The Office of Human Research Protections (OHRP) has announced changes to the federal regulations that protect the rights and welfare of human research participants, known as the Common Rule.
Effective date for implementation of the Revised Common Rule was January 21, 2019. OHRP provides training videos and resources for investigators/researchers.
Please note: These changes only apply to new studies approved on/after January 21, 2019.
No longer required for some minimal risk research, including studies where the only remaining activity is analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
New categories and clarification of existing categories. Some exemptions may require "limited IRB review," similar to an expedited review process.
A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not.
By law, the transition to the revised Common Rule is based on the status of initial applications on January 21, 2019. The IRBNet system shows the application status under BOARD Action located in the fifth column of your "My Projects" page.
The "In Between" Applications for New Studies as of 1/21/2019
| Application Status for New Studies | Version of the Common Rule |
|---|---|
| Work in Progress (Not Submitted) | Revised (2018 Requirements) |
| Pending Review | Revised (2018 Requirements) |
| Modifications Required | Revised (2018 Requirements) |
| Information Required | Revised (2018 Requirements) |
| Approved with Conditions | Revised (2018 Requirements) |
| Approved (studies prior to January 21, 2019) | Original (Pre- 2018 Requirements) |
Continuing Review for Expedited Studies
No longer required for some minimal risk research, including studies where the only remaining activity is analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
Please note: These changes only apply to new studies that are not approved as of January 21, 2019 OR new studies submitted on/after January 21, 2019.
You can expect to see the following changes:
1. IRBNet Smart Form and Supplemental Form Changes
2. Informed Consent Template and Optional Language Glossary Revisions
3. IRB Policy Revisions
4. For existing studies: There will be no change in process. These studies will fall
under the pre-2018 requirements.
Exemptions – AU has decided to adopt the "limited IRB Review" under exemption #2 and #3 only.
sIRB - AU IRBs will continue to assess its criteria for whether AU will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB.
Broad Consent - AU will not be adopting use of broad consent under exemptions #7 and #8 at this time.
Any changes made to IRBNet documents will still be housed in the IRBNet system under Forms and Templates.
|
Issue |
Date |
Focus |
|---|---|---|
| 1 | December 6, 2018 | Introduction/What studies are affected |
| 2 | December 13, 2018 | Foundational concepts (research & human subjects) |
| 3 | December 20, 2018 | Consent: New required elements and other consent related changes |
| 4 | January 8, 2019 | Exempt research |
| 5 | January 10, 2019 | Continuing review |
| 6 | January 23, 2019 | Summary; List of new and revised documents |