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 following are specifically excluded from the definition of Human Subject Research and do not need to be reviewed by the IRB:
interviews used to provide quotes or illustrative statements, such as those used in journalism;
gathering of information from a person to elucidate a particular item (or items) in a museum collection;
gathering of information from a person to assess suitability for and/or supplement a public program, publication, or cultural performance; or
survey procedures, interview procedures, or observations of public behavior that are conducted for Baruch internal purposes (program evaluation) only, the results of which will not be published or presented in a public setting (e.g., at conferences or professional meetings).
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.
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.
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.
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 IRB review. Exempt is a category of human subject research defined by Federal regulations and CUNY policies and procedures. Only the IRB 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 IRB. Please note that as of December 1, 2009, the exemption rules have changed. All exempt applications will receive a three-year IRB approval. Before IRB approval expires, the PI should submit an exempt continuing review form. See CUNY Research Compliance website for details.
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 IRB 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 what types of activities you are conducting and whether CUNY is engaged in research activities.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 primary affiliation. Human subjects protocols should only be submitted to one CUNY HRPP Office regardless of the number of CUNY campuses collaborating on the project. Please note that this change ONLY concerns multi-site research involving multiple CUNY colleges. Please refer to the Multi-Site Research Guidance Document for information regarding the review of multi-site protocols.
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.
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 and video equipment is allowed in exempt human subjects research. 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 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?
You do not have to have IRB approval or research determination for your project before submitting a grant application, just before you actually begin your human subject research. However, you should bear in mind that the IRB needs time to review your application and make its determination. 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.
If you are conducting research using human subjects, we recommend that you submit a research determination form to the UI IRB. 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 serves as a principal investigator, designs research, directs research, enrolls research subjects (including obtaining subjects’ informed consent or screening potential subjects), makes decisions related to eligibility to participate in research, conducts study procedures, analyzes or reports research data, analyzes or reports adverse events, authors manuscripts concerning the research for publication, or acts as a translator of application materials has to take the training and 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 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 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. Please note that while data is active (i.e. data collection, analysis of identifiable data, etc.) a continuing review form must be submitted to the UI IRB annually. For exempt projects, continuing review forms must be submitted every three years.
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 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 and Full Board applications lasts a year. Please note that while data is active (i.e. data collection, analysis of identifiable data, etc.) a continuing review form must be submitted to the HRPP Office. Continuing Review forms should be sent a month before the project expiration date. Please click here for CUNY Policy regarding Expired Studies.
If a continuing review form is not submitted within three months of the expiration date of the protocol, a new application will have to be submitted in order to continue the research.
As a courtesy, PI's will receive automatic email notifications 30, 60, and 90 days before the protocol expiration date.
If the project received exempt approval, PI's will receive a three-year approval that is renewable.
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.
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.
I have questions regarding IDEATE, are there directions?
Yes, there are directions under the Submitting Protocols in IDEATE section of our website. If you need additional information regarding how to submit IDEATE submissions please refer to the help documents link: http://cuny.edu/research/compliance/human-subjects-research-1/hrpp-policies-procedures/how-to-use-ideate.html. These documents are proprietary and require a username/password. Please contact your HRPP Coordinator for username/password access to these documents. Help documents are also available on IDEATE website in the help link on the top of the page.
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.