Impact of Final Rule Delay for Drexel University Researchers
August 8, 2018
On Wednesday June 19, 2018, the U.S. Department of Health and Human Services (HHS) issued the Final Rule delay for the general compliance date of the 2018 Requirements for an additional 6-month period until January 21, 2019. As a result of this delay to the general compliance date, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Common Rule until January 21, 2019.
The exception to this general rule is that institutions will be permitted (but not required) to implement, for certain studies, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018 through January 20, 2019). The three provisions are:
(1) The revised definition of “research,” which deems certain 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 review grant applications or other funding proposals related to the research.
If institutions choose to implement these three burden-reducing provisions for particular studies, such studies will be subject to the 2018 Requirements beginning on January 21, 2019. More information to follow regarding if, when, and which permissible provisions Drexel will implement.
Despite this delay, the proposed NIH policy changes(e.g., single IRB of Record
) HAVE TAKEN effect as of January 25, 2018.
More information on the 2018 Revised Common Rule can be found on the Office of Federal Register's website.
How will the implementation delay impact our researchers involved in Human Subject Research?
- Drexel IRB review of all of submitted research protocols will continue to review protocols under the Common Rule established in 1991, not the 2018 Revised Common Rule
- Please do not use previously saved versions of the consent form. The most recent version of our consent form can be found on our
- This delay DOES NOT impact the NIH requirement for a single IRB for multisite studies. The effect implementation date was January 25, 2018
- Next transition to the 2018 Revised Common Rule WILL NOT require a shutdown period or any pause in the submission of your research protocols
- Visit our website to view the External IRBs and Reliance Agreements
What to Expect going forward
- The 2018 Revised Common Rule does not impact studies approved prior to January 21,2019
- The 2018 Revised Common Rule does not impact studies which fall under the FDA regulations
- To prepare for implementation of the 2018 Revised Common Rule, expect to see post January 21, 2019:
- Revisions to the informed consent template currently on the HRP website
- Updates to the HRPP Investigator Manual (HRP 103)
- Minor IRB jurisdiction changes to facilitate workload changes
- If you are considering to propose Drexel as the single IRB for a NIH multi-site study, please consult with HRPP@drexel.edu and Kirstie McClung as early as possible.
- For existing studies, after the 2018 Revised Common Rule implementation date (January 21, 2019) the IRBs may choose to apply the new rules to minimize burden for investigators.
Office of Human Research Protection Actions
The Human Research Protections Program (HRPP), our IRBS, and research teams are working collectively to interpret the 2018 Revised Common Rule elements and update the University's policies, business processes, and systems to accommodate the changes while maintaining a high-level of subject protection.
What you can do
To ask a question, express concerns, or provide suggestions about human subject's research protections at Drexel, please send a message to HRPP@drexel.edu.
- Check this website periodically for new information. We will continue to add information through January 2019, as it becomes available.
- Look out for information and educational sessions in the coming months, advertised in newsletters, and on the Office of Research website
- Request an educational session for your research team or department in relation to these revisions by contacting HRPP@drexel.edu