• obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB (45 CFR 46.116; 45 CFR 46.117); (FDA 21 CFR 56.109).
• obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)); and
• ensuring that progress reports and requests for continuing review and approval are submitted to the IRB in accordance with the policies, procedures, and actions of the IRB as referenced in the institution’s OHRP-approved Federalwide assurance (45 CFR 46.103(b)(4), §46.109(e), §46.115(a)(1)), (FDA 21 CFR 56.108(a)(1) and §56.109(f)];

In certain circumstances, investigators also would be responsible for meeting the following additional regulatory requirements:

• providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others (45 CFR 46.103(b)(5) and (21 CFR 56.103);
• providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB (45 CFR 46.103(b)(5)); and
• keeping certain records as required by the HHS regulations for at least three years after completion of the study (45 CFR 46.115(b)); HIPAA Privacy Rule applies 45 CFR Part 164, a covered entity must maintain until six (6) years after the study closure or last effective date, all records including protocol, complaints and other actions required to be documented.

The MAH IRB may review investigator research records or conduct an audit of all protocol related activities to ensure compliance with human subject research regulations.
All Mount Auburn Hospital (MAH) investigators must complete human subject research training as well as any other MAH educational training before conducting human subject research. Investigators may access the CareGroup website for access to the protection of human subjects training:

Protecting Human Research Participants
NIH Office of Extramural Research
or Harvard Medical School, Harvard Ethics Training in Human Research (HETHR)
.

All investigators are required to submit a copy their certificate of training to the IRB office.

In some cases, other federal requirements regarding training for investigators must be met, such as the National Institute of Health’s (NIH) requirement for the training of key personnel in NIH-sponsored or -conducted human subjects research.

For more information on your Responsibilities as an Investigator, please refer to the Investigator Responsibilities section of the IRB Administrative Manual