COMPLIANCE OVERSIGHT BY OHRP

The Office of Human Research Protection conducts "for cause" and "not for cause" compliance oversight. If your organization has been notified that it is the subject of compliance oversight we can assist you with the following;

1. Review and response to notice from OHRP that an immediate suspension of research activities will be imposed pursuant to allegations or indications of noncompliance related to human subjects research
2. Review and assessment of inquiry letter from OHRP stating that your institution's human subjects research protections is being evaluated because of an allegation or indication of noncompliance
3. Assistance in preparing a response to allegations or indications of noncompliance including advice with regard to any related in-house investigation and, if appropriate, any corrective action plan
4. Review and assessment of a notice from OHRP that your organization's human subjects protections will be the subject of a not-for-cause evaluation
5. Preparation for not-for-cause evaluation process including, when appropriate, corrective action programs
6. Assistance with the preparation of requests for review by OHRP of any findings related to any "for-cause" or "not-for-cause" oversight evaluation.