Baruch Human Research Protection Program (HRPP) Office (formerly IRB)

           Keisha Peterson, HRPP Coordinator

           Baruch College Human Research Protection Program (HRPP) Office

           137 E25th Street - 10th Floor

           Room/ Box J-1028

           New York, NY, 10010

           Telephone: 646-312-2217

           Fax: 646-312-2219

 


 

What is a Human Research Protection Program?

The CUNY Human Research Protection Program (HRPP) is responsible for the protection of the rights and welfare of human subjects in research projects conducted at CUNY or by CUNY faculty, staff and students and RF CUNY staff. The program provides oversight, administrative support and educational training to ensure that CUNY research complies with federal and State regulations, University policy and the highest ethical standards. The CUNY HRPP comprises of 4 University Integrated Institutional Review Boards (IRBs) and 19 on-site HRPP offices.

A Human Research Protection Program concentrates not only on the review of IRB protocols but the quality of the overall research program university-wide. We accomplish this by the initiation of campus-wide training and education efforts under the direction of the University Director for Research Compliance.

The HRPP Coordinator is tasked with communicating CUNY and federal policies. Our main goal is the successful navigation of the UI IRB review process but also the education of PI's and the community at large regarding the use of human subjects in research.

About the CUNY UI (University Integrated) IRB

An Institutional Review Board (IRB) is a diverse body that may consist of faculty, staff and students. An IRB must have at least one community representative and one nonscientist. Each IRB is charged with protecting the rights and welfare of human research subjects. The IRB reviews proposed research protocols to ensure that the proposed research follows federal guidelines and accepted ethical principles to meet that goal. Academic and cultural diversity of IRB members ensures that research proposals are given a thorough review by members with varying interests.

In order to receive federal funding for human subjects research, an institution must pledge, in a document called a FederalWide Assurance (FWA), to follow certain ethical principles and federal regulations in the review of human subjects research proposals. CUNY applies these ethical principles and federal regulations to all human subjects research conducted at CUNY or by CUNY employees (faculty and staff) and students, regardless of funding or funding source.

CUNY faculty, staff and students, and community representatives to the IRB volunteer their time to ensure that CUNY research is conducted in concert with these ethical principles. Because the regulations were designed to be flexible, the IRB members must remain up-to-date on the interpretation of the regulations. They regularly attend training sessions and read research ethics related literature.

 

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Baruch University Integrated (UI) IRB Members

Baruch Human Research Protection Program (HRPP) Office Staff

  • Johanna DeLeon - HRPP Assistant
  • Elliott Larson - HRPP Liaison
  • Keisha Peterson – HRPP Coordinator

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Does Your Project Warrant UI IRB Review?

If a study is designed to develop or contribute to generalizable knowledge, and if it involves obtaining information from or about living individuals, the project requires advance UI IRB approval. Such projects include funded and non-funded questionnaire, interview, qualitative, secondary, and experimental research. Pilot projects that will be used for research purposes need review. In-class exercises done wholly for pedagogical purposes need not be submitted for prior  UI IRB review, and institutional research that is not disseminated externally does not require approval. Research conducted by faculty, staff and students needs IRB approval.  Please see the "When is CUNY HRPP or IRB Review Required?" guidance for details.

 

If you are unsure whether your project constitutes research, please go to the IRBnet website and submit a research determination form. For informal inquiries regarding research please contact the HRPP Coordinator.

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Training & Education - Collaborative IRB Training Initiative (CITI)

       CITI, the computer based training taken by CUNY researchers, research assistants, and other key personnel consists of several topical modules offered for distinct user groups.  While the entire training requires three to four hours, modules can be completed separately.

       Individuals can access CITI at www.citiprogram.org. If you have any questions regarding the CITI requirements, please contact the HRPP Coordinator.

 

      For more information regarding CITI training, please click here.

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                                                        UI IRB Application Submission

      After completing training and prior to undertaking a study, researchers should submit an CUNY IRB application to acquire approval for data collection from or about human subjects. All applications must be submitted via IRBNet.

     

Before submitting your application, please use the IRB Application Checklist to make sure that you have included all of the required documents. This will prevent delays which will result in a longer review time.

 

For more information about submitted protocols on IRBNet procedures click here.

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 UI IRB Approval Process

           The HRPP Coordinator confirms the researcher’s CITI training status, determines if the study involves vulnerable populations, and assesses any implications of external funding or other institutions’ involvement. The HRPP Coordinator will conduct an administrative review for all applications (also known as packages) submitted via IRBNet with the exception of continuing full board applications. The HRPP Coordinator will review exempt packages to determine if it meets the definition of research as defined by the federal regulations per 45 CFR 46.102 (d) (f).  Once all requested information has been submitted by the PI, the Coordinator will forward the package to a Expedited Reviewer for review. If particular expertise is needed, the Baruch HRPP Office in consultation with CUNY Central will select a CUNY UI IRB Member with the required expertise.

          Usually an Expedited Reviewer reviews each expedited application examining the researcher’s brief description of the study’s objectives, design, and procedures by focusing on identification of subjects, voluntary participation, potential risks and benefits, deception, informed consent, and confidentiality and requests revisions within three weeks. Upon acquiring the revised application, the CUNY UI IRB awards expedited approval that generally endures for one year and which can be renewed through a simple process.

            All full board applications will initially receive a document review from the HRPP Coordinator but will be forwarded for administrative review to the CUNY UI IRB Administrators. The IRB Administrative Review consists of an document review and regulatory check. Once the initial review has been conducted and the package has been deemed "complete" it will be assigned to primary and secondary reviewers from one of four CUNY UI IRB committees. The CUNY UI IRB will generally meet once a week to discuss full board protocols. Please go to the CUNY Research Compliance Website for submission details and schedule information.

            During the year researchers can seek approval of modifications to their studies by submitting an amendment form via IRBNet. Most full board amendments (if it is determined by a UI IRB Member to be a minor amendment), can be reviewed at the local campus by a Expedited Reviewer. Any full board amendment that is determined to be a major or substantive amendment must be forwarded to the CUNY UI Board for review.

         All Applications (Exempt, Expedited or Full) should be submitted to the PI's primary affiliation or home campus. Primary affiliation or home campus is where a PI has their full-time appointment.

         CUNY Students should submit their applications to the HRPP Office where their faculty advisor has their full-time appointment.

      

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Last Updated on 1/16/14