Human Subject Research
SVCC adheres to federal human research policy (Code of Federal Regulations: 45 CFR 46) and Board Policy 519.01 which ensures the ethical and responsible treatment of all human subjects in research. Human subjects have the rights of protection and refusal during all research activities.
Conducting Human Research May Require Authorization
Anyone considering human subject research on SVCC property or with SVCC employees or students, or under the auspices of SVCC, should contact the Chair of the Institutional Research Board (IRB) to clarify research expectations and to obtain a Human Subject Research Request Form to begin the authorization process before any research begins. This is necessary even if the researcher believes that the research falls under an exempt human research category.
SVCC student researchers must have an employee sponsor. The student or sponsor should contact the Chair of the IRB before beginning any human research.
All researchers are required to submit a completed Human Subject Research Request Form to the Vice President of Research, Planning, and Information Affairs, at least 30 days prior to conducting the research. This form will be reviewed by the SVCC Institutional Research Board (IRB) which will then authorize or reject the human research proposal. If a project is initiated prior to receiving approval, the researcher will be required to cease the research activities immediately. There are no exceptions.
Director of Research and Planning
Frequently Asked Questions Regarding Human Research
What is human subject research (HSR)?
For purposes of these procedures, human subject research is any systematic investigation using humans as subjects, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. If an activity follows a deliberate plan whose purpose is to develop or contribute to generalizable knowledge, such as an exploratory study or the collection of data to test a hypothesis, it is research. Additionally, if the aim of the research is to formally publish or disseminate
Who is a human subject?
A human subject is defined as "a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or obtains identifiable "
Subjects of research fall into the following categories:
- Subjects who are affiliated with SVCC, such as a student, an employee, or who are affiliated with SVCC in some other capacity;
- Subjects who are not directly affiliated with SVCC, but when the research is being conducted falls under the auspices of SVCC.
What does the Institutional Review Board (IRB) do?
The IRB was established by Board Policy 519.01 to "ensure the ethical and responsible treatment of human subjects in research." The IRB is made up of SVCC faculty and staff who have
What human research is considered exempt from IRB review?
- Research conducted by Sauk faculty or staff involving normal educational practices, such as a) research on instructional strategies, or b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), confidential survey procedures, or observation of public behavior, unless the information identifies the subjects and disclosure could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. If the subjects are children, research involving interview or survey procedures and research involving observations of public behavior in which the researcher(s) participate in the activities being observed are not exempt. However, research involving the use of educational tests and research involving observations of public behavior in which the researcher(s) do not participate in the activities being observed are exempt.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under section (2) above, if the human subjects are elected or appointed public officials or candidates for public office, or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Most research conducted by students as part of normal classroom assignments (including honors projects). Faculty and students should refer to this checklist to see which student human research projects should be reviewed by SVCC’s IRB.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: a) public benefit or service programs; b) procedures for obtaining benefits or services under those programs; c) possible changes in or alternatives to those programs or procedures; or d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, a) if wholesome foods without additives are consumed, or b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of
If the human research is not exempt, what are the criteria for IRB approval?
In making a decision to approve or reject proposed research activities, the IRB will ensure that:
- The risks to subjects are minimized and that the risks to subjects are reasonable in relation to anticipated benefits.
- The selection of subjects is equitable.
- Informed consent will besought from each prospective subject or the subject's legally authorized representative, and will be documented.
- Data collection will be monitored to ensure the safety of the subjects, that the subjects' privacy is protected, and confidentiality of data is maintained.
- Subjects may remove themselves from the research at any time.
- The rights and welfare of subjects from vulnerable populations are protected by additional safeguards.