Human Subjects Research
The SIUC Human Subjects Committee is responsible for reviewing all human-subjects research projects, regardless of discipline or funding source, conducted by individuals affiliated with SIUC, including students. This review protects not only the human subjects involved in a research project, but also the researcher and, by extension, the University. No research involving human subjects should be conducted before determining if the research is subject to HSC review and, if so, receives HSC approval.
Does your project require HSC review? Answer the following questions:
A. Is it Human Subjects?
2. Will you be collecting data indirectly about individuals from an existing source of data?
3. Will the data you collect be linkable to an individual by name or any other identifier, or by
4. Will the data you collect be used now or at a later time as part of a research project?
5. Does the data you plan to collect involve children, prisoners, persons with diminished mental
capacity, persons in a residential program, or clients of a human service program?
B. Is it Research?
2. Is the project part of a written honors project, thesis, or dissertation or will the results of the
research be published in a peer-reviewed journal?
If you answered “YES” to any question in part A, AND either question in part B, you MUST submit an application to the HSC for determination of review requirements. If you are unsure if your research requires submission of an application, please contact the HSC office to discuss your project. Failure to submit an application for research that requires Human Subjects Committee review can leave the researcher subject to liability and prevent the publication of the research results.
To submit a project for review, first familiarize yourself with the committee procedures and the Human Subjects Guide. Then fill out and submit a Human Subjects Research Application (see below). (Researchers, please note: Some aspects of the committee procedures have recently been revised; see the last three sections of that document in particular.)
Class Projects: Students and faculty should read Section 7.3 of the Human Subjects Guide for more information. Plan ahead. If a class project has to be reviewed by the committee, the project may be delayed for several weeks before it is finally approved.
* If the committee does not approve the revised protocol a revised application will be requested, the applicant can then choose to revise the protocol or withdraw the application. A protocol must receive approval before human subjects can be used in research.
The committee meets the first Friday of each month if they have received applications that require full committee review, please contact firstname.lastname@example.org for further information.
Human Subject: Any living individual about whom an investigator obtains (1) data through interaction or intervention, or (2) identifiable private information (45 CFR 46.102(f)).
Data: Information collected together for reference or analysis.
Intervention: includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (45 CFR 46.102)
Interaction: includes communication or interpersonal contact between investigator and subject (45 CFR 46.102)
Private Information: includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (45 CFR 46.102).
Research: Systematic gathering and analysis of information designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(d)).
Note: Although most activities that are considered journalism (e.g., investigations and interviews that focus on specific events, views, etc., and that lead to newspaper/news publication,
documentary production, or are part of professional training in journalism) are not research, care should be taken to assure that such activities do not meet the definition of research that must be reviewed by the HSC. When faculty or students conduct activities normally considered research that is intended to produce generalizable knowledge (e.g., systematic research, surveys, and/or interviews that are intended to test theories or develop models), these activities are subject to HSC review. This may include publications in journals, thesis and dissertations and even presentations. In such cases investigators should consult with the HSC before proceeding with the research.
Systematic Investigation: includes, but is not limited to, a hypothesis or research question, research development, testing, and evaluation.
Generalizable Knowledge: includes conclusions or information that are applicable to populations outside the research subjects, can be used to predict future events, and/or can be broadly applied to enhance scientific or academic theories or principles.
Secretary, Human Subjects Committee
Woody Hall C-214