Introduction to the CPHS Protocol Review and Submission Process
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). It is made up of individuals of varying interests, disciplines and expertise from the Houston as well as the UTHSC-H community. Its mandate is to review proposed research as it applies to the people being asked to participate as subjects in order to determine if adequate measures are in place to protect, for example, the autonomy, safety, emotional health, and financial considerations of those asked to participate in research.
UTHSC-H and the Department of Health & Human Services (DHHS) have signed a 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. The areas of jurisdiction of the CPHS are as follows:
Research conducted by any faculty, staff or student enrolling subjects/patients from any of the facilities of the University, the Memorial Hermann Healthcare System (MHHS), the Harris County Psychiatric Hospital (HCPC), the Harris County Hospital District (including LBJ General Hospital and Thomas Street Clinic);
Research conducted by any faculty, staff or student enrolling subjects/patient from any other facility, agency or hospital;
Research conducted by another University or agency faculty, staff or student enrolling subjects/patients from any of the facilities of the University, the Memorial Hermann Healthcare System, the Harris County Psychiatric Hospital, the Thomas Street Clinic, or the LBJ General Hospital (in such instances, a University faculty member must be identified who will agree to assume co-responsibility for the conduct of the research).
At its discretion, the CPHS may accept for review, and approve research projects that may be without involvement of members of the faculty, staff or students and which will take place in other settings.
The CPHS employs a review process which conforms to Federal regulations (both FDA and OHRP/HHS), and is supplemented by institutional regulations. The review process is the same for all research involving human subjects or human derived materials whether funded or non-funded.
Primary regulatory codes are in "Federal Policy for Protection of Human Subjects: Common Rule" (HHS), 45 CFR 46 and Food & Drug Administration 21 CFR 50 and 21 CFR 56. These codes also outline an Exempt category of research.
The type of review a project receives depends upon the risks to potential subjects posed by the research. The probability and severity of possible harm (physical, psychological, legal, social or economic) may vary from minimal to significant.