Faculty Handbook 2007-2008
The complete statement of Denison's Guidelines for Human Subjects Research, Procedures, Approval and Consent forms are available at http://www.denison.edu/offices/provost/ or contact the Associate Provost (Kim Coplin). Applications for Institutional Review Board approval should be submitted to the Associate Provost.
Denison University is responsible for assuring that research activities conducted under its auspices do not violate the rights and welfare of human subjects. Its Guidelines for Human Subjects Research are designed to conform to the Department of Health and Human Services Code of Federal Regulations, revised as of October 1, 1992 (Federal Register, 10-1-92 edition,119-129).The following activities are covered: all faculty research, all administrative research, and all student research (e.g., independent studies, senior research, student-designed research for courses). Normal classroom studies are not among the activities covered.
These principles apply to all of the above categories of research.
a. Informed Consent - Subjects' participation must be voluntary and informed.
Before participation, subjects must receive an explanation of the purposes of the research, what they will be asked to do, and any potential risks involved. They must be told that they may refuse to participate in the study and may discontinue participation at any time. In the case of minors or another protected group, signed permission should be obtained from a parent or legal guardian, after the parent or legal guardian has been informed (as indicated above).
Deception is basically a violation of informed consent and shall be avoided; if it is necessary to the integrity of the study, strong justification must be made (e.g., it is impossible to get the information in any other way).
b. Protection from Harm - Stress to subjects shall be minimized as much as possible. Signed consent must be obtained if the subject is subjected to more than minimal risk or stress.
c. Anonymity and/or confidentiality must be observed when possible. If anonymity or confidentiality cannot be maintained, the investigator must provide strong justification.
d. Risks to subjects must be outweighed by the sum of the benefit to subjects and the importance of the knowledge to be gained.
e. Debriefing - The exact nature and purpose of the study must be explained to subjects, either prior to or, after completing the study; subjects have a right of access to a report of the results of the study.
a. Investigator completes the Human Subjects Research Approval Form, available in the Office of the Provost. (In order to avoid duplication of efforts, the investigator may submit a departmental review form instead.)
b. The Associate Provost, acting in consultation with, or on behalf of, the Institutional Review Committee, will review the approval form and determine whether the research falls in the Exempted, Expedited, or Full Review category.
Procedures appropriate to that category will be followed.
c. In the case of Exempted or Expedited Review, the investigator will receive notification as soon as possible; in the case of Full Review, normally within ten class days of proposal submission. Full Review requires an evaluation by the full Institutional Review Board, chaired by the Associate Provost, and also composed of four faculty and a member of the local community who has no connections to Denison University.