January 14, 2018: The general compliance date for the revised Common Rule is currently January 21, 2019. We will continue to operate under the existing regulations until this date; the implementation of policy changes associated with the new regulations will ultimately take effect on Jan. 21, 2019.
The PowerPoint available here details changes to the Common Rule regulations as well as related updates to Lehigh University's IRB policy.
Single IRB-review of multi-site NIH-supported research is NIH policy and not affected by the Common Rule delay. Single IRB review of NIH-sponsored multisite research is required beginning January 25, 2018.
June 18, 2018 update: On June 18, 2018, OHRP announced an additional six-month delay in the general compliance date for the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule) until January 21, 2019.
The delay in the effective date of the federal Common Rule regulations means that the institution must continue to apply pre-2018 federal rules and are not legally able to implement the following planned changes: elimination of continuing review for federally funded, minimal-risk research, and expanded and revised exempt review categories.
April 20, 2018 update: On April 20, 2018, HHS published a "notice of proposed rulemaking" (NPRM) proposing to delay the general compliance date for the revised Common Rule an additional six months until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements. This proposed rule, if finalized, would require regulated entities to continue to comply with the requirements of the current Federal Policy for the Protection of Human Subjects (a.k.a the “pre-2018 Requirements”) until January 21, 2019.
January 17, 2018 update: On January 17, 2018 at 4:15PM, OHRP announced a six-month delay in the effective date and general compliance date for the revised federal Common Rule. Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. Both the effective and compliance dates of the regulations has been pushed back to July 19, 2018, with the potential for subsequent additional delays.
As of January 17, 2018, Lehigh University has moved forward with some of our planned institutional-level policy updates that are unrelated to the revised federal Common Rule regulations and not affected by the last-minute delay in the effective date. Institutional policy has been revised to clarify that only activity that meets the either the FDA or DHHS definition of "human subjects research" is subject to IRB review and oversight. Please see "What Types of Activities Require IRB Review" and "Human Subjects Research Determination" under "IRB Worksheets" for more information.
December 6, 2017 update: The Research Integrity office is moving ahead with revisions to our university policies and procedures to correspond to the Revised Common Rule, in anticipation of a January 19, 2018 effective date. Applicable revised policies, procedures, forms, and instructions will be posted to the IRB website in December 2017. In order to ensure that the university remains compliant with federal regulations, applicable revised policies will not take effect until January 19, 2018 . If the White House makes a last-minute decision to delay the implementation date, applicable revised polices will not go into effect on January 19, 2018. However, the university may elect at that point to apply some of the beneficial, burden-reducing aspects of the Revised Common Rule (e.g. elimination of continuing review requirements for minimal risk research) to research that is not federally funded.
October 17, 2017 update: On October 7, 2017, a proposed delay to to the implementation of the Common Rule was posted to the White House Office of Information and Regulatory Affairs website. The proposed action pending review is entitled "Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year". No additional information is available.
In a June 2017 letter to the HHS Office for Human Research Protections (OHRP), the collective four "Higher Education Associations" representing the interests of institutions affected by the revised Common Rule requested a one year delay in the compliance date, with an effective date for most provisions remaining January 19, 2018. This would allow the regulated community to move forward with any or all provisions of the rule, including those that would reduce administrative burden for investigators, while allowing institutions more time to come into full compliance, given the uncertainty and lack of guidance and templates that has resulted from the regulatory freeze and review of the role imposed by the current administration. Additional clarity on the proposed changes to implementation is anticipated when a notice of proposed rule making is issued in the next coming weeks.
The following is a succinct article by Bloomberg BNA that further explains the impact of the proposed delay: https://www.bna.com/hhs-research-oversight-n73014470727/
While the final outcome is currently unknown, the following are some possibilities:
The delay will not be approved and the revised regulations will go into effect on January 19, 2018.
The implementation date will be delayed by 60 days while OMB reviews them.
The implementation will be delayed by one year and will take effect on January 19, 2019 - with our without allowing the implementation of the three burden-reducing provisions.
The revisions to the regulations will be cancelled entirely and the current regulations will remain in effect.
This website will be updated as new information becomes available. The Research Integrity office is moving forward with planned policy and procedure updates.
Revised Common Rule Issued on January 19, 2017: Ending five and a half years of rulemaking and speculation, the US Department of Health and Human Services (HHS) and 15 other Federal Agencies released a final revision of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2017. These are the first revisions to the Common Rule since it was promulgated in 1991. Click here for a helpful summary of the revisions provided by PRIM&R.
The Common Rule regulations establish the foundation for the Lehigh University Human Subjects Research Policy. These regulatory changes affect not only the institution, but many federal agencies that fund billions of dollars in research involving human subjects.The Research Integrity office is in the process of revising applicable institutional policies, procedures, and forms to correspond to the revised regulations in anticipation of a January 2018 compliance date.