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Human Subject Research Frequently Asked Questions
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.It includes activities which meet this definition, whether or not conducted under a program considered "research" for other purposes. 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.
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 private information."
Subjects of research fall into the following categories:
Subjects who are affiliated with SVCC, such as a student, an employee, or in some other capacity;
Subjects who are not affiliated with SVCC, when the research is being conducted under the auspices of SVCC;
Subjects for a research project may come from both of the above categories.
Who is required to submit a HSR proposal?
A HSR proposal is required from anyone who proposes to conduct research involving human subjects, including SVCC students, employees, and researchers who are not affiliated with SVCC, whether the research uses SVCC students and/or employees, is conducted on the SVCC campus, or is conducted under the auspices of SVCC.
How long must I retain records related to my research?
Standard protocol is a minimum of five years.
What research is exempt?
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), survey procedures, interview 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 inwhich the researcher(s) do not participate in the activities being observed are exempt. [34 CFR 97.401(b)]
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.
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 the U.S. Department of Agriculture.
What is the Institutional Review Board (IRB)?
The IRB is established by Board Policy 519.01 to "ensure the ethical and responsible treatment of human subjects in research." The IRB must approve all human subject research prior to the start of the research project.
What is the make-up of the IRB?
The IRB will have at least five voting members whose expertise and experience together constitute an appropriate background for its decisions. Members will include:
Dean of Institutional Research and Planning
Academic Vice President
Dean of Student Services
Dean of Information Services
Dean of Instruction
A representative from Sinnissippi Centers
One or more SVCC faculty
What are the criteria for IRB approval?
In making a decision to approve or disapprove 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.