PI’s should work their way through our Researcher Guide in order to determine if their project needs review.
PI’s must submit their applications on-line via IRBManager. Please go to our Documents and Forms resource page for directions.
The revised Common Rule now identifies the following activities as not meeting the definition of research. They are the following:
Scholarly and Journalistic Activities ( e.g. oral history, journalism, biography, literary criticism, legal research and historical scholarship) that focuses directly on the specific individuals about whom the information is collected.
Public Health Surveillance Activities including the collection and testing of information or biospecimens conducted, supported, requested , ordered or authorized by a Public Health Authority.
Criminal Justice or Intelligence Activities collected (collection and analysis of information, biospecimens, or records) solely for criminal justice or criminal investigative purposes.
Authorized operational activities )as determined by a federal agency in support of intelligence, homeland security, defense, or other national security missions.
When researchers are not certain whether their activities constitute human subjects research, they should submit an application in IRBManager or contact the Research Compliance Specialist for an informal research determination. To assist the CUNY Research Community in determining whether CUNY HRPP or IRB review is required please see the “When is CUNY HRPP or IRB Review Required” guidance document on the CUNY Website.
According to the national Oral History Association (OHA), “Oral history refers both to a method of recording and preserving oral testimony and to the product of that process. It begins with an audio or video recording of a first person account made by an interviewer with an interviewee (also referred to as narrator), both of whom have the conscious intention of creating a permanent record to contribute to an understanding of the past. A verbal document, the oral history, results from this process and is preserved and made available in different forms to other users, researchers, and the public.” While oral historians, like some social scientists, gather information through interviews, the OHA notes that “oral history is distinguished from other forms of interviews by its content and extent. Oral history interviews seek an in-depth account of personal experience and reflections, with sufficient time allowed for the narrators to give their story the fullness they desire. The content of oral history interviews is grounded in reflections on the past as opposed to commentary on purely contemporary events.” Oral histories do not aggregate information from multiple interviews, seek to generalize to a larger population, or test hypotheses. Rather, they are intended to generate reflections and insights on the past.
General principles for evaluating Oral History type activities (Per OHRP Oral History Guidance):
a. Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalize findings would NOT constitute” research” as defined by HHS regulations 45 CFR part 46. As per the revised Common Rule these types of activities are not deemed to be research requiring HRPP/IRB Review.
Example: An oral history video recording of interviews with holocaust survivors is created for viewing in the Holocaust Museum. The creation of the video tape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories.
b. Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) WOULD constitute “research” as defined by HHS regulations at 45 CFR part 46.
Example: An open ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.
c. Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR part 46, the creation of such an archive WOULD constitute research under 45 CFR part 46.
When researchers are not certain whether their activities constitute human subjects research, they should submit an IRB Application in IRBManager or contact the Research Compliance Specialist for an informal research determination. To assist the CUNY Research Community in determining whether CUNY HRPP or IRB review is required please see the “When is CUNY HRPP or IRB Review Required” guidance document on the CUNY Website.
No, you still need review. Exemption is a category of human subject research defined by Federal regulations and CUNY policies and procedures. Only ORCO can determine if a research project fits one of the exceptions in the “Exemptions” category. As long as your activity is considered human subject research, it needs to be submitted to the Office of Research Compliance and Outreach. Continuing Review for exempt projects will be eliminated after the revised common rule goes into effect on January 21, 2019.
No, CUNY requires that these types of surveys be reviewed by ORCO especially if the intent of the survey is to produce generalizable knowledge.
It depends on what type of data is being collected and whether or not there is identifiable information. If the data is available to the general public without restriction or de-identified, then HRPP/IRB review is not required. If access is limited, for example to persons with certain qualifications, to persons who pay a fee, or requires some sort of data use agreement to access the data the research may require expedited or full board review.
Note that if you are utilizing a dataset that requires a data use agreement these agreements must be reviewed by Legal Affairs and signed by CUNY’s General Counsel if an institutional signature is required. CUNY UI IRB Approval will be contingent upon a signed and executed data-use agreement between CUNY and the Data Holder. Please review our Research Agreements page for details.
It depends on whether or not CUNY is engaged in research activities. CUNY is engaged in research activities when CUNY Affiliated persons are intervening/interacting with human subjects, obtaining private identifiable information about human subjects, or obtaining informed consent from human subjects. Please refer to the Non-Exempt Cooperative Human Subject Research Guidance Document for information regarding collaborative research.
When a research project is to be conducted in collaboration between two or more CUNY colleges, the human subjects research protocol should be submitted to the HRPP at the CUNY institution where the Principal Investigator of the project has their primary affiliation. Please refer to the Non-Exempt Cooperative Human Subject Research Guidance Document on the CUNY Website for additional information.
