IRB Regulations & Guidelines
The Institutional Review Board (IRB) is established at Fairleigh Dickinson University (FDU) to protect the rights and welfare of human research subjects as defined by general and permanent regulations known as the U.S. Health and Human Services (HHS) Code of Federal Regulations, CFR Title 45, Part 46 Protections of Human Subjects, a.k.a. the “Common Rule. It includes four primary regulatory Subparts:
- Subpart A–Basic HHS Policy for Human Research Subjects; and
- Subpart B–Additional Protections for Pregnant Women, Human Fetuses and Neonates in Research
- Subpart C–Additional Protections for Research involving Prisoners
- Subpart D–Additional Protections for Children as Research Subjects
IRB Review
1. All research involving human subjects as defined in 45 CFR 46 conducted at Fairleigh Dickinson University by FDU faculty, students or personnel affiliated with the University must be submitted to the Institutional Review Board IRB Compliance Manager for review. This applies to all research funded by an extramural agency (government, foundation or private sources), or unfunded and intended for conduct by a member of the University. The existence of the IRB is a condition with which the University must comply to accept federal funding, including student financial aid, scholarships, and research grants. Faculty and other investigators are encouraged to consult with the IRB well in advance of submitting a project for review to discuss IRB-related issues that may affect the design or conduct of the investigation.
This research includes, but is not limited to, the following:
- Dissertations, master’s theses, independent study projects, undergraduate honors projects;
- Proposals that involve gathering data off campus
- Any internal or external grant proposal;
- Studies involving the collection of archival data where no consent was obtained at the time of data collection.
2. No researcher, whether faculty or student, may disregard recommendations made by the IRB. The research project may not begin until the reviewer’s concerns, questions and recommendations have been addressed in writing and written approval has been given.
3. If any researcher (faculty, staff or student) disregards or ignores recommendations and requirements made by the IRB, appropriate action will be taken to correct the situation and verify participant’s rights as subjects are protected.
4. If ANY changes are made after the review process involving protection of human subjects (for example, changing the informed consent form, etc.), these changes must be submitted to the IRB, reviewed and approved before being implemented.
5. Any researcher has the right to appeal a decision of the IRB. The researcher should contact the IRB Chair with their concerns. The IRB Chair and OHRP Institutional Official will review the case and notify the appropriate Dean and/or University Provost. Sanctions may also be recommended for researchers who conduct research without first achieving IRB approval. If sanctions are considered appropriate, the matter will be referred to the University Review Committee (or in cases where a student has committed a violation, the School under whose supervision the research was undertaken).
Important Notes
Extramural Federal Grant Proposals and Compliance
A faculty member planning the submission of a proposal for extramural federal funding must adhere to sponsoring agency compliance regulations. FDU requires all such applicants to complete CITI training in Responsible Conduct of Research and Conflict of Interest training/disclosures prior to submission.
About IRB Approval for Extramutal Federal Submissions
Most federal agencies do not require IRB approval at time of submission. However, submitting an IRB application as soon as you are notified of an upcoming award will avoid delays in getting started. In those instances where a sponsoring agency requires IRB approval at the proposal stage, allow sufficient time for securing IRB approval and meeting the sponsor deadline for submission. No research, including advertising of the study or recruitment of participants, may begin until IRB approval is obtained.
When FDU faculty are co-Principal Investigators
When FDU faculty, staff or students serve as co-Principal Investigators on a research investigation led by another institution, research projects conducted by affiliate institutions may be reviewed by an IRB other than that of the FDU IRB. Information about which IRB will serve as the IRB of Record can be determined by contacting the FDU IRB Compliance Manager. However, this does not exempt FDU researchers from institutional “home” policies and requirements, e.g. Human Subject/IRB, Responsible Conduct in Research and Conflict of Interest training and disclosures.