​Appeal Decision
The Principal Investigator (PI) (US) / Qualified Investigator (QI) (CAN) and Sponsor/CRO have thirty (30) days from the date of receipt of a Board decision to appeal that decision in writing.
A Principal Investigator/Qualified Investigator, CRO/SMO or Sponsor can appeal a Schulman Associates Institutional Review Board (the "Board") decision. To appeal a Board decision, you must submit a detail written explanation of why the Board should reverse its decision. The 30-day period begins when Schulman receives confirmation, i.e., delivery receipt, FedEx tracker, USPS receipt, etc., that its written decision has been successfully delivered to you. If the Board does not receive a written appeal within 30 days, the Board's decision will be final.
Appeals can be related to, but are not limited to, the following Board decisions:
Denial of an application for approval to conduct a research study;
Suspension of enrollment for a study;
Termination of a study; and
Withdrawal of approval.
APEALING A BOARD DENIAL OF AN APPLICATION TO CONDUCT A RESEARCH STUDY
A written appeal should contain, but is not limited to:
A letter, signed and dated by the Principal Investigator/Qualified Investigator, addressing in detail:
Documented evidence that the issue(s) have not reoccurred after the implementation of the action(s) and/or corrective measure(s);
Additional documented evidence that the safety and confidentiality of the study subjects and the scientific integrity of the study are being protected by the Principal Investigator/Qualified Investigator's adherence to Federal and State regulations, Board requirements, and Good Clinical Practice Guidelines that are referenced under Investigator's responsibilities.
A written appeal of a Board denial of an application to conduct a research study is to be submitted initially via email to 
Board Support to the attention of the Schulman Associates IRB Chairperson followed by submission of the the signed original via the U.S. Mail to:
Schulman Associates IRB
Chairperson
4445 Lake Forest Drive
Suite 300
Cincinnati, OH 45242
The appeal must arrive within the defined 30-day period.
APPEALING A BOARD SUSPENSION, TERMINATION, OR WITHDRAWAL OF APPROVAL
A written appeal should contain, but is not limited to:
A letter, signed and dated by the Principal Investigator/Qualified Investigator, addressing in detail:
the issue(s) the prompted the Board's decision;
the specific manner in which that the protocol, federal regulations, and/or Board requirements were not followed; and
the action(s) and/or corrective measure(s)* the Principal Investigator/Qualified Investigator has implemented or will implement.
Documented evidence that the issue(s) have not reoccurred after the implementation of the action(s) and/or corrective measure(s);
Additional documented evidence that the safety and confidentiality of the study subjects and the scientific integrity of the study are being protected by the Principal Investigator/Qualified Investigator's adherence to Federal and State regulations, Board requirements, adn Good Clinical Practice Guidelines that are referenced under Investigator's responsibilities.
A written appeal of a Board suspension, termination or withdrawal of approval is to be submitted initially via email to the Schulman Associated IRB Subject Safety Manager, followed by submission of the signed original via the U.S. Mail to:
Schulman Associates IRB
Chairperson
4445 Lake Forest Drive
Suite 300
Cincinnati, OH 45242
To speak with the Subject Safety Manager, call 513-761-4100
.
The appeal must arrive within the defined 30-day period.
*Corrective measures must address the factors that contributed to the issue(s) and the new processes, forms, etc., which have been implemented to correct the issue(s). Corrective measure(s) also must include a description of the Investigator's role in helping to prevent future occurrences.