Human Subjects & IRB

Policies, Procedures and Regulations

The IU HRPP Polices below describe the mandatory requirements for conduct of human subjects research. Research conducted at IU and its affiliates must be conducted in accordance with IU HRPP Policies.  IU HRPP Policies apply the Common Rule protections to all research, with some very minor differences, and apply other relevant requirements based on additional federal regulations, state law, and institutional policy.  Each policy includes the following:

  • A scope statement which clearly defines the research governed by the policy. All IU HRPP Policies govern research reviewed by the IU IRBs; however, some policies also govern exempt research or research conducted by IU and its affiliates which is reviewed by an external IRB.
  • Policy statements which reflect requirements mandated by regulation, policy, or accreditation standards
  • Mandatory procedures for implementation of the policy statements, where applicable
  • Sanctions
  • History, including a summary of the most recent revision
  • Related information, including hyperlinks to relevant guidance, regulations, policies, accreditation standards, etc.

Applies to exempt research reviewed by IU IRBsApplies to non-exempt research reviewed by IU IRBsApplies to all IU HRPP research, regardless of the reviewing IRB
Adult Individuals Lacking Consent Capacity in ResearchSection 2.1 Only
Auditing
Children in Research
Conflict of Interest Reporting to the IRB
Emergency Research Requesting Exception from Informed Consent (EFIC)
Emergency Use of Investigational Test ArticlesNot Applicable-not research; applicable to clinicians under jurisdiction of the IU HRPP
Exempt Research
Humanitarian Use Devices (HUDs)Not Applicable-not research; applicable to clinicians under oversight of the IU IRBs
Informed Consent
IRB Executive Committee
IRB Meeting and Minutes
IRB Membership
IRB Records and Retention
IRB Reporting
IRB Review Process
KC IRB
Pregnant Women, Fetuses, Neonates in Research
Prisoners in Research
Recruitment of Human Subjects
Reliance
Reportable Events
Research Data Management
Research Personnel Responsibilities
Use of Education Records in Research
Use of Personal Health Information (PHI) in Research
Definitions

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 federal regulations, IU’s HRPP 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.  In service of this mission, the HRPP endeavors to:

  • create an atmosphere of respect for, and awareness of, the rights and welfare of human research participants at IU and its affiliated organizations.
  • inform established researchers about changes to and ongoing application of federal regulations and ethical principles to their particular area of research in order 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 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 Indiana University Institutional Review Boards (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 subjects recruited to participate in research activities and to ensure compliance with applicable university and organizational policies and federal regulations.

These boards are responsible for reviewing all research projects involving human subjects that are 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 that involve 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 they have formal affiliation agreements.

The Vice President for Research is the leader of the Human Research Protection Program (HRPP) and has responsibility and authority for implementation of this program.  The Vice President for Research relies on IRB staff for knowledge of the regulations and day-to-day operations and is directly involved in allocation of resources to the HRPP.  The Vice President for Research employs mechanisms to ensure that:

  • Human participants are provided protections.
  • The HRPP is provided support.
  • The research review unit functions independently and free from coercion and undue influence.
  • Legal counsel not conflicted by other organizational responsibilities is made available to the research review unit.
  • Access to senior officials of the organization, when the IRB deems it to be warranted, is made available to the research review unit.
  • The IRBs’ work and meeting spaces are evaluated and resources adjusted when necessary.
  • Educational programs for IRB staff and members are provided and the development of Standard Operating Procedures (SOPs) and Policies is supported.
  • The IRBs function independently of other organizational entities.

For guidance, including best practices and recommendations, see Guidance on the conduct of human research.

Contact

The Indiana University Human Subjects Office provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.

Indianapolis (Main):

Human Subjects Office
Office of Research Compliance
Indiana University
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202
  • Phone: (317) 274-8289
  • Email: irb@iu.edu

Bloomington:

Human Subjects Office
Office of Research Compliance
Indiana University
2218 N. Dunn St.
Bloomington, Indiana 47408
  • Phone: (812) 856-4242
  • Email: irb@iu.edu