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III.01
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Research Requiring Review by the Committee for Protection of Human Subjects
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PURPOSE
1. The purpose of this policy and procedure to describe the criteria used for determining whether an activity is research involving human participants and requires review by the Committee for Human Subjects Protection (CPHS).
SCOPE
2. This policy and procedure is applicable to all research involving human subjects.
DEFINITIONS
3. 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.
4. 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:
- Subject to requirements for prior submission to Food and Drug Administration; or
- 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.
5. 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.
6. Identifiable Information - Protected health information (PHI) is any information in the medical record or designated record set that can be used to identify an individual and that was created, used, or disclosed in the course of providing a health care service such as diagnosis or treatment. There are 18 Identifiers according to HIPAA:
- Names;
- All geographical subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if according to the current publicly available data from the Bureau of the Census:
- The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and
- The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
- All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
- Phone numbers;
- Fax numbers;
- Electronic mail addresses;
- Social Security numbers;
- Medical record numbers;
- Health plan beneficiary numbers;
- Account numbers;
- Certificate/license numbers;
- Vehicle identifiers and serial numbers, including license plate numbers;
- Device identifiers and serial numbers;
- Web Universal Resource Locators (URLs);
- Internet Protocol (IP) address numbers;
- Biometric identifiers, including finger and voice prints;
- Full face photographic images and any comparable images; and
- Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data)
POLICY
7. It is the policy of UTHealth 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:
- Research conducted by any UTHealth 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).
- Research conducted by non-UTHealth 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.
PROCEDURE
8. Determination of Research Status – If an activity meets the definition of research involving human subjects, the Principal Investigator must submit an application for CPHS review and approval.
8.1. 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 including at least the objectives and methods of the activity. The ORSC Director or designee will review the information and make a determination whether or not the described activity meets the definition of research involving human subjects. If in doubt, the CPHS Staff will consult the IRB Chair. The ORSC Director or designee will provide the investigator written notification with the final determination.
RESPONSIBILITY
9. The ORSC Director is responsible for determining what activities meet the definition of research involving human participants.
10. The Principal Investigator is responsible for seeking prior approval for all research involving human participants under the CPHS jurisdiction.