The New York Times Magazine published a riveting piece in its August 9 edition about the tensions that can develop between clinicians and researchers when unapproved drugs are considered for patient treatment, as we have seen with Covid-19. Rather than trying to summarize the article, we strongly encourage everyone to give it a close read. […]
New “consenting subjects who don’t speak English” policy now available
The IRB has updated its policy 15.4, titled Non English-speaking research subjects and when the short form of consent is allowed, and it is now available on the IRB’s website. We hope the research community finds the revised version’s discussion of this potentially confusing subject a bit clearer. Some of the high points of the new […]
Revised IRB Policy 6.3 on meeting minutes now posted
The IRB office has updated its policy on meeting minutes, IRB Policy 6.3. This policy recaps the regulatory requirements and best practices for what has to be documented when the IRB reviews a study. While the changes are minimal from the previous iteration of this policy, it’s important to note the IRB takes these policy […]
Fresh new look throughout IRB policy section 14, Recruitment Practices
Revised versions of all five of the IRB’s policies pertaining to recruitment practices are now posted on the IRB’s website. This section describes considerations in recruiting, selecting, and compensating subjects. These issues are critically important to the protection of human subjects and the promotion of subjects’ rights, safety, and welfare. Research teams and the IRB […]
Updated “Special Populations” Policies now available
We’ve updated the following policies in the IRB’s “Special Populations” policy section, and the new policies are now posted: 17.2, Persons with Diminished Functional Capacity (renamed from “Cognitively Impaired Persons”) 17.4, Subjects in Long Term Care 17.8, Pregnant Women, Human Fetuses, and Neonates Involved in Research 17.10, Students, Employees, and Healthy Volunteers Many of the […]
Updated IRB policies about investigational drugs and devices now available
We’ve posted updated versions of all the policies in IRB policy section 18. These policies address investigational drugs (18.1), investigational devices (18.2), and emergency uses of test articles (18.3). Projects that involve these items are subject to FDA oversight, so it’s important to become familiar with these policies and the sources from which they’re drawn.
Policies on risk/benefit analysis and subject selection revised, posted
The questions of whether risks and potential benefits are in balance, and whether subject selection is equitable, are critical to the IRB’s review of proposed research. We’ve updated our policies that discuss Risk/Benefit Analysis, IRB Policy 7.1, and Subject Selection, IRB Policy 14.1, to give researchers and IRB members clearer guidance about concepts that guide […]
Patient-driven research
Medical research drives improvements in medical care. Serious diseases that affect many patients attract a lot of research attention. Rare, life-threatening conditions, however, are often not the subject of research, because so few patients may benefit from the results. That’s where patient-driven research comes in. The term refers to patients and their families who advocate […]
Revised IRB protocol template
The IRB has updated its protocol template to add language about multisite research. We try to keep the template current and adapt it as needed when we notice trends in the protocols that come through the IRB office. While template use is not required, it is strongly encouraged for investigators who are writing their study […]
Updated policy on Risk/Benefit Analysis posted
The IRB has updated its policy 7.11, Risk/Benefit Analysis. Like many of the policy changes we’ve posted about recently, many of the updates relate to formatting and editing to improve readability. This policy, in particular, we think really benefited from this update, given the importance of the material it addresses (and the fact that the […]