On November 19, 2018, OHRP published a draft guidance document titled Activities Deemed Not to Be Research: Public Health Surveillance, 2018 Requirements. This guidance document is intended to help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018 Requirements. The public may submit comments until December 19, 2018.
On July 20, 2018, the Office for Human Research Protections (OHRP) made available three draft guidance documents that relate to the three burden-reducing provisions in the revised Common Rule. Institutions may choose to implement these three provisions during the delay period for general compliance with the revised Common Rule (July 19, 2018 through January 20, 2019). The three draft guidance documents are now available on OHRP's website:
(1) Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements
(2) When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements
(3) Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements
Soon, OHRP will issue a Federal Register Notice of Availability (NOA) about these draft documents. The public will be able to comment on them during a 30-day period starting the day the NOA is published.
On June 18, 2018, HHS released a final rule confirming the delay of the general compliance date for the revised Common Rule until January 21, 2019.
In addition to delaying the general compliance date, the rule allows institutions to implement three "burden-reducing provisions " of the revised rule during the delay period:
(1) use of the revised definition of "research, " which deems four categories of activities not to be research;
(2) the allowance for no annual continuing review of certain categories of research; and
(3) the elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research.
Read the final rule in the Federal Register.
For more information on implementing these provisions during the delay period, see PRIM&R's April 2018 blog post.
On April 19, 2018, HHS released an NPRM proposing to delay the general compliance date for the revised Common Rule until January 21, 2019. A 30-day comment period was open until May 21, 2018.
In addition to delaying the general compliance date, the NPRM proposes to allow institutions to implement three "burden-reducing provisions " of the revised rule during the delay period.
Read the April 2018 NPRM in the Federal Register.
The comment period for the interim final rule closed on March 19. View all submitted comments.
Published in the Federal Register on January 17 at 4:15, the "Delay of the Revisions to the Federal Policy for the Protection of Human Subjects " delays the effective date and general compliance date of the revised Common Rule to July 19, 2018, 6 months after the original date of January 19, 2018.
On January 4, 2018, HHS submitted a final rule titled Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects. This final rule, which would delay the implementation date of the revised Common Rule for an unspecified amount of time, is currently undergoing regulatory review by the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB). This final rule is separate from the 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, which was submitted on October 7, 2017, and remains under review at OMB.
On October 7, 2017, HHS proposed a one-year delay of the general implementation date of the revised Common Rule.
The official published version of the new Common Rule was made available on January 19, 2017.