Human Research Protection Program: Policy
Policies and Other Information for HRPP Personnel
Adopted
By: All Campus IRB
Adoption
Date: January 5, 2006
Policy
I. UW-Madison assures that all personnel involved in human subjects
research and research review comply with all relevant federal regulations,
ethical principles and University policies governing human subjects protection
by providing:
A. up-to-date written policies and procedures, forms, instructions,
guidance documents, and other pertinent information on human research
protection, and
B. prompt dissemination of information on changes in laws, regulations,
federal guidance, University policies and procedures and emerging scientific
and ethical issues that may affect research involving humans.
Procedure
I. Written Policies and Procedures
A. The Research Policy Office (RPO) is responsible for assuring that Human
Research Protection Program (HRPP) policies, procedures, forms, instructions,
guidance documents and training materials (a) are consistent with applicable
ethical principles, local, state and federal laws, federal guidance and University
practices, and (b) are available in a location and format that is accessible by
all individuals involved in conducting human subjects research and in the
research review process at the University. The RPO maintains a Web site that
includes these documents.
II. Reviewing and Revising Program Documents
A. The RPO 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 the University’s policies and procedures relating to research
involving human participants, and emerging scientific and ethical issues
relating to human research.
B. Review of human research policies and procedures will be done either
(a) when changes occur in state and federal laws, federal regulations and
guidance, University policies, or established research practice that may impact
the University’s existing policies or procedures, or (b) as part of a regular
review cycle.
III. Dissemination of New Information
A.
The RPO keeps abreast of new information that may affect human subject
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,
University policies and procedures and emerging scientific and ethical issues
that comes to the attention of an individual involved in conducting or
reviewing human subjects research should be forwarded to the RPO prior to
dissemination to the rest of the University community. The RPO will review the
new information and assess the implications of the new information for the
University’s existing policies, procedures, forms, instructions, guidance
documents and training materials. If necessary, the RPO, in conjunction with
the IRBs, will revise existing documentation or develop new documentation to
address the new information. If necessary, the RPO, in conjunction with the
IRBs, will also plan and conduct educational programming relating to the new
information.
