3655P Use of Human Participants in Research Activities (Procedures)

Original Date: 4/21/2009 * Last Revision Effective: 4/28/2015
Policy Contact: Associate Vice President, Effectiveness and Strategic Planning


The following procedures are established to meet the requirements for implementing policy #3655 – Use of Human Participants In Research Activities.


Role and Responsibilities of the Institutional Review Board (IRB)

The purpose of the IRB review is to protect the rights and welfare of participants in research projects.

The Associate Vice President of Effectiveness and Strategic Planning or his/her designee who serves as the appointed compliance officer for the purpose of reviewing and monitoring activities will receive the completed request from the investigator. The IRB will then verify the following items:

  • The research proposal form has been completed, including the investigator’s certification.
  • The proposal meets the requirements of the Code of Federal Regulations (CFR) Protection of Human Subjects, 45 CFR 46.
  • The appropriate signatures have been obtained by the investigator.
  • The results will be disseminated in a fashion that protects the identity of the participants and, if appropriate, the college. Names of individuals will not be used in the study unless the individuals grant permission in writing. The name of Bellevue College can be used only if the research receives IRB approval.

Responsibilities of the Principal Investigator (PI)

Principal investigators will make an initial determination whether the research will involve human subjects as defined in 45 CFR 46.102 (f).

If it is not clear whether research involves human subjects as defined in 45 CFR 46, investigators will seek assistance from the IRB Chair in making this determination.

Membership of the IRB

The membership of the IRB is determined and established following the regulations of CFR 46.107.

Meeting Schedule

The Institutional Review Board meets monthly to review proposals during the previous month.

IRB Records  The IRB maintains records as required by 45 CFR 46.115.

Timeline and Notification of Approval or Disapproval 

The IRB will notify investigators in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval within seven (7) days of making a decision.

If the IRB disapproves a research activity, its written notification will include a statement of the reasons for its decision and will give the investigator an opportunity to respond in person or in writing. A revised proposal, or sections thereof, may be submitted for reconsideration.

Requirements for Complete Research Application

  • Complete mandatory online certification.
    1. Mandatory online certification is required for all investigators through one of the following institutions: the National Institutes of Health (NIH) Office of Extramural Research; Collaborative Institutional Training Initiative (CITI) Programs Human Subject Research; other trainings as developed and approved by the IRB.
    2. Certification of completion must accompany the research project application.
  • Complete a Research Project Application.
    1. The application identifies and explains the following components of the research project:
      1. Title of Research Project
      2. Principal Investigator
  • Populations of Human Subjects Involved in the Study
  1. Abstract Describing Project and Purpose
  2. Project Protocol
  3. Instrumentation and Recruitment Materials
  • Project Precautions
  • Confidentiality of Data
  1. Informed Consent
  • Prepare an Informed Consent document following guidelines set in CFR 116 and 46.117.
  • Submit application form.
    1. Application must be submitted to the IRB Chair at least 60 days prior to the start of the research.
  • Make changes to research as required by the review of the IRB.
  • Report any unanticipated problems to the IRB as required by CFR 46.103 (5) (i).
  • Report any changes to protocol, instrumentation or recruitment materials to the IRB as required by CFR 46.101 (5).
  • Maintain records and annually renew authorization (if needed) with the IRB.
  • Submit a Close-out Form to the IRB.

Evidence of Research Misconduct Allegations of research misconduct will be responded to in compliance with Public Health Service regulation as required by 42 CFR Part 93.


Applicable definitions for the above material are located throughout the Code of Federal Regulations.

Subpart A:        Basic HHS Policy for Protection of Human Research Subject Definitions

Subpart B:        Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Definitions

Subpart C:        Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Definitions

Subpart D:        Additional Protections for Children as Subjects in Research Definitions

Revision History

Original 4/21/2009
Revisions 5/21/2009; 9/11/2012; 4/7/2015; 4/28/2015

Approved By

All College Council
President’s Cabinet

Last Updated April 28, 2015