Our Research Ethics Program is responsible for the ethical and regulatory compliance of research that involves human subjects. We are committed to protecting the rights and welfare of subjects enrolled in its research activities.
As a result, in 2009 the PSI Board of Directors established a Research Ethics Board (REB) to review all human subjects research conducted by us or under our direction. The REB is guided by the fundamental principles presented in the Belmont Report and applies the US federal regulations for the protection of human subjects set forth in 45 CFR 46 to all research activities involving human subjects regardless of funding source.
We obtained a Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) and our REB, designated on the FWA, is registered with OHRP.
Our REB accepts complete submissions on a rolling basis. A submission determined to be minimal risk or exempt status will be reviewed immediately. Those determined to be more than minimal risk will be reviewed by the full board.
Since the overwhelming majority of the submissions to the REB meet the regulatory criteria for expedited approval, our REB convenes on an as-needed basis. If a submission is found to require a full board review, the REB Manager will convene the board within four weeks of submission.
Determining if an activity requires ethical review
Is my activity research? Does my activity require ethical review? We is involved in activity X, but we’re not recruiting participants, do we need ethical review?
These are common questions posed by our staff and researchers. Our Research Ethics Program has developed the following guidance to help staff determine when activities are required to receive ethical review and guidance on questions to consider at this stage of the process.
- Our guidelines for deciding whether an activity requires REB review
- Is my activity research? A decision tree
- Request for determination of research or non research
- Questions to answer before developing a submission for ethical review
Pre-submission: Understanding the REB review process and preparing a complete package
Understanding our REB review process and elements of a complete submission are key to an efficient and quality review. Our Research Ethics Program developed the following documents to provide detailed explanation on the review process, training requirements for key personnel and how to prepare a complete packet for our REB.
- Research ethics board review process and timeline
- Training requirements for key personnel
- Preparing a complete packet for the REB
REB forms and instructions
The REB requires the completion of the appropriate forms for new submissions, modification requests and continuing review applications.
- Cover sheet for new submission
- Instructions for completing the REB cover sheet for new submission
- Modification form
- Modification procedures and submission instructions
- Continuing review form
- Continuing review procedures and submission instructions
- Reportable event form
- Reportable event procedures and submission instructions
REB policy and procedures manual
This manual documents the policies of our REB and the procedures by which the policies are implemented.