News and Announcements

So, you are a graduate student looking to do research with human subjects. You have taken those required research methods classes. You have some classroom experience conducting your own research, and you’ve even got a few A’s here and there. And now, you know the next step is to submit an Institutional Review Board (IRB) protocol for review. But you hesitate and ponder other options for research—perhaps you’ll analyze the contents of a book instead. I mean, who... Read More
Many IRBs use an assigned reviewer system. Most typically, an assigned reviewer is a member of the IRB who is assigned to review a protocol and make a recommendation. Assigned reviewers can be assigned for full board protocols and in this capacity, they may work with the PI on changes prior to the convened meeting. They may also present the protocol at the meeting and present their criticisms or concerns prior to other members of... Read More
Last month, NIH released the “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research”. They have coined this process as the “sIRB”, making it sound somewhat fashionable . The policy requires that only one IRB hold the responsibility for multi-site projects, leaving the oversight of the study to one site only. While there are indications that the sIRB will be part of the revisions to the Common Rule later... Read More
One of the more frequent (and frankly just) complaints) about IRBs is that they involve themselves to deeply in reviewing and often modifying the scientific design of a study, sometimes to the point of r adically re-writing the protocol. There are circumstances where the IRB does need to evaluate the scientific design, and there are other circumstances where it should not get involved in these questions. A look at the regulations provides little guidance. The question of... Read More
Having spent over 10 years working with Institutional Review Boards, I became intrigued by the potential for an online compliance management system that was efficient, effective and inexpensive. Based on programming work I had done to help with my course management, I knew I needed a program that would dynamically generate web pages and web forms from a database. My initial efforts resulted in a system that I put to use in my role as... Read More
One recurring discussion that occurs at our full IRB board meetings is what is “more than minimal risk”. According to 45 C.F.R 46.102(i), aka “The Common Rule”, minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Those of us who work at smaller institutions with... Read More
There has been much discussion among Research Compliance professionals about proposed changes to 45 CFR 46 , aka “The Common Rule” These discussions have been ongoing for years and if you’re like me you’re wondering what the final rules will be and when they will be published. Rumor has it in my neck of the woods that it will be finalized by the end of the year, prior to the next White House administration. There is a rush... Read More