What Are My Responsibilities

Before beginning with a new research submission, investigators must complete the Pre Submission Investigator Requirements.

New research submissions to the IRB require specific forms for review. The question of what forms you need to submit is best answered by considering the type of review.

Investigators

Principal Investigators are the responsible leader of a team of investigators (and research team), who have the ultimate responsibility for the conduct of the research.

Faculty Sponsors (for research originating from a university) are full or part-time faculty who engage in classroom instruction, supervise on or off campus internships, clinical experiences or practica, or mentor students who are conducting independent projects.

  • What do I do as a first time, principal investigator?
    All principal investigators, co-investigators, (anyone involved in the design, conduct, or reporting of the research, or having significant interaction with subjects) including personnel obtaining informed consent listed on the IU Health Bloomington IRB application will need to complete Collaborative Institutional Training Initiative (CITI) training. CITI is a web-based tutorial and testing site that is frequently updated to reflect changes in human subject law and regulation. Additionally, CITI meets the Federal Requirement that researchers using human subjects demonstrate the completion of education in the protection of human research participants. Additionally, principal investigators will need to meet the Pre Submission Investigator Requirements.
     
  • What do I need to do as a principal investigator?
    The Principal Investigator (PI) is responsible for ensuring that research with human subjects is properly conducted such that participants are adequately protected. The environment in which investigators conduct research and the type of research they conduct influence their roles and responsibilities. Competent, informed, conscientious, compassionate and responsible investigators provide the best possible protection for research subjects. Additionally, there are many regulatory agencies to guide the PI in the proper conduct of research involving human subjects.
     
  • What do I need to do as a co-investigator?
    The Principal Investigator is ultimately responsible for the adequate conduct of research involving human subjects; however, he/she may delegate research-related responsibilities to other members of the research, provided these individuals are appropriately qualified and trained. Co-investigators who will be responsible for the design, conduct, or reporting of the study; will have access to subjects (i.e., will consent subjects, conduct parts of the study); will be making independent decisions about the inclusion or exclusion of participants; or will have access to identifying and confidential information will need to meet the Pre Submission Investigator Requirements.

Conflicts

  • Do I need to declare any conflicts?
    IU Health Bloomington has set forth policy on the avoidance, disclosure, management, and resolution of financial conflicts of interest. This Policy applies to all persons at IU Health Bloomington who are “Investigators”. An “Investigator” is anyone who participates in designing research, collecting research data or performing other substantive research activities, or reporting research; and anyone who participates in designing, conducting, or reporting with respect to a sponsored program.

Links