Principal Investigators are required to maintain a research file for all COUHES approved studies. This file will act as the investigator's documentation of proper performance of the study. This file should include:
- All correspondence with COUHES and the research sponsor (if applicable)
- Documentation of subject eligibility
- Copies of the signed consent forms obtained from all subjects participating in the study regardless of whether or not the subjects completed the study
- Any data derived from the study
- Copies of all documentation relating to the privacy of a subject’s protected health information, including signed copies of the Authorization for Release of Protected Health Information form, and a record of all disclosures of protected health information made over the previous 6 years
In accordance with federal regulations the research file must be kept in a secure location by the principal researcher for at least 3 years after completion of the research. COUHES encourages researchers to maintain the file for longer periods, if practicable. The conditions for maintaining confidentiality of the subjects and the research records are however, required for the life of the data.
The research file may be reviewed by COUHES, federal, state or local authorities, sponsors, and other authorized individuals to ensure proper performance of the study.
These rules also apply to student researchers.