Creation and Dissemination of Policies and Related Documentation

This document describes how the UW-Madison develops Human Research Protection Program (HRPP) policies and assures that study personnel have access to up-to-date written policies and procedures and other pertinent information governing human participant research.

  1. UW-Madison HRPP policies can be created at the campus-wide HRPP or local HRPP level.

    1. Campus-wide HRPP policies are developed by the Office of Research Compliance in conjunction with the IRB Office Directors, the Office of Legal Affairs and other stakeholders. Campus-wide HRPP policies are then approved by the Cross-Campus HRPP Committee.

    2. Policies specific to the Health Sciences HRPP, such as those covering FDA- or VA-regulated research, are developed and approved by the Health Sciences IRBs Policy Committee.

      1. The Health Sciences HRPP is also responsible for developing and maintaining their own guidance documents and standard operating procedures that reflect procedures specific to that office.

    3. The Education and Social/Behavioral Science component of the HRPP develops guidance documents and SOPs that reflect procedures specific to that office. The IRB Chair and Associate Chair review and provide input for those documents.

  2. The Office of Research Compliance (ORC) is responsible for assuring campus-wide HRPP policies and related documentation are and remain consistent with applicable ethical principles, local, state and federal laws, federal guidance and University practices and are accessible to the entire HRPP via the ORC website.

  3. The Health Sciences HRPP component is responsible for ensuring that its policies and related documentation are and remain consistent with applicable ethical principles, local, state and federal laws, federal guidance and University practices and are accessible to the entire HRPP.

    1. The Health Sciences IRBs Policy Committee notifies the Cross-Campus HRPP Committee of any new policies or significant changes to their policies, so that the Cross-Campus HRPP Committee has an opportunity to identify and comment on any concerns related to accreditation or consistency in IRB policy across campus.

  4. The HRPP keeps abreast of new information that may affect human participant research through news alert services and listservs, including those offered by the Office for Human Research Protections (OHRP), The Council on Governmental Relations (CoGR), Public Responsibility in Medicine and Research (PRIM&R) and the National Council of University Research Administrators (NCURA). UW-Madison Office of Legal Affairs provides additional information from the National Association of College and University Attorneys (NACUA).

    1. The impact of any new information on the University's existing policies, procedures, forms, instructions, guidance documents and training materials will be assessed collaboratively by ORP and all potentially affected components of the HRPP.

    2. If necessary, existing documentation will be revised or new documentation developed to address the new information and conduct educational programming.

  5. Campus-wide HRPP policies are posted to the ORC website and are publicly available.

    1. These policies are annotated to reflect updates and modifications.

    2. The ORC provides periodic communications to study teams updating them on policy and compliance issues.

  6. The Health Sciences and Education and Social/Behavioral Science components of the HRPP post any local policies and guidance to their websites, which are publicly accessible.

    1. These policies are annotated to reflect updates and modifications.

    2. The HRPP components provide periodic communications to study teams updating them on policy and compliance issues.

  7. Campus-wide HRPP policies and HRPP component policies and guidance are cross-referenced.

Adopted By: All Campus IRB
Adoption Date: January 5, 2006
Revised By: Cross Campus Human Research Protection Program Advisory (HRPP) Advisory Committee
Revision Date: July 7, 2015

Copyright © 2015 University of Wisconsin System Board of Regents

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Keywords:publish website federal regulation policies up-to-date review revise disseminate new information   Doc ID:29756
Owner:Travis D.Group:VCRGE and Graduate School
Created:2013-04-19 14:02 CSTUpdated:2017-10-03 11:07 CST
Sites:Health Sciences IRBs, VCRGE and Graduate School
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