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?
"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.
"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.
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. Interaction includes but is not limited to surveys, interviews, and questionnaires.
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.
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.
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 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.
All research involving human subjects must be reviewed by the CUNY UI IRB before research can begin.
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).
Research Determination solely rests with the HRPP Office and not the individual researcher. See CUNY Policies and Procedures Section 7.2 for details.
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.
PI’s conducting Oral History research must submit a Human Subjects Research Determination Form to the UI IRB so that a determination can be made as to whether or not the project being conducted constitutes research under federal regulations and CUNY polcies and procedures.
If your intention is to interview people who have a unique perspective on a particular historical event or way of life, and you also intend to let the individuals’ stories stand alone, with no further analysis, the research is most likely oral history which will only require a Human Subjects Research Determination Form form be submitted to the UI IRB. These forms are now to be submitted via IRBNet.
However, if the surveys or interviews are conducted with the intention of comparing, contrasting, or establishing commonalities between different segments or among members of the same segment, it is safe to say your research will contain regular survey/interview procedures, because you will be generalizing the results your research may need IRB review. See CUNY Policies and Procedures Sections 19.6 through 22.214.171.124 for details.
Determination of research decisions solely rests with the HRPP Office and not the individual researcher.
PI's must submit their applications on-line via IRBNet. Please go to the Submitting Protocols in IRBNet section of our website for directions.
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.
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 CUNY Policies and Procedures Section 7.7 for continuing review details.
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, the research can be considered for exempt review. 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.
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 CUNY Research Compliance Website for information regarding the review of multi-site protocols involving collaborations with non-CUNY institutions or investigators.
Please note 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.
Yes. The use of audio and video equipment is allowed in exempt human subjects research and is eligible for review as long as the research could not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
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.
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.
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 60 days before you intend to start your research.
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’s 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.
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.
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 CUNY Policies and Procedures Sections 7.5.3 through 126.96.36.199 for Research Application requirements.
The CUNY UI IRB will generally meet once a week. Please click here for University Integrated (UI) IRB 2012 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.
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.
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.
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 and 46.117 (c) and (d). Most waivers/alterations will fall under 45 CFR 46.117 (c). Please click here for Informed consent requirements and consent waiver 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.
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.
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.
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.
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.
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.
If you have additional questions or need help with forms, please contact Baruch HRPP Office at 646-312-2217.