Tips & Traps: Ethics Board Approval!

How to Get Your Protocol Approved by the Ethics Board: Tips and Traps

The 2009 Tips and Traps Workshop is Wednesday December 2, 10:00 - 12:00 CIBC Hall 308. -contact ethicsoffice@mcmaster.ca if interested in attending

Workshop presentation by Dr. Daphne Maurer, Chair of the McMaster Research Ethics Board

PDF

 

What Requires Review?

Traps: Thinking there is no need for MREB review if there is no risk or no consent form or someone else said it's O.K.

  • I am only talking to people; there are no risks
  • It's just an anonymous survey; sending it back indicates consent
  • It's naturalistic observation in a public place; anyone could sit there
  • It was already reviewed at Toronto; they said it's O. K.

Tri-Council Policy Statement

  • Research: "Systematic investigation to establish facts, principles, or generalizable knowledge" Section 1: Ethics Review
  • Involving human subjects or their remains
  • Or records from human subjects (chart review; use of data for new purpose)
  • Research by students for courses or theses
  • Pilot projects
  • Research outside McMaster

 

Why?

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  • Research Ethics Board = Arm's length body
  • Values research, but no particular interest
  • From perspective of participants
  • Review criteria differ re:
    • Level of risk
    • Research method (naturalistic observation, interviews with public figures, psychology experiments)

What Does Not Require Review?

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  • Use of public records
  • Quality Assurance
  • Naturalistic observation where invidividuals are seeking exposure (e.g., political rallies)

Which Board?

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McMaster Research Ethics Board

  • Within the Board's expertise
  • Does not review protocols from Hamilton Health Sciences/ Faculty of Health Sciences or St. Joseph's Healthcare
  • ASK http://www.mcmaster.ca/ors/ethics/
  • Membership of the Board 2008 - 2009
    • Daphne Maurer, Psychology, Chair
    • Dorothy Pawluch, Sociology, Vice-chair
    • Jeannie An, Innis Library
    • Donna Baines,Labour Studies
    • Marshall Beier, Political Science
    • Nick Carick, Divinity College
    • Debra Clinton, Community Member
    • Elisabeth Gedge, Philosophy, Ethicist
    • Yaro Konar, grad student Psychology
    • Andrew Mitchell School of the Arts
    • Bruce Milliken, Psychology
    • Jim Lyons, Kinesiology
    • Violetta Igneski, Philsophy/Communication Studies
    • Lynne Lohfeld, CE & B/ Program on Education Research and Development
    • Cindy Sue McCormack, Community Member, Social Planning & Research Council
    • Linneth Maride, Undergraduate
    • Gail McKeegan, Community Member
    • Tina Moffat, Anthropology
    • Tony Porter, Political Science
    • Ryan Smith, Lawyer, Community Member
    • Wayne Warry, Anthropology
    • Carol Wood, Chaplaincy
    • Isik Zeytinoglu, School of Business

How? Ethical Framework

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  • Respect for human dignity
  • Beneficence/non-malficence
  • Justice

Philosophical underpinnings & online tutorial

What? Reviewer's Form

Methodology

Selection and Recruitment

Risks/Benefits

Informed Consent / Consent Form

Right to Withdraw

Privacy / Confidentiality

Risks / Benfits

 

Methdology

  • Bad research may not be ethical
    • Puts participants at risk for no possible benefit
    • Misleads participants
  • Better methodology increases possible benefit

Selection and Recruitment

  • Justification of exclusion of certain populations
  • Special concerns if:
    • "captive populations" - students, employees, colleagues
    • "vulnerable" populations - mentally incompetent, dying

Informed Consent / Consent Form

  • Informed consent is a process, not a form
  • Participants must be competent for particular choice
    • Full disclosure of purpose, what will happen, risks, benefits
    • Voluntary choice

Right to Withdraw

  • Without consequence
  • Clearly stated to participant
  • What will happen to data already collected
  • Can participant skip parts and remain in the study?

Privacy and Confidentiality

  • Normal default = respect privacy by offering confidentiality
  • Transparency about degree of confidentiality
  • Best assurance is through anonymity

Risks / Benefits

  • Reasonable in relation to anticipated benefits to participant (if any) and importance of knowledge that my result
  • Forseeable harms should not outweigh anticipated benefits
  • Risk should be minimized

Is it more than minimal risk?

