Human Subjects Research 2017-2018 Regulatory 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: https://grants.nih.gov/policy/clinical-trials.htm.
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: https://grants.nih.gov/policy/clinical-trials/definition.htm.)
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:https://nexus.od.nih.gov/all/2017/12/07/be-careful-to-pick-the-right-funding-opportunity-announcement-foa/?utm_source=nexus&utm_medium=email&utm_content=nihupdate&utm_campaign=nov18.
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: https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm. We 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 (www.citiprogam.org). 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: https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm.
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: https://smartirb.org/. Please contact the IRB team in ORIA at firstname.lastname@example.org as you are designing your multi-site human subjects research projects and we will assist with enabling single IRB review.
5) Clinicaltrials.gov. 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 ClinicalTrials.gov can be found here: https://clinicaltrials.gov/ct2/manage-recs/present. Bess Dieffenbach, IRB Manager, serves as Mason’s Clinicaltrials.gov administrator and should be contacted at email@example.com to request access to and assistance with this site.