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Human Subjects Research (IRB)


What is "Human Subjects Research"?

Human Subjects Research includes any data gathered on humans for scientific purposes. Data collections for administrative or pedagogical purposes is not included.

Why does UMSL review research involving human subjects?

Review of Human Subjects Research is mandated by the National Research Act (Public Law 93-348) and implemented by Federal Regulations (45 CFR 46). A university not in compliance with the law could lose federal funding of its programs.

Whose research is reviewed?

The research of faculty, staff and students of UMSL that involves human subjects requires review.

Who reviews the research?

The Institutional Review Board (IRB) reviews Human Subjects Research. Members of the committee come from a variety of disciplines, including one member whose primary concerns are nonscientific and one member who is not affiliated with the University.

Does the entire committee review all research activities on campus?

The IRB can exempt certain projects from full review. A principal investigator must apply for this exemption. See IRBNet for additional information.

What subject groups require special protection?

Federal regulations require special protection for Human Subjects Research involving prisoners, the cognitively impaired, fetuses, pregnant women, or human in vitro fertilization. Studies of these groups cannot be granted an exemption from full review and such exemption for minors (children under 18) is limited.

What are consent and assent forms?

In most studies, the subject or a person responsible for the subject must sign a consent form before the research can proceed. The consent form must fully inform the subject about the research in which they are about to participate. A subject who is a minor must sign an assent form and his or her guardian must sign a consent form.

What are the requirements for confidentiality?

The investigator must ensure that others are not privy to the identity of subjects or to identifiable information about them without their consent. How confidentiality is maintained must be described in detail on the application form and in plain English on the consent form. Any limitations on the investigator's ability to maintain confidentiality must also be stated (e.g. many professionals are legally required to report cases of child abuse). Maintaining confidentiality is especially important when the research concerns criminal activity or uses prisoners. State law makes certain communications to specific professionals such as physicians, clinical psychologists, ministers and rabbis "privileged," meaning that the professional may not testify about those communications unless the client consents. This type of privilege does not extend to researchers, and researchers may be ordered by court to produce information obtained in their research.

How are risks assessed?

When you apply for human subjects review, you will be asked to assess the risks of your research. Human research almost always involves risk that may be social, psychological, financial, or even physical. For example, a seemingly innocuous survey question about test anxiety might bring back truly traumatic memories. Others, in addition to the participant, may be at risk, including persons discussed in the study, the investigator, society at large, and UMSL. The IRB does not expect research to be free from risk, but it does expect the investigator to be aware of the risks, to minimize risk when possible, and to take appropriate precautions whenever necessary. For the proposed research, the benefits should outweigh the risks.

What precautions must I take if my research involves deception?

The investigator must show that the research could not be accomplished without using deception and describe how the degree of deception has been minimized. An investigator should debrief subjects after the deception and include the debriefing statement in the application.

How can I verify UMSL's OHRP Assurance and Registration?

You can search the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) Database for Registered IORGs and IRBs and Approved FWAs by IORG number, FWA number or IRB registration number (see below):

DHHS Office for Human

    Research Protections (OHRP)

→ DHHS booklet: "Protecting
    Personal Health Information in
    Research: Understanding the
    HIPAA Privacy Rule"

Federal Regulations on the
    Protection of Human Subjects

NIH Statement on Required
    Education on the Protection of
    Human Research Participants

PHS Office of Research Integrity