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What are my responsibilities?

Before continuing with a new research submission, you must complete the pre-submisson 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. Also see   what type of review is required?

   Links:

    Sponsorship of
       Applications

   IU Policy on Conflicts
       of Interest

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. In order to determine these responsibilities, there are eligibility guides. In addition to eligibility guides, there are other criteria that can assist in outlining the responsibilities.

• Who is eligible to be a principal investigator?
  There are eligibility guidelines for determining whether an individual can serve as a principal investigator for a human subjects research study or a faculty sponsor for student projects. Please see PI and Faculty Sponsor Eligibility Guide and the Sponsorship of Applications links in the Tool kit to the right.
  
  
• What do I do as a first time investigator?
  Principal Investigators must complete the Protection of Human Research Participants Certification Test. It is required to ensure that the Principle Investigators are adequately trained. There are Web-based, self-paced
  tutorials are designed to meet the Federal Requirement that researchers using human subjects demonstrate the completion of education in the protection of human research participants.
  
  
• What do I need to do as a principal investigator?
  The PI has some general responsibilities and some specific responsibilities regarding the conduct of research involving human subjects.


General & Specific Responsibilities...more >


General responsibilities include: Conducting and supervising the research Adhering to investigational plans Ensuring the safety and welfare of the study subjects Must comply with the ethical principles and federal regulations Specific responsibilities include: Study status and progress responsibilities of the PI Informed consent and authorization responsibilities Certifications for research supported by the federal department or agency Additional responsibilities for research involving investigational drugs Additional responsibilities for research involving investigational devices Additional responsibilities for both investigational drugs and device studies adhering to investigational plans, ensuring the safety and welfare of the study subjects, and must comply with the ethical principles and federal regulations

• What do I need to do as a co-investigator?
  The PI 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.

• Do I need to declare any conflicts?
  The University has set forth policy on the avoidance, disclosure, management, and resolution of financial conflicts of interest regarding University research and sponsored programs. There are other areas in which financial conflicts may arise. Refer to the 'IU Policy on Conflicts of Interest' PDF in the Tool kit located to the upper right of this page.