What are the PI's responsibilities?
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 in summary include:
• Acknowledging and accepting their ethical and legal responsibilities for protecting the rights and welfare of human research subjects and for complying with all applicable policies, guidance and determinations of the IRB;
•Providing training and oversight for all study-team members;
• Ensuring the compliance of all co-investigators, student investigators, and research staff members with the IRB decisions, conditions, and requirements;
• Following the ethical principles that guide the university in the conduct of human research during all phases of the project;
• Conducting the research as presented in the protocol and approved by the IRB;
• 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 (§46.116; §46.117);
• 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 ( §46.103(b)(4)) ;
• 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 ( §46.103(b)(4), §46.109(e), §46.115(a)(1));
• Providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others §46.103(b)(5);
• Providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB ( §46.103(b)(5));
• Submitting a Final Report when all human subject research activities have been completed, including recruitment and data collection/analysis;and
• Keeping certain records as required by the HHS regulations for at least three years after completion of the study ( §46.115(b)).