Investigator Handbook Chapter 3: THE ROLE OF THE CPHS
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 Houston as well as the UTHSC-H community. Its mandate is to review proposed research as it applies to those being asked to participate as subjects in order to determine whether adequate measures are in place to protect autonomy, safety, emotional health, and financial considerations.
Institutional Review Board (IRB): A specially constituted review body established or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical or behavioral/social science research.
Federal Wide Assurance
UTHSC-H and the Department of Health & Human Services (DHHS) have signed a Federal Wide Assurance Document (FWA #00000667) outlining the obligations 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 (HRP PP I.01 Institutional Assurance).
Research conducted by any 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.
Research conducted by any faculty, staff or student enrolling subjects/patient from any other facility, agency or hospital.
Research conducted at UTHSC-H by other faculty and staff or students from any other institution.
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 OPRR/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 un-funded.
All such research must be submitted to the CPHS for review and approval before its initiation.
All such 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.
The CPHS is empowered to approve, modify, or disapprove a research project. The Committee is empowered to terminate approval for any research activity that is not conducted in accordance with the methodologies approved or that is associated with unexpected serious harm to subjects.
Institutional Review Boards are mandated by federal law, and the CPHS reports annually to the Department of Health and Human Services (DHHS) on its membership structure and activity.
CPHS Committee Guidelines and Membership
CPHS comprises 3 panels, each of which serves as an IRB. Each panel is led by a Chair, designated by the President on recommendation from the Executive Vice President for Research from the membership.
The Membership of each CPHS panel requires at least five individuals whose backgrounds shall be varied to ensure adequate scientific and ethical review of all research, and sufficiently qualified through the experience, expertise and diversity of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects (HRP PP II.01 CPHS Membership). They include:
At least one member whose primary concerns are in scientific areas;
At least one member whose primary concerns are in nonscientific areas;
At least one member not affiliated with the institution and not an immediate member of a family affiliated with the institution; and
One or more individuals who are knowledgeable about and experienced in working with any vulnerable human subject population.
The Charge to the CPHS is to ensure UTHSC-H's compliance with the procedures and principles contained in Federal legislation and regulations relating to the protection of human subjects in all research activities carried out by its units and personnel. No research involving human subjects may be conducted prior to approval by the CPHS.
The CPHS Executive Committee coordinates the function of the 3 panels and is responsible to the committee as a whole. The CPHS reports to the Executive Vice President for Research.
A roster of current CPHS members is maintained on UTHSCH-H’s website.
IRB Fees
IRB fees are required for the review of new protocols and annual continuing review applications for clinical studies of drugs and devices sponsored by pharmaceutical firms and other for-profit entities. Fees will not be charged for Federal, non-profit foundations, or investigator-funded studies.
UTHSC-H IRB Fees*
Size of Contract
IRB Fee
>$50,000
$1,500
< $50,000
$1,000
Continuing Contracts
$300
< $5,000
Discuss possibility of waiver with CPHS
* Fees are subject to change.
Payment of IRB fees are invoiced to PIs when protocols are scheduled for CPHS review, and all fees are the responsibility of the PI. PIs should include IRB fees with associated indirect costs, if applicable, as a line item in the budget of the formal contract as an upfront and non-refundable item.
Office of Research Support Committees (713) 500-7942
