Faculty Handbook 2012 - 2013

Denison University is responsible for assuring that research activities conducted under its auspices do not violate the rights and welfare of human participants. Its Guidelines for Human Participants 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). Some classroom studies may fall into the exempt category. A faculty member must consult with a member of Denison's Institutional Review Board to make this determination with respect to student research they are supervising. IRB members' names are listed on the website: http://www.denison.edu/offices/provost/human_participants_review.html. Faculty members cannot approve their own research. In such cases, faculty members should consult with the chair of their respective departments or with another faculty member in their department to make the decision about whether the faculty member's research falls into the exempted category.

These principles apply to all of the above categories of research.

a. Informed Consent - Participants' participation must be voluntary and informed.

Before participation, participants 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 cases of oral consent, a witness must be present, and a written copy of the oral summary must be approved by the IRB and given to the participants or to the participant's legal guardian. In the case of minors or another protected group, signed permission must be obtained from a parent or legal guardian, after the parent or legal guardian has been informed (as indicated above).

Deception is a basic violation of informed consent and shall be avoided; if it is necessary to the integrity of the study, strong justification must be made that specifies why deception is necessary, is not likely to cause harm to participants and how consequences of the deception will be managed.

b. Protection from Harm - Stress to participants shall be minimized as much as possible. Signed consent must be obtained if the participant 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 participants must be outweighed by the sum of the benefit to participants and the importance of the knowledge to be gained.

e. Debriefing - The exact nature and purpose of the study must be explained to participants, either prior to or, after completing the study; participants have a right of access to a report of the results of the study.

a. Investigator completes the Human Participants 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 Board, 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.