Research Protections: IRB/IACUC
The Institutional Review Board (IRB) is committed to protecting the rights, welfare, and privacy of human participants in research. The IRB reviews proposed research involving human participants 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 (HHS), Office for Human Research Protections (OHRP) called a Federalwide Assurance (FWA #00023526; OHRP IRB #0003970).
When is IRB approval required?
IRB review is required when you are conducting research on human subjects. According to federal guidelines (45CFR 46.102(d, f)), this means that you are:
- Conducting “a systematic investigation…designed to develop or contribute to generalizable knowledge”
- On “a living individual about who an investigator conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information."
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 a 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 Coordinator (firstname.lastname@example.org) or Co-Chairs.
Who may serve as a PI on an IRB application?
- Full-time faculty and staff can serve as a PI on an IRB proposal.
- Part-time/adjunct faculty and staff can be a PI with departmental approval.
- Graduate students (masters and doctoral) may serve as PI but must have a faculty advisor included on the project.
- Undergraduate students cannot serve as a PI; a member of the faculty or staff must be the PI on undergraduate projects. Undergraduates can, however, be co-investigators on a proposal.
The committee is tasked with ensuring that all research involving human subjects is done ethically, responsibly, without undue risk the participants, and in line with federal regulations. The committee members represent different disciplines and have expertise in different research methodologies; the varying backgrounds of the members ensure a complete and adequate review of different research activities commonly conducted at Pace. The IRB consists of at least one community member, who is not affiliated with Pace and is not part of the immediate family of a person who is affiliated with the institution. Additionally, the IRB has at least one member whose primary concerns are in non-scientific areas. When research that involves vulnerable populations (e.g., prisoners, pregnant women) is reviewed, the IRB may invite other individuals with specific expertise to join the committee.
IRB members may not participate in a review of a protocol in which they have an apparent or real conflict of interest (e.g., IRB member or family member is an investigator on the protocol). Under these circumstances, the IRB member will recuse him or herself from the deliberations and not vote on the protocol.
IRB Submission And Review Process
How do I submit to the IRB?
Pace University uses the IRBNet platform for IRB submissions and reviews. To register, please go to https://irbnet.org/release/index.html. The New User Guide can help you get started. Once you are registered, you can download the application, consent form template, checklist, and other applicable supplementary materials. When these are completed, please upload the documents via IRBNet, route for any necessary signatures, and submit the application for review.
Your application will be reviewed by the IRB if it is determined that your project fits the definition of research with human subjects. 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. 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.
Investigators must still submit an application and obtain approval from the IRB if their research falls within the exempt category. The review of exempt proposals is conducted by the IRB Committee Chair, in consultation with other committee members when appropriate.
Expedited category: Participants are subjected to minimal risk and the study only involves procedures in one or more of the 9 federally designated expedited review categories. Expedited studies can involve:
- Collection of biological specimens,
- Voice, video, digital or image recordings,
- Noninvasive procedures,
- Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies (if it doesn’t fall under exempt category).
Review of projects categorized as exempt will be conducted by the IRB Chair and one other committee member (additional members may participate when necessary).
For exempt and expedited review, investigators would typically be notified of the committee decision within 4 weeks of a complete application submission (more time may be necessary over holiday or summer breaks).
Full review category: Full committee review is required for research that is greater than minimal risk and/or does not qualify for 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 participants fall into a vulnerable category such as prisoners).
Once a semester, the IRB committee is convened to review these applications. At these meetings, a majority of the members of the IRB must be present, including at least one member whose primary concerns are in non-scientific areas. To be approved, the proposal must receive the approval of a majority of those members present at the meeting.
Applications for full review are accepted on a rolling basis. Investigators must submit materials at least 2 weeks in advance of a scheduled meeting to allow time for adequate review of the materials by the committee.
Criteria used by the IRB when reviewing studies
IRB committee members consider many factors when reviewing research applications involving human subjects (regardless of review category). To receive approval, the following requirements must be met:
- Risks to subjects are minimized,
- Risks to subjects are reasonable in relation to anticipated benefits,
- Selection of the subjects is equitable,
- Informed consent will be sought and appropriately documented,
- When applicable, the research plan makes provisions for monitoring the data collected to ensure subjects’ safety,
- When applicable, there are provisions to protect the privacy of subjects and to maintain the confidentiality of data,
- Appropriate additional safeguards are included when the subjects come from a vulnerable population (e.g., children, prisoners, pregnant women).