"no greater than ... encountered in everyday life" re: probability and magnitude (Tri-Council Policy Statement, Section 1, Article C.1

HOW TO FILL OUT THE PROTOCOL FORM

SECTION B - SUMMARY OF THE PROPOSED RESEARCH

9. Rationale:

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Describe the purpose and background rationale for the proposed project, as well as the hypotheses(is)/research questions to be examined.

Trap: Say too little or too much

Tips: State objectives clearly; include brief rationale

Reviewers' Questions:

  • Are objectives clear?
  • Does method match objectives?
  • What are possible benefits?

10. Methodology:

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Describe sequentially, and in detail, all procedures in which the research participants will be involved...N.B. Attach a copy of all questionaire(s), interview guides or other test instruments.

Trap: Say too little

I will interview teachers about their union. This is qualitative research and I will follow leads.

Trap: Ask for personal information that isn't needed: age, job, income, sexual orientation

Trap: Write it for academics

Reviewers' Questions:

  • What will happen from participant's perspective?
  • Does it match purpose?
    • Are any personal questions necessary?
  • Will it be described adequately to potential participants?

Special Issues in Qualitative Research

Open-ended:

  • Researcher does not know where the interview may lead - cannot fully inform REB or prospective participant.
  • Methodology includes everything: pauses, smiles, breaks, posture

May be done in social context - talking to another human

  • Makes it hard to withdraw
  • May create risk from loss of support at end

Can be intimate - risks of embarrassment, regret, guilt

Tips: Provide an interview guide

Tips: Indicate how these points will be described clearly to the prospective participant

 

11. Experience:

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What is your experience with this kind of research?

Reviewers' Questions:

  • How qualified are experimenters with these methods?
  • Can affect likelihood or magnitude of possible harms

 

12. Participants:

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Describe the number of participants and any salient characteristics (such as age, gender, location, affiliation, etc.)

Trap: Don't mention number

Reviewers' Questions:

  • Is the number within the range of appropriate? Enough to learn something but not more than needed.
  • Do the charactersitics match the rationale?
  • Are exclusion criteria justified?

 

13. Recruitment:


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Describe how and from what sources the participants will be recruited, including any relationship between the investigator(s) and participant(s) (e.g. instructor-student: manager-employee). N.B. Attach a copy of any poster(s), advertisement(s) or letter(s) to be used for recruitment.

Trap: I'll ask my friends

Trap: It will be conducted during an optional class

Trap: The agency will give me a list of clients

Trap: I will use a snowball technique whereby each inteviewee identifies others

Trap: I will test 100 teachers (no HOW they will be tested)

Reveiwers' Concerns:

Free from coercive elements?

  • Having to decline in front of peers
  • Having to decline when asked by someone in authority - teacher of class student is taking, service provider, employer

Tips: Use a third party

Tips: Describe how you will get the names

Tips: Give easy outs (I know you are busy)

Tips: Make non-participation invisible to others (e.g. allow to turn in blank survey)

Could it compromise confidentiality? Knowing who else is likely to have participated if numbers are small

Tips: Get many more referrals than needed; tell participants will use only fraction

 

14. Compensation:

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(a) Will participants receive compensation for participation? Financial or In-Kind?

Reviewers' Questions:

  • Is it large enough to be respectful?
  • Is it so high as to create undue pressure?

(c) If participants choose to withdraw, how will you deal with compensation?

 

Reviewers' Questions:

  • Will there be pressure to continue?
  • Is it so high as to create undue pressure?

REB Test: Would participatant consent without the compensation (or other influence)?

  • consistent with values
  • adequately informed about risks
  • influence is consistent with respect for human dignity

 

 

SECTION C - DESCRIPTION OF THE RISKS AND BENEFITS OF THE PROPOSED RESEARCH

15. Possible Risks:

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1. Indicate if the participants might experience any of the following risks:

a) Physical risk (including any bodily contact or administration of any substance)?

Physical discomfort

Pain

Injury or disease

Electrodes, x-rays, ultrasound, MRI, exercise

b) Psychological risks (including feeling demeaned, embarrassed worried or upset)?

