Human Subjects Protections:
The University of Rhode Island Institutional Review Board (IRB) reviews research projects which involve human subjects to ensure that two broad standards are upheld: first, that subjects are not placed at undue risk; second, that they give uncoerced, informed consent to their participation.
The IRB Policy on Human Subjects Research: IRB Policy Governance and Operating Policies.With representation from a wide range of scientific disciplines and from outside the academic community, the IRB gives individualized attention to the numerous research projects at the University.
URI’s Human Research Protection Program operates under Federal wide Assurance # FWA00003132.
Notification regarding upcoming changes to the federal regulation governing human subject research.
Changes to the Federal Policy for the Protection of Human Subjects (a.k.a. the “Common Rule“) will go into effect on January 21, 2019.
All studies approved after that date will be required to comply with the New Rule.
The NIH Office of Human Research Protections (OHRP) have the new rule and regulations on their website.
OHRP Revised Common Rule Videos
- What’s new in IRB review under the Revised Common Rule YouTube Video
- When Does the Common Rule Apply? Review of the Basics Under the Revised Rule YouTube Video
Major Regulation Changes
- Exempt Review – The New Rule has new Exempt Categories and clarification of existing categories. A new abbreviated Exempt Review application form, along with guidance documents have been developed. For details, see the new URI Exempt Review webpage.
- Continuing Review – May not be required in the following circumstances:
- Studies approved through the Expedited Review procedure
- Studies approved by the Full Board once subject interaction is completed
In most cases, projects approved prior to January 21, 2019 will continue to require annual Continuing Review.
For Expedited Review projects approved after January 21, 2019, an IRBNet generated annual notice will be sent to investigators as a reminder that modifications, reportable events and termination reports still need to be submitted to the IRB. [§46.109(f)(1)].
- Informed Consent – A new “Key Elements” section and a rearrangement of content is designed to facilitate a potential subject’s decision to participate or not. Informed consent templates with the required content are available at The Research Resources page.
What to do Next
The new regulations do not impact projects approved prior to the proposed implementation date of January 21, 2019. In most cases, ongoing research will remain under the pre-2018 regulations (those issued in 1991.) The URI IRB will maintain two sets of Standard Operating Procedures. Investigators are not required to make any changes to ongoing research. The IRB will issue guidance on how to request transition to the new rules, if desired, and the circumstances where transition might be beneficial. Investigators should be aware that transitioned studies might need additional IRB review and re-consenting of subjects. Final determination on whether to transition an individual study is made by the IRB.
For new projects:
- Review the exempt guidance documents and exempt review form to determine if your project meets one of the exempt categories.
- Utilize the informed consent templates when preparing a project application.
- If planning on submitting project that will require Expedited Review consider delaying until after January 21, 2019 as approval after this date would likely eliminate the need to Continuing Review. Use of updated consent language will be required.
Decisions Made to Date
Exemptions – URI has developed an abbreviated Exempt Review application. We anticipate the new application form, along with the more defined Exempt Review categories will result in an increased number of projects to be reviewed as Exempt. The new Exempt Review application is available on IRBNet in the Forms and Templates Library.
Broad Consent – URI will not implement the new regulatory “Broad Consent” option as an informed consent process at this time. Exemptions 7 & 8, which rely on Broad Consent, also will not be implemented.