The U.S. Department of Health and Human Services (HHS) published a very useful document about Common Rule changes called Companion Q&As about the Revised Common Rule. Our office is planning a Common Rule info session for early February (details forthcoming) to discuss some of the more notable changes, but we encourage you to review the FAQs in the meantime and reach out to us with any questions: email@example.com.
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.
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have issued final revisions to the Common Rule, which is the Federal Policy for the Protection of Human Subjects. The changes will go into effect on January 21, 2019. These changes to the federal policy will result in a number of changes to CUNY HRPP policies and procedures, as well as the CUNY IRB application. The changes are outlined on the CUNY Central HRPP website, and a brief overview of some of the more notable changes that will impact SPH researchers is provided on the Common Rule Changes section of our SPH HRPP website. Revised CUNY HRPP policies, procedures and guidelines will be available on the Central HRPP website on January 18, 2019.
During the coming weeks, our HRPP office will be sharing additional resources with SPH faculty, staff, and students about Common Rule changes, as well as holding an info session (TBD), so stay tuned for more information. In the meantime, SPH researchers with questions should contact Kristen Cribbs, SPH HRPP Director, at firstname.lastname@example.org or 347-921-2391.
Dear SPH Researchers:
Happy New Year! We are pleased to present our first Annual Report, with facts and figures about the SPH HRPP Office’s activities in 2018. HRPP engagement increased across the board from 2017, as reflected in the growing numbers of HSR Assessment Form entries and IRB application submissions that were received.
In addition to issuing HSR determinations, processing IRB applications, and providing ongoing guidance to researchers, last year, our office aimed to enhance supports and resources for the SPH research community, including the introduction of Video Tutorials and strengthening HRPP processes for fieldwork students.
We look forward to a productive 2019 as we continue to support SPH faculty, students, and staff in their human subjects research activities. Please feel free to reach out with any questions, comments, or suggestions.
SPH HRPP team
Just a friendly reminder that it is the responsibility of faculty, staff, and student researchers to be aware of the status of their IRB protocols in IDEATE and, upon completion of a study, submit a final report in IDEATE to close out the project in the system. Please note that you will not be able to re-open a protocol once it has been closed (you’ll need to create a new IRB application), so please be sure not to submit a final report until all study activities have concluded, including data analysis and publication using study data.
Masters and doctoral students: Upon graduating, you are no longer considered a CUNY affiliate for HRPP/IRB purposes, so your research can no longer continue to be covered by the CUNY IRB. Please remember to submit a final report for your research after you graduate from the SPH.
On June 18, 2018, the federal Department of Health and Human Services again postponed the effective date of Common Rule changes (originally slated to go into effect on January 19, 2018) from July 19, 2018 to January 21, 2019. CUNY will continue to operate under current regulations until the new effective date, and no changes will be made to the IRB application or protocols and procedures until this time. Please contact us with any questions.
We’re excited to announce the launch of our new Video Tutorials page, which aims to provide SPH researchers with additional guidance on HRPP/IRB processes. We recently posted a Fieldwork orientation video for doctoral and masters students and are in the process of developing more content, so be sure to check back in the coming months! Suggestions for future tutorials are welcome—contact us with any ideas you might have.
Once submitted, a CUNY IRB application undergoes a pre-review by the SPH HRPP office before an exempt determination is made by our office or the application is forwarded to the IRB for expedited or full-board review. Submission of an incomplete or inadequate application adds substantial time to the pre-review process, as multiple rounds of revision and resubmission by the PI may be needed to get the application “decision-ready.” So, how can you avoid processing delays? Our HRPP office developed a resource, Top Ten Tips to Avoid Delayed HRPP/IRB Protocol Review, with the most common application issues we see. We encourage you to take some time to review this document when developing an IRB application to avoid potential processing delays down the line. The document can also be found on the Faculty and Student Investigators pages under Part 2: Pre-IRB application submission steps and planning.
On January 17, 2018, the federal Department of Health and Human Services postponed the effective date of Common Rule changes from January 19, 2018 to July 19, 2018. CUNY will continue to operate under current regulations until the new effective date, and no changes will be made to the IRB application or protocols and procedures until this time. Please contact us with any questions.