UBC BEHAVIOURAL RESEARCH ETHICS REVIEW: TIPS AND TRAPS Jean Ruiz, - - PowerPoint PPT Presentation

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

1.

Respect for Persons

 Respecting autonomy (free & informed consent)  Protect those with developing/diminished autonomy

2.

Concern for Welfare

 Consider risks & potential benefits of research  Welfare of participants & group

3.

Justice

 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 2nd 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

• btain 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

Consent forms/documents

 BREB Guidelines:

http://research.ubc.ca/sites/research.ubc.ca/files/uploads/Fin al%20revised%20ICF%20guidelines.doc

 These are guidelines only  Information provided to participants should be dictated by

specifics of your project (e.g., study population & what you plan to do)

 Consent guidelines list 12 standard elements  You do NOT have to include all these elements (see TCPS2,

Article 3.2)

 Provide cover letter explaining why you are departing from standard

procedures/elements

Tips for graduate students

 Your supervisor must be PI on application

 Ensure you are listed as co-investigator  List yourself as primary contact

 Question 4.4 Peer review

 Committee approval is sufficient

 Question 5.1 Research summary

 Make it clear that the study is being conducted for your dissertation

 Question 7.3 Research qualifications

 State specific as well as general qualifications

Example

“Jane Doe has a Master’s degree in social work and has prior research experience and training in qualitative research methods; her dissertation was based on formal, semi-structured interviews with 25 cancer patients. She also served as a volunteer at the BC Cancer Agency for two years between 2008-2010. She is therefore attuned to the needs of this population and the sensitivities surrounding the subject matter

• f the study.”

Post submission

Application submitted   Reviewed by Department Head   Appears in research ethics board administrators’ inbox : Minimal risk studies  Associate Chair reviews Full board studies  2 primary reviewers  reviewed at board meeting  Approved – certificate of approval  Provisos (Amendments) *most common scenario  Deferred – provisos with responses to be reviewed by full board  Study can begin

Summary

 Make sure what you want do & how you want to do it is clear

• n application

 Take time to go through application to ensure no errors in

consistency, no blank spots, etc

 Time spent now will save time later!

 Demonstrate awareness of any ethical issues connected with

your research (e.g. dual researcher/practitioner relationship) & how you will deal with them

Key resources

ESSENTIAL READING

 Behavioural Research Ethics Board guidance notes:

http://research.ubc.ca/ore/breb-forms-guidance-notes

Consultation

 Shirley Thompson, Manager of BREB

Ph: 604 827 5112 Email: shirley.thompson@ors.ubc.ca

 Nadia Rad, Senior Administrative Coordinator

Ph: 604-827-5114 Email: nadia.rad@ors.ubc.ca

 Jean Ruiz, Senior Research Ethics Analyst - Behavioural

Ph: 604 827 5310 Email: jean.ruiz@ors.ubc.ca