Please note in certain situations if the collaborator is at an institution other than CUNY, ORCO will request a copy of the approval letter from the external IRB. UI IRB approval will be contingent upon receipt of the external institution’s IRB approval letter.
If a collaborator is not affiliated with an institution, their institution does not have an IRB, or they have not obtained approval from their institution’s IRB a research agreement may be required. Please contact the Research Compliance Specialist if you have any questions regarding research agreements.Any human subjects research conducted at Baruch or by Baruch faculty, staff, employees or students must be reviewed and approved by the CUNY UI IRB.
The use of audio-visual equipment is allowed in exempt human subjects research under certain circumstances. An exempt determination will be made based on whether or not the project meets exemption criteria.
No. Approvals cannot be shared. If changes are made to a protocol such as adding of key personnel or changing research documents, an amendment form must be submitted and approved by the UI IRB.
As a guide, investigators should plan to submit a complete application for IRB review at least three months prior to beginning low risk studies. Researchers planning studies with international subjects, protected or vulnerable populations, or other greater- than-minimal-risk research should plan to submit at least six months prior to beginning the study. Sufficient time should be provided in your research plan, as allowance for any IRB-required changes to the research protocol and office/campus closures. Failure to plan for the IRB review process may delay your timeline for the initiation of the research. See our HRPP/IRB Review Policy for additional information.
IRB approval or research determination is not required before submitting a grant application, only before human subject research activities begin. However, you should bear in mind that the HRPP/IRB needs time to review your application and make their determinations. Therefore, you may want to begin the application process while your grant is under consideration in case you receive the funding and need or want to start your project right away.
Please note that RF-CUNY requires UI IRB approval or research determination for all projects involving human subjects before allowing access to funds. PI’s will not receive reimbursement for items that were not purchased within the approval period if it is determined that the research being conducted is human subject research requiring UI IRB approval. The IRB can not provide retrospective approval for research projects conducted without IRB approval.
Before engaging in any human subject research, every person who conducts human subject research activities (intervening/interacting with human subjects, obtaining private identifiable information about subjects, or obtaining informed consent from subjects) must provide ORCO with a certificate of completion. This includes but is not limited to PI’s, Co-PIs, and Research Assistants. Please go to CUNY website for policies regarding CITI Training. Please note that key personnel not affiliated with CUNY will be required to submit an IRB approval letter from their institution or obtain a research agreement in order to participate in research. Please click here for details.
Free training in the protection of human subjects in research can be obtained at http://www.citiprogram.org/. After completion of this training, you will be issued a certificate as proof that you have completed the training required by the City University of New York (CUNY). Please go to CUNY Website for policies regarding CITI Training.
Every researcher is expected to understand the policies set forth in CUNY Policies and Procedures and the Federal Regulations from which it is derived. In addition to the general protections for human subjects of research, every researcher must comply with any professional, ethical, methodological and cultural standards specific to the subject area being investigated. See Researcher Responsibilities Guidance Document on the CUNY Website for details.
If you want to make any changes in research you must submit an amendment form on IRBManager. If you encounter any unanticipated problems involving risk to participants or others, ORCO must be contacted. Most projects requiring expedited review will not require continuing review effective January 21, 2019. Continuing Review for exempt projects will be eliminated after the revised common rule goes into effect on January 21, 2019.
You will receive a IRBManager notification email of UI IRB approval. PI’s can also go to the IRBManager website and download the approval letter and stamped consent forms. For step-by-step instructions on downloading forms/approval letters please see this video.
Projects approved pre-revised Common Rule were given 1 to 3 years depending on whether or not the project was eligible for extended IRB Approval. As a courtesy, PIs will receive automatic email notifications 30, 60, and 90 days before protocol expiration date. Most projects requiring expedited review will not require continuing review effective January 21, 2019. Expiration dates for exempt projects will be eliminated after the revised common rule goes into effect on January 21, 2019. Greater than Minimal Risk studies (i.e. studies requiring full/convened board review) will still receive expiration dates.
When you’ve completed data collection and analysis, PIs must submit a final report on IRBManager. If you are only conducting data analysis with de-identified data, you do not need to submit an continuing review. Please go to CUNY Website for guidance regarding study closures. Most projects requiring expedited review will not require continuing review effective January 21, 2019. Expiration dates for exempt projects will be eliminated after the revised common rule goes into effect on January 21, 2019.
PIs will receive email notices when a protocol is approved, expires, or if a final report is received and accepted. Most projects requiring expedited review will not require continuing review effective January 21, 2019. Continuing Review for exempt projects will be eliminated after the revised common rule goes into effect on January 21, 2019.
