Compliance Updates and Information
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018.
The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.
Human Subject's Protection: Changes to the Common Rule
The effective date of compliance is set to take effect on January 19, 2008. The previous rule applies to research approved prior to January 19, 2018 and will not transition to the new rule.
See "Changes to the Common Rule" for summary of updates.
The 2017 Final Rule was originally slated to become effective on January 19, 2018, and institutions Required to comply with its new requirements by that same date. However, on January 20, 2017, President Trump issued an executive memorandum freezing all regulations that had been published but were not yet effective.
On October 7, 2017, the Office of Management and Budget (OMB) received a proposal from the Department of Health and Human Services (DHHS) that, by its title, seeks a “1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year.”
Until a formal delay is published by final rulemaking, we will continue to prepare for the implementation to comply with the updated changes by January 19, 2018.
NIH Changes to Certificates of Confidentiality
Effective October 1, 2017, NIH will automatically issue Certificates of Confidentiality to all research funded by NIH that is collecting or using identifiable sensitive information. Additional information can be found on the NIH Certificates of Confidentiality Kiosk at https://humansubjects.nih.gov/coc/NIH-funded. In part, the new policy reads:
"For the purposes of this Policy, consistent with subsection 301(d) of the Public Health Service Act (42 U.S.C 241), the term "identifiable, sensitive information" means information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research.
Consent document wording related to the NIH Certificate of Confidentiality has been provided by NIH consent sample language.
Guidance on Exceptions to the NIH Single IRB Policy
Notice Number: (NOT-OD-18-003) National Institutes of Health
Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
Notice Number: (NOT-OD-18-004) National Institutes of Health
NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research.