On December 29, 2009, the FDA issued a proposal to amend 21 CFR 50.25, its regulation for informed consents. The new mandate requires that the informed consent documents for applicable drug and device clinical trials include a statement that applicable clinical trial information
has been or will be submitted to the National Institutes of Health/National Library of Medicine
(NIH/NLM) for inclusion in the statutorily required clinical trial databank,www.ClinicalTrials.gov. This rule is effective on March 7, 2011. The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date.
The need for this rule arises from section 801(b)(3)(A) of the Food and Drug Administration Amendments Act of 2007 (FDAAA) which promotes transparency of clinical
research to participants and patients. It requires that the current regulations for
informed consent documents and process be changed to include a statement that clinical trial information from the clinical investigation has been or will be submitted to www.clinicaltrials.gov.
The FDA has made the decision that revising the general informed consent section is the
appropriate step by which to fulfill the requirements of the statute, and will give the pertinent information and protection for clinical trial participants.
Several objections were made to the inclusion of this informed consent statement for various reasons. Some reviewers believed the statement would cause confusion or anxiety to the participants.
Others believed the statement would distract the participants from focusing on the substantive issues concerning the study that would affect one’s decision to participate in the study. Some commenters insisted that the overall effect of the statement would be a reduced participation rate for prospective participants.
In response to the objections of the new informed consent element, the FDA acknowledges that additional time will be required to read and, if necessary, discuss the statement that
FDAAA mandates be included in the informed consent documents and process. The FDA does not agree, however, that the benefit of the statement to the participant is directly related to the time
it takes to read and discuss the statement. The FDA also has revised the statement to make it shorter and easier to understand by deleting those terms that could be expected to cause anxiety
and confusion. The FDA believes that in doing so it has reduced the theoretical possibility that the statement would cause some participants to abandon the study as much as possible while still
fulfilling the FDAAA mandate.
In 2009, the FDA issued a qualitative explanation of the expected benefits of the proposed rule to
clinical trial participants:
1) The rule would increase the transparency of clinical trials by increasing participant and patient
awareness of the existence of the clinical trials databank (www.clinicaltrials.gov) and those trials
that are registered in the databank;
2) By helping to create a system of checks and balances through which participants,
patients, and health care providers are encouraged to check whether information about a trial of interest is registered in the databank, it would provide greater accountability of clinical
trial investigators for outcomes and adverse events, thereby raising confidence in the validity of the
3)It would encourage physicians and patients to obtain more information in order to
make more educated treatment decisions.
The FDA has not tried to quantify these benefits, but believes that the overall impact of the rule on public health would be positive.
The cost of incorporating the new rule into the informed consent documents is expected to be very small. The new statement would only need to be written once per protocol and is estimated to take about 5 minutes. The total costs of the final rule to both industry and the clinical trial
participant population are estimated to range from $3.14 million to $5.46 million annually. This equates to $611 to $1,061 per trial protocol, or about $2.95 to $3.05 per clinical trial participant.
FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Office of Policy, Office
of Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4248, Silver Spring,
MD 20993–0002, 301–796–4830.
References: Federal Register, / Vol. 76, No. 2 / Tuesday, January 4, 2011 / Rules and Regulations, pp 256 – 270.