In light of the current situation that we are facing with COVID-19, to protect the health and welfare of the SPH community and research participants, human subject research involving direct interaction with study participants should be suspended to minimize risk of contracting or spreading COVID-19. Where feasible, in-person research procedures should be converted to online or virtual formats (note that such procedures must be approved by the CUNY IRB prior to implementation).
Dear SPH Researchers:
Happy New Year! We are pleased to present our 2019 Annual Report, with facts and figures about the SPH HRPP Office’s activities last year. SPH researcher engagement with our Office increased across the board from 2018, as reflected in the growing numbers of IRB application submissions and HSR Assessment Form entries that were received.
In addition to executing our core functions of issuing HSR determinations, processing IRB applications, and providing ongoing guidance to SPH researchers, last year, we sought to facilitate the smooth implementation of the 2018 Federal Common Rule, which went into effect in January 2019 and resulted in significant updates to CUNY HRPP policies and procedures.
We look forward to a productive 2020 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
Dear SPH research community,
We hope the new academic year is off to a great start! Just a friendly reminder that the SPH HRPP Office is here to support you in your research endeavors. We have a variety of resources on our website for students and faculty who are planning to conduct human subjects research (HSR) and are also available for one-one-one or group consultation to provide guidance about the HRPP/IRB process here at CUNY. Please don’t hesitate to contact us, and we look forward to working with you!
-SPH HRPP Office
Please be advised that IDEATE will be unavailable tomorrow, July 17, at 8pm until 10:30am on Thursday, July 18.
Please be advised that IDEATE will be intermittently unavailable on Saturday, April 20th, from 7:00 AM until 4:00 PM, due to scheduled server maintenance.
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: firstname.lastname@example.org.
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 email@example.com or 347-921-2391.