38. Responsibilities: Researchers
Members of the research team, including student and co-investigators, and research assistants and coordinators are responsible for
- Complying with regulatory and institutional requirements;
- Familiarizing themselves with the IRB-approved protocol and attachments;
- Performing their research roles and duties according to professional and ethical standards, regulatory requirements, and IRB approval;
- Using only IRB-approved recruitment and consent materials and processes;
- Abstaining from enrolling any individuals in IRB-approved research when instructed by the PI or the IRB to cease enrollment activities;
- Complying with University human protection training requirements and additional training requirements requested by the PI; and
- Informing the PI of conflicts interest when these may be related to the research.
Additional Student Investigator Responsibilities
The IRB reviews and holds student research projects to the same standards as human subject research conducted by faculty or staff; however University and affiliate students and other persons considered to be in training (e.g., medical residents, post-doctoral students) may not be principal investigators for human subject research. Consequently, only University and affiliate faculty or other qualified, senior personnel may serve as Principal Investigators for human subject research conducted under the auspices of the University.
Student investigators are responsible regularly apprising the PI of the following:
- IRB reviews, requests, and determinations;
- status of participant enrollment;
- implementation of the research;
- conduct of research personnel;
- potential noncompliance with the approved IRB protocol;
- unanticipated problems, and complaints from subjects or others; and
- Investigation or review by the RI QI Officer, sponsor, federal agency, or other external regulatory body.
While the research is being conducted, student investigators must insure that the PI has access to all study records including research data and specimens, IRB applications and researcher forms, consent documents, and IRB requests and decision letters.
When the research concludes or a student investigator leaves the University, the complete set of study records must be stored on campus by the PI until the end of the data storage period, as approved by the IRB.