Create an atmosphere of respect for, and awareness of,
    the rights and welfare of human research participants at
    Indiana University and its affiliated organizations.

  Continue to inform established researchers about the
    application of the federal regulations and ethical principles
    to their particular area of research in an effort to keep
    researchers current with evolving standards.

  Educate students, faculty, and staff who conduct research
    about the ethical principles and federal regulations guiding
    research with humans.

  Assess the effectiveness of the Institutional Review
    Boards (IRBs) in their review of research activities,
    facilitation of compliance of researchers with the federal
    regulations, and protection of research participants.

  Develop new approaches that better serve the
    overarching mission of the HRPP, such as state-of-the-art
    educational materials, more efficient methods for
    processing applications, tracking and monitoring research
    activities, and assessing the overall effectiveness of
    the HRPP.

The Institutional Review Boards (IRBs) for Indiana University-Purdue University Indianapolis (IUPUI), and its affiliated organizations are responsible for the review and approval of all research involving human subjects conducted under the auspices of these institutions. The IRBs are charged with protecting the rights and welfare of human research subjects recruited to participate in research activities and to ensure compliance with applicable University and organizational policies and federal regulations.

The IRBs are responsible for reviewing all research projects involving human subjects conducted at these institutions’ facilities or property, sponsored by these institutions, conducted by or under the direction of any employees or agents of these institutions in connection with their institutional responsibilities, or involving the use of these institutions’ non-public information to identify or contact human research subjects or prospective subjects. In addition, the IRBs may be asked by organizational officials to review research protocols on behalf of other institutions with which these institutions have formal affiliation agreements.

Ms. Shelley Bizila, MS, CIP, is the leader of the Human Research Protection Program (HRPP) and is responsible for implementation of this program. Ms. Bizila relies on Office of Research Administration (ORA) staff for knowledge of the regulations and conduct of day-to-day operations. She is directly involved in allocation of resources to the HRPP.

Ms. Bizila employs mechanisms to ensure that:

    human participants are provided protections;

    the HRPP is provided support;

    the IRBs function independently and free from coercion and undue influence;

    the IRBs have access to legal counsel who is not conflicted by other organizational
     responsibilities;

    the IRBs have access to more senior officials of the organization, when the IRBs deem such
     access to be warranted;

    appropriate resources, including work and meeting space, are available to the IRBs;

    IRB members and support staff are provided with appropriate educational materials and
     programs; and

    Standard Operating Procedures (SOPs) governing the operation of the HRPP are developed
     and implemented.