Non-compliance means conducting research involving human subjects in a manner that disregards or violates Ursinus College policy or federal regulations governing such research.
Non-compliance can include, but is not limited to the following:
- Failure to obtain IRB approval for research involving human subjects prior to commencing such research,
- Failure to satisfy contingencies set by the IRB prior to commencing research,
- Failure to conduct research as delineated in the IRB-approved study,
- Failure to follow recommendations made by the IRB to ensure the safety of subjects,
- Failure to obtain informed consent from each prospective subject according to the IR approved study inadequate supervision of personnel during the conduct of research,
- Failure to report promptly adverse events involving harm to subjects,
- Failure to obtain approval for modifications to a study prior to implementation, or
- Failure to provide ongoing progress reports as requested by the IRB
Whenever a non-compliance allegation or complaint is made in regard to an IRB-approved study, the Chair will either investigate the allegation or refer the investigation to another IRB member with appropriate expertise. The Chair will send written notice of the allegation to the researcher and request a response. The Chair (or designated member) will review the allegation of non-compliance, the researcher’s response, and any other information necessary to determine whether a full investigation is warranted. At the conclusion of her/his inquiry, the Chair (or designated member) will report findings to the IRB and to the IO. Recommendations for sanctions, correction, or educational measures will be established by the IO in consultation with the IRB.
The Board may take action to suspend or terminate approval of research. If the IRB suspends or terminates the study, the investigator will be notified of the Board’s action. In such circumstances, the IRB has the authority to refuse further research with human subjects by a researcher.