As mentioned previously, one of the most contentious proposals in the current Common Rule draft requires the obtaining of informed consent for future research use of tissue specimens. Here’s one opinion on how this requirement might impact communities with limited access to health care – a concern relevant to many areas of Arkansas.

Author Paul McLean has probably given a lot of thought to medical ethics, both as an ethics fellow at Harvard Medical School, and as the parent of a child who directly benefited from medical research. And apparently he’s a dog person too. Read his family’s story at the link above.

The following research history trivia quiz should get us thinking both about just how long research has been going on, and why maintaining certain ethical standards is important. Q. Where would you look to find a description of the earliest known activity that might be described as research involving one or more human subjects? Published descriptions of […]

One of the IRB’s responsibilities in its research reviews is to assess a proposal’s risks and benefits. For each study, the IRB is to determine that risks to participants are minimized by using procedures consistent with sound research design, and risks to participants are reasonable in relation to anticipated benefits, if any, to subjects, and […]

The New York Times published a report Jan. 15 about six healthy volunteers falling gravely ill during their participation in a Phase 1 drug trial. We’ll add additional posts as more information becomes available.

There has been some discussion recently about whether its helpful to include page numbers on the IRB office staff’s draft contingencies. We will try to include page numbers in the future. However, we have long made it a practice to include enough information in our draft contingencies for you to be able to use the […]

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 (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 […]

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 […]

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. […]