Yearly Archives

2016

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
Research in an educational setting can be challenging - for the researcher, IRB members and professional research administrator.  But, research in schools is also among the most important types of research. Still, specific guidelines related to research in this setting are only mentioned in the federal guidelines a few times. For instance, 45 CFR 56, (aka “The Common Rule” )section 46.101 mentions “educational settings” only a few ways: (1) Research conducted in established or commonly accepted educational settings, involving normal... 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
What should Research Compliance staff look for in a vendor of online IRB system? Here are some general areas on which you should not compromise. We all know what IRB software systems are, but often times evaluating systems, and the companies behind them, is difficult. Too often it is hard to move beyond the superficial information gleaned from the sales representative you might meet at a yearly conference; if you are lucky enough to have the... Read More