Does My Research Require Ethical

Review?John Russell

Chair, Langara College Research Ethics BoardChair, Langara Department of Philosophy

Talk for Langara PD DaysApril 24, 2013

(Revised May 14, 2014)

1. When research involving humans requires review by the Langara Research Ethics Board

2. Which of two Langara REB review processes may applicable, either by

a) the full Langara REB (for research not done solely for pedagogical purposes), or

b) by the Langara REB chair or delegated REB member (for research conducted by students solely for pedagogical purposes, i.e., “course-based research” involving humans)

What you should learn today

Meet the Langara REB!

July 2013 pursuant to MOU with the federal Tri-Council (SSHRC, NSERC, and CIHR)

Members appointed by the Langara President to two-year renewable terms.

Operates under the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2010) (TCPS2)

Establishment of Langara REB

Reviews the ethical acceptability of all research involving collection of data from living humans conducted within Langara's “jurisdiction or under its auspices regardless of where the research is conducted.” (See TCPS2, Article 6.1)

Applies to all Langara faculty, staff, and students    Operates "independently" in its decision-making and is

"free of inappropriate influence" (TCPS2, p. 62)

Includes responsibility for ethics review of “course-based research” involving humans

Langara REB Mandate

Research involving:

(a) [data collection from] living human participants;

(b) human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

“Research” = “an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.”

(TCPS2, p. 15, added text in parentheses)

What Is Research involving Humans?

Research and activities not requiring REB review:

1. Research that relies exclusively on publicly available information, if it

 a) is legally accessible, and

b) is publicly accessible and there is no reasonable expectation of privacy. (TCPS2, Article 2.2)

Examples: Public archives, court decisions, media reports, gathering data on/from public "blogs," etc.

Exceptions 1-5

2. Research involving observations of people in public places, if

- no intervention or direct interaction by researcher

- no reasonable expectation of privacy- data dissemination does not allow

identification of specific individuals (TCPS2, Article 2.3)

Examples: acts or behaviour in a public natural environment.

3. Research that relies exclusively on secondary use of “anonymous” information or biological materials

(Article 2.4)

“anonymous” = data/materials never had personal identifiers associated with them (TCPS2, p. 57)

Examples: questionnaires completed anonymously

But, research requires REB review if anonymous data can be used or linked to permit identification

4. Quality Assurance/Quality Improvement Studies (TCPS2, Article 2.5)

QA/QI = Studies assessing the performance of an institution or its employees or students

Examples: course and program evaluations, staff performance reviews

5. Creative practice activities (TCPS2, Article 2.6)

“Creative practice activities” = process by which an artist makes or interprets art; study of how a work of art is created.

Examples: Portrait painting, analyses of an artist’s creative process, etc.

If in doubt about whether research/activity requires REB review, contact the Langara REB

chair:

John Russelljrussell@langara.bc.caLoc. 5453

1. Complete Request for Ethics Approval Form

2. Provide two signed copies to Office of the Deans, Langara REB chair or administrator at least 14 days before scheduled meeting.

3. The chair appoints a primary reviewer to present the Request for Ethics Approval.

4. The Langara REB deliberates and decides to i) Approve, ii) Approve subject to satisfactory responses to provisos, iii) Defer, or iv) Reject.

5. An appeal process exists if disagreement about an Langara REB decision cannot be resolved.

6. There is a process for amendments and annual renewals.

7. The Langara REB’s administrative assistant is Ramon Rodrigo (rrodrigo@langara.bc.ca,604-323-5933).

8. See Langara Policy B5007 Ethical Conduct for Research involving Humans

Langara REB Review Process for Research Not Solely for Pedagogical Purposes

Langara REB members keep knowledge of and deliberations about applications confidential; declare conflicts of interest

Ethical implications of research methodology discussed where ethically relevant (bad science is often unethical)

A “proportionate approach” to ethics review is taken

Researchers are invited to attend and present their studies if they wish, but cannot remain during deliberations

Other Aspects of Review Process

Langara REB review is not strictly a scientific peer review process, but at a small institution is often the only opportunity for peer review.

Most studies are “minimal risk” and could, in theory, be handled by “delegated review.”

Others?

Issues for Discussion

Course-based research involving collecting data from living humans will be eligible for review by the REB chair or delegated REB member, if the research is

◦ Conducted solely for pedagogical purposes

◦ “minimal risk” (as follows):

Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects of their everyday life that relate to the research.( TCPS2, Glossary)

Research must not expose students to more than minimal risk

Students collecting data from living humans as part of an instructor’s or another researcher’s study is not “course-based research” and requires full REB review

REB Review of Course-Based Research

1. Instructors submit applications for students to conduct research involving data collection from living humans for each of the instructor’s courses (not classes) that require or permit students to undertake such research

2. Complete the Application Form for Course-Based Research and submit to Langara REB chair, John Russell, or REB administrative assistant Ramon Rodrigo

3. Deadlines are August 15, November 15, March 15 for the following terms

4. The instructor’s research component (including research ethics training and oversight) is approved for indefinitely for each course

5. But, any changes to the nature of the research involving humans or to ethics training or to ethics oversight must be submitted to the Langara REB chair and approved before changes are implemented

Process

See Information on the ethical review process for course-based research for more details

More Information