Principal Investigator (PI)/Faculty Advisor responsibilities and qualifications

The PI (Faculty Advisor for student research) must have the experience, appropriate training and credentials to conduct and oversee human subject research. Researchers are ultimately responsible for the conduct of their research and for obtaining IRB review and approval prior to the commencement of research activities. Though research responsibility may be delegated to research staff, researchers must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility. Northern Arizona University is responsible for ensuring that faculty, staff, and students are in compliance with University, sponsor, and state and federal regulations.

The Pl of the study (and the faculty advisor if a student project) and I RB are mutually responsible for ensuring that:

• Risks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk
• Risks to human subjects are reasonable in relation to the anticipated benefits
• Selection of human subjects and patients for research participation is equitable
• Individuals and the IRB are adequately informed of the risks and benefits of research and any change that may affect their willingness to continue to participate in the research study
• Informed consent of human subjects will be obtained in advance of research participation and appropriately documented
• The privacy of human research subjects is protected and the confidentiality of data is maintained
• Appropriate additional safeguards are included in the study to protect the rights and welfare of human subjects who are likely to be vulnerable to coercion or undue influence

The PI (and the faculty advisor if a student project) of an approved research study is/are solely responsible for the following:

• Conduct the study in strict accordance with the current I RB-approved research protocol except where a change may be necessary to eliminate an apparent immediate hazard to a given human subject
• Ensure that prospectively obtained and appropriately documented informed consent is obtained in accordance with the current I RB-approved project
• Maintain adequate records during and after the study concludes of research data, outcomes, reportable items, and communications with the IRB and sponsor
• Ensure that all research staff, collaborators, or colleagues assisting in the conduct of the research study have the appropriate training and credentials to conduct the research; and are appropriately 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
• Promptly respond to all requests for information or materials solicited by the IRB and HRPP
• Promptly report any local reportable items and non-compliance
• Request I RB approval for any proposed amendment prior to implementing such amendment
• Obtain initial approval and renewal of research in a timely manner to maintain IRB approval throughout the life of the study
• Promptly conclude or transfer research activities when the Pl leaves the institution or completes the study
• Ensure 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
• The PI must have the experience and training to ensure, if applicable, that conduct of the research study adheres to Good Clinical Practice guidelines, and FDA guidance such as on data retention, and regulations related to FDA drugs (21 CFR 312) or devices (21 CFR 812)
• Do not accept ‘finder’s fees’ or ‘bonus payments’

Version 2023-1