The Department of Health and Human Services (HHS) published a final rule today to delay the general compliance effective date to update the federal regulations that protect the rights and welfare of human research participants (AKA the 2018 Requirements). These updates seek to modernize, strengthen and make more effective the federal policies for the protection of human research participants. The effective date for compliance with these requirements is January 21, 2019.
The UMBC Institutional Review Board (IRB), along with the Office of Research Protections and Compliance (ORPC) will continue preparations for the 2018 Requirements implementation. The IRB and ORPC are revising procedures and forms for UMBC investigators to comply with the January 21, 2019 effective date.
Common Rule changes include:
- · What is NOT considered human subjects research
- · New exemption & revised exemption categories
- · Continuing review changes for minimal risk studies
- · Single IRB review for multi-site research (effective January 20, 2020)
- · Consent form changes
The ORPC has created a document that describes how the 2018 Requirements impacts human subjects research at UMBC. Staff from the ORPC will provide educational outreach (via the IRB website, the ORPC myUMBC page as well as in-person education sessions) to provide investigators guidance about procedures and application processes and forms.
To summarize, the compliance schedule to adhere to the 2018 Requirements is as follow:
Previously approved ongoing protocols, prior to January 21, 2019
UMBC protocols will continue to follow all pre- 2018 Requirements - current IRB protocol processes -for the duration of the approved study. The ORPC will verify with investigators the intended end-point of a study to ensure close out occurs on a timely basis.
Protocols approved on or after January 21, 2019
UMBC protocols will follow the 2018 Requirements for all protocols submitted to or approved by the IRB on or after 01/21/2019. IRB website guidance, procedures and application forms will contain updates prior to the 2018-2019 winter break to use for new protocol submissions.
Investigators – please take note of the following:
EXISTING FULL BOARD PROTOCOLS
Protocols reviewed by the full board and are open to enrollment or still in an intervention phase will see the fewest changes under the 2018 Requirements. At the time of the next renewal that occurs after 01/21/2019, the ORPC will request you to update the waiver and consent form to meet the new requirements.
EXISTING EXPEDITED PROTOCOLS
Most studies that originally expedited by the IRB under the pre- 2018 Requirements will now be eligible for less frequent review beginning on 01/21/2019. At the time of the next renewal that occurs after 01/21/2019, the ORPC will request you to update the waiver and consent form to meet the new requirements.
EXISTING EXEMPT PROTOCOLS
There will be no changes to these protocols. If you have an exempt study that has ended, it is important to close the study with the IRB.
For more information, please contact the ORPC staff at email@example.com or 5-2737.