Compliance Services

Human Subjects

Welcome to the IRB

Welcome to the new homepage of the IU Human Subjects Office, main support for the IU Human Research Protection Program.

The successful review of human subjects research requires the collaboration of three parties: the research team, the Human Subjects Office and the Institutional Review Board and/or IRB reviewer. In addition, it is our commitment and goal, through both this website and in our daily practice, to facilitate this collaborative effort. We look forward to working with you to facilitate the review of your research, to facilitate the IRB’s review of your research, and to work together to improve the quality and processing of IU’s research.

Please do not hesitate to contact us if, as you use this website, you have suggestions for how we may improve it by adding additional information, clarifying existing information, or otherwise re-organizing. Thank you and we look forward to working with you in advancing human subjects research at IU.

Sincerely,

John Baumann, PhD

Executive Director, Human Research Protection Program
baumannj@IU.edu

Mission of the Human Subjects Office

The overarching mission of the Indiana University Human Research Protection Program (HRPP) is to protect the rights and welfare of human research participants recruited to participate in research conducted under the auspices of Indiana University. Rather than ensuring mere compliance with the federal regulations, IU's HRPP, consisting primarily of the Human Subjects Office and the IU Institutional Review Boards (IRBs), strives to adhere to the highest ethical standards in its protection of human research participants and seeks to further develop the methods and mechanisms for protecting human research participants. To meet this mission, the HRPP in collaboration with the IU research community seeks to:

  • Create an atmosphere of respect for, and awareness of, the rights and welfare of human research participants at IU 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 IU IRBs and their affiliated organizations are responsible for the review and approval of all research involving human subjects conducted under the auspices of these institutions. These boards 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 boards are responsible for reviewing all research projects involving human subjects that are conducted at these institutions' facilities or property; are sponsored by these institutions; are conducted by or under the direction of any employees or agents of these institutions in connection with their institutional responsibilities; or involves the use of these institutions' non-public information to identify or contact human research subjects or prospective subjects.

IRB Statement of Compliance

The Indiana University Institutional Review Boards (IRBs) comply with all federal requirements for IRBs as defined in DHHS regulations 45 CFR Parts 46 and 164 and Food and Drug Administration regulations 21 CFR Parts 50 and 56.

Contact Your Human Subjects Team

The Human Subjects Office is a university-wide entity with operations on both the Bloomington and Indianapolis campuses. The office is divided into three teams to most effectively serve the widespread needs of the IU research community.

Human Subjects Office Locations

  • Bloomington

Human Subjects Office
Office of Research Administration
Indiana University
Carmichael Center, Room 203
530 E. Kirkwood Avenue
Bloomington, Indiana 47408

  • Indianapolis

Human Subjects Office
Office of Research Administration
Indiana University
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202