Human Subjects

FDA ramps up enforcement of clinical trials

On August 14, the FDA released new guidance detailing increased penalties for identified cases of noncompliance with the requirement to register their studies and post results on This motion arises out of recent findings that compliance with these requirements remains low, and more so within academia than industry. Further, it is believed that poor compliance is likely reflective of a lack of enforcement by regulators, and stepping up enforcement efforts would be a useful remedy for the issue.

Currently, federal requirements mandate the use of this service in order to monitor clinical trial information for potential concerns as specified in 42 CFR 11.10(a). Specifically, researchers must register within 21 days of the first study subject enrollment, and the results must be posted within one year of completion. This applies to any studies that fall under FDA’s regulatory thumb, or studies receiving funding from the NIH. Failure to comply with this policy could result in penalties up to $10 thousand for each day until the violation is corrected, as well as civil or criminal proceedings.

To identify such violations, evidence is typically collected either during inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO) or based on the evaluation of complaints received at the agency. Once discovered, the FDA said it’s continuing to send what it calls “pre-send notice letters,” which alert a company of potential violations and gives it 30 days to fix it. During a pilot enforcement project before the issuance of the rule, the FDA said it sent 15 such letters out and all the companies subsequently complied – further evidence that a more active stance would be beneficial for bolstered compliance.

Additional Information:


Human Subjects

Human Subjects Research 2017-2018 Regulatory Changes

NIH Changes

Starting on January 25, 2018 there will be some changes at the proposal stage as well as after you receive funding for human subject research from NIH. NIH has a web page that details these requirements:

Please note, the definition of clinical trials by NIH is: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” This has been broadly interpreted by NIH, based on recent case studies issued, and now includes social and behavioral research projects that previously were not considered to be clinical trials (see case studies and decision tree here:

Specific Changes

1) Funding Opportunity Announcement (FOA) process. An updated process for issuing FOAs will go into effect on January 25, 2018. FOAs will now specify “clinical trials required, clinical trials optional, or clinical trials not allowed.” You must keep the above broad definition of clinical trials in mind as you select the FOA. NIH has published further details here:

2) Good Clinical Practice training (GCP). Since January 1, 2017 all investigators involved in the design, conduct, or reporting of clinical trials have been required to take GCP training. Information about this requirement can be found here: previously provided communication about this requirement but wish to remind you that Mason offers training available to meet this need as part of the CITI program ( There are two different CITI GCP courses available: one that focuses on social behavioral research and one that focuses on clinical trials involving investigational drugs and medical devices (FDA focused). Researchers may choose the course that best meets their needs. Information about additional GCP course options that will satisfy the requirement can be found on NIH’s GCP webpage.

3) Application Form. A new human subjects form will be added to the NIH application form on January 25, 2018. They have published a website, including an informative video, that details the expectations for responses to questions on this form:

4)  Single IRB. For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.  This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research.  In preparation for this change, Mason has joined the SMART IRB consortium which enables easier reliance on other institutions and their reliance on Mason’s IRB:  Please contact the IRB team in RDIA at as you are designing your multi-site human subjects research projects and we will assist with enabling single IRB review.

5) As we previously communicated, on January 18, 2017 NIH issued additional guidance on the requirement to register and update information about clinical trials. This requirement applies to all clinical trials funded by NIH (broadly defined as noted above). Investigators must register their trials within 21 days of enrollment of the first subject. Training materials for can be found here: Bess Dieffenbach, IRB Manager, serves as Mason’s administrator and should be contacted at to request access to and assistance with this site.