Original Date: 4\/21\/2009 * Last Revision Effective: 5\/27\/2026
\nPolicy Contact: Executive Director of Effectiveness, Research, and Analytics<\/p>\n
The following procedures are established to meet the requirements for implementing policy #3655 \u2013 Use of Human Participants In Research Activities<\/a>.<\/p>\n The purpose of the IRB review is to protect the rights and welfare of participants in research projects.<\/p>\n The executive director of effectiveness, research, and analytics or 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:<\/p>\n Principal investigators will make an initial determination whether the research will involve human subjects as defined in 45 CFR 46.102 (f). <\/span><\/a><\/p>\n If it is not clear whether research involves human subjects as defined in 45 CFR 46<\/span><\/a>, investigators will seek assistance from the IRB Chair in making this determination.<\/p>\n The membership of the IRB is determined and established following the regulations of CFR 46.107<\/span><\/a>.<\/p>\n The Institutional Review Board meets monthly to review proposals during the previous month.<\/p>\n The IRB maintains records as required by 45 CFR 46.115<\/span><\/a>.<\/p>\n 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.<\/p>\n 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.<\/p>\n Allegations of research misconduct will be responded to in compliance with Public Health Service regulation as required by 42 CFR Part 93<\/span><\/a>.<\/span><\/p>\n Applicable definitions for the above material are located throughout the Code of Federal Regulations Subpart A-D: Basic HHS Policy for Protection of Human Research Subject Definitions, Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Definitions, Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Definitions, and Additional Protections for Children as Subjects in Research Definitions.<\/p>\n Original 4\/21\/2009 President\u2019s Cabinet<\/p>\n","protected":false},"excerpt":{"rendered":" Original Date: 4\/21\/2009 * Last Revision Effective: 5\/27\/2026 Policy Contact: Executive Director of Effectiveness, Research, and Analytics Purpose The following procedures are established to meet the requirements for implementing policy #3655 \u2013 Use of Human Participants In Research Activities. Procedures Role and Responsibilities of the Institutional Review Board (IRB) The purpose of the IRB review ...more about 3655P Use of Human Participants in Research Activities (Procedures)<\/a><\/p>\n","protected":false},"author":2703,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-419","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.bellevuecollege.edu\/policies\/wp-json\/wp\/v2\/pages\/419","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bellevuecollege.edu\/policies\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bellevuecollege.edu\/policies\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bellevuecollege.edu\/policies\/wp-json\/wp\/v2\/users\/2703"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bellevuecollege.edu\/policies\/wp-json\/wp\/v2\/comments?post=419"}],"version-history":[{"count":7,"href":"https:\/\/www.bellevuecollege.edu\/policies\/wp-json\/wp\/v2\/pages\/419\/revisions"}],"predecessor-version":[{"id":4340,"href":"https:\/\/www.bellevuecollege.edu\/policies\/wp-json\/wp\/v2\/pages\/419\/revisions\/4340"}],"wp:attachment":[{"href":"https:\/\/www.bellevuecollege.edu\/policies\/wp-json\/wp\/v2\/media?parent=419"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Procedures<\/h2>\n
Role and Responsibilities of the Institutional Review Board (IRB)<\/strong><\/h3>\n
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Responsibilities of the Principal Investigator (PI)<\/strong><\/h3>\n
Membership of the IRB<\/strong><\/h3>\n
Meeting Schedule <\/strong><\/h3>\n
IRB Records\u00a0<\/strong><\/h3>\n
Timeline and Notification of Approval or Disapproval\u00a0<\/strong><\/h3>\n
Requirements for Complete Research Application<\/strong><\/h3>\n
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Evidence of Research Misconduct<\/strong><\/h3>\n
Definitions<\/h2>\n
Revision History<\/h2>\n
\nRevisions 5\/21\/2009; 9\/11\/2012; 4\/7\/2015; 4\/28\/2015; 5\/27\/2026<\/p>\nApproved By<\/h2>\n