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:

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 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.

(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.

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. 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.

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

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 CPHS staff in writing with a summary of the proposal including at least the objectives and methods of the activity. The IRB 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 IRB Director or designee will provide the investigator written notification with the final determination.

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.

Below are some examples of activities:

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.

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. Cell lines purchased from commercial vendors (e.g. ATCC) may not need CPHS 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 CPHS for review to determine if the research qualifies for exemption or is not human subjects research.

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/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 – Research involving deceased individuals does not meet the DHHS definition of human subjects research. The Institutional Anatomical Oversight Review Committee (IAORC) is responsible for maintaining oversight of the appropriate management of deceased human bodies and human anatomical specimens. 

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.

APPLICABLE REGULATIONS

1.                   45 CFR 46.102

2.                   21 CFR 50.3

3.                   38 CFR 16.102

REFERENCE TO OTHER POLICIES

1.                   None

ATTACHMENTS

1.                   Research Requiring Review by the CPHS – Some Examples.

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

Document Number:

101-C01

Approved by:

Executive Director, Research Compliance 

Effective:

1 Aug 2008

Revision History:

1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 2 Apr 2020


CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
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Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713-500-7943
Fax     713-500-7951
Email cphs@uth.tmc.edu 

IRIS Support 713-500-7960

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