You may have heard whispering about new regulations for conducting human subjects research. Well, the rumors are true – the federal Office of Human Research Protections (OHRP) released revised regulations in January and they will become effective on January 19, 2018.
While we believe that most of the changes will result in a much-appreciated reduction in administrative burden for investigators and increased efficiency for our office, the transition will involve considerable preparation and education regarding changes to Brown’s policies and procedures for human subjects research.
To facilitate a smooth transition, beginning December 20, 2017, there will be a freeze on all new protocol submissions to the HRPP.
During this freeze period:
- We ask that investigators work with HRPP staff to finalize any submissions that are currently under review – failure to obtain approval for existing submissions prior to January 20, 2018 will unfortunately result in closure of the submission and required re-submission under the revised regulations.
- The HRPP will be evaluating currently active protocols to determine if they meet new exemption or expedited criteria under the revised regulations (and, therefore, may be subject to reduced administrative burden for investigators!)
- The HRPP intends to complete all continuation reviews for current studies that expire in January 2018 in late December/very early January, which may result in a slight change in anniversary date moving forward.
- The HRPP will consider exceptions to the freeze period for urgent situations, such as JIT requests, to be evaluated on a case-by-case basis.
Unless you need to start your research in January or February of 2018, we suggest that it would be best for you to wait and submit your protocol after the implementation of the new regulations in January, to avoid confusion during the review and to take advantage of new regulations and procedures that may mean less work for you. If you are concerned about the timing of a particular submission, please consult with HRPP staff and we'll be happy to help you figure out the best way forward.
The HRPP will provide additional information and educational opportunities about the revised regulations during the next several months. Informational sessions will be announced on this page, in Morning Mail, and in LearningPoint. Stay tuned!
Around the same time as the implementation of the revised Common Rule, the NIH policy that mandates single IRB review for all multi-site clinical trials that include the same protocol at all sites goes into effect. All investigators who will be submitting a proposal to NIH on or after January 25, 2018, should contact the HRPP as soon as possible to discuss the use of a single IRB and associated cost/budgeting questions.
The HRPP will also be hosting a webinar offered by the NIH Office of Extramural Research on Wednesday, October 18th, from 2:00 - 3:30 PM in the 2 Stimson Ave, 3rd floor conference room. In this webinar the NIH will share the latest information regarding the NIH policy on a Single Institutional Review Board (sIRB) for Multi-Site Research involving non-exempt human subjects. Topics to be discussed will include:
• Implementing the NIH sIRB policy;
• Expectations for the NIH sIRB;
• Process to request exceptions to the policy; and
• Responsibilities of the IRB, the investigator, and the institutions in implementing the sIRB policy.
HRPP team members will also be available after the webinar to answer any questions you may have about Brown's implementation of the sIRB mandate. This webinar is open to all, no pre-registration is required.
Certificates of Confidentiality (CoC) help researchers protect privacy and confidentiality of human subjects enrolled in sensitive, health-related research by allowing them to refuse to disclose names or other identifying characteristics of research subjects in response to legal demands. Traditionally, investigators conducting sensitive research with human subjects were required to apply to their funding agency for a CoC, and the process was often confusing and lengthy. As part of the 21st Century Cures Act, NIH has released a revised policy related to Certificates of Confidentiality that goes into effect October 1, 2017.
Under the new policy, all biomedical, behavioral, clinical, or other research that was commenced or ongoing on or after December 13, 2016, funded wholly or in part by the NIH, that collects or uses identifiable, sensitive information is deemed to be issued a CoC and is therefore required to protect the privacy of individuals who are subjects of such research. Going forward, CoCs will be granted automatically to all applicable studies as a part of the regular terms and conditions of award.
All studies that have a CoC are required to include specific language in all consent documents to inform participants of the protections provided by the CoC as well as the limits of those protections. HRPP staff are assessing currently active studies that are deemed to have a Certificate of Confidentiality under this new policy (and hadn't previously requested a CoC), and will be reaching out individually to investigators to guide them in making the appropriate changes to their consent documents.
Additional information about the new policy can be found on the NIH website. Please call the HRPP office with any questions or concerns about this new rule.
In 2016, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials. The goal of this effort is to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. The NIH definition of a clinical trial was revised in 2014 in anticipation of these stewardship reforms to ensure a clear and responsive definition of a clinical trial. In August 2017, the NIH released additional resources to clarify the definition and help investigators understand whether there existing or proposed research falls under the definition of a clinical trial. While the intent of these resources, including FAQs , Case Studies, and a decision tool for using Four Questions to identify clinical trials, was not to expand the definition to cover a broader subset of research studies, the way the resources were worded seemed to do just that. On September 8, in response to outcry from the research community NIH revised the resources, most notably Case Study #18, which has somewhat assuaged concerns, although some confusion remains. While the NIH has stated that additional guidance will be forthcoming as needed, Brown is moving ahead with implementation of the new interpretation of the definition and ensuring that affected PIs and studies are in compliance with the requirements for clinical trials that are effective or will become effective in January of 2018 (GCP training, registration on CT.gov, single IRB review, specific funding opportunities and new proposal forms).
The HRPP, RAIS and OSP will team up for an informational session on Thursday, October 19, 2017, 1-2pm, to assist investigators / research teams with determining whether their research is considered an NIH Clinical Trial. We will also clearly lay out what investigators must do to comply with new requirements and how we can help with compliance moving forward. Register for the session on LearningPoint.
HRPP staff is in the process of assessing which studies we believe to be affected by this change and will reach out to investigators individually. If you don't hear from us or you have questions, please contact our office at x3-3050.