When human subjects research does not qualify for review under the exempt or expedited categories, it must undergo a full review by the CPHS. UTHSC-H has three CPHS panels which each meet monthly, and protocols are assigned to a Committee based on when they are received through iRIS.

Criteria for Approval

Protocols undergo an initial review by a Subcommittee that subsequently makes recommendations to the full Committee. The following are considered in the review process.

1. Risks to subjects are minimized by using procedures which are:
   a. consistent with sound research design ,
   b. do not unnecessarily expose subjects to risk, and
   c. when appropriate, already being performed for diagnostic or treatment purposes.
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. A research benefit is considered something of health-related, psychosocial, or other value to an individual research subject, or something that will contribute to the acquisition of generalizable knowledge. Money or other compensation for participation in research is not considered a benefit, but rather compensation for research-related inconveniences. Some research may offer direct potential benefit to individual subjects but most research studies are likely to yield generalizable knowledge about the subject's disorder or condition. In early clinical trials of new drugs, devices and procedures, risk assessment is based solely on animal toxicity data or known risk from similar interventions. Reevaluation of the risk/benefit ratio must be an ongoing process as investigation proceeds.
3. Selection of Subjects is Equitable – In making this assessment, CPHS will take into account:
   a. the purposes of the research,
   b. the setting in which the research will be conducted, and
   c. special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally acceptable representative.
5. Informed consent will be appropriately documented.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects as outlined in policies and procedures XXX.