Please see below for important information about implications of the new Common Rule on existing IRB protocols in IDEATE beginning January 22, 2019:
- IRB applications in-development (pre-HRPP/IRB approval): On 1/22, IRB applications that are in-development (i.e., have not yet been submitted) or in various stages of the HRPP/IRB approval process (e.g., returned to the PI for modification, under HRPP review, or under IRB review) will be automatically updated in IDEATE to reflect CUNY IRB application revisions that are being made due to Common Rule changes. Beginning that day, PIs will be required to complete these new portions of their applications and attach new consent documents before HRPP/IRB approval can be granted.
- Active IRB protocols: In order to comply with Common Rule changes, beginning on 1/22, PIs with active IRB protocols will need to make modifications to their protocols during the following times:
- At the time of their first Amendment submission (post-Common Rule implementation). The creation of an Amendment on or after 1/22 will trigger the population of Common Rule-related CUNY IRB application revisions that the PI will be required to complete (see below).
- At the time of their next Continuing Review (CR) submission. At the time of a PI’s CR submission, they should also create a protocol Amendment, which will trigger the population of Common Rule-related CUNY IRB application revisions that the PI will be required to complete (see below).
Unless a PI is submitting a CR application or an Amendment for an unrelated purpose (e.g., addition of new personnel), they are NOT required to submit an Amendment to their existing protocol solely to comply with Common Rule changes.
In both of the above scenarios, PIs with existing protocol will be required to:
–Complete new questions/fields in the body of their IRB application
–Attach new consent documents (using the new CUNY consent templates), including a new broad consent form (if applicable), ONLY IF participants are still being enrolled in the research
Be advised that, with Amendment approval, the study’s expiration date will be removed to reflect the new Common Rule’s elimination of continuing review for qualifying minimal-risk research. Additionally, the exempt or expedited approval categories of a previously-approved protocol may change due to the new regulations.
We will continue to post updates here about these upcoming regulatory changes as we receive them from the Central HRPP Office, so be sure to check back regularly. Don’t hesitate to contact us with any questions or concerns.