Frequently Asked Questions
Human Subjects Research (IRB)
What is "Human
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
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
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
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):
- Institutional Review Boards (IRBs) are operated IRB Organizations (IORGs).
An initial registration with OHRP registers both the IORG and its IRB or IRBs. UMSL's IORG number is "0000445."
- Federalwide Assurance (FWA) for the Protection of Human Subjects (more info on OHRP rules and regulations). UMSL's FWA number is "00000011."
- UMSL's IRB Registration number is "00000756."