Few aspects of Notice of Proposed Rulemaking regarding the Common Rule have generated as much discussion as the possible requirement to obtain informed consent for the future use of biological specimens, including those without identifiers attached. Rebecca Skloot’s book The Immortal Life of Henrietta Lacks (well worth a read if you haven’t gotten to it yet) […]
Community Based Participatory Research is Becoming More Common
Community based participatory research (CBPR) aims to allow the people affected by a particular issue to be involved in the development and carrying out of research related to that issue. In successful CBPR projects, the research involving community members means that the research findings both come from and go directly back to the people who need them […]
Update on upcoming CRS course offerings
The Spring 2016 calendar is filling up with educational opportunities for those seeking to obtain their Certified Research Specialist certification. Here are some upcoming live activities, so mark your calendars to earn some hours: Essentials of Quality Human Subject Research. Wednesday, February 10, 9am to 4pm; IDW 214A/B Developing a Research Protocol. Thursday, February 18, 1 […]
The mandated reporter language is mandatory in informed consent materials
Arkansas state law requires certain individuals to report suspected abuse or an intent to harm oneself or others. Healthcare providers and teachers are among these so-called “mandated reporters;” see IRB policy 15.1 for the full list (it’s surprisingly long) of reporters. This reporting requirement is a limit to the confidentiality of research data that must […]
Remember to affiliate with UAMS when taking CITI training
The UAMS IRB requires all study personnel who interact with subjects or with identifiable private information to be current on human subject protection training through citiprogram.org. Please note that not all CITI trainings are the same, and the IRB asks that you take the UAMS-specific training. To do this, please be certain to affiliate with […]
Reviewing for scientific or scholarly validity
Should an institution consider a proposal’s scientific or scholarly validity when reviewing research? Yes, according to the Association for the Accreditation of Human Research Protection Programs (AAHRPP). You may recall a) AAHRPP is the organization that accredits us and b) we are in the throes of a reaccreditation process right now. Specifically, AAHRPP expects us to […]
Continuing Review comes once a year, at least
We’ve gotten a query or two in recent weeks asking if we can waive the requirement for continuing review (CR), since, say, the IRB just approved a modification so it must have just reviewed the study anyway, or there hasn’t been anything new on the study in the past year. Our short answer to requests asking […]
Remember — No IRB Meeting Dec. 29, or on three 5th Tuesdays in 2016
Because the UAMS IRB meets only on the first four Tuesdays of every month, there will be no meeting on Dec. 29th, which is a fifth Tuesday. If you have something awaiting review, the next available agenda is for Tuesday, Jan. 5. Looking ahead to 2016, we notice that March, May, and August all have […]
IRBs and their oversight of researchers getting a closer look, article says
Workloads, member qualifications, and potential conflicts of interest are concerns when assessing the performance of institutional review boards, according to a recent article in Modern Healthcare. This scrutiny of IRB operations coincides with the announced proposal to revise the Common Rule, which is the federal regulation that outlines the requirements for research involving human subjects. […]
Remember — Only one form at a time can be open in CLARA
CLARA generally allows only one form at a time to be under IRB review. This restriction means, for example, you can’t submit a modification on a study until your new submission is approved, or, importantly, you can’t submit a continuing review (CR) form while a modification is outstanding. The only exceptions are that CLARA will […]