Review and Approval of Studies

Before conducting research involving human subjects, investigators must obtain, complete, and submit an application for COUHES approval of the study.

  • For most studies, a full application for approval to use humans as experimental subjects (standard form) must be submitted.
  • For studies that qualify for exempt status, an abbreviated application for approval to use humans as experimental subjects (exempt status form) may be submitted.

Applications are reviewed at monthly meetings by the full COUHES Committee. However, at the discretion of the Chairman, where there exists no more than minimal risk to subjects, an expedited review may be performed.

After reviewing the application, COUHES reports its decision to the responsible investigator.

  • Protocols may be approved as submitted. For research involving minimal risk approval is for one year. For research involving more than minimal risk the Committee will determine the duration of the approval, which maybe for less than one year.
  • If a protocol does not meet COUHES stated criteria for acceptance, or if an application is incomplete, COUHES may inform the investigator of suggested modifications and request revision and re-submission.
  • If an investigator fails to respond within 60 days to a written request from COUHES for information or protocol changes then the application will be withdrawn. The investigator will be informed of this decision in writing. To continue the research the investigator will have to resubmit an application to COUHES.

Where the research involves collaboration with another institution(s), then COUHES requires that the principal investigator and his collaborating researcher(s) obtain approval from that institution(s) institutional review board (the COUHES equivalent), and forward copies of the approval to COUHES.

Approval is subject to continuing review. Approval must be renewed (usually annually). Once the study is completed, principle investigator must submit a final report.