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Human Subjects Certification FAQs

Do I Need to Take CITI if I am the PI on a Training Grant?

If you are mentoring students conducting human subject research, you need to take the CITI modules. If you are listed as the PI on a training grant but you are not mentoring any students conducting human subject research you do not need to take the CITI modules. Grants and Contracts will have you sign an attestation form verifying that you are not conducting human subject research and that you are not mentoring any students conducting human subject research.

Do I Need to Take CITI Again If I Have Completed Behavioral Modules?

The modules you took to satisfy the behavioral research requirements will be accepted by the HRPO.

How Do I Access the CITI program?

You can log into the CITI system by identifying TCNJ as your institution and register using your active TCNJ username and password. If you are collaborating with a non-TCNJ researcher who needs to complete a human subjects training, they may also use the TCNJ CITI account and log in using their own personal address. If you have a non-TCNJ person use the CITI training as a component of your research together, please send an email to srcompliance@tcnj.edu with the affiliates name and institutional/organizational affiliation each time any person who uses CITI that is not a TCNJ employee or student.

Do All Key Personnel Need to Take CITI Training?

Consistent with other TCNJ policies, the TCNJ Human Subjects requirement defines key personnel as any individual responsible for the design, conduct, or reporting of research. Key personnel are engaged in the research when they (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes ( 45 CFR 46.102(d),(f) ) Only those key personnel that are “engaged in the research” must take the mandatory human studies education modules.

Do Research Administrative Staff Need to Complete CITI Training?

Administrative staff who are“engaged” in human research must complete the necessary education. Examples of engagement: a. Dr. Smith who is a PI on a research study asks a house staff member to conduct a clinical exam on an individual who happens to be a research participant. The clinical examination is not part of Dr. Smith’s research protocol. The house staff member is performing ordinary clinical duties and is not engaged in the research. She does not need to take the mandatory human studies education module. b. A photographer is asked to take a picture of a research participant. This picture will be included with the article being written that describes the results of the research. The photographer is taking a picture as part of his normal duties, thus he is performing commercial services and is not engaged in the research. He does not need to take the human studies training module. c. Jane Smith, a TCNJ undergrad working as a research assistant in a Psychology lab, is asked to obtain informed consent from a research participant. Jane Smith is engaged in the research. She needs to take the mandatory human studies education module. d. The intake worker at a local counseling services agency is asked to pass along a flyer advertising a research study to anyone that might be interested or that she feels may qualify for the study. The intake worker is not engaged in the research. She does not need to take the human studies education module. e. A group of research participants are referred to a weight management clinic. Referral of these participants is part of the research protocol. Once referred, these research participants are treated as any other referral into the program. Those assisting/instructing the research participants regarding weight management are not engaged in the research and do not need to take the human studies education module.

Do Faculty Sponsors Need to Complete CITI Training?

Yes. Faculty Sponsors are responsible for guiding students in the ethical conduct of research, including policies governing research with human participants and for ensuring that the student-reseacher has sufficient training and experience to conduct the study. The Faculty Sponsor, therefore, must be well educated in human research requirements in order to fulfill these responsibilities.

Do Undergraduates Need to Complete CITI Training?

Yes. Undergraduate students who are identified as Research Assistants of the Study Team must complete the necessary education.

Does the Education Requirement Apply to Collaborators at Foreign Institutions?

Yes. If they are “engaged” in human research and under the auspices of another institution that has a Federal Wide Assurance (FWA), they do not need to provide proof of their human subjects education. If TCNJ is the IRB of Record, these individuals will need to take the CITI training. If no FWA is available for the institution, HRPO and therefore TCNJ reserve the right to require human subjects education training.

Do Non-TCNJ Collaborators Need CITI Training?

There are two types of non-TCNJ employees. This includes individuals working in other countries. GROUP 1 – Employees of outside institutions whose institutions have an IRB. This group is governed by an IRB operating under a Federal Wide Assurance. These individuals do not have to take the mandatory CITI human studies training modules. GROUP 2 – TCNJ is the IRB of Record. These non-TCNJ employees (including undergraduate students, graduate students, and local collaborators as well as those from foreign institutions) who collaborate on TCNJ research are at institutions that do not have an IRB. TCNJ is most concerned about those non-TCNJ employees not governed by an IRB. In this instance, TCNJ becomes the IRB of Record for these individuals. These individuals must take the mandatory CITI human studies training modules.

What Human Subjects Education Program Is Accepted at TCNJ?

Only the CITI program is offered by TCNJ for faculty, students, and staff at no charge. TCNJ will also accept the PHRP training, although this training has a $40 fee. It used to be free, but recently was converted to a fee for service training.

What Does “Engaged” in Research Mean?

Engaged persons are those individuals who will have contact or interactions with research participants or identifiable private research data. These individuals should be listed as Study Team members on the iMedris application and protocol.

Who Must Be Educated in Human Subject Protections?

All individuals who are “engaged” in research with human participants where TCNJ is the Institutional Review Board (IRB) of Record.

Adapted with permission from Washington University School of Medicine

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