Draft guidance focuses on informed consent
FDA updates its thinking on IC issues
The Food and Drug Administration (FDA) released new draft guidance in July to update its 1998 Informed Consent Information Sheet guidance.
"The draft guidance document was developed as a means to consolidate, in one document, information related to informed consent that appears in several documents as well as to address new issues related to both the informed consent document and the process by which it is obtained," the FDA’s Center for Drug Evaluation and Research (CDER) told IRB Advisor in a statement. "In consolidating previously issued documents, we provide updates on many topics and provide new information on others."
The guidance was issued as the regulatory bodies continue to mull changes to the Common Rule through the Advance Notice of Proposed Rulemaking (ANPRM) issued in 2011. So far, there is no indication of when the final rule will be released.
The FDA is also mum on the status of the ANPRM. "FDA issues this draft guidance while the agencies continue to explore potential changes to the Common Rule," according to CDER’s statement. "To the extent that the issues in the draft guidance intersect with the Common Rule, FDA plans to coordinate with other relevant federal agencies to facilitate consistencies across policies."
What’s new
While much of the draft guidance remains the same, there are a few notable updates. The following are new sections that have not been included in previous guidance documents:
• Section IV, subsection D on FDA Responsibilities states that sponsors generally are not required to submit informed consent for FDA review, and materials that are submitted are reviewed for clear communication.
• Section V, subsection A on Review of Patient Records describes instances of patient record reviews in which informed consent may or may not be required. Instances in which IC is not required include surveying patient records to determine whether there are a sufficient number of subjects; reviewing records to determine whether a patient is eligible for a study; and for certain retrospective reviews after a study is complete.
• Section V, subsection E on Impaired Consent Capacity describes ethical considerations for obtaining consent from a subject with impaired capacity.
• Section V, subsection F, Children as Subjects describes requirements for obtaining assent from children, and those who are wards of the state.
• Section V, subsection G, Subject Participation in More than One Clinical Trial. The FDA "strongly discourages" accepting subjects enrolled in simultaneous clinical trials. "Investigators should inquire about multiple enrollments and discourage this practice in the consent form and during any informed consent discussions," the guidance states.
• Section V, subsection H, Suspension/Termination of a Study provides guidance on what IRBs, sponsors, and investigators should do if a study is suspended or terminated, and reasons for doing so.
• Section V, subsection K, Reporting Aggregate Results of the Clinical Investigation describes rules for registering and reporting clinical trial outcomes at ClinicalTrials.gov.
Other updates
Other updates include information incorporated from other guidance documents, or just additional details. These updates include the following:
• Alternative Methods of Informed Consent in Section III has been updated to reflect the use of new technologies in obtaining informed consent. The FDA is seeking comments from those who use newer methods. "Parties interested in pursuing alternate methods of obtaining informed consent are encouraged to contact FDA," the guidance states. "Currently, FDA is considering alternative methods using these new technologies and would be interested in comments on these alternative methods." Face-to-face consent interviews and consent via email or fax are also detailed.
• Most of Section IV, Responsibilities for Informed Consent, updates information and includes information from guidance documents "Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects," "Financial Relationships and Interests in Research Involving Humans Subjects," and "Using a Centralized IRB Review Process in Multicenter Clinical Trials."
• Other sections update existing guidance while providing further details. For example, Section V, subsection B on Non-English-Speaking Subjects defines "understandable" language and explains that the proposed inclusion of translated consent forms in an approved study "may be considered no more than a minor change to the research and may qualify for an expedited review procedure under FDA regulations at 21 CFR 56.110(b)," according to the document. The subsections on subjects with low literacy and numeracy and physically challenged subjects are also updated with additional material.
The entire draft guidance document can be found at http://www.fda.gov/RegulatoryInformation/Guidances/ucm404975.htm. The FDA will be accepting comments on the document through September 15.
