Office of Administrative Counsel & Rules
Privacy - Human Subjects Review Board
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 access to copies of vital records or other personally-identifiable records collected and maintained by ADHS for the purpose of human subject research. The HSRB is registered with the Federal wide 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 ADHS for human subjects 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.
Submissions to the Human Subjects Review Board
Submissions to the HSRB must include:
- Submission application signed by the principal investigator
- Confidentiality statement signed by the principal investigator and all researchers involved in the project
- Securities consideration checklist
- Copy of protocol for research project/study
- Copy of local IRB approval
- CVs for principal investigator and co-investigator(s) (if applicable)
- Copies of Consent Forms, Assent Forms (if applicable)
- Survey(s) Questionnaires (if the project will be utilizing these forms in their research project/study
- An original and three copies of the research project/study must be submitted to the HSRB
Send all Submissions to:Human Subjects Review Board
Arizona Department of Health Services
1740 West Adams, Room 203
Phoenix, AZ 85007
Answers to questions regarding submissions to the Board, please call 602-542-6330.
Downloadable versions of related documentation:
- Annual Report for Human Subjects Review
- Human Subjects Review Board Procedure
- Application for Submission
- Confidentiality Statement
- Security Considerations for Applicants
- Certificate of Destruction (completed at the end of the project/study)
***This webpage and the material contained herein are provided as a public service for informational purposes only. It should not be considered legal advice or opinion; and, unless expressly noted, does not reflect official ADHS policy.