OHRP and FDA should conduct risk assessments annually to ensure they are routinely inspecting enough IRBs, according to a newly released report from the federal General Accounting Office (GAO). The GAO was asked to review independent IRBs, the processes used to protect human subjects, and standards of IRB quality. The agency found that independent IRBs […]
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OHRP facing resource constraints
The federal Office for Human Research Protections (OHRP) appears to be facing the same kind of, um, resource constraints many other human subject research institutions are also facing, per a recent article in Report on Research Compliance. A large percentage of its positions are vacant, per the report. OHRP is the agency that oversees human […]
Completing the new submission form’s “Lay Summary”
The CLARA new submission form requires study teams to provide a so-called “lay summary” about their study. Consider the lay summary an opportunity to summarize the study and highlight any important points someone would want to know as they’re reviewing the study. Providing complete information in this section will speed your review and approval. For […]
Protocol and Consent Form Changes
Protocol amendments often entail changes to consent forms. However, sometimes a revised protocol is ready for submission before the revised consent form is. When is it acceptable to submit a protocol change before the new consent form is ready? This practice should be avoided when possible, according to a recent blog post by WCG IRB. […]
Updated HIPAA Research Authorization Template
The HIPAA Research Authorization template has been updated with one big and a couple of little changes. The revised form is now posted on the IRB’s website’s “Templates, Training, and Tools” page. The little changes include some minor wording changes to clarify what we’re trying to convey in the form. Specifically, we now state that […]
Willowbrook Study to be discussed March 10th
The Willowbrook study, in which institutionalized, mentally disabled children were deliberately infected with hepatitis, will be the topic of the next Research Ethics Book and Journal Club meeting, scheduled for March 10 at 10 am. Location and the in-person v. Zoom decisions are still being finalized, but it’s not too early to save the date […]
Completing modification forms
The Modification form is what to use when trying to make a change to your study. Filling the questions out completely is crucial for the reviewer looking at it to fully understand WHAT you are changing and WHY. Here are some tips on two of those questions that are often neglected: “Please describe the requested […]
HIPAA and Identifiable Health Information From Outside the U.S.
The HIPAA privacy regulation is, of course, a U.S. federal law. However, human subject research has porous borders — some UAMS research studies involve identifiable health information originally created/collected outside the U.S. We recently reviewed a study that involved clinically created data collected outside the country and then brought to UAMS. That got us to wondering […]
The FDA Continues to Work on Harmonization With the Revised Common Rule
The Food and Drug Administration continues its efforts to harmonize its human subject protection regulations with those of the Office for Human Research Protections. You’ll recall that OHRP regs apply to all federally funded or supported research, and FDA regs apply to studies looking at FDA-regulated products, including industry sponsored studies. Revisions that are in […]
Language Understandable to the Subject
We talk about the concepts of health literacy and “language understandable to the subject” a lot in human subject research. What do subjects, and potential subjects, hear when we use certain terms? This vignette found on Twitter, although it doesn’t relate to research, illustrates the divide between what medical and research staff say, and what […]