Baruch Human Research Protection Program
Baruch Human Research Protection Program (HRPP) Office
I need to determine if my project needs review, what do I do first?
PI's should work their way through our Researcher Guide in order to determine if their project needs review.
I know my project needs to be reviewed, what do I do?
PI's must submit their applications on-line via IDEATE. Please go to the Submitting Protocols in IDEATE section of our website for directions.
Are there any examples of activities that aren't considered Human Subjects Research?
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 acivities )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 IDEATE or contact the HRPP Coordinator 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 http://www2.cuny.edu/research/research-compliance/human-research-protection-program-hrpp/hrpp-policies-procedures/.
I think my project is “oral history” and doesn’t need to be reviewed by the IRB. How can I be sure?
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 IDEATE or contact the HRPP Coordinator 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.
If my project fits one of the "Exempt"categories does this mean I don’t have to have it reviewed by the IRB?
No, you still need review. Exemption is a category of human subject research defined by Federal regulations and CUNY policies and procedures. Only the HRPP 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 HRPP Office. Continuing Review for exempt projects will be eliminated after the revised common rule goes into effect on January 21, 2019.
I’m not gathering names on my survey, does that mean it’s anonymous and doesn’t need to be reviewed because I won’t have “identifiable private information”?
No, CUNY requires that these types of surveys be reviewed by the HRPP especially if the intent of the survey is to produce generalizable knowledge.
Does research with pre-existing data require review?
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. CUNY UI IRB Approval will be contingent upon a signed and executed data-use agreement between CUNY and the Data Holder.
I am working with a collaborator and my collaborator has had the project reviewed by the IRB at their institution, do I have to submit it to the CUNY UI IRB?
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 identifable information about human subjects, or obtaining informed consent from human subjects. Please refer to the Cooperative Research Guidance Document for information regarding collaborative reseach.
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 Office at the CUNY institution where the Principal Investigator of the project has their primary affiliation. Please refer to the Cooperative 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, the HRPP Office 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 HRPP Coordinator 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..
I will be conducting interviews that I will audio or videotape and later transcribe. Does my study qualify for Exempt Review?
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.
When should I submit my proposal for review by the UI IRB?
If you are applying for exempt or expedited review and approval, you should submit your application at least 30 - 45 days before you intend to start your research. This allows the IRB time to review and approve it. By submitting it that far in advance, it will also give you time to make any changes that the UI IRB requests in a timely manner and still meet your start date. For projects requiring convened/full IRB review, you should submit your application at least 90 days before you intend to start your research.
How do I coordinate UI IRB review with my grant application?
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 indeed human subject research requiring UI IRB approval. The IRB can not provide retrospective approval for research projects conducted without IRB approval.
CUNY requires that Baruch employees and key personnel have to complete training in the protection of human subjects in research. Who exactly has to take this training?
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 the HRPP Office with a certificate of completion. This includes but is not limited to PI’s, Co-PIs, and Research Assistants. Please click here for CUNY 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.
Where can I get the training I need in order to engage in human subject research?
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 click here for CUNY policies regarding CITI Training.
What special knowledge is expected for persons doing human subjects research?
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.
In what situations do I need to contact the UI IRB after my research has been approved?
If you want to make any changes in research you must submit an amendment form on IDEATE. If you encounter any unanticipated problems involving risk to participants or others, the HRPP Office 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.
How will I know when my UI IRB application has been approved? When can I start my research?
You will receive a IDEATE notification email of UI IRB approval. PI's can also go to the IDEATE website and download the approval letter and stamped consent forms from the Communications and Attachments Tabs of the IDEATE Application. A read-only version of the IDEATE protocol can be accessed by clicking on the protocol number in the LiveList.
How long does my UI IRB approval last?
Generally, UI IRB approval for Expedited projects can last from 1 to 3 years depending or whether or not the project is eligible for extended IRB Approval. As a courtesy, PI's will receive automatic email notifications 30, 60, and 90 days before the protocol expiration date.
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.
I've completed my study and data analysis, what should I do?
When you've completed data collection and analysis, PI's must submit a final report on IDEATE. If you are only conducting data analysis with de-identified data, you do not need to submit an continuing review. Please click here for guidance regarding study closures. 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.
Other than approval letters, will I receive any other UI IRB notices regarding my protocols?
PI's 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.
I have questions regarding IDEATE, are there directions?
If I have additional questions or need help completing an application to have my research reviewed by the IRB, who do I contact?
If you have additional questions or need help with forms, please contact Baruch HRPP Office at 646-312-2217.