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.
SPH research community:
New federal regulations for human subjects research go into effect on Friday, January 19, at which time the CUNY Central HRPP office will roll out a revised CUNY IRB application template in IDEATE that reflects these Common Rule changes. Changes to the IRB application on the 19th will be reflected in all forms.
All new applications, including those that are in-development or pending (i.e., not yet approved by the CUNY HRPP/IRB) on or after January 19, will be subject to review as per the revised Common Rule and revised HRPP Policies and Procedures, and must adhere to the revised policies, guidance and templates.
- If you plan to submit a new protocol for HRPP/IRB review, please wait until January 19 or later to create your IDEATE application, as this will ensure that you are using the revised IRB application.
- For applications that are in development prior to the 19th, the IRB application updates will be applied to the existing applications. Researchers will need to complete all new questions in the application prior to submitting.
- For applications that are pending prior to the 19th, the applications can either be processed or returned to the PI for updating.
If you would like to discuss your application, please contact us with the IDEATE protocol number and title.
Please note that PIs are NOT required to submit amendments to their existing protocols as a general rule due to the changes to the Common Rule. PIs should consult our HRPP office to discuss whether any modifications to their protocols are needed at the time of Continuing Review.
Please familiarize yourself with these important federal regulation changes, summarized on our new Common Rule Changes webpage. Further information can be found on the CUNY Central HRPP website. Our office will be educating SPH faculty, students, and staff on these changes and their implications for researchers in the months ahead.
Please do not hesitate to contact us with any questions, and stay tuned for more information. Thank you for your patience as we become familiar with the revised Common Rule and CUNY HRPP policies and procedures, and develop guidance for the SPH research community.
Dear SPH Researchers:
With the end of the year approaching, we wanted to provide you with an update about SPH HRPP activity during the past year. In 2017, our HRPP office received:
- 55 initial IRB applications, of which 27 were approved following expedited IRB review and 16 exemptions were granted.
- 14 continuing review applications
- More than 70 protocol amendment applications
- 170 submissions to the SPH Human Subjects Research Assessment Form
These figures reflect a substantial increase from 2016.
Our office aims to make the HRPP/IRB review process as efficient as possible. On average, HRPP pre-review of protocols submitted to IDEATE were completed in 1 business day. Exempt protocols were reviewed and processed by our office in an average of 2 business days from time of receipt, and expedited protocols were reviewed by the IRB and processed by our HRPP office in an average of 4 business days. While we make every effort to facilitate timely HRPP/IRB review, please be reminded that there are several factors that may affect the duration of review, including the type of application, the quality of the application, the number of submissions received, and available IRB member expertise.
This year, our office streamlined and strengthened many of our systems and processes, including developing this website and a host of guidance and resource documents for SPH researchers. We look forward to another productive year ahead and continuing to support SPH faculty, students, and staff in their human subjects research activities. As always, please don’t hesitate to contact us with any questions, comments, or suggestions.
Happy New Year,
SPH HRPP team
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 19, 2018. These changes to the federal policy will result in a number of changes to CUNY HRPP policies and procedures. The impact of Common Rule changes on CUNY HRPP policies and procedures is summarized here. Related information from the HHS Office for Human Research Protections (OHRP) is available here. Updated CUNY policies and procedural documents will be available on the CUNY HRPP website on January 19.
The SPH HRPP office will be providing ongoing support and resources to SPH researchers regarding these changes in the coming months.
The CUNY Central HRPP Office has issued a revised SOP on IRB Authorization Agreements (IAA) (also known as a Reliance Agreement, Cooperative Agreement, or IRB Memorandum of Understanding (MOU)). An IAA is formal document that provides a mechanism for an institution engaged in human subjects research to designate the institutional review board (IRB) of another institution as the IRB
of Record for one or more human subject research protocols. An IAA is an agreement between the institution(s) that 1) Specifies which institution’s IRB will be the IRB of Record for some or all components of a study; and 2) Defines the responsibilities for the IRB and for each institution.
The CUNY Office of Research, in collaboration with the CUNY Office of General Counsel and the CUNY Office of Institutional Research, has revised the guidance and procedures document to assist researchers (e.g., CUNY faculty, staff, post-doctoral associates, students) in ensuring compliance with Family Educational Rights and Privacy Act (FERPA) when using CUNY’s educational records for research purposes. Please familiarize yourself with this updated guidance.
In response to the increasing number of requests for inclusion of independent researchers (i.e., volunteer researchers) in CUNY research, the Office of Research, in collaboration with the Office of General Counsel, has developed procedures and an application to allow for the involvement of independent researchers in CUNY research. Please note that the authority to approve the involvement of independent researchers resides with the CUNY college or school where the research will take place. The procedures and application are available on the Research Agreements web page.
Welcome to the new SPH HRPP website! Along with developing a more user-friendly site, our Office has created a variety of resources and tools to aid SPH researchers in understanding and meeting regulatory requirements surrounding human subjects research. We hope you’ll find this information useful. As always, please feel free to contact us with questions, comments, or feedback.