Human Subject Research and IRB
Policies, procedures, and approval resources for conducting research involving students, employees, or individuals associated with Illinois Eastern Community Colleges.
Conducting Research at IECC
Illinois Eastern Community Colleges (IECC) is committed to ensuring the safety, rights, and welfare of all participants involved in human subjects research (HSR). Any internal or external researcher requesting the collection of data involving human subjects currently or previously enrolled, employed, or otherwise associated with IECC must receive formal approval prior to commencing research. Depending on the project, that review may be handled by the HSR Coordinator or by the Institutional Review Board (IRB).
How to Apply for Approval
Submit Request
Coordinator Review
Receive Decision
Core Ethical Standards
All research conducted within the IECC district is evaluated to ensure:
- Equitable selection of subjects and minimization of risk.
- Informed consent is obtained prior to the involvement of any subjects.
- Strict confidentiality of data collection and protection of subject privacy (including FERPA compliance).
- Voluntary participation: subjects must be notified orally and in writing that they may withdraw at any time.
Key Terms
- HSR
- Human Subjects Research: research that collects data from or about people, here including anyone currently or previously enrolled, employed, or otherwise associated with IECC.
- IRB
- Institutional Review Board: a committee of at least five members, including at least one person not affiliated with IECC, that the HSR Coordinator convenes to review proposals when needed. Its decision is final.
- HSR Coordinator
- The IECC official who receives and reviews requests. This role is held by the IECC Chancellor or a designee.
- Review levels
- Exempt projects fall outside the policy. Expedited projects are approved at the Coordinator’s discretion without a full IRB review. IRB Review means the full board evaluates the proposal. A request can also be Denied. See the Procedure tab for the criteria.
- Informed consent
- Participants agree to take part, before any involvement, after being told what the research involves. They must also be told that they may withdraw at any time.
- FERPA
- The Family Educational Rights and Privacy Act, the federal law that protects the privacy of student education records.
- 45 CFR 46
- The federal Health and Human Services regulations for protecting human subjects in research, which IECC’s policy follows.
Human Subjects Research Policy (200.7)
Illinois Eastern Community Colleges (IECC) is committed to ensuring the safety, rights, and welfare of all participants involved in human subjects research. All research involving human subjects must be conducted in compliance with all applicable federal, state, and local regulations, including the HHS regulations for the protection of human subjects in research (45 CFR 46).
All prospective research projects will be reviewed by the HSR Coordinator, who will make a decision or convene the Institutional Review Board (IRB) for further review and determination. IECC prohibits any research involving participants under the age of 18.
Purpose of the HSR Review Process
The purpose of the HSR review process is to ensure:
- Equitable selection of subjects.
- The risk to subjects is minimized.
- Any deception is justified.
- Data collection is confidential and subject privacy is protected.
- Informed consent is obtained prior to the involvement of subjects.
- Subjects can withdraw from the study at any time.
Human Subjects Research Procedure (200.7)
The following procedures are pursuant to IECC’s Human Subjects Research Policy and describe the course of action for any internal or external researchers requesting the collection of data involving human subjects currently or previously enrolled, employed, or otherwise associated with Illinois Eastern Community Colleges.
I. Compliance
To ensure compliance with the Human Subjects Research Policy, IECC has appointed a Human Subjects Research (HSR) Coordinator with sufficient authority and training to fulfill their responsibilities. The IECC Chancellor (or designee) will serve in this capacity.
Individuals who plan to conduct research shall submit a Request for HSR Approval to the HSR Coordinator at least 30 days prior to commencement of the research project.
II. Research Review and Approval Process
Within 10 days, the HSR Coordinator will review the form, determine the level of review required, and mark as: Exempt, Denied, Expedited Approval, or IRB Review. The HSR Coordinator will provide the researcher with a copy of the completed form.
The Exempt determination indicates the request does not fall under the constraints of this policy and procedure. Under 45 CFR 46.101(b) (Department of Health and Human Services (DHHS)), the HSR Coordinator may determine a research activity to be exempt where the only involvement of human subjects will be in one or more of the following six categories:
- Research in established or commonly accepted educational settings involving normal educational practices.
- Surveys and interviews (with adults), educational tests, observations of public behavior.
- Research involving benign behavioral interventions with adults.
- Secondary use of information or biospecimens.
- Federal research and demonstration projects.
- Taste and food quality evaluation and consumer acceptance studies.
Certain projects may not require an IRB Review and will be granted approval at the discretion of the HSR Coordinator. Qualifying categories include:
- Clinical studies of drugs and medical devices only when certain conditions are met.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts.
- Prospective collection of biological specimens for research purposes by noninvasive means.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
When necessary, the HSR Coordinator will convene the Institutional Review Board (IRB), which will be comprised of a minimum of five members with the following considerations:
- Members of varying backgrounds and professions
- Not all members of the same gender
- At least one member who is not affiliated with IECC
- One member whose primary concern is scientific
- One member whose primary concern is not scientific
The IRB will promptly review the research proposal and the HSR Coordinator will inform the applicant in writing of the board’s decision, which is final.
A research request may be denied for one of the following reasons. A denied decision by the HSR Coordinator is considered final.
- Unacceptable risk to subjects
- Ethical or legal reasons
- Use of coercion or undue influence
III. Quality Standards
Approved proposals shall adhere to the following guidelines:
- All research projects will comply with applicable government regulations regarding research on human subjects and must recognize the civil rights embodied in the Family Educational Rights and Privacy Act (FERPA) and the Civil Rights Act.
- Student education records are considered confidential and may not be released to third parties without written consent from the student unless disclosure is permitted through the IECC Release of Information Policy.
- Informed consent is received prior to involvement of the participant(s).
- Data collection is confidential and participant privacy is protected.
- Participation by students and/or staff in any research project is voluntary, and subjects of research may withdraw from participation at any time. Subjects are to be notified in writing and orally of this right.
- Topics for study must be related to the educational process or experience and an area of concern for IECC.
- All proposals to conduct research must demonstrate that no unauthorized costs will be incurred to IECC; the researcher shall be responsible for the costs unless an exception was agreed upon beforehand.
- All findings will be shared with the HSR Coordinator and all documents retained by the office of the IECC HSR Coordinator.
Ready to Apply?
HSR Coordinator Contact
- Coordinator: connm@iecc.edu
- CETL Office: cetl@iecc.edu
Submit 30 days prior to research.
Initial coordinator response within 10 days.