It is the policy of UTHSC-H that all research involving human participants and deceased persons must be reviewed and approved by the Committee for Protection of Human Subjects if it falls in one of the following categories:

1. Research conducted by any UTHSC-H employee (faculty, staff, administrative and professional), student, or resident in any facility/location (including Memorial Hermann Healthcare System, Harris County Psychiatric Hospital, Thomas Street Clinic, LBJ General Hospital).
2. Research conducted by non-UTHSC-H investigators that involves subjects/patients from any UTHSC-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.

The definition of research under Department of Health and Human Services (DHHS):

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Human Subject means a living individual about whom an investigator conducting research obtains data (including tissue, specimens, and cognitive phenomena) through intervention or interaction, whether identifiable or not, or private information.

Intervention includes both physical procedures by which data are gathered and manipulations of the participant or participant’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and participant.

Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the investigator or associated with the information) in order for obtaining information to constitute research involving human subjects.

The definition of research under United States Food and Drug Administration (FDA):

Clinical Investigation is any experiment that involves a test article and one or more human participants and that is one of the following:

1. Subject to requirements for prior submission to Food and Drug Administration; or
   
2. Not subject to requirements for prior submission to Food and Drug Administration, but the results of which are intended to be submitted later to, or held for inspection by Food and Drug Administration as part of an application for a research or marketing permit.

Human Subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or patient.

Test Article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulation.

The definition of human subject under the FDA IDE regulations is a human who participates in an investigation either as an individual on whom or on whose specimen an investigational device is used or as a control.

If an activity meets the definition of research involving human subjects, the Principal Investigator must submit an application for CPHS review and approval. When in doubt whether an activity requires CPHS review and approval, the Principal Investigator must communicate to the ORSC Staff with a summary of the proposal. The ORSC Staff will review the information and make a determination whether or not the described activity meets the definition of research involving human subjects. The Principal Investigator may request written notification with the final determination from ORSC Staff.

EXAMPLES OF HUMAN SUBJECTS RESEARCH AND RESEARCH LIKE ACTIVITIES

Activities that involve systematic investigation and are designed to develop or contribute to generalizable knowledge are considered research. When such activities involve human participants, they will require review and approval by CPHS. Some examples of research involving human subjects are clinical trials, epidemiological research, retrospective medical records review research, and genetic research. However, we do recognize that it is not always easy to determine whether an activity is research involving human participants. The purpose of this guidance is to give some examples to help make this determination.

When in doubt whether an activity requires CPHS review and approval, the Principal Investigator must write to the ORSC Director with a summary of the proposal. The ORSC Director or designated ORSC staff will review the information and make a determination whether or not the described activity meets the definition of research involving human subjects. The ORSC Director or designated staff will send a written notification to the researcher with the final determination.

Case Reports – Case reports do not involve systematic investigation; however the intent is to contribute to generalizable knowledge. Case reports are not considered to be research involving human subjects and do not require prior CPHS review and approval. However, a series of 3 or more subjects qualifies as a research project and hence should be submitted for review and approval by CPHS prior to initiation.

Retrospective Medical Records Review - All retrospective medical record reviews to be conducted at LBJ Hospital, Harris County Psychiatric Hospital, Thomas Street Clinic, or at a hospital within the Memorial Hermann Healthcare System for the purposes of research must be approved by CPHS. This may be accomplished by submitting a request through the iRIS system, which will be reviewed and approved administratively. Retrospective medical chart reviews also require approval by the Memorial Hermann Research Office when using Memorial Hermann Hospital or one of the MHHS community hospitals.

Tissue Repositories - Operation of Human Tissue Repositories and data management centers are subject to oversight by CPHS. CPHS will review and approve protocols specifying the conditions under which data and specimens may be accepted and shared, and ensure adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. CPHS will also review and approve a biological sample collection protocol and consent document.

Research involving biological materials – Research involving biological materials or data from individually identifiable living persons must be reviewed by CPHS. Researchers who are uncertain whether an activity is human research must contact CPHS. Below is a list of human derived materials and whether they require CPHS approval.

