Human Subjects Compliance
The U.S. Dept. of Health and Human Services requires that all research projects involving human subjects be screened to confirm that the subjects' rights, privacy, welfare, and civil liberties are protected. Human subjects are living individuals about whom an investigator obtains (a) data by intervention or interaction with the individual, or (b) identifiable private information. The private information may include the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens.
The SIUC Human Subjects Committee is responsible for reviewing all human-subjects research projects 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. 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.)
No research involving human subjects should be conducted prior to receiving committee approval.
Note that most class projects designed to teach research methods are not considered research, and the SIUC Human Subjects Committee does not review them. There are exceptions, however. 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.
Questions? Contact the secretary of the Human Subjects Committee at ORDA (siuhsc@siu.edu, 453-4533, Woody Hall C-214).
Human Subjects Research Applications
Choose the one appropriate to your research:
- Standard Application (fillable Word document)
- Existing Data Application (fillable Word document)
- Oral History/Field Research Application (fillable Word document)
- Extension Request for Category I or II Projects (Word document)
- Extension Request for Category III Projects (Word document)
Required Training for Researchers
- Human Subjects Training Module
The National Institutes of Health requires education on the protection of human research participants for all investigators submitting NIH applications for research involving human subjects and for all key personnel on any current or pending NIH grant involving human subjects. To meet this requirement, SIUC researchers may use the above computer-based tutorial developed by NIH. Complete this training at your own pace, print out the certificate that you receive after completing the tutorial, and mail or bring it to the Human Subjects Office, ORDA, Woody Hall C-214, MC #4709. Other federal agencies also may require training, but currently all are accepting the NIH tutorial as satisfying their requirements.
In addition, the Human Subjects Committee requires that all researchers planning projects which will require a Category III review (see Section 5 of the Human Subjects Guide) must complete the NIH tutorial, regardless of the funding source. Please submit the printed certificate from NIH with your Category III application. Receipt of the certificate is a condition for approval of Category III projects. If you plan on doing Category III projects in the future, you are advised to submit the certificate in advance so that it can be put on file.
Guidance for Researchers
Sample Consent Forms; HIPAA Requirements
Sample consent forms:
- Sample Consent Form (Word)
- Sample Cover Letter (Word)
- Sample Telephone Script (Word)
- Sample Consent Form for Taping (Word)
- Sample E-Mail Solicitation Request (Word)
Health Insurance Portability and Accountability Act (HIPAA) requirements:
New federal law has mandated changes in the procedures needed to access private health information. Researchers should contact the agency that owns the health records and ask them for the specific language that they require in consent forms before they will release subjects' health records. The consent form must identify what specific health care information will be collected from the files. Below is a link to a sample form, but most agencies will have their own requirements.