Eligibility Exception Request
Individuals who do not meet study-specific, IRB-approved eligibility criteria may not be enrolled into the study. A researcher may, however, request IRB approval for an exception to the eligibility criteria. The only other exception to eligibility criteria is that situation in which the eligibility exception deviation is necessary to eliminate apparent immediate hazards to the human subject. The IRB would be contacted under these circumstances.
No subjects who fail to meet eligibility criteria shall be enrolled in a study without IRB approval. Failure to meet this standard may potentiate the CPHS Non-Compliance process. The PI shall immediately report any unplanned exceptions to eligibility criteria to the CPHS Chairperson and the CPHS Administrator.
Submission Deadline: Rolling submissions are accepted but must be received, reviewed, and approved prior to initiation of a planned eligibility exception.
Submission Requirements: Complete Protocol Deviation/Eligibility Exception Form. All the questions on the form are to be answered appropriately.
Sample Forms & Documents: All necessary documents with instructions can be downloaded from the www.irbnet.org in the "State of New Hampshire DHHS CPHS, Manchester, NH" Library.
How do I know when to make an eligibility request or to change the protocol?
Answering the specific questions on the form is helpful to make a decision around this question and can be used as a guide when making this determination.