Communication by the IRB to the investigator
The principal investigator will receive email correspondence upon submission if their application is incomplete or additional information is required. After review by the IRB, the PI will subsequently receive an email informing them of the outcome. If the project has been approved, the PI will receive a study approval letter. If the project requires modification, a detailed explanation of necessary changes and instructions for resubmission will be provided to the PI. If the IRB decides to disapprove of a research activity, its reasons will be clearly communicated to the investigators, who will be given the opportunity to respond in person or in writing (note that research can only be disapproved after full committee review and not through expedited procedures). Investigators may check on the status of their application at any time on the IRBNet website.
Revisions/modifications to an approved protocol
If investigators wish to make changes to an approved project, they must submit a revision form to the IRB. This is required if there are changes to the:
- Consent form or recruitment materials,
- Study procedures,
- Number of enrollees,
- Key personnel.
Expedited procedures can be utilized for review of minor changes that are proposed within the period for which approval is authorized.
Reporting unanticipated problems
Investigators have the responsibility of reporting unanticipated problems promptly to the IRB. Unanticipated problem is defined as:
- Unexpected (in terms of nature, severity, or frequency) given a) the research procedures described in protocol-related documents, and b) the characteristics of the subject population being studied; and
- Related or possibly related to participation in the research; and
- Suggests that the research places subjects or at others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.
Unanticipated problems must be submitted to the IRB through a form via IRBNet. The PI must submit this report as soon as possible, but no later than 5 business days upon the PI’s knowledge of the event. Review will be conducted by one or both of the Co-Chairs; the co-chair may request further review by a subcommittee or the fully-convened IRB. The IRB will consider different corrective actions, including suspension or termination of the research, modification of protocol and/or consent documents, or requiring additional training of the researcher or team.
Not all adverse events are unanticipated problems that require reporting to the IRB. There is extensive online guidance for determining whether an event constitutes an unanticipated problem. If you have questions or are unsure about whether an event needs to be reported to the IRB, please contact the IRB Coordinator and/or Chair for help and/or clarification.
Approvals for projects reviewed by full committee or expedited procedures expire after one year. If research procedures are ongoing, investigators should submit an application for continuing renewal at least 30 days prior to expiration. PIs will receive reminder notices as the expiration date approaches. 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 recruit or enroll participants, engage in study procedures, or analyze identifiable data until the IRB renewal is reviewed and approved.
Generally, expedited procedures can be used for continuing review when the original application was categorized as expedited. For projects originally reviewed by the full committee, expedited continuing review may be appropriate when: the research is permanently closed to enrollment, all subjects have completed research-related interventions, and the research remains active only for long-term follow-up of subjects; or if no subjects have been enrolled and no additional risks have been identified; or the remaining research activities are limited to data analysis.
Following continuing review, the committee can approve, require modifications, suspend, or terminate approval of research.
Some IRB-approved projects may require more frequent continuing reviews than the typical 1-year period, in order to ensure protection of human subjects in research. The IRB will consider the following factors when determining the appropriate interval for review:
· The nature of the risks inherent in the research,
· The degree of uncertainty regarding the risks,
· The vulnerability of the subject population,
· The experience of the investigators,
· The projected rate of enrollment, and
· The novelty of interventions or procedures.
The IRB committee will determine and specify the duration of the approval period in the approval letter. During the time of continuing review, the committee will consider whether the current frequency of review is appropriate or should be adjusted.
When an IRB-approved research project has ended, investigators should close their study by submitting a Final Report. 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 https://www.citiprogram.org/. We have developed a guide that provides step-by-step instructions for registration. The required course is the Human Subjects Basic/Refresher Course. To take this module, after registering with CITI you should select Question 1 (Human Subjects Research), and then choose either "Social & Behavioral Research Investigators" or "Biomedical Research Investigators”, depending on your field. You are welcome to take other modules, but this is the one required for IRB applications. CITI certifications are valid for three years; to renew your certification, please complete the Basic/Refresher Course.
IRB Committee Co-Chairs
Gerald P. Ardito
School of Education
Lucille R. Ferrara
College of Health Professions
Director, Dept. of Graduate Studies
Phone: (212) 346-1153
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 (email@example.com; 212-346-1646).