The discussion about the use of electronic systems in research continues, with the FDA releasing a draft guidance titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers.” While the guidance is a draft, it appears to touch on most of the topics we hear about when discussing the use of […]
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FDA Warning Letter about research without an IND
Investigational drug studies must have an IND granted by the FDA before they begin. Unsurprisingly in this regulated world, the definition of “investigational drug” can vary, but in summary, if a study needs an IND, it better have one before it gets started. Figuring out what needs an IND and what doesn’t is tricky, tricky […]
Mandated Reporter Language in Consent Forms
Arkansas law requires people working in certain capacities to report things like suspected abuse, an intent to harm self or others, or a positive result on certain infectious disease tests to the authorities. Many of the people who interact with research subjects fall into this “mandated reporter” category, so this reporting requirement applies to them. […]
Report recommends assessing IRB inspection program; evaluate IRB effectiveness
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 […]
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 […]