The IRB has had some heated discussions about genetic testing done now, and also the potential for future testing of stored biological specimens. This article from the Los Angeles Times delves into issues we’ve discussed before on the blog – the use of genetic information made available by people who voluntarily use publicly available genetic […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
New Marshallese and Spanish short form consent templates now available
We are thrilled to announce we have posted Marshallese and Spanish language versions of our new short form consent templates. Arkansas has sizeable populations of people whose primary language is Marshallese or Spanish, and having these forms readily available will make it easier to discuss research participation with members of these groups. Note that the […]
Revised IRB Policy 15.2 now posted
An updated version of IRB Policy 15.2, titled Consent Exceptions – Planned Emergency Research, is now posted on the IRB’s website. We’ve updated the language to delete a reference to a policy that has been archived, and changed the formatting to fit our current style. The policy’s main idea hasn’t changed – the UAMS IRB still does […]
Updated IRB Policy 2.4 now available
As we work our way through updating the IRB policies, we’ve now reached IRB Policy 2.4, describing the relationship between the IRB and the UAMS Office of Research Compliance. The changes primarily relate to formatting, with minimal content change. The two offices maintain their status as independent from each other, with each reporting to a […]
Tension between clinical care and research
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 […]
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.
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 […]