Principal Investigator Responsibilities

The principal investigator of the research study is ultimately responsible for assuring compliance with the IRB’s policies and procedures, DHHS Federal Policy regulations, and FDA regulations; and for oversight of the conduct of the research study and the informed consent process.

Education in the protection of human research subjects is recommended for all investigators, and is required for investigators participating in federally-funded studies. While all investigators need education in the basics of human subjects research, some may wish to consider more intensive study if their work involves especially difficult topics or special populations.

General Responsibilities of Research Study Investigators

As a general condition for the approval of a research study, the principal investigator of the study is responsible for ensuring that:

1) Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research; and that informed consent will be obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by IRB policies and federal regulations.

2) The informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by IRB policies and federal regulations.

3) The privacy of human research subjects is protected and the confidentiality of data is maintained.

Specific Responsibilities of Study Investigators

The principal investigator and co-investigators of an approved research study are responsible for:

1) Promptly responding to all requests for information or materials solicited by the IRB, including the timely submission of the research study for periodic review or renewal.

2) Abstaining from the enrollment of any individual in a research study (i) until such study is approved in writing, by the IRB; (ii) during any period wherein the IRB or sponsor/principal investigator has suspended study activities; or (iii) following IRB- or sponsor/principal investigator-directed termination of the study.

3) Ensuring that all associates, colleagues, and other personnel assisting in the conduct of the research study are fully informed of (i) the study procedures; (ii) informed consent requirements; (iii) the potential adverse events associated with study participation and the steps to be taken to reduce potential risks; (iv) adverse event reporting requirements; and (v) data collection and record keeping criteria.

4) Conducting the study in strict accordance with the current IRB-approved research protocol.

5) Requesting IRB approval of any proposed modification to the research protocol or informed consent document(s) prior to implementing such modifications.

6) Obtaining prospectively and documenting informed consent in accordance with the current IRB-approved informed consent document(s).

7) Maintaining adequate, current, and accurate records of research data, outcomes, and adverse events to permit an ongoing assessment of the risk/benefit ratio of study participation.

8) Reporting promptly to the IRB (and, if applicable, the sponsor and FDA) any serious or unexpected adverse events that are observed with human research subjects and/or any significant changes in the risk/benefit of study participation.

9) Reporting promptly to the IRB any notifications received from the study sponsor of serious or unexpected adverse events and/or significant changes in the risk/benefit of study participation.

10) Ensuring that, in the event of an adverse event, every reasonable effort is made to provide the involved research subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible.

11) Ensuring that human research subjects are kept fully informed of any new information that may affect their willingness to continue to participate in the research study.