3655 Use of Human Participants in Research Activities

Original Date: 4/21/2009 * Last Revision Effective: 3/5/2014
Policy Contact: Associate Vice President, Effectiveness and Strategic Planning

Policy

Bellevue College and federal policies and regulations require that any research activities involving human subjects be conducted in such a manner as to:

  • respect and protect the rights and welfare of the subjects involved;
  • ensure that informed consent is obtained when this is appropriate/required; and
  • ensure that potential benefits from the research outweigh any risks

The college is fully committed to ensuring the responsible and ethical treatment of any human subjects involved in research, whether conducted by college students or employees directly, or in partnership with others on or off campus It is the policy of this college to review these activities through an institutional review board (IRB).

To implement this policy, the college will establish and maintain an institutional review board (IRB) under the leadership of the associate vice president of effectiveness and strategic planning or his/her designee who will serve as the appointed compliance officer for the purpose of reviewing and monitoring all proposed and ongoing activities, as defined above. The purpose of the IRB is to minimize the risks of injury to human subjects and to insure maximum protection for the rights and welfare of subjects. Operating guidelines of the IRB shall be consistent with the “Belmont Report” regarding ethical principles and guidelines for research involving human subjects, published in 1979 by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Proposals with certifications that human subjects are involved shall be referred by the associate vice president of effectiveness and strategic planning to the IRB for initial and continuing review. Approved proposals shall be submitted to the Department of Health and Human Services in accordance with Part 46 of Title 45 of the Code of Federal Regulations.

Definitions

Human Subject

  • Is defined as 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; i.e., information about behavior in a context in which an individual can reasonably expect that no observation or recording is taking place or information provided for specific purposes that the individual can reasonably expect will not be made public.

Research

  • Is defined as “any systematic investigation designed to develop or contribute to generalizable knowledge.” Generalizable knowledge refers to any systematically gathered data which is intended for dissemination (publication or presentation) beyond the institutional setting and which might reasonably be generalized beyond the research sample.

Risk

  • Means that as a consequence of participating in an activity, an individual may reasonably be expected to be exposed to the possibility of injury (physical and/or psychological), beyond the ordinary risks of daily life.

Relevant Laws and Other Resources

Bellevue College Procedure #3655P Use of Human Participants in Research Activities

Revision History

Original 4/21/2009
Revision 5/21/2009; 9/11/2012; 3/5/2014

Approved By

All College Council
President’s Cabinet
Board of Trustees