Primary responsibility for assuring that the rights and welfare of research participants are protected lies with the Principal Investigator (PI) conducting the research. Others engaged in the research share this responsibility. Faculty who assign or supervise research conducted by students or staff have an obligation to consider carefully whether those individuals are qualified to adequately safeguard the rights and welfare of participants.

Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include:

• 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;
• obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document;
• 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;
• providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others;
• providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements of the IRB; and
• keeping certain records as required by the HHS regulations for at least three years after completion of the study.

For more information, including instructions for submitting a protocol for IRB review, please complete the Human Subjects Protection (HSP) Training or visit the Human Subjects website.

Additional Resources