Research Protections: IRB/IACUC
Welcome to the Pace University Institutional Review Board (IRB) website! The IRB is committed to protecting the rights, welfare, and privacy of human participants in research. The IRB reviews all proposed research involving human participants that will be conducted by members of the Pace community (faculty, students, and staff), and by external parties who wish to conduct research either with Pace faculty, staff or students as participants or on any Pace University owned and/or operated site.
The IRB is guided by ethical guidelines outlined in the Belmont Report, the Code of Federal Regulations 45 CFR Part 46, as well as Pace University policies and procedures. The Pace IRB is authorized to review and approve research involving human participants through an agreement with the US Department of Health and Human Services, Office for Human Research Protections called a Federalwide Assurance (FWA #00023526; OHRP IRB #0003970).
If you have questions or would like information or clarification on any aspect of the IRB process, please contact Mr. Jose Cueto at email@example.com or firstname.lastname@example.org. IRB office: 163 William Street, Room 326, Pace University - New York Campus.
- IRB Policies and Procedures
- Initial Review
- Continuing Review
- Revisions to an Approved Protocol
- Final Report
- Research Training
- Frequently Asked Questions
- IRB Committee
IRB Policies and Procedures
To submit an application for IRB review, please complete the application packet and email the documents to Jose Cueto at email@example.com. IRB approvals expire after 1 year; investigators must then submit either an application for renewal (if the research is ongoing) or a final report (if the research is completed). Details for the IRB procedures at each stage of this process are outlined below.
IRB review and approval is required if you are conducting research on human subjects. According to federal guidelines (45CFR 46.102(d)), research is defined as “a systematic investigation…designed to develop or contribute to generalizable knowledge.” You may not need IRB approval for some activities, such as certain class assignments, interviews with content experts about an external topic (in which no personal information is obtained), or collection of oral histories (for archival purposes, without the intent to compare or contrast across respondents), as they would not fit the federal definition of research. If you have questions about whether your project/activity requires IRB approval, please contact the IRB Co-Chairs or Coordinator.
If you determine that your project fits the definition of research with human subjects, your application will be reviewed by the IRB. The IRB is authorized to conduct three levels of review, depending on the scope and nature of the research.
Exempt category: Participants are subjected to minimal risk and the research fits one of the 6 federally designated exempt review categories [see 46.101(b)1-6]. Investigators must still submit an application packet and obtain approval from the IRB if their research falls within the exempt category.
Examples of exempt studies could involve:
- Normal education practices,
- The use of tests, survey or interview procedures, or observation of public behavior in which the human subjects cannot be identified and disclosure of their responses could not place them at risk,
- Analysis of publically available data or archived data.
Expedited category: Participants are subjected to minimal risk and the research fits in one of the 9 federally designated expedited review categories.
Examples of expedited studies could involve:
- Collection of biological specimens (e.g., saliva, hair and nail clippings, excreta and external secretions, mucosal and skin cells),
- Collection of data from voice, video, digital or image recordings made for research purposes,
- Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus groups, program evaluation, human factors evaluation, or quality assurance methodologies (if it doesn’t fall under exempt category).
For exempt and expedited categories, please allow 4-6 weeks for review.
Full review category: Full committee review is required for research that is greater than minimal risk and/or does not qualified by exempt or expedited review (for example, identification of the subjects and/or their responses could reasonably place them at risk of criminal or civil liability or be damaging to the subjects in some way). The IRB committee meets 1 time per semester to review these applications. The next meeting is scheduled for Fall, 2016. If your application requires full review, please submit all materials at least 2 weeks prior to the meeting in which you would like your application reviewed.
IRB approvals expire after one year. If research procedures are ongoing, investigators should submit an application for continuing renewal (form below) at least 30 days prior to expiration.
Projects should be renewed if:
- Enrollment is active,
- Enrollment is active pending IRB approval of revisions,
- Enrollment is closed, but participants continue to be involved in study procedures,
- Enrollment is closed, but analyses using participants’ identifiable information is ongoing.
If there is a lapse in approval, investigators may not enroll participants, engage in study procedures, or analyze identifiable data until the IRB renewal is reviewed and approved.
Revisions to an Approved Protocol
If investigators wish to make changes to an approved protocol, they must submit a revision form (see below) to the IRB. This is required if there are changes to the protocol, consent form, study procedures, number of enrollees, or key personnel.
When an IRB-approved research project has ended, investigators should close their study by submitting a Final Report (see below). Projects should be closed if:
- All participant recruitment and enrollment is completed,
- All participant records and data have been obtained and no further contact with participants is necessary,
- Analyses of participants’ identifiable data, records, or specimens are completed (note that it is allowable to analyze de-identified data when a study is closed).
All faculty, staff, students, and other key personnel who will be conducting or overseeing human subjects research are required to complete the CITI (Collaborative Institutional Training Initiative) online program. The CITI tutorial provides information and guidance for the responsible conduct of research involving human participants that is consistent with federal and University requirements and accepted scientific standards. All individuals involved in the research (lead researcher, co-investigators, personnel and faculty sponsors) must provide proof of completion of the tutorial prior to the approval of an application, or approval of a revision if it includes a change in personnel.
You can access the CITI program at citiprogram.org; we have developed a guide that provides step-by-step instructions for registration. Those who will be engaged in social and behavioral science human subjects research should complete the Social and Behavioral Responsible Conduct of Research Module. CITI certifications are valid for three years; to renew your certification, please complete the Social & Behavioral Research – Basic/Refresher Course.
IRB Committee Co-Chairs
Gerald P. Ardito
School of Education
Lucille R. Ferrara
Director, Dept. of Graduate Studies
College of Health Professions
The Pace University Institutional Animal Care and Use Committee (IACUC) ensures the humane and sensitive care and use of research animals. The Chair of the IACUC committee is Dr. Nigel Yarlett. For additional information on IACUC, please contact Donna Sarno (firstname.lastname@example.org; 212-346-1646).