CPHS-Related Links
- California Information Practices Act, Civil Code, Section 1798.24 (SB 13)
- FDA Regulations
- FDA Web Site
- HIPAA Privacy Rule
- Common Rule
- Office for Human Research Protections (OHRP)
- Public Responsibility in Medicine & Research and Applied Research Ethics National Association (Prim&R and ARENA)
Contact CPHS at:
400 R Street, Suite 369
Sacramento, CA 95811-6213
Phone: (916) 326-3660
Fax: (916) 322-2512
E-mail: cphs-mail@oshpd.ca.gov
Committee for the Protection of Human Subjects (CPHS) Home
Mission and Purpose
The Committee for the Protection of Human Subjects (CPHS) serves as the institutional review board (IRB) for the California Health and Human Services Agency (CHHSA). The role of the CPHS and other IRBs is to assure that research involving human subjects is conducted ethically and with minimum risk to participants.
Ethical Principles
The CPHS is guided by principles delineated in the Belmont Report, which was issued by the U.S. Department of Health, Education, and Welfare in April 1979. These principles include:
Respect for Persons
"Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy."
Beneficence
"Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms."
Justice
".the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research."