Human Research Protection Program: Policy

Role of the Office of Research Policy

 

Adopted By: Associate Dean for Research Policy, UW-Madison, Graduate School

Adoption Date: December 11, 2006

Purpose:  The University of Wisconsin - Madison’s (UW-Madison’s) Office of Research Policy (ORP) provides the central mechanism for coordinating UW-Madison’s Human Research Protections Program (HRPP).  The ORP works with the Institutional Review Board (IRB) Offices to assure that research with human participants conducted at the UW-Madison complies with applicable ethical principles, state and federal laws, federal guidance, international codes of conduct, and UW-Madison policies and procedures.  The ORP coordinates compliance reviews and audits, coordinates education programming on human research protections, and communicates pertinent and timely information about human research to members of the research community as well as the UW-Madison in general. 

Policy

I.      HRPP Advisory Committee and IRB Staff Support

A.  The ORP provides staff support for the HRPP Advisory Committee in fulfilling its responsibilities as listed in the Advisory Committee Charter.

B.  The ORP provides staff support for the IRB electronic protocol management and submission system.

C.  The ORP maintains a website that describes the roles and responsibilities of the Advisory Committee and each of the UW-Madison IRBs.

D.  The ORP maintains, updates and renews the UW-Madison Federalwide Assurance and IRB registrations, including IRB rosters. 

E.  The ORP processes IRB Authorization Agreements, Independent Investigator Agreements and Certificates of Confidentiality.

II.     Written Policies and Procedures

A.  The ORP is responsible for assuring that HRPP policies, procedures, forms, instructions, guidance documents and training materials (a) communicate the UW-Madison’s expectations of those involved in research involving humans consistent with applicable ethical principles, local, state and federal laws, federal guidance and UW-Madison policies and procedures, and (b) are available in a location and format that is accessible by all individuals involved in conducting human research and in the research review process at the UW-Madison.  The ORP maintains a Web site that includes these documents.

III.    Reviewing and Revising Program Documents

A.  The ORP is responsible for assuring that existing policies, procedures, forms, instructions, guidance and training documents are periodically reviewed and revised to reflect changes in local, state and federal laws, federal guidance and UW-Madison’s policies and procedures relating to human research protections and emerging scientific and ethical issues relating to human research. 

B.  Review and updating of UW-Madison policies and procedures will be done either (a) when changes occur in local, state and federal laws, federal guidance, UW-Madison policies, or established research practice that may impact the UW-Madison’s existing policies or procedures, or (b) as part of a regular review cycle. 

IV.   Education

A.  The ORP works with the IRB Offices to develop and update educational material for posting on the HRPP web site, including an on-line tutorial. 

B.  The ORP also helps coordinate seminars and workshops for faculty, academic staff, students, and other administrative staff relating to human research protections.

C.  The ORP will provide a central contact point for questions, concerns and complaints about the IRBs and the HRPP from investigators, participants, IRB personnel and the UW-Madison community at large.

V.    Dissemination of New Information

A.  The ORP keeps abreast of new information that may affect human research through news alert services and listservs, for example 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 Legal Services provides additional information from the National Association of College and University Attorneys (NACUA).

B.  Any information regarding new laws, regulations, federal guidance, UW-Madison policies and procedures and emerging scientific and ethical issues that comes to the attention of an individual involved in conducting or reviewing human research projects should be forwarded to the ORP prior to dissemination to the rest of the UW-Madison community.  The ORP will review the new information and assess the implications of the new information for the UW-Madison’s existing policies, procedures, forms, instructions, guidance documents and training materials.  If necessary, the ORP, in conjunction with the IRBs, will revise existing documentation or develop new documentation to address the new information.  If necessary, the ORP, in conjunction with the IRBs, will also plan and conduct educational programming relating to the new information. 

VI.   Internal Audit of HRPP

A.  The ORP will coordinate periodic audits of research protocols, the IRB review process and the overall HRPP as a means of evaluating compliance with local, state and federal laws, federal guidance and UW-Madison policies and procedures as well as international standards for human research protection.  The audit will include a review of the HRPP participant and community outreach activities.  The audits will also provide the benchmark for improvements in the HRPP.