You have 30 calendar days to appeal a Board decision. To request an appeal of a Board decision, submit a detailed written explanation of why the Board should reconsider and reverse its decision.
The 30 calendar day period begins when Schulman receives confirmation that the Board decision has been successfully delivered to the designated study representative or Principal/Qualified Investigator (PI/QI).
If we do not receive a written request for reconsideration and appeal within 30 calendar days, the Board’s decision is final.
The following Board decisions may be appealed:
- Denial of an application for approval to conduct a research study
- Suspension of enrollment for a study
- Termination of a study
- Withdrawal of approval
- Disapproval of a proposed consent process or monitoring plan for a pregnant partner of a male subject in approved research.
As a minimum, an appeal should contain a letter signed and dated by the submitting representative at the sponsor, CRO, or the PI/QI addressing in detail:
- Issues that prompted the Board’s decision; and
- Actions or corrective measures* that have been or will be implemented.
- For Board denial of an application to conduct a research study: Evidence that the issues have not recurred after the corrective actions or measures were implemented;
- For Board suspension, termination or withdrawal of approval: The specific manner in which the protocol, federal regulations, and/or Board requirements were not followed
- Additional evidence that the safety and confidentiality of the study subjects and scientific integrity of the study are being protected by the sponsor, CRO, PI/QI adherence to federal and state or provincial regulations, Board requirements and GCP guidelines that are referenced under Investigator’s Responsibilities.
*Corrective measures must address factors that contributed to the issues and new processes, forms, or other changes implemented as corrective action. Corrective measures also must include a description of the investigator’s role in helping prevent recurrence, as applicable.
Submit an appeal of the Board decision via e-mail to Board Appeals to the attention of the Board Chairperson.