The principal investigator (PI) on any project is ultimately responsible for the ethical conduct of research with human subjects. PIs and their entire team must comply with all 51³Ô¹ÏºÚÁÏ policies and procedures, as well as all applicable federal, state, and local regulations for the protection of human subjects in research.
The responsibilities include, but not limited, to the following:
- Obtaining IRB approval prior to involving any human subjects (including their data or tissue) in research studies.
- Only the IRB may determine if research is exempt from federal regulations. (Investigators may not make the final determination of exemption.)
- Any recruitment, including obtaining lists of names, is considered research activity with human subjects.
- Ensuring that only qualified personnel conduct the study according to the approved protocol, and in compliance with each individual’s scope of practice.
- Ensuring the rights and welfare of each research subject are protected. The subject’s rights and welfare must take precedence over the goals and requirements of the research.
- Implementing no changes in the approved protocol or informed consent form without prior Institutional Review Board (IRB) approval, except in an emergency, if necessary to safeguard the well-being of human subjects.
- Ensuring that anyone obtaining informed consent has read the protocol and has sufficient knowledge of all information provided in the informed consent document.
- Obtaining legally effective informed consent from human subjects or their legally responsible representative before any research-related screening or intervention commences and using only the currently approved informed consent form when applicable.
- Providing each subject enrolled in the study a copy of the IRB-approved informed consent document at the time of the consent, unless the IRB has specifically waived this requirement.
- Unless specified otherwise, all signed informed consents and other research related documents (including but not limited to paperwork submitted to and approved by the IRB) should be retained throughout the study and for an additional three years after the study is completed/closed with the IRB.
- Promptly reporting any injuries, unanticipated problems, or adverse events to the IRB in writing within five working days of occurrence or discovery of occurrence.
- Reporting progress of approved research to the appropriate IRB, as often as and in the manner prescribed by the IRB on the basis of risks to subjects, but not less than once per year. This includes submitting a closure report to the IRB once the research is completed.
- Completing training as required by the Institutional Review Board.
- If conducting research involving products regulated by the Food and Drug Administration (FDA), the investigator will comply with all applicable FDA regulations and fulfill all investigator responsibilities (or investigator-sponsor responsibilities, where appropriate), including those described at:
- 21 CFR 312: Investigational New Drugs
- 21 CFR 812: Investigational Device Exemptions
If the PI is unavailable to conduct or direct this research personally, as when on sabbatical, leave, or vacation, to: (1) arrange for a co-investigator to assume research related responsibilities in the researcher's absence, and (2) to notify the IRB in writing of this change prior to the absence.
- In the event that employment with the university is discontinued, to do one of the following with each approved/active study prior to leaving the university: 1) transfer the study to a new principal investigator, or 2) close the project. These changes must be sent in writing to the IRB by submitting modification request. This modification must be submitted prior to the termination of employment.
All investigators should review and be familiar with:
As well as all pertinent instructions on 51³Ô¹ÏºÚÁÏ’s ORI-HSR website.