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

Human Subjects Research FAQ's

What is Human Subjects Research?

What is "generalizable knowledge"?

What does "intervention or interaction with the individual" mean?

What is "identifiable private information"?

What are the differences between anonymous, confidential and de-identified?

How do I know if my research project needs to be reviewed?

Are there any examples of activities that aren't considered Human Subjects Research?

If I am just talking to people and there are no experiments or clinical trials, do I need human subjects approval?

I think my project is "oral history" and doesn't need to be reviewed by the UI IRB. How can I be sure?

I know my project needs to be reviewed, what do I do first?

If my project fits one of the "Exempt" categories does this mean I don't have to have it reviewed by the UI IRB?

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"?

Does research with pre-existing data require review?

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 UI IRB?

I will be conducting interviews that I will audio or videotape and later transcribe. Does my study qualify for Exempt Review?

Can I share my research approval with a colleague working on a similar project or add a colleague to my project without IRB review or approval?

Can I submit an amendment form to amend several different protocols at once?

When should I submit my proposal for review by the UI IRB?

How do I coordinate UI IRB review with my grant proposal?

Does "Expedited Review" mean that it's fast?

What Does "Full Board Review" mean and why do I have to submit my application for full review?

How often does the UI IRB convene Full Board Meetings?

The application that I have to submit for my research project says 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?

Where can I get the training I need in order to engage in human subject research?

What special knowledge is expected for persons doing human subjects research?

I am confused about the informed consent requirements. Can you please explain how this works and what I have to do?

In what situations do I need to contact the UI IRB after my research has been approved?

How will I know when my IRB application has been approved? When can I start my research?

How long does my UI IRB approval last?

I've completed my study and data analysis, what should I do?

Other than approval letters, will I receive any other UI IRB notices regarding my protocols?

I have questions regarding IRBNet, are there directions?

If I have additional questions or need help completing an application to have my research reviewed by the UI IRB, who do I contact?

 

1. What is Human Subjects Research?

"Research" refers to a systematic investigation designed to develop or contribute to generalizable knowledge.  This usually implies collection and analysis of data the researcher hopes to report in a scientific publication or at a professional meeting, but that isn’t always the case.  "Human subject research" is research where the investigator obtains from a living human individual (1) data through intervention or interaction with the individual; OR (2) identifiable private information.  

 2. What is “generalizable knowledge”?

"Generalizable knowledge” means that the intent of the research is to add information to your field of study; the results can be applied beyond the subject population to other settings.  It doesn’t matter if the results will be published or not, if your research activity is designed with the aim of discovering information that can be applied in other settings, it can be considered research.

3.  What does “intervention or interaction with the individual” mean?

If you perform physical procedures on a person, manipulate the person, manipulate the person’s environment, communicate with a person, or have interpersonal contact with a person, you are engaged in an intervention or interaction with that person. Interactions include but are not limited to surveys, interviews, and questionnaires.

4a.  What is “identifiable private information”?

For information to be considered “identifiable private information” two criteria must be true.  First, the information must be private, meaning it is either about behavior that occurs in a context where the individual reasonably expects no observation is taking place or the individual has provided the information for a specific purpose and reasonably expects the information will not be made public.  Second, the information must be individually identifiable, meaning the identity of the person is or may be readily ascertained by the investigator or the identity of the person is or may readily be associated with the information.

4b. What are the differences between anonymous, confidential and de-identified?

The IRB often finds that the terms anonymous, confidential, and de-identified are used incorrectly. These terms are described below as they relate to an individual’s participation in the research and the way that their data are collected and maintained for analysis.

 Participation

 An individual’s involvement in a research project can be described as anonymous if it is impossible to know whether or not an individual participated in the study. For example, participation in an online survey that cannot be linked in any way to the individual would be considered anonymous.

 When participation is confidential, the research team knows that a particular individual has participated in the research but is obligated not to disclose that information to others outside the team, except as clearly noted in the consent document.

 Data

 Data are anonymous if no one, not even the researcher, can connect the data to the individual who provided it. No identifying information is collected from the individual. Researchers should be aware, however, that while they may not collect direct identifiers such as name, address or student identification number from participants,collection of information regarding other unique individual characteristics (indirect identifiers) might make it possible to identify an individual from a pool of subjects. For example, a study participant who is a member of a minority ethnic group might be identifiable from even a large data pool.

 When data are confidential, there continues to be a link between the data and the individual who provided it. The research team is obligated to protect the data from disclosure outside the research according to the terms of the research protocol and the informed consent document. In order to protect against accidental disclosure, the subject’s name or other identifiers should be stored separately from their research data and replaced with a unique code to create a new identity for the subject. Note that coded data are not anonymous.

 Data are considered de-identified when any direct or indirect identifiers or codes linking the data to the individual subject’s identity are destroyed.

 5. How do I know if my research project needs to be reviewed?

All research involving human subjects must be reviewed by the CUNY UI IRB before research can begin.

 6. 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 a Human Subject Research Determination Form in IRBNet 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.

 7. If I am just talking to people and there are no experiments or clinical trials, do I need human subjects approval?

Yes. Federal regulations define human subjects research to broadly cover interactions as well as interventions with human subjects for research purposes. Surveys, interviews, questionnaires, oral history interviews, etc., are all covered by the federal regulations. IRB approval must be obtained prior to commencing your research.

