UTHealth 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 UTHealth CPHS before it is initiated if it falls in one of the following categories:
- Human subjects research conducted by any UTHealth employee (faculty, staff, administrative and professional), student, or resident in any facility/location (e.g. Memorial Hermann Healthcare System, Harris County Psychiatric Hospital,Thomas Street Clinic or LBJ General Hospital.
- Human subject’s research conducted by non-UTHealth investigators that involves subjects/patients from any UTHealth facility (including Harris County Psychiatric Hospital). In such instances, a University faculty member must be identified who will agree to assume co-responsibility for the conduct of the research.
- Human subject’s research conducted by non-UTHealth investigators in Memorial Hermann Healthcare System facilities.
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:
- risks to subjects are minimized;
- 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;
- selection of subjects is equitable;
- informed consent will be sought from each prospective subject or their legally authorized representative;
- informed consent will be appropriately documented;
- the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; and
- 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.