The Research Compliance Committee (RCC) provides support for faculty, staff, and students in regulatory requirements for research and teaching activities involving vertebrate animals, research involving the use of human subjects, and research involving the use of hazardous agents. The RCC is responsible for the development and implementation of university policies and for coordinating institutional compliance with federal and state law/regulations. The RCC supports the university in promoting the responsible conduct of research.
The Research Compliance Committee presently serves in the following capacities
- Institutional Review Board (IRB)
- Institutional Animal Care and Use Committee (IACUC)
- Institutional Biosafety Committee (IBC)
All research conducted by faculty, staff and students, on- and off-campus, regardless of funding support, if any, for the project, in the following areas must be reviewed by the Research Compliance Committee:
- Research/ projects/ study involving vertebrate animals.
- Research/ projects/ study involving hazardous chemicals or biological agents.
- Human subjects research.
Two initial questions human subjects researchers should consider are:
According to Federal regulations governing research with human subjects (45 CFR 46), Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." [45 CFR 46.102(d)]
The core of this definition is "a systematic investigation...designed to develop or contribute to generalizable knowledge." It should be noted that the RCC considers the definition of "a systematic investigation" to vary widely depending on the discipline of the investigation and recognizes that it might be more appropriate in some fields to refer to research results as transferable, rather than generalizable.
The RCC does not make a determination of whether or not a project constitutes research based solely on the criterion of public presentation / publication. We do this because we recognize that many factors other than public access play into the generalizability or transferability of particular studies.
Human subject means "a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information" [45 CFR 46.102(f)].
Generally speaking, information coming from experience or opinions is not likely to be replicable across people, even in similar situations, and thus means the data are "about" the individual from whom they are gathered. In contrast, factual information should not vary depending on the respondent. Thus the collection of factual data generally does not result in the "informant" becoming a human subject. A few examples of questions that are likely to elicit responses drawing on experience or opinions are "What is your projection of next year's sales data?," "What would be the best ways to improve this system?," and "Has this change in policies impacted the morale of employees?" A few examples of factual questions are "Does this organization have a policy for parental leave?," "What is the annual input into this system?," and "When did this company implement its new inventory structure?"1
1Taken from Clemson University Office of Research Compliance (http://www.clemson.edu/research/compliance/irb/guidance/)
Please contact the RCC Chair, Dr. Steve Hayduk ( , 644-5296), with any questions or concerns about projects you are considering. The Research Compliance Committee is happy to assist in determining the proper forms needed for submission, as well as answering questions about completion of the documents.
RCC Policies and Forms
Policy 1 - Human Subjects Research with No Affiliation
Policy 2 - Principal Investigator Assignment and Responsibilities
Policy 2 Variance Form - Request for Approval to serve as Principal Investigator