1. Who must file with the JJ HRPP?
Faculty, staff, students, or other member of the John Jay community conducting covered research must seek JJ HRPP approval. Also, anyone who uses the College’s facilities or uses John Jay community members as research subjects must file.
2. Do you have to take any type of human subject research training?
Collaborative Institutional Training Initiative (CITI) is a required program that has to be taken by all CUNY researchers and key personnel involved in human subjects research regardless of whether the research is funded or non-funded.
CITI Training in the Protection of Human Subjects
Follow the instructions at the site. Select “City University of New York” as your institution rather than a campus. In order to start, you will need to select a Learner group. You do not need to complete all the modules all at once. CITI will save the work you have completed. The certificate is good for three years. Researchers that have a CITI certificate that has expired will have to do a refresher course.
3. How does one determine if a research protocol constitutes human subjects research?
To determine whether a research protocol constitutes human subjects research, CUNY uses the definitions provided at 45 CFR 46.102 (see the link below). Researchers who are unsure of whether their research meets these definitions, and therefore requires exemption or approval from the IRB, must submit a request for human subjects’ research determination to the HRPP Office of the college with which they have primary affiliation. The determination of whether a project constitutes human subjects research will be made by the HRPP Coordinator of the respective CUNY College. The HRPP Coordinators works in consultation with the University Director for Research Compliance and the IRB members.
4. What kind of research is covered?
According to federal regulations, covered research means “a systematic investigation . . . designed to develop or contribute to generalizable knowledge.” 45 CFR 46.102(d). In addition, this research must involve interaction with living human beings or individually identifiable private information about living individuals. A classroom exercise for educational purposes is not “research.” The Research Determination Form may help you determine if your project involves covered research. If you need assistance, you may call (212) 237-8961 or email email@example.com the HRPP Office.
5. How does the review process work?
There are three types of review: Exempt, Expedited and Full. Only Full review requires a decision of the CUNY UI Board. Exempt reviews are conducted by the HRPP Coordinator and Expedited reviews are distributed among a list of reviewers from various CUNY campuses.
6. Which of the three types of review applies to my project?
Exempt Review 45CFR 46.101(b) (1)-(6). Although exempt research does not require IRB review, this research is not exempt from the ethical guidelines of the Belmont Report (see the link below).
Expedited Review Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more of the following categories 1-7, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110.
Full Review applies to all other covered research that may pose greater than minimal risk to subjects. Initial review, continuing review and amendment submissions involving non-exempt research that may pose greater than minimal risk to subjects must be reviewed by a Convened IRB.
7. Where can get more information about Federal Regulations?
The homepage for the Office of Human Research Protections, US Department of Health and Human Services provides information such as: