Keene State College Human Subject Research Policy and Procedures

Keene State recognizes the need for investigations in which human being serve as research subjects. The College is also cognizant of its responsibility for ensuring the privacy, safety, health and welfare of subjects are adequately protected. An Institutional Review Board (IRB) has been established to review and approve the adequacy of human subject protection. Additionally, the College has established a Federal Wide Assurance with regard to the conduct of human subjects research (FWA # FWA00001990).

The policies of the College, with respect to research involving human subjects are guided by The Belmont Report, a federal government document that charges each researcher with the responsibility while conducted human subject research of demonstrating respect for persons, beneficence (maximizing benefits and minimizing risks), and justice.

The policies are based on the following principles:

• Participation in any research project must be voluntary;
• The risks of participation must be acceptable when measured against the possible benefits to the participant or by the importance of the knowledge gained,
• Research and training activities involving human subjects must be supervised by a qualified person,
• All research programs that involve human subjects must be reviewed and approved by the IRB prior to initiation of the protocol.
• Per Federal Regulations, all continuing research must be reviewed on an annual basis.
• This applies to all research involving humans, not just clinical research and regardless of whether or not the research is funded.

Required IRB Review

Anyone who intends to conduct human subject research must submit a proposal to the IRB Chairperson (Tony Scioli, Psychology Department; 603-358-2541 or tscioli@keene.edu).

Types of Review

There are three levels of IRB review and approval: exempt, expedited, and full review. Only the IRB can make the determination of which level of review is required.

“Exempt” means a protocol does not require extensive initial review. There are 6 regulated exempt categories, which delineate the lowest level of risk.

“Expedited reviews” fall into any of 10 regulated categories and typically involve data collection that is not anonymous or involves more than minimal risk to subjects.

“Full review” requires the full IRB committee to review the protocol for compliance with all applicable federal, state, local, and College regulations. Protocol, which involve protected categories of subjects (such as children or institutionalized subjects) or are in particularly sensitive topic areas such as substance use and abuse, sexuality, and others, will fall into the full review level.

Faculty in some classes encourage or require students to conduct small-scale studies, interview members of the campus or local community, or other research activities. If the procedure is standardized, a blanket approval may be obtained from the IRB.

Training in the Protection of Human Subjects

All individuals (students, faculty, staff) planning to be involved in the conduct of Human Subjects Research are encouraged to complete online training regarding the protection of human subjects. Such training is mandatory for all researchers participating in projects funded by the National Institutes of Health.

Free online training

If more information is needed or you would like to consult with the IRB about a potential project, contact the IRB chair (Tony Scioli, Psychology Department; 603-358-2541 or tscioli@keene.edu).

Helpful links:

Office of Human Research Protections (OHRP)

OHRP Database for Registered IORGs and IRBs, and Approved FWAs (including Keene State College)