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 […]

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 […]

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.

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 […]

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 […]

The IRB has updated policies 10.2, Events that must be reported to the IRB and IRB actions, and 10.3, Protocol content and IRB submissions. Again, the vast majority of the changes relate to formatting and adding references. While the content hasn’t changed much, consider this  a friendly reminder to review IRB policies frequently. We find […]

A new institutional Data Sharing for Research policy is now available. It describes requirements and best practices for, well, sharing research data, as its name implies. The policy was jointly developed by Cancer Clinical Trials & Regulatory Affairs, IRB, research compliance, and legal, among others. It contains limits on the eligibility of data sharing that […]

The IRB has posted updated policies regarding reviews and determinations about reports of potential noncompliance and potential UPIRTSOs. These processes are described in IRB Policy 12.5, Reports of Potential Noncompliance and Potential UPIRTSOs,  and 12.6, IRB Determinations of Noncompliance and UPIRTSOs. We’ve also posted a revised IRB Policy 2.6, which describes the IRB’s procedures for […]

Because we know you all lie awake at night wondering about the process the IRB uses to create its weekly agenda, we’ve updated IRB policy 6.1, Agenda, to include more details about the process. A few takeaways from this revised version: When submissions are ready for full board review, we will put them on the […]

Research subjects who are minors when they join a protocol typically must be reconsented after they turn 18 to be able to continue on the study. While the IRB can waive this reconsent requirement when such a waiver is justified, this issue falls into an ethical gray area when it comes to the long-term storage […]