UBC BEHAVIOURAL RESEARCH ETHICS REVIEW: TIPS AND TRAPS Jean Ruiz, M.A. Senior Research Ethics Analyst - Behavioural UBC Office of Research Ethics
Tri Council Policy Statement Overarching Canadian policy framework for research involving human participants All researchers should be familiar with TCPS2 TCPS guidelines recently revised and the latest addition was released in Dec. 2010. TCPS2 available at: http://www.pre.ethics.gc.ca/eng/policy- politique/initiatives/tcps2-eptc2/Default/ TCPS2 tutorial (‘CORE’) available at: http://tcps2core.ca/welcome Medical residents and all students involved in research are required to complete tutorial
TCPS2 core principles Respect for Persons 1. Respecting autonomy (free & informed consent) Protect those with developing/diminished autonomy Concern for Welfare 2. Consider risks & potential benefits of research Welfare of participants & group Justice 3. obligation to treat people fairly & equitably Equal access to benefits/equal share of burdens Avoid underprotection & overprotection
TCPS key definitions Research (Article 2.1. Application Section): “An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation” Human participants: “those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question” * Authorized personnel who release information or data in ordinary course of their employment about organizations, policies, procedures, professional practices or statistical reports are not considered participants
Research exempt from institutional review Article 2.2: Research that relies exclusively on publicly available information Legally accessible to public & appropriately protected by law Publicly accessible information & no reasonable expectation of privacy Article 2.4: Secondary use of anonymous information or human biological materials So long as process of data linkage does not generate identifiable information UBC Policy #89 states that genetic material is never considered anonymous unless a REB determines otherwise
Article 2.3: Naturalistic observation of people in public places where: No intervention staged by researcher or direct interaction with individuals or groups Individuals or groups targeted for observation have no reasonable expectation of privacy Dissemination of research results does not allow identification of specific individuals
RISe All applications and associated documents must be submitted online RISe (Researcher Information Services): http://rise.ubc.ca/ From RISe homepage follow the link on the right hand side “Accessing RISe” Need campus-wide login (CWL) Account (http://www.it.ubc.ca/cwl/homelink.shtml) Need Researcher # from ors@ors.ubc.ca
BREB ethics review categories Minimal risk No greater than risks of everyday life No deadlines for minimal risk (reviewed by academic members) If bumped up to full board, time in review increases Full board Once a month every 2 nd Thurs. of the month Check website for deadlines http://research.ubc.ca/ethics/meeting-dates-deadlines-0
What studies would not be minimal risk? Under new guidelines MOST social science/behavioural research is expected to meet minimal risk guidelines Except research that involves BOTH vulnerable populations AND personal, sensitive or incriminating topics or questions Studying people engaged in illegal activities (e.g. heroin use or euthanasia) about these activities Experiences of bullying amongst school-aged children Talking to abused people about their experiences of abuse Research that uses deception Unless researcher has convincingly argued that deception is minor & possibility of harm is remote
Minimal Risk Matrix Research Risk: Physical, Emotional, Psychological, Financial, Legal, Privacy, Reputation, Group Vulnerability Low Medium High Low Delegated Delegated Full board Medium Delegated Full board Full board High Full board Full board Full board
General tips & traps Consistency Clarity Detail
Consistency Make sure details provided are consistent throughout application: Recruitment Procedures Consent & assent forms Advertisements Major areas of inconsistency: numbers of people to be recruited, inclusion/exclusion criteria, study procedures, switching between first/third person
Example 1. Q 6.1. How much time will a participant be asked to dedicate to the project: “30 mins-1 hr” Consent form : “your involvement will entail an interview of 1-2 hrs” Recruitment ad : “you are invited to participate in a 30 min-2 hr interview”
Clarity Explain your procedures as clearly as possible: what you plan to do, how you plan to do it, to whom & how often In other words, BREB needs to know what will happen to participants in your study: Exactly how they will be recruited Details of who will obtain consent, when and how Exactly what participants are required to do DON’T just cut & paste from grant application, research proposal, etc!
Example 1. (Bad) Q 5.6. Summary of Procedures: “The overarching goal of the proposed study is to evaluate the feasibility of supporting the BSM efforts of specific sub- populations of PLWD. This goal will be achieved by completing a three part environmental scan whereby we will: 1) Map the BC distribution of PLWD; 2) Describe HCPs current practices and perceptions for how best to support BSM in PLWD; and 3) Compare and contrast the BSM of men and women living with diabetes”.
Example 2. (Better) • Q 5.6. Summary of Procedures: • Interviews will be conducted with less than or equal to 50 people with a history of cancer to obtain a better understanding of their experience of cancer survivorship. Once a participant contacts the researcher expressing an interest in being interviewed, they will be screened for eligibility & then an interview time & place will be determined & a consent form will be provided via email. The interview will be held in a location specified as convenient for the participant & with the participant’s consent it will be audio-recorded. Depending on how much the interviewee has to say, the interview will last between 1-2 hours.
Detail All sections on form must be complete Be sure to provide enough detail, e.g.: • Q5.4 “provide a detailed description of method of recruitment” – don’t just say “by letter” Even small details are important • E.g., proviso likely to be issued if you fail to indicate where your data will be stored Balance between providing too little detail & too much • Don’t make reviewer sift through response to find necessary info
Example 1. (Bad) Q 6.2 “describe what is known about the risks” “N/A”
Example 2. (Better) Q 6.2 “describe what is known about the risks” “There are no known risks associated with this study design. Procedures might make those who are low in SES conscious of having lower social status compared to other students, but such feelings are not atypical compared with what one might experience in daily life and any negative feelings should be short lived. In addition, we have a debriefing procedure where we will explain the significance of the research so that they can put their experience in a larger perspective”.
Research with minors Age of majority in BC is 19 BUT age of majority does NOT dictate whether minors can provide their own consent (e.g., mature minor doctrine) TCPS2 emphasizes individual capacity for consent: “Capacity refers to the ability of prospective or actual participants to understand relevant information presented about a research project, and to appreciate the potential consequences of their decision to participate or not participate. This ability may vary according to the complexity of the choice being made, the circumstances surrounding the decision, or the point in time at which consent is sought” (TCPS2, Article 3.8) BREB consents requests for obtaining consent from minors on case-by- case basis If you are working in institutional contexts you may be required to obtain parental consent (e.g., Vancouver School Board)
Documenting consent TCPS 2, Article 3.12: “Evidence of consent shall be obtained either in a signed consent form or in documentation by the researcher of another appropriate means of consent” TCPS2, Article 10.2: “Under a variety of circumstances, signed written consent is not appropriate in qualitative research” Factors to consider: How will you explain the project (Email? Verbally? Information sheet?) Submit a copy of the email or the consent script to section 9 How will you document consent? (Fieldnotes? Audio-recording? Email?) This needs to be explained
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