The IRB has posted an updated version of its policy 3.1, titled Qualifications of Committees. This policy describes the steps the IRB takes to ensure its convened boards include members with the appropriate expertise to review the research they’re assigned. We also try to ensure our boards are able to understand potential subjects’ perspectives, and that […]

The IRB’s mission is clear – to ensure human research subjects’ rights, safety, and welfare are protected to the extent possible. It cannot allow itself to be influenced by outside pressures as it makes its determinations, and must remain independent. IRB Policy 1.5, IRB Independence from Undue Influence, has just been revised, and the updated […]

The COVID-19 pandemic has forced us to make many adaptations in both our personal and professional lives. Should those changes extend to loosening some of the usual ethical restrictions related to human subject protections for studies related to the pandemic? Authors of an April 27, 2020, op-ed piece in the Washington Post say yes, we […]

Once we got on a policy roll, there’s no stopping us. We’ve posted the following revised IRB policies on the IRB’s website: IRB Policy 1.1, Principles Governing the Committee, describes the principles underpinning human subject research and the IRB’s responsibility to ensure they are upheld. IRB Policy 1.2, Authority of the Committee, indicates all human […]

The U.S. Food and Drug Administration (FDA) says it is making available a free app to facilitate the obtaining of informed consent in situations where face-to-face consent processes are not practical. The app, now called COVID MyStudies, is designed to address situations where a potential participant with COVID-19 may be in an isolation room, or […]

An updated IRB Policy 3.3, Reviewer and Consultant Conflict of Interest, is now available on the IRB’s website. The revisions add another criterion to the definition of a financial conflict (the addition of a financial relationship for which a reviewer is on a management plan); highlights’ reviewers responsibilities to notify the IRB office or chair […]

The IRB has updated its policy 3.9, titled “Consultants.” The newly revised policy is now available on the IRB’s website. The policy describes the process to be used when the IRB determines it needs input from someone with a particular type of expertise to appropriately review research. For example, someone with experience in a particular […]

The IRB office has posted an updated IRB Policy 4.7, Participant Contact. Remember how the IRB typically requires IRB contact information to be included in consent documents? Well, this policy underscores why that contact information should be included, and how the IRB will process any contacts it receives from participants. We note that this is […]

The IRB has posted an updated version of IRB Policy 17.9, Prisoners in Research. Most of the changes from the previous version are cosmetic; the policy has been reorganized a bit in an attempt to improve readability. Please note that the prisoner requirements apply both to studies that target prisoners in their recruitment, and also […]

A revised IRB Policy 8.1, titled “Modifications to Previously Approved Research,” is hot off the presses and posted on the IRB’s website. The changes are mostly formatting related, although we did make a few minor content changes (e.g. we don’t, in fact, require a copy of the updated FDA Form 1572 with a PI change […]