The Committee for the Protection of Human Subjects

The Committee for the Protection of Human Subjects (CPHS) is the Institutional Review Board (IRB) for the University of Texas Health Science Center at Houston (UTHSC-H). CPHS is made up of three IRB committees. Serving on each of the committees are individuals of varying interests, disciplines, and expertise from the UTHSC-H and Houston community. CPHS is charged to review proposed research as it applies to the individuals being asked to participate as research subjects in order to determine if adequate measures are in place to protect autonomy, safety, emotional health, and financial considerations.

History
The recognition of the need for guidelines dealing with human subjects in research emerged following the Nuremberg trials, where the medical experimentation abuses of World War II Nazi doctors came to public attention. This led to the creation of the Nuremberg Code in 1945, the first legal attempt to deal with ethical issues of modern research. As biomedical research efforts expanded the international need for a more specific code of ethics was formulated in the 1964 Declaration of Helsinki.

In the United States, by 1953 the National Institutes of Health required that all proposed clinical research projects at its center in Bethesda obtain approval from a protection of human subjects review panel. In 1966, the United States Public Health Service issued its first set of regulations extending this review requirement to all "extramural" research supported by the agency. These rules were further revised in 1971 and 1974 and led to the establishment of institutional review boards (IRBs) at hundreds of institutions receiving federal funding for research.

During this period revelations of human subjects’ abuse in the U.S. culminated in the 1972 public disclosure of the 30-year government supported Tuskegee Syphilis Study, in which 300 black rural men were left untreated for diagnosed syphilis after effective antibiotics became available. This prompted Public Law 93-348 calling for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979 the Commission published recommendations, known as the Belmont Report, which served as the basis for revised federal regulations published in the Federal Register in 1979 and subsequently revised several times resulting in the current Code of Federal Regulations Title 45-Part 46 Protection of Human Subjects (45 CFR 46) effective as of 1991.

The Belmont Report established three general ethical principles that continue to be applied to the research of human subjects:

Mission
UTHSC-H and the Department of Health & Human Services have a signed Federal Wide Assurance Document (FWA #00000667) defining the obligation of the University to be certain that the rights and welfare of human subjects of research are protected, and the role that the CPHS plays in fulfilling this obligation.  Human subject’s research is defined as research involving human subjects, human derived materials, or human derived data. All human subjects research, funded and unfunded, must be reviewed and approved by the UTHSC-H CPHS before it is initiated if it falls in one of the following categories:

Members of CPHS receive and review research protocols electronically via the Internet Research Information System (IRIS).  Once submissions are received, it is the task of the committee members to assess the following prior to approval of the submission:

1. risks to subjects are minimized;
2. risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result;
3. selection of subjects is equitable;
4. informed consent will be sought from each prospective subject or their legally authorized representative;
5. informed consent will be appropriately documented;
6. the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; and
7. there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

All human subjects research, except exempt research, receives ongoing monitoring by the CPHS appropriate to the level of risk involved, but in every instance at least annually.

All modifications to approved research protocols must be submitted to the CPHS for review and approval prior to implementation.