OBJECTIVE

To provide guidance in handling concerns, complaints, or questions received regarding a research study involving human subjects GENERAL DESCRIPTION The right of research subjects to lodge a concern (e.g., allegation), complaint, or question and to be assured that the concern, complaint, or question is taken seriously and resolved in a timely manner is of prime importance. The Research Compliance Officer (RCO) or designee in the Office of Research Integrity (ORI) is responsible for investigating concerns, complaints, and questions from subjects and any improprieties involving investigators or their staff. The RCO or designee handles these issues in a timely manner, assuring protection of human subjects, and the IRB holds any violators accountable to the applicable regulation. A research subject (past, current, or prospective), a designated spokesperson, family member, or anyone with a concern about a human research study may raise concerns, complaints, or questions about a research project by telephone, in writing, or in person to the RCO or designee. Each IRB approved informed consent document includes a toll free telephone number to reach the RCO or designee; the toll free telephone number is also listed on the ORI and University websites