 8.  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 a Human Subject Research Determination Form in IRBNet 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.

 9. I know my project needs to be reviewed, what do I do first?

PI's must submit their applications on-line via IRBNet. Please go to the Submitting Protocols in IRBNet section of our website for directions.

10. 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.

11. 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. However if data is no longer being collected and the data being analyzed is de-identified and anonymous, the IRB will not require continuing review. See "Study Closure" Guidance for details.

 12. 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 ultizing 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.

 13. 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?

Yes.  Any project conducted by Baruch faculty, staff, employees or students must be reviewed by the UI IRB. 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.

 14. I will be conducting interviews that I will audio or videotape and later transcribe.  Does my study qualify for Exempt Review?

Yes.  The use of audio and video equipment is allowed in exempt human subjects research.

15. Can I share my research approval with a colleague working on a similar project or add a colleague to my project without UI IRB review or approval?

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.

16. Can I submit an amendment form to amend several different protocols at once?

No. You must submit an amendment form for each protocol you wish to amend even if you are changing the same item in each protocol.

17. 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.

18. 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.

 19. Does “Expedited Review” mean that it is fast?

No.  “Expedited” is a specific category defined in Federal Regulations.  In spite of the name, it is not a speedier review reserved for last minute.  Research activities must fall into one of the nine federally defined categories to be considered “expedited”.  This kind of research is reviewed by one UI IRB member instead of the entire UI IRB membership at a convened meeting. Please see CUNY Guidance - Expedited Review for CUNY procedures.

20a. What Does "Full Board Review" mean and why do I have to submit my application for full review?

Full Board applications are applications that require that the IRB convene a meeting to review it. Full review as defined by federal regulations and CUNY Policies and Procedures involve research that is greater than minimal risk and do not fit into the Exempt or Expedited review categories. In other words, the probability and magnitude of harm and discomfort are greater than those regularly encountered in daily life. In social behavioral research this can mean a variety of things. Some examples are research with a high degree of deception, surveys that asks potentially embarrassing or risky questions such as sexual behavior, HIV status, crimes, prisioner research, etc. Unlike medical research, the risks involved in Social Behavioral Research are psychological and emotional such as embarrassment or discomfort for participants. It is important for PI's to acknowledge these risks and account for them when submitting an application to the HRPP Office for review. Please see the "Covened IRB Review" Guidance document for details.

20b. How often does the UI IRB convene full board meetings? 

The CUNY UI IRB will generally meet once a week. Please click here for University Integrated (UI) IRB meeting schedule.

 21. The application that I have to submit for my research project says 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.

 22. 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).  You must provide a copy of the certification to IRB with every application submitted. Please click here for CUNY policies regarding CITI Training.

23. What special knowledge is expected for persons doing human subjects research?

Every researcher is expected to understand the policy 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.

24. I am confused about the informed consent requirements.  Can you please explain how this works and what I have to do?.

Except in certain situations, all research conducted at CUNY must involve some type of informed consent.  This is the foundation of our respect for the rights and welfare of human subjects.  The consent process allows the researcher to inform the potential subject about the research and ensure that the potential subject is aware of all the risks and is joining the study voluntarily.  Any information that could reasonably affect a person's willingness to participate in the research must be disclosed in the consent process.

 Usually the consent process will involve giving the potential subject a written form explaining in terms understandable to the subject who is doing the research, what the project is about and it’s goal, how the research is being done, any risks and potential benefits of the research and that participation is voluntary and can be withdrawn.  If the subject agrees to participate in the research, he or she would sign the consent and would be given a copy to keep and you would retain a copy for your records.

 However, in certain situations such as internet research, on-line surveys, and phone interviews a different process will be called for such as waiver of documentation (i.e. physical signatures) or alteration of informed consent. 

There are two federal regulations for Waiver/Alteration of informed consent 45 CFR 46.116 (c) or (d). Waivers of documentation (i.e. participant signatures) usually fall under 45 CFR 46.117 (c)(1) or (2).  Please click here for Informed consent process and documentation requirements.

 If you need help preparing a consent form, a template and list of requirements for informed consent are available in the Downloadable Forms section of our website.

 25. 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. 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.

 26. How will I know when my UI IRB application has been approved? When can I start my research?

You will receive a IRBNet notification email of UI IRB approval. PI's can go to the IRBNet website and download your approval letter and stamped consent forms from the Reviews link under Project Administration.

27. 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 your expiration date. Please click here for CUNY Policy regarding Expired Studies.

If you do not submit a continuing review form within three months of the expiration date of your protocol, you will have to submit a new application in order to continue your research.

As a courtesy, you will receive automatic email notifications 30 and 60 days before the protocol expiration date.

If you received exempt approval, you will receive a three-year approval that is renewable. Please see question 10 for details.

28. 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 IRBnet. 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.

29. Other than approval letters, will I receive any other  UI IRB notices regarding my protocols?

Yes, notices are sent whenever an action is taken by the UI IRB. PI's will receive email notices when a protocol expires, is closed, or if a final report is received and accepted.

30. I have questions regarding IRBNet, are there directions?

Yes, there are directions under the Submitting Protocols in IRBNet section of our website. For complete directions please click here.

31. 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.

 

 

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