Opus IRB

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Investigator/SMO

Conflicts of Interest

Opus IRB is dedicated to providing unbiased review of clinical trial studies. In providing quality review services to Opus IRB clients, we are also committed to the evaluation of conflict of interest/financial disclosure information provided to Opus IRB by all Principal Investigators. Opus IRB follows the rules and regulations as outlined in 21 CFR Part 54 and encourages any Investigator with questions to contact Opus IRB directly.

Each Principal Investigator is responsible for completing the conflict of interest/financial disclosure form and full disclosure throughout the study entirety is expected by each Investigator.

OPUS IRB strives to assist investigators to make sure any conflict of interest or potential appearance of a conflict of interest is resolved prior to the start of an approved clinical trial.

Training

Belmont Report

Association of Clinical Research Professionals (ACRP)

Drug Information Association (DIA)

Collaborative IRB Training Initiative (CITI)

The Nuremburg Code

International Conference on Harmonisation (ICH)

National Institute of Health (NIH)

Guidance on Good Clinical Practice (GCP)

Declaration of Helsinki

Society of Clinical Research Associates (SOCRA)

The Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule)