NIH has recently made a number of policy changes that directly impact the Office for Research Protections IRB and Quality Management operations regarding certificates of confidentiality, clinical trials, and single IRB review. The following is a brief overview of each.
Certificates of Confidentiality
Effective October 1, 2017, certificates of confidentiality--an assurance intended to prohibit disclosure of sensitive, identifiable information in response to legal demands--will be issued automatically for applicable NIH awards. Consequently, NIH grantees no longer need to apply for a certificate of confidentiality. The policy is retroactive and applies to all NIH-funded research commenced or ongoing on or after December 13, 2016.
Under this new policy, human participants enrolled in research for which informed consent is sought will need to be informed of the protections afforded by the certificate and limitations of these protections. If this policy applies to your ongoing study, at your next Continuing Review, the IRB will work with you to make any necessary changes to your protocol or consent form regarding certificates of confidentiality.
To obtain a certificate of confidentiality for studies not funded by NIH, researchers must still apply for a certificate of confidentiality; the NIH website provides instructions on how to do so, depending on your funding source. Researchers can contact the IRB program (IRB-ORP@psu.edu) with any questions about certificates of confidentiality.
As announced earlier this year, NIH has implemented new policies regarding clinical trials. It’s important to note that the NIH definition of a clinical trial is broad, particularly because the NIH definition includes not just studies treating a medical condition but also basic biomedical research and basic social and behavioral research. Here is one example from NIH of a clinical trial:
The study involves the recruitment of physicians who will be randomly assigned to use a new app or an existing app, which cues directed interviewing techniques. The study is designed to determine whether the new app is better than the existing app at assisting physicians in identifying families in need of social service support. The number of community service referrals will be measured. (Case #23, https://grants.nih.gov/policy/clinical-trials/case-studies.htm)
This example is a clinical trial because the app is an intervention, the physicians are prospectively assigned, and “the effect being evaluated, the number of referrals, is a health-related outcome.” For additional explanation of why this study is a clinical trial and for more case studies, see https://grants.nih.gov/policy/clinical-trials/case-studies.htm
NIH-funded studies meeting the definition of a clinical trial must now to be registered in clinicaltrials.gov and have results reported there. This requirement applies to all awards received on or after January 18, 2017 and all NIH-funded studies that start on or after that date. You can find out more about clinicaltrials.gov registration on the Office for Research Protections Quality Management website.
In addition, all NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP). This new training requirement became effective January 1, 2017, and applies to all new and existing NIH clinical trials. The policy requires basic GCP training and refresher GCP training every three years. Penn State investigators and staff can complete their training through the CITI Program. You can find out more about the CITI Program, GCP training, and how to complete it at the University's CITI Program website.
Finally, NIH is now issuing clinical trial-specific funding opportunity announcements. If your study meets NIH’s definition of a clinical trial, you MUST submit through an FOA specifically designed for clinical trials or one that is "clinical trial optional" starting January 25, 2018. You can read more about NIH’s requirements for clinical trials on their website or contact the ORP’s Quality Management team for guidance (ORP-QM@psu.edu).
Single IRB Review
For grant applications submitted on or after January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research are expected to utilize a single IRB-of-Record (sIRB) for the ethical review required for the protection of human subjects. The NIH policy applies to the following, with limited exceptions:
a. NIH-sponsored multi-site studies, where each site will conduct the same protocol (not to include collaborative research studies where each site will conduct different pieces of the study)
b. Domestic research sites only
A plan for the use of an sIRB needs to be included in the grant application, so applicants must engage the IRB early in the proposal development stage to make arrangements for IRB review. It is important to know that even if Penn State’s IRB will not be the reviewing IRB, submission of an external IRB request to Penn State’s IRB is still required, and an IRB Authorization Agreement MUST be executed in order for Penn State’s IRB to cede review to another IRB for a given study.
If you are preparing a grant application for a multi-site study to be submitted on or after January 25, contact the IRB program (IRB-ORP@psu.edu) for more information.
Have questions about your NIH-funded study? We recommend NIH’s 15-minute video about all their recent changes. You may also be interested in the Office for Research Protections presentation: "The New NIH Rules in 15 Minutes." And more training opportunities will be coming this winter. You're also welcome to email us anytime at IRB-ORP@psu.edu.