Human Subjects & IRB

Policies, Procedures and Regulations

The IU HRPP Policies describe the requirements for conduct of human subjects research. Research conducted by IU faculty, staff, and students or by employees and staff of IU-affiliate institutions that have contracted with the IU Institutional Review Boards (IRBs) for review and oversight of human subjects research must be conducted in accordance with IU HRPP Policies, as applicable. IU HRPP Policies apply the Common Rule protections to research supported by federal Common Rule agencies. For research not subject to the Common Rule, IU applies equivalent protections for human subjects, with some minor differences to reduce administrative burden. Additional relevant requirements are based on other federal regulations, state law, accreditation standards, and institutional policy. IU HRPP Policies are written, reviewed, and revised periodically by IU HRPP staff to ensure they accurately reflect research processes at IU. IU HRPP staff seek additional topic experts to assist in review and revision of Policies as necessary. The IU HRPP maintains a record of these Policies, and a copy of these Policies is made available below.

Each IU HRPP Policy includes the following:

  • A scope statement which defines which research is subject to 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, institutional policy, or accreditation standards
  • Procedures for implementation of the policy statements, where applicable
  • Potential sanctions for individuals in violation of a Policy
  • History, which includes a summary of the most recent revisions
  • Related information, including hyperlinks to relevant guidance, regulations, policies, accreditation standards, etc.

Indiana University Human Research Protection Program (HRPP) Policies

Adult Individuals Lacking Consent Capacity

Auditing Human Subjects Research

Children in Research

Conflict of Interest Reporting to the IRB

Emergency Research Requesting Exception From Informed Consent (EFIC)

Emergency Use of Investigational Test Articles

Exempt Research

Humanitarian Use Devices (HUDs)

Informed Consent

IRB Meetings and Minutes

IRB Membership

IRB Records and Retention

IRB Review Process

KC IRB

Pregnant Women, Fetuses, and Neonates in Research

Prisoners in Research

Recruitment of Human Subjects

Reliance

Reportable Events

Reporting to Oversight Agencies

Research Data Management

Research Personnel Responsibilities

Students and Use of Education Records in Research

Use of Protected Health Information (PHI) in Research

PolicyApplies to research granted exemption under the IU HRPPApplies to non-exempt research reviewed by the IU IRBsApplies to all IU HRPP research, regardless of the reviewing IRB
Adult Individuals Lacking Consent Capacity √Section 2.1 only
Auditing Human Subjects Research√√√
Children in Research √Section 2.1 only
Conflict of Interest Reporting to the IRB√√√
Emergency Research Requesting Exception from Informed Consent (EFIC) √ 
Emergency Use of Investigational Test ArticlesN/A – not research; applicable to clinicians generally under the oversight of the IU IRB
Exempt Research√  
Humanitarian Use Devices (HUDs)N/A – not research; applicable to clinicians generally under the oversight of the IU IRB
Informed Consent √ 
IRB Meetings and Minutes √ 
IRB Membership √ 
IRB Records and Retention√√ 
IRB Review Process √ 
KC IRB√√√
Pregnant Women, Fetuses, and Neonates in Research √ 
Prisoners in Research √Section 2.4 only
Recruitment of Human Subjects √ 
Reliance √√
Reportable Events√√ 
Reporting to Oversight Agencies √ 
Research Data Management√√√
Research Personnel Responsibilities√√√
Students and Use of Education Records in Research√√√
Use of Protected Health Information (PHI) in Research√√√
Definitions √√√

What is the Indiana University Human Research Protection Program (HRPP)?

Institutional Review Boards (IRBs) are made up of a group of people with varying backgrounds and are responsible for the review and approval, or disapproval, of research involving human subjects. IRBs were established to protect the rights and welfare of human subjects by reviewing research with safety in mind.

The day-to-day operations of the IU IRBs are administered and supported by the IU Human Subjects Office (HSO), a unit of the IU HRPP. Like the IRB, HSO staff have varying backgrounds. Some HSO staff, also known as screeners, conduct preliminary review of all research submitted to the IRB to ensure that it is in an acceptable form for the IRB to review. HSO staff provide guidance to researchers as to whether an activity requires IRB review; however, HSO staff may consult with IRB members with any questions. The Quality Improvement Office, also a unit of the HRPP, conducts not-for-cause and for-cause audits of human subjects research. Additionally, HRPP staff are available to answer questions, and offer educational and training opportunities to researchers as it relates to human subjects research. 

IU HRPP staff, processes, and resources are evaluated on an ongoing basis with a focus on developing methods to measure and improve the quality, effectiveness, and efficiency of the program, and adjusted as needed. Research community feedback is always welcome or you may contact an IU HRPP staff member directly.  Additionally, the Indiana Clinical and Translational Sciences Institute (CTSI) engages in community outreach activities which are designed to engage patients throughout all phases of research. These community outreach activities are periodically evaluated by CTSI in collaboration with the HRPP to identify areas of improvement.

IU HRPP Mission Statement:

The mission of the Indiana University Human Research Protection Program (HRPP) is to protect the rights and welfare of human research subjects. Rather than ensuring mere compliance with federal regulations, the IU HRPP strives to adhere to the highest ethical standards in its protection of human research subjects and seeks to further develop the methods and mechanisms for protecting human research subjects. The HRPP achieves this by:

  • creating an atmosphere of respect for, and awareness of, the rights and welfare of human research subjects at IU and its affiliated organizations,
  • informing 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,
  • educating students, faculty, and staff who conduct research about the ethical principles and federal regulations guiding research with humans,
  • assessing the effectiveness of the Institutional Review Boards (IRBs) in carrying out this mission, and
  • developing new approaches that better serve the 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) are responsible for the review and approval of research involving human subjects conducted by Indiana University and its affiliate institutions. IRBs 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.

The IU IRBs are responsible for reviewing research projects involving human subjects that are conducted by IU faculty, staff, and students or employees and staff of IU-affiliate institutions that have contracted with the IU IRBs for review. In addition, the IU IRBs may review research protocols on behalf of other institutions with which IU has written reliance agreements.

IU holds one Federalwide Assurance (FWA000003544) for research conducted on its seven campuses.  While IU’s FWA commits to apply the Common Rule and its subparts only to federally-funded research, the IU HRPP Policies and the ethical principles governing review of human subjects research apply to all research regardless of funding source except where noted. The Office for Human Research Protections (OHRP) has approved the registration of four IU IRBs. The following IU IRBs are registered in accordance with 45 CFR 46 Subpart E and 21 CFR 56.106:

  • IRB00000220 – Indianapolis IRB-01 (noncompliance committee and social/behavioral research)
  • IRB00000219 – Indianapolis IRB-04 (biomedical research)
  • IRB00004960 – Indianapolis IRB-07 (ad hoc emergency review only)
  • IRB00000222 – Bloomington IUB IRB (social/behavioral/educational research)

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

To view the complete listing of policy abbreviations and glossary of terms, see Policy Definitions.

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