Examples of material not needing CPHS approval, include but are not limited to:

1. anonymized nucleic acid
2. human cells or cell lines from established external repositories and tissue banks (such as ATCC)
   
3. anonymized commercially available blood
   
4. anonymized commercially available macrophage cell lines
   
5. anonymized cell lines, cell products, or material purified from cells, tumor cells or cultured cell lines

Examples of material that do require CPHS approval, include but are not limited to:

1. embryonic or fetal tissue, including the placenta, amniotic fluid, umbilical cord blood and stem cells
   
2. tumor tissue
   
3. tissues from individual donors
   
4. material from cadavers
   
5. diagnostic specimens collected for or being used for research purposes
   
6. deciduous teeth at time of exfoliation or permanent teeth extracted for clinical purposes
   
7. saliva, supra-and subgingival dental plaque, and calculus
   
8. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings

Research Involving Coded Data or Specimens – Research involving coded private information or biological specimens, that were not collected for the current research proposal do not need IRB review as long as the investigator cannot link the coded data/specimens back to individual subjects. Note: At UTHSC-H, such projects may qualify for exemption. Investigators must submit an application to CPHS for review.

Publicly Available Data – Research involving publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the CPHS if they are not sure whether the data qualifies as “publicly available”.

Quality Assurance and Improvement Projects (QA / QI) – Activities designed to determine if aspects of any practice are in line with established standards are called quality assurance. When an activity is designed to improve the performance of any practice in relation to an established standard, it is called quality improvement. When these QA / QI Projects involve systematic investigation and contribute to generalizable knowledge they must be reviewed and approved by CPHS. Additionally, any QA or QI activity where participants are subjected to additional risks or burdens beyond standard practice must be reviewed and approved by CPHS. If there is uncertainty whether an activity is human subjects research, CPHS must be contacted.

Research involving deceased individuals – Research involving deceased individuals does not meet the DHHS definition of human subjects research, but at UTHSC-H, such research must be reviewed and approved by the CPHS.

Outbreak investigations – Outbreak investigations are important activities that benefit public health. Such activities are not considered to be research and do not require CPHS review. However any interventional studies conducted during an outbreak would require review and approval by CPHS. CPHS will make an effort to expedite the review and approval process for such protocols.

Infection control – Rapid investigations to reduce the current or future spread of disease or infection carried out as part of an infection control program are not considered as research and these do not require review by CPHS. Planned research conducted by an Infection Control department requires review and approval by CPHS.

Compassionate / Emergency Use of Investigational Drug - When a physician wishes to use an investigational drug for treatment of an individual patient for a single use or a single course of treatment, and the use is not covered by an existing CPHS approved protocol, contact CPHS office with the request and justification. The Executive Chairperson will advise if the justification for such use is sufficient for approval. This is discussed in greater detail in the Policy and Procedure on Emergency Use of an Investigational Drug.

Compassionate / Emergency Use of Unapproved Medical Device - If an emergency arises where an unapproved medical device may offer the only possible life-saving alternative, but an Investigational Device Exemption (IDE) for the device does not exist, or the proposed use is not approved under an existing IDE, a physician may use the device if each of the following conditions exist: 1) the patient is in a life-threatening condition requiring immediate treatment; 2) no generally acceptable alternative is available; and 3) there is no time to use existing procedures to get FDA approval for the use. This is discussed in greater detail in Policy and Procedure on Emergency Use of an Unapproved Medical Device

Off-Label Use Of Marketed Drugs, Biologics, and Medical Devices - Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).

Investigational Use of Marketed Drugs, Biologics and Medical Devices - Investigational use suggests the use of an approved product in the context of a clinical study protocol. When the principal intent of the investigational use of a test article is to develop information about the product's safety or efficacy, submission of an IND or IDE may be required. All such activities require prior CPHS review and approval.

THE REVIEW PROCESS

The CPHS review process conforms to Federal regulations, and is supplemented by institutional policies. 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. The review process is the same for all research involving human subjects or human derived materials, whether funded or non-funded.

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

Ongoing monitoring by the CPHS is also required with the frequency dependent on the level of risk involved, but in every instance an annual review is required.

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.