When completing modification forms in CLARA, please help speed IRB review and approval by using the “Notes for IRB reviewer(s)” open text response to: –Specifically address whether any currently enrolled subjects will be affected by the proposed change and if so, how you will inform them of the change. For example, will they be asked […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
“Key information” guidance draft arrives
Hot off the presses – the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued the long-awaited draft guidance on “Key Information and Facilitating Understanding in Informed Consent.” OHRP has required a “key information” discussion at the beginning of consent processes since the 2019 Implementation of the Revised Common […]
FDA guidance on charging for investigational drugs
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 […]
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 […]