The Institutional Review Boards (IRBs) for Indiana University 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.
May 2010 Update Regarding Human Subjects Research Audit Plan:
The IRB Executive Committee has approved an amended Plan for
Human Subjects Research Audits. See 
Audit Plan
IRB Registration and 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.
A full statement of compliance is located in the 'Tool Kit' to the right.
What is the Human Subjects Office?
The Human Subjects Office
provides support to the IUPUI/Clarian Institutional Review Boards (IRB) which are responsible for reviewing all research involving human subjects, ensuring the protection of human subjects in research conducted by researchers on the IUPUI campus (including non-IU or Clarian researchers using subjects on the IUPUI campus), and overseeing the University’s compliance with the federal regulations and guidelines.
Why do you need IRB approval?
Under Federal regulations and University policy, all researchers who conduct research that involves human subjects or materials of human origin must submit an application to the IRB. Approval of the research protocol must be in place BEFORE the research begins. This includes data collection, which refers to any gathering of information from or about living human beings.
Research includes not only faculty research, but also, research conducted for master theses and doctoral dissertations, and may included undergraduate, staff, postdoctoral and research scientist research as well.
What requirements must be met in order for the IRB to approve a research project?
- Risks to the subjects are minimized.
- Risks to the subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative and appropriately documented, unless waived by the IRB.
- When appropriate, the research plan makes adequate provision to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled person, or economically or educationally disadvantaged persons, appropriate additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Studies are rarely disapproved by the IRB. However, many studies require additional information for adequate review. Occasionally, the IRB requests investigators to revise their procedures. Examples of common problems causing delays in the review and approval process are:
- Failure to use a current application form.
- Failure to provide evidence of pre submission investigator requirements (CITI training, COI, acknowledgement)
- Failure to complete each section of the Summary Safeguard Statement in a legible and comprehensible manner (making it difficult for the Committee to understand the research project and what subjects will be asked to do).
- Failure to provide additional materials as directed in the instructions (e.g. recruitment materials, surveys, questionnaires, etc.).
- Lack of acknowledgment of risk, although some element of risk is clearly present.
- Inadequate informed consent statement (e.g. missing relevant information or not written in language comprehensible to the prospective subject population).
When approval is granted, the investigator will be sent the Documentation of Review and Approval with the Chairperson's (or other IRB member designated by the Chair) signature and date. This page, along with an approval letter, will be sent to the designated contact person (as applicable) and the investigator (and faculty sponsor, in the case of student research).
What records are kept?
Human Subjects Office
maintains the following files:
- Federal regulations and communications, as well as University memoranda and letters of assurance.
- Minutes of the IRB meetings.
- Protocols and correspondence sent to, and received from, investigators.
- Protocols from which approval has been withheld and for which suitable remedial action has not yet been taken.
All protocols are kept for a minimum of three years after completion of the research, and then are destroyed.
