The Compliance Review Procedure in Brief
The Application for Review and Certification of Compliance enables a review of a proposed research study for the purpose of certification of compliance with various governmental and organizational rules and guidelines for the protection of human participants. A critical aspect of compliance is the principal investigator’s described understanding of the present and potential feelings of the proposed research participants and the principal investigator’s plan to ameliorate any possible adverse reaction to participation. Simply, there are inherent risks associated with any research involving interaction with human participants. It is the principal investigator’s responsibility to control to a reasonable extent any potential harm and to have a plan ready to correct any potential harm.
Required Study and Documentation to Conduct Research Concerning Human Participants:
-Research Proposal(s)
-Therapeus’ IRB Handbook
-IRB Guidelines and Information
-CITI Assessment
-IRB Application Portfolio (Exempt, Expedited, or Full Review)
-Use of Approved Editors
-Possible Program Journal Submission