Trust, honesty, humility, transparency and accountability are the building blocks of a positive reputation. Trust is the foundation of any relationship.
Transparency of clinical research to participants and patients is what the FDA is going for with their amended informed consent regulations.
The new regulations stem from the Food and Drug Administration Amendments Act of 2007 (FDAAA), which required that FDA amend the current informed consent regulations to include language that informs potential clinical trial participants that data from the trial will be publically accessible on the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine – the website we all know (and love) as ClinicalTrials.gov.
The new mandatory language for all ICFs (per amended 21 C.F.R. § 50.25) is as follows:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Website will include a summary of the results. You can search this Web site at anytime.”
While the informed consent requirements may have seemed simple enough in the 2007 FDAAA the proposed rule was published in December 2009 and open for comments – of which 68 were received from sources such as IRBs, academic research centers, pharmaceutical industry, and contract research organizations, to name a few.
After consideration of all comments, the final rule has been adopted and will become effective on 07 March 2011. Don’t worry, you have a grace period of 1 year to run out and incorporate these changes into your informed consent templates and checklists. The FDA will begin to enforce the final rule for informed consent documents for applicable drug, biological product, and device clinical investigations that are initiated on or after 07 March 2012.
A couple of other random points of interest regarding the new regulations, for transparency’s sake…
- The language was revised a number of times. FDA considers that the final approved language will not significantly increase the length of an informed consent form or informed consent process and should not hinder a participant’s ability to understand the form.
- When using a short form of an informed consent document, the new mandatory language must also appear in the short form.
- For clinical trial participants already enrolled (and consented) in an ongoing clinical study, re-consent solely for the purpose of the new language by the compliance date is not required. Similarly, if an informed consent form for an ongoing investigation (before the compliance date) has to be updated for any other reason (and we’ve all had experience with that, I’m sure), the new language is also not required (but wouldn’t be bad to add, in my opinion).
- For those large multi-site studies, a multi-site clinical trial is considered “initiated on or after 07 March 2012” if informed consent documents have been approved for at least one more site – but not necessarily all sites – by the compliance date.
- Make sure there is transparency between the PI and the trial sponsor, as the informed consent form is an investigator responsibility, but it is typically the sponsor who posts and updates information to ClinicalTrials.gov.
- HHS Proposes Changes to HIPAA (ask-cato.com)
- Data Quality and Integrity: From Clinical Monitoring to Marketing Approval (ask-cato.com)
- Electronic Data Capture Webinar with Merge Healthcare (ask-cato.com)