Before initiating research, the following list of required documentation should be carefully reviewed, playing attention to timelines and and IRB review process.
Appeal of IRB Determinations
- Required Materials
- Timeline for Obtaining IRB Approval
- Submission Guidelines
- Review Process
- General Principles
- Special Populations Research
- Research Utilizing Electrical Equipment
- International Research
- Non-English Language Documents
In accord with federal regulatory requirements [45 CFR 46.112], appropriate Seton Hall University officials (President, Provost, General Counsel) may review any research protocol and have the right to disapprove the implementation of a research protocol that has been approved by the IRB. However, no person, committee or University official may approve the implementation of any research protocol, nor may it override the decision of the IRB concerning a research protocol, that has been disapproved by the IRB.
Seton Hall University’s IRB will provide the investigator with a written statement of its reasons for disapproving or requiring modifications in proposed research and will give the investigator an opportunity to respond in writing. The IRB will carefully and fairly evaluate the investigator’s response in reaching its final determination.