POLICY
It is the policy of UTHealth Houston that all research involving human participants in which it is engaged must be reviewed and approved by the IRB if:
- Research is conducted by any UTHealth Houston employee (faculty, staff, administrative and professional), student, or resident in any facility/location (including Memorial Hermann Health System, Harris Health System).
- Research involves patients at a UTHealth Houston facility.
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 Participant means a living individual about whom a researcher conducting research: i) obtains information or biospecimens 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
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. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations.
Human Participant 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:
- 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)
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 there is uncertainty about whether an activity requires IRB review, an IRB Application should be submitted through the iRIS system. This allows for careful review of the project and will result in a formal determination letter. It is the IRB’s responsibility to make the determination on whether a project requires IRB review.
Researchers may submit request for human subjects determination in the following manner:
- Abbreviated IRB application requesting for non human subjects research determination may be submitted via iRIS.
- Project leaders conducting quality improvement activities may submit their project through the QI Registry system
IRB submissions for NHSR determination are reviewed by IRB staff. IRB staff use the OHRP Human Research Regulations Flowchart to make HSR/NHSR determination. If the project is determined to be NHSR, IRB staff will issue a written notification via iRIS. If the project is determined to be HSR – the researcher is asked to submit an application for IRB review.
QI Registry submissions are reviewed by the IRB staff. In addition to the OHRP Human Research Regulation Flowchart, IRB staff will also be guided by the responses to the QI Registry application to determine if the project meets the definition of human subjects research. If the project is determined to be HSR, the researcher is asked to submit an IRB application via the iRIS system.
IRB staff are guided by the OHRP Guidance Engagement of Institutions in Human Subjects Research (2008) in making determination whether a researcher or the University is engaged in research.
The IRB does not provide retroactive approval or determinations for research activities that have already taken place.
Examples of Human Subjects Research and Non-Human Subjects Research 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 a systematic investigation and are generally not considered research involving human subjects; therefore, they do not require prior IRB review and approval. However, a case series involving three or more subjects is considered a research project intended to contribute to generalizable knowledge and must be submitted to the IRB for review and approval prior to initiation.
Classroom Activities - Student class assignments are activities conducted as part of an official course to support learning and teach research or course concepts. These activities may involve interactions with individuals or data about individuals and are typically completed within a single term. They are not intended to produce generalizable knowledge or scholarly publications and therefore do not meet the definition of research. As a result, student class assignments generally do not require IRB review or approval.
Medical Records Review - All medical record review studies that involve the use of resources from UTHealth Houston, 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.
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 are not deemed research and not subject to IRB oversight.
Intelligence Activities - Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions are not deemed research and not subject to IRB oversight.
REFERENCES
- 45 CFR 46 Protection of Human Subjects
- 21 CFR 50 Protection of Human Subjects
- Health Information Privacy - Research
- OHRP Guidance Engagement of Institutions in Human Subjects Research - 2008
- OHRP Human Research Regulation Flowchart
If you find errors in this document, contact [email protected]
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Document Number: |
101-C01 |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 21 Jan 2018, 1 Jun 2021, 1 Sep 2021, 1 Jan 2026, 1 Jun 2026 |
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB Office House: Thursdays, 1–4pm via Teams Room
Email: [email protected]
IRB Helpline: 713-500-7943 (please leave a message and we will get back to you as soon as possible)
iRIS Helpline: 713-500-7960
IRB Review Feedback: IRB Survey
Houston, Texas 77030
Phone: 713-500-7943
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
