
• Research Ethics Officer, Social Sciences and
  Humanities
• dean.sharpe_at_utoronto.ca, 8-5585

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References

• Tri-Council Policy Statement (TCPS), tutorial,
  Social Sciences Humanities Working Committee
  (SSHWC) policy initiatives
• pre.ethics.gc.ca/english/policystatement/policysta
  tement.cfm
• pre.ethics.gc.ca/english/tutorial/
• pre.ethics.gc.ca/english/workgroups/sshwc.cfm
• UT/ORE website and Guidelines and practices
  manual
• www.research.utoronto.ca/ethics/
• www.research.utoronto.ca/ethics/pdf/human/nonspeci
  fic/ERO_Guidelines_Manual.pdf
• e.g., see section 7.8.1 on key informant
  interviews
• e.g., see section 7.8.2 on participant observation