The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication, GCP Questions, FDA Answers.

Question: In section A of the information sheet on recruiting study subjects, there are certain types of materials that are called out as being not included in media advertising (communications for healthcare professionals, news stories and publicity for other audiences). Is it intended that those materials that are “not included” are those that are not subject to IRB review, or that they shouldn’t be included in any clinical study recruitment campaign?

We have had a news release and a radio interview with a study investigator pitched as an idea for helping with clinical trial recruitment, and we aren’t sure if it would be an acceptable practice. We understand that media coverage of clinical trials can happen without our involvement, and those are outside our control, which is likely why they aren’t included as something that would be subject to IRB review. But can a sponsor try to get coverage of the trial picked up by the media and help shape what that coverage looks like? We would, of course, obtain an IRB review of the pitch materials and any guidance that is created for the media interviews, but there is still some element of it that we wouldn’t be able to completely control.

Answer: IRB review may not be required for news stories. However, every particular situation is different. You as the sponsor will need to closely work with your reviewing IRBs and document any conversations or decisions.

FDA has not developed guidance on the use of social media for clinical trial subject recruitment. FDA’s Center for Drug Evaluation and Research held a November 2009 public meeting on the use of social media tools to promote FDA-regulated medical products. As FDA considers policy and guidance in this regard, we will be looking broadly at how its use impacts products we regulate and clinical studies of such products.

Also, please be aware of patient/subject confidentiality under the HIPAA privacy rules. FDA does not administer HIPAA; that law is implemented by the Department of Health and Human Services, Office for Civil Rights (OCR). For more information about the applicability of relevant HIPAA regulations, you would need to contact OCR directly.

With regard to the advertisement of the availability of clinical trials, our present guidance was written before networking of this type (media coverage) was common. Our thoughts are summarized here:

“Generally, FDA believes that any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included in advertisements. It should be noted, however, that FDA does not require inclusion of all of the listed items.

• The name and address of the clinical investigator and/or research facility;
• The condition under study and/or the purpose of the research;
• In summary form, the criteria that will be used to determine eligibility for the study;
• A brief list of participation benefits, if any (e.g., a no-cost health examination);
• The time or other commitment required of the subjects; and
• The location of the research and the person or office to contact for further information.”

Question: Should the IRB review and approve material used to advertise or documents provided to the public during community consultation efforts? If the FDA considers direct advertising the start of the informed consent process and therefore needs review and approval, is this also applicable when there is no informed consent? What type of review is required for materials created after approval (infographics, flyers, etc.)? Would the Recruiting Study Subjects — Information Sheet be applicable at this point?

Answer: Research involving the exception from informed consent requirements for emergency research is a unique type of research that requires the IRB find and document a number of additional protections for subjects, such as a determination that participating in the research holds out the prospect of direct benefit to the subject, that available treatments for the condition under study are unproven or unsatisfactory, and that subjects are unable to give their informed consent as a result of their medical condition.

Item #64 in the FDA guidance Exceptions from Informed Consent Requirements for Emergency Research recommends IRBs review the protocol and the plans for community consultation and public disclosure as a package (i.e., collectively) given that the adequacy of the community consultation plan and the public disclosure plan cannot be properly considered without understanding the protocol. As part of the review, IRBs should review and approve materials to be used as part of the community consultation and public disclosure; this would include materials used to advertise the study and documents provided to the public during community consultation efforts.

For additional materials created after approval of the study, FDA recommends they be reviewed by the IRB before they are used in any community consultation or public disclosure activity. The Recruiting Study Subjects — Information Sheet is a useful guidance to consider when reviewing information to be shared during public disclosure and community consultation.

However, it must be remembered that the intent of public disclosure and community consultation is not recruitment but rather should be considered as activities designed to disseminate information and provide an opportunity for discussion with, and soliciting opinions from, the community in which the study will take place and the community from which the study subjects will be drawn.