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2019 Annual Report

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.

Best wishes,

SPH HRPP team

Exception to the Required Use of a Single IRB for Certain HHS Cooperative Research

The Office for Human Research Protections (OHRP) in the Office of the Assistant Secretary for Health of the Department of Health and Human Services (HHS) has announced its determination of exception for two categories of research from the required use of a single institutional review board (IRB) to review cooperative research under the HHS regulations for the protection of human subjects.  This determination is specific to research conducted or supported by HHS.  The announcement with the OHRP determination of exception has been put on public display by the Office of the Federal Register and can be accessed here. The determination of exception can also be accessed on OHRP’s website.
OHRP determined that for HHS cooperative research subject to the revised Common Rule (also referred to as the 2018 Requirements), and for purposes of 45 CFR 46.114(b)(2)(ii), an institution may continue to use multiple IRBs, in lieu of a single IRB, for the following research:
(1) Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB initially approved the research before January 20, 2020.
(2) Cooperative research conducted or supported by NIH if either:
a. the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
b. NIH excepted the research from its single IRB policy before January 20, 2020.
Note that this determination is only made for purposes of section 46.114(b)(2)(ii) – namely, for determining whether certain cooperative research may be excepted from the single IRB mandate.  This determination does not prevent, nor should it be viewed as discouraging, the voluntary use of a single IRB in cooperative research subject to the 2018 Requirements that would fall within the above two categories.  Further, note that category (2)(b), above, applies for the duration of NIH’s exception from its policy for the particular research study; categories (1) and (2)(a) apply for the duration of the research.

Welcome to a new academic year!

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

Scheduled IDEATE maintenance 7/17-7/18

Please be advised that IDEATE will be unavailable tomorrow, July 17, at 8pm until 10:30am on Thursday, July 18.

Scheduled IDEATE maintenance 4/20

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.

New Common Rule informational video

Our office has developed an informational video about the new Common Rule to educate the SPH research community about these changes and implication for researchers. Check it out on our Video Tutorials page, and don’t hesitate to reach out with any questions, comments, or concerns.

Common Rule FAQs

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: hrpp@sph.cuny.edu.

 

Important information about existing IRB protocols under the new Common Rule

Please see below for important information about implications of the new Common Rule on existing IRB protocols in IDEATE beginning January 22, 2019

  1. 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.
  2. 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:
    1. 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).
    2. 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.

Common Rule changes effective January 21, 2019

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 kristen.cribbs@sph.cuny.edu or 347-921-2391.

2018 Annual Report

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.

Best wishes,

SPH HRPP team

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