General Questions for Principlal Investigators (PIs)
- Does my research require review?
- Why does the IRB need to review my research?
- What is the IRB review process?
- Can I be the PI on an IRB protocol if I am an adjunct or part-time faculty?
- Does all research go through the same review process?
- How long does this process take?
- How long is approval valid?
- What if my study involves multiple IRBs?
- I received a complaint from a participant or participant’s guardian. Who do I notify?
- What if data was entered or used in analysis while the protocol was expired?
If you are a faculty, staff member, or student at Montclair State University and have research involving human participants, your research requires review.
Research means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute "research" for the purposes of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. (from Department of Health and Human Services Regulations, Code of Federal Regulations 46.102, Definitions).
"Human subjects" are individuals whose physiological or behavioral characteristics and responses are the object of study in research. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information [Federal Policy • 45 CFR 46.I 02(f)].
Federal, state, and university regulations requires that the IRB review and approve all research projects that are done under the auspices of Montclair State University. The purpose of IRB review is to examine the purpose, protocol, and participant populations that are to be used in the proposed study to determine if the benefits outweigh the risks. The review includes an analysis of
- how participants are recruited to be in the study
- how the privacy of participants will be protected
- participants' exposure to the physical, psychological, and sociological risks, any discomfort, and/or stress
The IRB will consider the design of the study to the extent needed to assist in the determination if the benefits outweigh the risks. It will also consider if there is a less risky approach that might be used to accomplish the proposed aims of the study.
In the review process, the IRB will examine any advertisements, flyers, letters, e-mail scripts, telephone scripts, consent documents, assent documents, and debriefing statements that will be used in the course of the study. These are reviewed to determine if the materials accurately reflect the study and if the documents are written in simple, lay language level that is appropriate to the participant pool.
An application for approval of the use of human participants in research is a five-step process:
- The research protocol is developed by the investigator(s), and an application for approval is prepared for submission to the IRB. The submission includes any documents that will be used in the course of the proposed study.
- The protocol is reviewed and approved by the IRB.
- The investigator(s) conducts the research and files any reports that may be needed.
- The investigator(s) submits an application for continuing review no more than 60 days before the previously approved document expires.
- The investigator(s) completes the study in its entirety and files a project completion form.
Can I be the Principal Investigator (PI) on an IRB protocol if I am an adjunct or part-time faculty?
At present, the MSU IRB requests that all adjunct or part-time faculty partner with a full-time faculty member who can serve as the PI. The adjunct faculty member would then serve as the co-investigator (Co-PI) for the study.
No, the type of review that is used is determined by the IRB. The determination depends in part on the amount of perceived risk to the participants. There are three categories of review:
- Exempt - To qualify as an exempt study, the research must fall within one of the specific governmental categories AND satisfy the other regulatory and MSU institutional exceptions. The MSU IRB will make the exemption determination, not the principal investigator. Any study that the MSU IRB believes is not exempt must undergo either expedited or full review.
- Expedited - Research activities that (1) present no more than minimal risk to human subjects and (2) involve only procedures listed in one or more of the government categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110
- Full - Research activities that involve more than minimal risk must be reviewed at a convened IRB meeting.
The IRB has set goals for turnaround time from the time of receipt of the application to the time of approval. The time it takes for a complete review of an application, regardless of type of review, depends in part on completeness of the application, the time spent by the investigator in responding to the concerns of the IRB, and the need for additional review.
- Exempt - Goal: One to Two weeks
- Expedited - Goal: Four to Six weeks
- Full - Goal: Six to Eight weeks
Approval is generally valid for one year; however, this is not a guarantee. The length of approval is determined by the IRB and depends in part of the amount of risk perceived to be in the study. Length of approval can be time-limited or it may be limited to a prescribed number of procedures. The letter of approval will indicate the length of the approval period.
In cases where a Montclair faculty or a student is collaborating with another Institution, the PI must first identify who will serve as the primary IRB. Generally, the primary IRB is identified as the primary site for recruitment or where the overall Principal Investigator resides. If you have a subaward or contract from another institution, which is the primary award recipient, MSU will likely serve as the secondary IRB. If you are unsure about whether the Montclair IRB is primary or secondary, please contact the IRB office.
MSU is the secondary IRB:
The MSU faculty or staff member should submit an application to the IRB only after all documents have been approved at the primary IRB site.
MSU is the primary IRB:
The MSU faculty of staff member should submit an application to the IRB with all site agreement letters. After IRB approval is obtained, the PI is responsible for sharing approved documents with any collaborating investigators and/or IRBs. The Montclair IRB cannot serve as the IRB of record for any outside facility or recruitment site.
Investigators or research staff must report to the IRB, any complaints received from a research participant, parent, or guardian within 3 days of its occurrence. (Click here for more information on Unanticipated Problems) The IRB office and Research Compliance Administrator will track receipt of any complaints and follow?up with the IRB Chair on any necessary mitigation.
The IRB Chair will contact the PI in response to a research participant’s concern. The PI is required to respond to that request at the first possible opportunity and address the questions posed by the IRB Chair. If an amendment to the protocol or consent form is required, the PI must submit this amendment with the appropriate amendment application to the IRB within 7 working days.
A summary of all subject complaints and any repeated non?compliance will be reported to the full IRB committee at the regularly scheduled meetings. The IRB committee will consider any repeated non?compliance as a serious matter and may consider a vote to suspend the IRB approval of research in accordance with 45 CFR 46.113.
This type of data entry activity is considered a deviation from the study design (not involving additional risk or harm to participants). All such activities should be reported to the IRB via email to (firstname.lastname@example.org) and on the following continuing review form. We also ask that the PI provide a reasonable corrective action plan to correct future occurrences.
At present, we do not have a deviation form since the IRB capacity allows for review on a case-by-case basis. However, the PI should be aware the IRB office tracks protocol non-compliance. Continued protocol deviations or non-compliance would carry additional implications as decided upon by the IRB committee.