Trap: Check none to avoid trouble or because haven't thought about

Tips: Acknowledge possible unpleasant psychological effects

  • Loss of self-confidence or self-respect
  • Embarrassment from personal questions
  • Stress from memories of unpleasant events
  • Regret or guilt over what revealed (or hidden)

c) Social risks (including possible loss of status, privacy and / or reputation)?

Trap: Check none to avoid trouble or because haven't thought about

Tips: Acknowledge possible social risks.

  • Loss of respect by others
  • Loss of status or reputation if not confidential
  • Risks to others from revelation of information (incest, child abuse, illness disguised from employer, corruption in NGO, "Mohawk")

 

Reviewers' Questions:

  • Whose consent is needed?
  • Are there secondary subjects?

15 - (3). Describe how the risks will be managed (including an explanation as to why alternative approaches could not be used)

Trap: There are no risks

Tips: How can risks, however small, be mitigated from participant's perspective?

  • Skip parts find troublesome?
  • Withdraw from participation without embarrassment?
  • Offer of follow-up support?
  • Review transcript for accuracy or second thoughts?

 

Reviewers' Questions:

  • Are remaining risks acceptable from a participant's perspective?
  • Informed adequately before consent?

e) Are any possible risks to participants greater than those the participants might enounter in their everyday life?

 

Reviewers' Questions:

  • Is it more than minimal risk?

Proportionate approach: some social and psychological risks are part of everyday life -- participants are willing to assume them if informed clearly in advance about:

a) those risks and

b) possible benefit of research

Tips: Explain how this applies to your research

 

16. Possible Benefits:

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Discusss any potential direct benefits to the participants from their involvement in the project. Comment on the (potential) benefits to (the scientific community) / society that would justify involvement of participants in this study.

Trap: Claim too much

Trap: Don't say anything

 

Reviewers' Questions:

  • Is the risk:benefit ratio acceptable?
  • Are the benefits described accurately to the prospective participants?

 

17. The Consent Process:

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Describe the process that the investigator(s) will be using to obtain informed consent (including a description of who will be obtaining the informed consent; if there will be no written consent form, explain why not). N.B. Attach a copy of the Letter of Information (if applicable), the Consent Form (if applicable), the content of any telephone script (if applicable) and any other material which will be utilized in the informed consent process.

Trap: Subjects will be required to sign the attached consent form

Trap: Complex language, academic jargon

 

Reviewers' Questions:

  • Is information complete?
  • Is it comprehensible to the target population?
  • Who will get consent? How? Is the process appropriate?
  • How will the process be documented?

Tips: Signature on consent form is not only option

20. Debriefing (Participant feedback):

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Explain what feedback / information will be provided in the project. (For example, a more comlete description of the purpose of the research, access to the results of the research). N.B. Please provide a copy of the written debriefing form, if applicable.

Trap: None or they can call me later to ask for a copy of my thesis

Tips: Think of as part of benefit to participant

 

Reviewers' Questions:

  • Is it comprehensible?
  • Is it appropriately complete?

 

SECTION E - CONFIDENTIALITY

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22. a): Will the data be treated as confidential?

b) Describe the procedures to be used to ensure anonymity of participants or confidentialityof data both during the conduct of the research and in the release of its findings

c) Explain how written records, video / audio tapes and questionnaires will be secured, and provide details of their final disposal or storage

d) If participant anonymity / confidentiality is not appropriate to this research project, explain, including providing details of how all participants will be advised of the fact that data will not be anonymous or confidential.

Trap: Confusing anonymous and confidential

Trap: Asking for identifying information when not needed

Tips: Anonymous is better; signed consent form may be unnecessary

Trap: Forgetting that focus group members may reveal what others say

Tips: Ask them to keep remarks confidential but warn cannot guarantee this will happen

Trap: Reporting aggregate data down to very small categories

Trap: Forgetting to warn about duty to report

Tips: Think through what you will do in advance and what to tell subjects

Trap: Mistakes (losing the laptop)

 

Reviewers' Questions:

  • Are researcher's intentions appropriate?
  • How might they go astray?
  • Would that put participants at risk?
  • Will participants understand limits to confidentiality before deciding to participate?
  • Can design be altered to ensure greater confidentiality?

 

Most Important Tips