INVESTIGATOR HELP:

The Faculty Advisor must ensure the student Principal Investigator complies with all Federal, State, and local laws, as well as DOH IRB policies and procedures.

It is the responsibility of the Faculty Advisor to notify the IRB in writing of extended absences or termination of employment for either the Faculty Advisor or the student Principal Investigator. During times of extended absences, another DOH-approved Faculty Member must be named to serve as the Faculty Advisor. If employment is being terminated, a permanent replacement Faculty Advisor must be identified.

NOTE: It is the responsibility of the student Principal Investigator or the Faculty Advisor to notify the IRB in writing to close the research study before the student Principal Investigator graduates.

IRB POLICIES AND PROCEDURES:

IRB Policy 2.1 - Investigator Qualifications

It is the policy of the Department of Health (DOH) Institutional Review Board (IRB) that all Investigators meet the following requirements to conduct human subjects research under the jurisdiction of the DOH IRB.

IRB Policy 1.2 - Activities Subject to IRB Jurisdiction

It is the policy of the Department of Health (DOH) Institutional Review Board (IRB) to have jurisdiction over all human subjects research subject to its Assurance.

FEDERAL REGULATIONS/GUIDANCE:

OHRP IRB Guidebook

Chapter I: Institutional Administration

Section C. Principal Investigators

The qualifications of the principal investigator should be considered when reviewing proposals. The investigator's professional development should be taken into account and related to the degree of protocol complexity and risk to human subjects. IRBs may require less experienced research investigators to be sponsored by seasoned researchers. Proposals that require skills beyond those held by the Principal Investigator should be modified to meet the investigator's skills, have additional qualified personnel added, or be disapproved.