Cornell has chosen to adopt some burden-reducing provisions of the Revised Rule early. The following provisions are effective now.
Annual or triennial continuing review ("renewal") is no longer needed for expedited protocols.
The most important change is that the annual renewal requirement has been eliminated for all expedited review studies.
As before, but even more important now, PIs must continue to seek approval for any changes to approved protocols by submitting amendments, and only begin procedures once amendments are approved by the IRB. Unexpected events must also be promptly reported to the IRB.
Effective July 19: You do not need to complete a renewal request for approved expedited protocols
- IRB staff will contact PIs and faculty advisors prior to the scheduled expiration date of each protocol to remind them of the change to the policy and provide an updated approval letter and stamped consent documentation showing no expiration date. If you need to make any changes to your consent form, study materials or recruiting materials, submit an amendment to the IRB.
- If you have received a reminder for annual review of have recently submitted a renewal application, you don't need to do anything at this time. The IRB staff will contact you.
- At each anniversary of approval, you will receive a courtesy message from the IRB office, reminding you to keep your protocol updated, submit amendments as needed, report unexpected events and close the protocol when the study is over. While no action will be required on your part, we recommend that you take this opportunity to ensure that your study procedures are in compliance with your approved protocol.
Two other burden-reducing provisions of the Revised Common Rule are also now in effect.
The grant congruency process for HHS funding has been eliminated.
- A revised definition of regulated "research," excepting journalism, oral history and similar activities. Cornell's current interpretation is consistent with the new definition, so no change is anticipated.
- The grant congruency process for HHS funding has been eliminated. This change removes a significant administrative step for faculty and staff. PIs are responsible for making sure that research with human participants that is part of a project sponsored by the HHS (or any other agency) is approved by the IRB.
Non-federally funded studies involving benign experiments may qualify for exemption using criteria from the Revised Common Rule that the IRB has chosen to apply early.
The IRB voted to allow exemptions to be issued for new, non-federally funded research that meets criteria described in certain new and expanded exemption categories in the Revised Common Rule.
In order to approach IRB reviews with greater flexibility, reducing administrative workload and regulatory burden without compromising the protection of human research subjects, the Cornell IRB limits the application of its Federal-wide Assurance (FWA) to federally funded research. Consistent with this approach, the IRB voted to allow exemptions to be issued for new, non-federally funded research that meets criteria described in certain new and expanded exemption categories in the Revised Common Rule, in advance of the January implementation date. If you submit an IRB application describing research that meets these criteria, IRB staff will issue an exemption, provided your application indicates that there is no current or anticipated federal funding for the study. No special actions are needed for your submission to be considered for exemption under these new/expanded criteria, which are described below:
- New Exemption Category for "Benign Behavioral Interventions":The intervention must be "brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing." Example: having subjects solve puzzles under various noise conditions. Additional requirements:
- Adults only; no minors (under 18 years old)
- No direct or indirect identifiers are recorded or, if responses were disclosed outside the research setting, this would not reasonably place the subjects at risk of harm
- No deception is permitted, unless the subject is told during the consent process that they will be unaware of or misled about the nature or purposes of the research
- Data collected can include verbal or written responses, data entry, observation, audiovisual recording. No data collection via physical procedures (EEG, FitBits, blood draw, etc.)
- Broadened Exemption Category for Secondary Research: The exemption covering secondary research use of identifiable private information or identifiable biospecimens has been broadened so that the data no longer need to be existing ("on the shelf") when the exemption is granted.
As a reminder, all exempt studies require a formal determination of exemption before research with human participants begins. Researchers may not self-determine that their work is exempt, but must submit an application form to the IRB office.
If you have any questions or concerns about these changes to IRB processes, please do not hesitate to contact the IRB office.