38. Responsibilities - Researchers

Updated June 23, 2021

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 Principal Investigator (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.

Student Investigator Responsibilities

Students and other trainees (including residents and fellows) may serve as members of research teams, but not serve as principal investigator or use data, or human biological specimens that have been collected for clinical, administrative, or research purposes. The PI will be available to research staff when needed. The PI only delegates responsibility to student researcher commensurate with their training and qualifications.

Student research must be reviewed if the student is collecting data (e.g., tasks, interviews, videotaping, tests, observations, etc.) from human participants, or if they are administering a treatment of any kind to human participants. Some student classroom projects may not be considered research (and might not require IRB review) if they meet all three of the following criteria:

• procedures are low-risk or no-risk
• the objective is to provide students with training about and experience with research methods
• the data will not be used, published or otherwise disseminated outside of the classroom

The IRB reviews and holds student research projects to the same standards as human 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 research. Consequently, only University and affiliate faculty or other qualified, senior personnel may serve as Principal Investigators for human 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 participants or others; and
• Investigation or review by the Research Integrity Research Compliance Officer, sponsor, federal agency, or other external regulatory body.

While the research is being conducted, student investigators must ensure 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.