| The Arizona
Department of Health Services (ADHS) Human Subjects Review Board (HSRB) was
formed pursuant to the provisions of Section 474 of the National Research Act
(Public Law 93-348) and Regulations (45 CFR 46.101. et. seq.), to review
biomedical and behavioral research involving human subjects conducted, funded,
or sponsored by the Arizona Department of Health Services (ADHS) in order to
protect the rights of the human subjects of such research. In addition, the HSRB
has been charged with the review of requests for the use or copies of vital
records or other personally-identifiable records collected and maintained by
ADHS for purposes of human subject research. The Board has recently been
registered with and received a Federalwide Assurance from the Office for Human
Research Protections, U.S. Department of Health and Human Services.
Key to review of applications
is that risks to research subjects posed by participation in research should be
justified by the anticipated benefits to the subjects or society. This
requirement is clearly stated in all codes of research ethics, and is central to
the federal regulations. One of the major responsibilities of the HSRB,
therefore, is to assess the risks and benefits of proposed research. In
addition, informed consent is one of the primary ethical requirements
underpinning research with human subjects; it reflects the basic principle of
respect for persons. Informed consent assures that prospective human subjects
will understand the nature of the research and can knowledgeably and voluntarily
decide whether or not to participate. The HSRB must also review the proposed
research to ensure that the privacy of human subjects and confidential
information are protected. For those research projects conducted, funded, or
sponsored by ADHS, the HSRB has a continuing responsibility to provide oversight
of the research.
The HSRB does not approve,
grant or provide funds for research.
When addressing applications
for vital records or personally-identifiable records maintained by the
Department for human subject research, approval by the HSRB does not obligate
the ADHS or its subordinate organizational units to necessarily collect,
compile, or provide the data requested, but only that the requestor appears
capable of managing the data in a confidential manner so as to protect the human
subject and the subject’s privacy and not cause the ADHS undue criticism.
The following are
downloadable versions of related documentation. To view these documents Acrobat Reader™ must be installed
on your machine.
|
