Research Which Requires Review by IRB

POLICY

It is the policy of UTHealth that all research involving human participants must be reviewed and approved by the Committee for Protection of Human Subjects if:

1. Research conducted by any UTHealth employee (faculty, staff, administrative and professional), student, or resident in any facility/location (including Memorial Hermann Healthcare System, Harris Health System).
2. Research 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.

KEY TERMS

Department of Health and Human Services

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 (whether professional or student) conducting research: i) obtains information or biospecimen through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens  or ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) 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.

Identifiable Private Information is private information for which the identity of the subject is or may be readily ascertained by the investigator or associated with the information.

Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Food and Drug Administration

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.

Research means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration, or need not meet the requirements for prior submission, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations.

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. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used. When medical device research involves in vitro diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.

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.

Health Insurance Portability and Accountability Act

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:

1. Names;
2. 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
3. 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;
4. Phone numbers;
5. Fax numbers;
6. Electronic mail addresses;
7. Social Security numbers;
8. Medical record numbers;
9. Health plan beneficiary numbers;
10. Account numbers;
11. Certificate/license numbers;
12. Vehicle identifiers and serial numbers, including license plate numbers;
13. Device identifiers and serial numbers;
14. Web Universal Resource Locators (URLs);
15. Internet Protocol (IP) address numbers;
16. Biometric identifiers, including finger and voice prints;
17. Full face photographic images and any comparable images; and
18. Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data)

PROCEDURE

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 the IRB. Some examples of research involving human subjects are clinical trials, epidemiological research, retrospective medical records review research, and genetic research.

When in doubt whether an activity requires IRB review and approval, individuals may contact the IRB office for advice.  For a written determination from the IRB,  a summary of the project/proposal should be submitted to the IRB either by email, in the QI registry system or the iRIS system. The IRB Director or designated IRB staff will review the information and make a determination whether or not the described activity meets the definition of research involving human subjects. The IRB Director or designated staff will send a written notification to the researcher with the final determination.

Examples of HSR and NHSR Activities: :

Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected are deemed not to be research.

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 IRB 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 IRB prior to initiation.

Medical Records Review - All retrospective medical record reviews to be conducted at UTHealth, Harris County Psychiatric Hospital, Memorial Hermann Health System or Harris Health System for the purposes of research must be submitted via iRIS to the IRB for review and approval.

Tissue Repositories - Operation of Human Tissue Repositories and data management centers are subject to IRB oversight. The IRB 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. The IRB 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 the IRB. Researchers who are uncertain whether an activity is human research must contact the IRB. Cell lines purchased from commercial vendors (e.g. ATCC) do not need IRB review.

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.  Investigators must submit an application to the IRB for a written not human subjects research determination.

Publicly Available Data – Research involving publicly available data does not require IRB review.  Examples: census data, labor statistics.  Note: Investigators should contact the IRB 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 the IRB. Additionally, any QA/QI activity where participants are subjected to additional risks or burdens beyond standard practice must be reviewed and approved by the IRB. For a written determination of not human subjects research, project leaders should submit an application in the QI Registry System.

Public health surveillance activities – public health surveillance activities including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority are deemed not to be research. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

Emergency Use or Single Patient 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 IRB approved protocol, contact the IRB office with the request and justification. This is discussed in greater detail in the Policy and Procedure on Emergency Use of an Investigational Drug.

Emergency Use or Single Patient 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 IRB review and approval.

Criminal Justice Agency Activities - Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

Intelligence Activities - Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.

APPLICABLE REGULATIONS

1. 45 CFR 46 Protection of Human Subjects
2. 21 CFR 50 Protection of Human Subjects
3. Health Information Privacy - Research
4. OHRP Guidance Engagement of Institutions in Human Subjects Research

REFERENCE TO OTHER POLICIES

1. None

ATTACHMENTS

1. None

If you find errors in this document, contact [email protected]

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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