The Food and Drug Administration (FDA) has just released a Q&A formatted guidance about charging for investigational drugs under an IND. While the guidance is geared toward industry, it contains helpful information for investigators who sponsor their own INDs, and for study teams and HRPP staff involved in drafting consent forms and creating budgets. We […]
FDA to allow consent waivers
The Food and Drug Administration (FDA) has made it official – it will allow waivers/alterations of informed consent processes for certain studies, according to a new rule to take effect this month. You may recall the FDA issued a guidance in 2017 saying it would not object to consent waivers/alterations on certain minimal risk studies. […]
CLARA form’s HIPAA section updates
The CLARA new submission form’s HIPAA section has been updated to make it easier to describe specific protected health information (PHI) elements to be accessed/recorded/used in research. Instead of asking you to describe “PHI data elements,” the first question now asks you to describe “specific health information that will be used/recorded for the research.” We […]
Revised IRB policies posted
The IRB, in consultation with the Human Research Protection Program Advisory Committee, has completed its annual review and updating of IRB policies. Revised policies are now available here. A summary of revisions is available here. Need to see an older policy version? The policy archives are also on our webpage.
Biologic use draws scrutiny
Concerns about a biologic product used in procedures at a New York hospital prompted a complaint by a researcher against his supervisor, according to a recent New York Times article. The Food and Drug Administration (FDA) had issued a warning letter to the product manufacturer, citing concerns about the manufacturing process and also stating the […]
GDPR and SPIND information
In a field full of acronyms, here are two more. GDPR refers to the European Union’s General Data Protection Regulation and SPIND refers to Single Patient Investigational New Drug application, which is a type of expanded access program for investigational drugs. We now have available some good resources about the GDPR and SPINDs. The GDPR […]
HSP education option for community partners
Investigators are increasingly collaborating with community partners in research projects. These community partners typically don’t have much research experience and don’t work at research institutions, meaning they may not have too much human subject protection background. However, they play a vital role in making research opportunities available to populations around Arkansas. The UAMS IRB and […]
FDA finalizes informed consent guidance
The federal Food and Drug Administration (FDA) has released the final version of its guidance on informed consent. This guidance finalizes a draft guidance that dates to 2014. This guidance addresses a lot of those random little questions that we don’t often think about. For example, page 27 indicates that when a subject provides consent […]
A proposal regarding IRBs
Are IRBs inherently conflicted in their work? Whether they’re part of an institution or a private, independent IRB, they have stakeholders who have an interest in IRB review outcomes, and who potentially can exert pressure on IRBs, according to a recent article in Nature Medicine. Authors Jonathan M. Green and Stephen Rosenfeld, who both have […]
Clinical Research and Abortion Restrictions
A recent publication in the journal Science claims that changing laws related to abortion availability can have implications for the review and conduct of some clinical research. Click on the link to read these authors’ thoughts on the topic and some of their suggestions for addressing these issues.