Here's a look at the most recent developments in the Human Research Protection Program:
The Auburn University Institutional Review Board and the Office of Research Compliance (ORC) will be holding open forums on the dates below to discuss regulatory changes related to human research. All human research investigators are encouraged to attend. Please contact the ORC with questions (334-844-5966 or firstname.lastname@example.org).
- Thursday, October 26, 2017 – OIT Building 1st Floor Meeting Room – 3:30 - 4:30pm
- Wednesday, November 29, 2017 – CASIC Building 1st Floor Meeting Room - 3:30 - 4:30pm
New NIH Policy for Issuing Certificates of Confidentiality – effective October 1, 2017
A new NIH Policy (NOT-OD-17-109) related to issuance of Certificates of Confidentiality (CoC) was released September 7, 2017. Under the new policy, as of October 1, 2017, NIH funded researchers will no longer have to request a CoC from NIH, nor will they receive an actual certificate. The CoC will be issued automatically to NIH funded grants, cooperative agreements, contracts and intramural research projects funded wholly or in part by the NIH that collect or use identifiable, sensitive information. Compliance with the requirements will become a term and condition of the award. All NIH funded research that was commenced or ongoing on or after December 13, 2016 that is within the scope of this policy will be deemed covered by a CoC. For non-NIH funded research, NIH will continue to consider CoC applications submitted to NIH institutes and centers through the NIH online CoC application system. NIH maintains a CoC Kiosk for information, sample consent language, and applications. Additional information is available in the NIH CoC Table and the AU CoC Process.
New NIH Policy on the Use of a Single IRB for Multi-Site Research – effective January 25, 2018
A new NIH Policy (NOT-OD-16-094) on the use of a single Institutional Review Board (sIRB) for multi-site research will become effective January 25, 2018. Under the new policy, NIH establishes an expectation that a sIRB of record will be used for the ethical review of non-exempt human subject research funded by the NIH where the same protocol will be carried out at more than one site in the United States. Applicants must include a sIRB Plan in the proposal/application or a justification for how the project meets one of the defined exceptions. Execution and maintenance of Authorization (Reliance) Agreements between the sIRB and participating sites which documents roles, responsibilities, and communication of sites are required. Participating sites will provide information on local context (including state and local law) to the sIRB and may be required to meet other regulatory requirements. Additional information is available on the NIH Office of Science Policy website. A summary of the NIH sIRB Policy and AU implementation is available in the NIH sIRB Chart and the AU sIRB Process.
Revised Common Rule – 45 CFR 46 – effective January 19, 2018 (most provisions)
The U.S. Department of Health and Human Services and 15 other federal agencies issued a final rule to update regulations that safeguard individuals who participate in research. Most provisions in the new rule will go into effect January 19, 2018. Compliance with the cooperative research requirements is not required until January 20, 2020. The new rule is intended to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects. The revised common rule contains numerous changes from the prior regulation which have been in place since 1991. Items and topics with significant changes include: the definition of human subject research along with other definitions, consent forms and required elements including a new broad consent, public posting of certain consent forms, use of stored identifiable data or identifiable biospecimens, limitations on waiver of consent, new and revised exempt categories, a new type of IRB review (limited IRB review), elimination of the requirement for continuing review of certain studies, and review of cooperative research. Additional information is available on the Office of Human Research Protection (OHRP) website. A summary of changes to the Common Rule is available in the Revised Common Rule Chart (coming soon).