Common Rule Changes - OHRP DELAYS Effective Date and General Compliance Date - New Effective Date - 07.19.18
- Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes go into effect July 19, 2018.
- The changes to the Common Rule do not apply to FDA-regulated studies.
- ORIC is working to roll out these changes at ECU. The announcements section of the ORIC > UMCIRB webpage and the ePIRATE homepage will be your main source of information and updates about the revised Common Rule roll out.
- Studies submitted on or after July 19, 2018 will be reviewed under the revised Common Rule. Currently approved studies will continue to fall under the pre-2018 Common Rule requirements.
- The revisions to the Common Rule go into effect July 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date.
- New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after 07.19.18.
- Revised SOPs will be posted on the UMCIRB website.
- Existing expedited studies approved prior to January 19, 2018 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with ORIC, an existing study may be revised to meet the new federal requirements. An amendment would need to be submitted and approved within the electronic IRB submission system to document this transition.
- Keep our website and the ePIRATE homepage checked for continuing and updated information.
- Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu.
- Remember, the revised Common Rule does not apply to FDA-regulated studies.
The short form consent (both the English and Spanish versions) has been updated. The new version date for the short form is 10/09/2017. In addition, an attestation of translation has been obtained for the Spanish translated version of the short form and is available on the UMCIRB website under "Forms, Docs & Templates". Please be sure to use this new template when submitting a short form for IRB review and approval.
Users will now select "Final Report" on the left side of each study's workspace to close a research study. This option was added to help users navigate to the correct application more easily when they are ready to close a study. Brief tutorials have also been added to the website.
Common Rule & Other Changes
COMPLIANCE DATE DELAYED: On Wednesday, January 17, 2018 OHRP announced the delay of the compliance date for the changes to the federal rule governing human research (Common Rule). The following is an excerpt from their announcement:
"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. Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations."
The Revised Common Rule - click here to read a copy of the revised Common Rule which contains tracked changes.
The following table provides a basic summary of the upcoming Common Rule changes:
|Revised "Human Subject" Definition|
|Informed Consent Changes|
|Revised Exempt Categories|
|Continuing Review Requirement Changes|
|Single IRB Requirement for Cooperative Research|
|How do these changes affect you?|