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Underside photo of Wright B Flyer Federal guidelines, university forms... Federal guidelines, university forms...

WSU Human Subjects Policies & Procedures

Federal/External Regulations & Guidelines

  • DHHS Human Subjects Regulations (45 CFR 46)
       (contains list of Exempt categories in 46.101)

  • List of Expedited Review Categories (via OHRP Web Site)

  • Informed Consent Checklist (via OHRP Web Site)

  • FDA IRB Regulations

  • NIH Guidance: Inclusion of Children in Research

  • NIH Guidance: Inclusion of Women/Minorities in Research

  • National Bioethics Advisory Commission (incl. report on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity, December 1998)

  • Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the Belmont Report)

  • The Declaration of Helsinki

  • Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English

  • DHHS Guidance: Conflicts of Interest

  • OHRP and NIH Guidance on Certificates of Confidentiality

  • Additional OHRP guidance on numerous topics

    Additional resources for investigators:

    		•

    University Documents


  • WSU Federalwide Assurance [as required by 45 CFR 46] [click here for additional information concerning protocols reviewed by an external IRB]

  • Petition for Approval of Research Involving Human Subjects [use this document to request initial approval for human subjects use in research] [click here for information on avoiding common mistakes]. Return completed petitions to Robyn Wilks, IRB Coordinator, 201J University Hall.

  • Form for Requesting Modification/Amendment of an existing protocol.

  • Checklist for Submission of Human Subjects Petition [provided as a guide; not a required form]

  • Continuing review petition: full board (protocols numbered HSP___) and Screening Committee (protocols numbered SC___) versions [use these documents to request renewal of human subjects use approval beyond current expiration date; recommend right-clicking and selecting "save as", then opening in Word, rather than opening directly in your browser]

  • IRB Charter and Standard Operating Procedures [IRB Guidelines]

  • Cover Letter/Consent Form Guidelines [HIPAA-compliant]

  • Form for Reporting Adverse or Unexpected Events

  • 2008 schedules of IRB Full Board and Screening Committee meetings

  • Recommendations on how to avoid common mistakes when petitioning for Expedited Review

  • Guidelines on advertising to recruit study subjects

  • Guidelines on paying study subjects

  • Guidelines on re-consenting study subjects

  • Guideline on use of sponsor name in consent forms

  • Form for Requesting IRB Authorization Agreement

  • Composition of the WSU IRB

  • WSU is pleased to offer on-line human subjects protection training for any interested faculty, staff, or student member, including Principal Investigators, other key personnel on projects involving human subjects, and IRB members. This training is available through the Collaborative Institutional Training Initiative (CITI). At the log-in page, either click on "New Users - Register Here" or, if you're already registered, enter your username and password. The succeeding forms to be filled out are fairly self-explanatory.

    • WSU Animal Subjects Policies & Procedures

    Federal

    University

    Submittal of Petition for Research Activities

    Submittal of Petition for Teaching Activities

    Training

    • On campus training is offered by Laboratory Animal Resources (LAR). This training is required for anyone proposing to use or otherwise handle laboratory animals. Contact Debra Hager in LAR for additional information (775-2792; debra.hager@wright.edu)
    • In cases where intiation of animal use is critical and the on campus training cannot be scheduled in a timely manner, WSU is pleased to offer on-line lab animal welfare training that can be a stop-gap until the on campus training is completed. This training is available through the Collaborative Institutional Training Initiative (CITI). At the log-in page, either click on "New Users - Register Here" or, if you're already registered, enter your username and password. The succeeding forms to be filled out are fairly self-explanatory.
    • CITI training is also available for LACUC members.


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