Human Subjects Research FAQ’s
- 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.
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.
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.
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.
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.