Human research rules have become a compliance bureaucracy, argues sociologist Sarah Babb in her 2020 book Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy, but that's not an inherently bad thing. The social and political climate the first research regulations were made in, and the enforcement mechanisms that would eventually take hold, have rationally led to the large and sophisticated bureaucracy that human research protections is today. Read more
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Just by reading this title you probably have guessed that I am a big Star Wars Fan. We are a special breed, one that grew up with the movies and who like to complain about changes to the original saga. I will save you from my opinion on whether Han truly shot first or not, but as the last movie of the Star Wars franchise was released, I cannot help but notice some parallels between the journey of a Jedi and the work of an IRB professional working with single IRB studies.
A Jedi in these movies is a reluctant student, one forced to learn the ways of the Force due to the [...] Read more
In August, the RAND Corporation, a policy research organization, released the first comprehensive profile of IRB demographics and function in 20 years: a “Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule.” The report investigates questions about IRB practices, efficiency, and effectiveness on the cusp of implementation of the revised federal regulations, including single IRB review. (In December of 2017, PRIM&R helped get the word out to potential survey respondents.) Read more
The International Conference of Harmonization (ICH), which is made up of the regulatory bodies and pharmaceutical trade associations of key drug developing countries, recently released their revised “E8(R1) General Considerations for Clinical Studies” document. On September 16, PRIM&R submitted comments approving of ICH’s work to modernize their guidelines and suggesting that the document could benefit from a better discussion of the broad ethical principles that underlie many of the human subject protections the document details. We also recommend that the ICH consider reorganizing some of its guidelines to make it easier for those designing and conducting research to learn more about these fundamental ethical principles and related best practices. If you are based in the United States, we encourage you to consider submitting your own comments on the newly revised E8 document before the September 30 deadline. You are welcome to cite or quote PRIM&R’s comments. Read more
In March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients." The guidance is one of the latest moves by the agency to expand eligibility criteria, and hence the knowledge base for how drugs work in various populations, for the clinical trials they regulate. It makes recommendations not only for sponsors but also for IRBs. On May 13, PRIM&R submitted comments in response to the draft guidance. PRIM&R also has an upcoming webinar, Pediatric Risk Determination: IRB Considerations and Cases, on Thursday, September 19 that will review considerations for IRBs in assessing the risks and benefits of pediatric studies. Read more