CREB Peer - Scientific Review Requirement

The UBC Clinical Research Ethics Board (CREB) would like to announce the implementation of a peer review pilot project which will run from July 1, 2015 to January 2016.

The aim of this pilot project is to implement a mandatory arm's length peer review for all protocols which have not been reviewed by an independent review panel. This initiative is designed to support the UBC CREB Guidance notes article 8.2 – Peer Review.

Peer review (sometimes referred to as scholarly or scientific review) is generally understood by UBC's REBs as a review of the importance of the research question (value) and the validity of the methodology. Practices around scholarly review vary between disciplines, fields of research and groups. The primary goal of this pilot project is to ensure that above minimal risk research protocols that are submitted for ethical review satisfy the relevant disciplinary standards in terms of both value and scientific validity. It is anticipated that this in turn will facilitate the ethics review process for the REB, reduce the number of provisos and deferrals issued to researchers, and improve the overall success of the research.

The peer review form must be completed and attached to an application when a protocol:

  • Is above minimal risk; AND
  • Has not undergone internal or external peer review (includes granting agency approval); AND
  • Will be submitted to the UBC CREB.

For this project the CREB has consulted with members from the UBC Faculty & Department of Medicine, as well as the VCHRI. Through consultation there were a number of questions which arose regarding the responsibility for peer review, how peer review relates to the REB and what changes will be made to the guidance notes to support this project. We have answered these questions below, and welcome additional questions throughout this pilot. 

Why is scientific peer review relevant to the ethics review process?

“Scientifically unsound research involving humans as subjects is ipso facto unethical in that it may expose them to risk or inconvenience to no purpose…”

(International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002)) 

It is well recognized that in order for research to be ethical, it must also be both valid and have some value in social, scientific and/or clinical terms.  Using limited research resources and exposing research participants to any kind of risk or burden simply cannot be justified if, for example, the research is so poorly designed that it cannot generate meaningful results or if the research question being asked has already been answered and the results proven.  The peer review form is designed to assist applicants and peer reviewers in identifying any potential issues with respect to the protocol in advance of ethical review.

Who is responsible for providing peer review?

While value and validity considerations are important aspects of ensuring a proposed research study is ethical, peer review is NOT the REB’s responsibility.  For example, the TCPS2 indicates that an REB may, in limited circumstances, conduct a scientific or peer review of a study it is reviewing; however, this is only where there is no other available mechanism and where the REB has or acquires the appropriate scholarly expertise.  Instead, it is the principal investigator who must ensure that the research being submitted for ethical review has undergone some form of scientific or peer review. This can be challenging, particularly in the context of unfunded, investigator-initiated research or graduate research.  This pilot project provides some additional structure and support that may be particularly helpful in such cases.

The CREB recommends that individuals who require a peer review of their protocol may approach any individual within their field who can provide an objective, arm’s length review. Residents and trainees are encouraged to approach an individual other than their supervisor.

When will this become a requirement and where do I get the form?

This peer review form will be required as of 01 July 2015 on all NEW applications that meet all three of the criteria outlined above. The RISe application will be updated to include a hyperlink to the document in Box 4.5 under Peer Review. 

We will reevaluate this requirement after a period of 6 months, in January 2016. 

Should you have any questions in terms of who should be completing this review, when the review is required or the peer review form itself, please do not hesitate to contact CREB staff.