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UTA's Criteria for Approval

University of Texas at Arlington
Guidance to Criteria for Institutional Review Board (IRB) Approval

All researchers who intend to submit protocol(s) seeking approval to enroll human subjects must meet federally mandated criteria before the research can be initiated.  The criteria are based on federal regulations at 45 CFR 46.111 and the ethical principles discussed in the Belmont Report.  Additional criteria unique to the University of Texas at Arlington human research protections programs (HRPP) will also apply. 

All IRB application and submission materials are found within the online submission system after an investigator as selected the option to Start a New Protocol, Submit a Modification Request, or Submit a Continuing Review(with or without Modification Request).

The UTA IRB must apply the following criteria, taken from 45 CFR 46.111, before approving research protocols involving human subjects.  Their findings for approval (or disapproval) must be clearly documented:

Risks to subjects are minimized [§46.111(a)(1)]:

By using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to [§46.111(a)(2)]:

  • Anticipated benefits, if any, to subjects, and
  • Importance of the knowledge that may be expected to result.
    • In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from risks and benefits of other activities or therapies that subjects would receive even if not participating in the research).  The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
    • The IRB must also consider the professional qualifications and resources of the research team as identified in the study personnel listing on the Form #1 to ensure appropriate expertise is represented. 
    • For clinical research using FDA regulated products including investigational drugs, devices and/or biologics: Additional information is obtained on the FDA status of the project (e.g., approved, Phase I, Phase II, Phase III); the available animal toxicity and side effect data; and the short-term and long-term risks to which human subjects will be exposed during the course of research.  Where appropriate, the IRB reviews provisions for monitoring the data collected to ensure the safety of the subjects. 
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Selection of subjects is equitable [§46.111(a)(3)]:
In making this assessment, the IRB takes into account the purposes of the research and the setting in which the research will be conducted and is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, fetuses, neonates, English as a second language (ESL) populations, mentally disabled persons, or economically or educationally disadvantaged persons. 
 
Informed consent will be sought from each prospective subject or the subject's legally authorized representative unless this requirement is waived by the IRB. [§46.111(a)(4)]:

Informed consent is a process.  To minimize coercion, the IRB considers the circumstances under which consent is obtained including but not limited to timing, relationship between perspective subject and individual obtaining informed consent, language used to recruit prospective subjects, and qualifications of individuals obtaining informed consent,  Also, informed consent, whether oral or written, may not include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.  Compensation language to accommodate industry sponsored research protocols may be considered on a case-by-case basis. 

First person language and the use of, “I understand that..” is strictly prohibited.  Use of the first person (e.g., "I understand that ...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject. Use of scientific jargon and legalese is not appropriate. Think of the document primarily as a teaching tool not as a legal instrument.  
 
Informed consent will be appropriately documented as required by local, state and federal regulations unless the requirement is waived by the IRB. [§46.111(a)(5)]: 

The IRB template informed consent document (ICD) is designed to ensure that documentation of informed consent includes federally mandated basic and additional elements of informed consent. 

When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects[§46.111(a)(6)]:

The IRB reviews if applicable:

  • Procedures for promptly detecting harm and mitigating potential injuries.
  • Implementation of monitoring procedures and frequency.
  • Procedures to ensure adequate feedback of information to researchers and volunteer participants.
  • Procedures for ensuring appropriate reporting of findings to the IRB.
  • Procedures for reporting temporary or permanent suspensions of a study to the appropriate entity (ie. funding agency) and the criteria for suspension or termination of the study.
  • Any quality control measures to ensure protocol adherence (e.g., audit, monitors site visit).
  • Procedures and plans for communications such as protocol modifications, monitoring reports and unanticipated problems between sites when research is part of a multicenter study in which UTA is the coordinating institution or a UTA investigator is the lead investigator.  (Each participating site that is engaged in the research must have an OHRP approved Federalwide Assurance (FWA) prior to participation.
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When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. [§46.111(a)(7)]:

The IRB reviews, if applicable:

    • The methods used to identify and contact potential participants.
    • The settings in which an individual will interact with the investigator.
    • The appropriateness of all personnel present for research activities.
    • The methods used to obtain information about participants.
    • The nature of the requested information.
    • Information that is obtained about individuals other than the “target participants,” and whether such individuals meet the regulatory definition of “human participant” (e.g., a subject provides information about a family member for a survey).
    • Privacy guidelines developed by relevant professional associations and scholarly disciplines (e.g., oral history, anthropology, psychology).
    • How to access the minimum amount of information necessary to complete the study.
    • The long-range plan for protecting the confidentiality of research data, including a schedule for destruction of identifiers associated with the data.
    • The consent form and other information presented to potential research participants adequately and clearly describe confidentiality risks.
  • The informed consent process and the informed consent document clearly delineates who will have access to the subject’s information and under what circumstances data may be shared (i.e., government agencies, sponsors).
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When appropriate, additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence. *1 [§46.111(a)(7)(b)]: 

When some or all of the subjects, such as children, prisoners, decisionally impaired persons, persons who use English as a second language (ESL) or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence or for subjects found at international sites, the UTA IRB shall consider whether additional safeguards have been included in the study, to protect the rights and welfare of these subjects.

Additional review by other committees may be required for review of proposed social, behavioral, or educational research (SBER).

  • Institutional Biosafety Committee (IBC)
  • Institutional Animal Care and Use Committee (IACUC)
  • Committee on Research Integrity (CRI)
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Advertisements and Recruitment Incentives:

The IRB reviews the recruitment procedures according to DHHS and, if applicable, FDA recommendations found in the FDA Information Sheets. 

Payment and/or cost to Research Subjects:  
At a minimum, the IRB considers the following for appropriateness when applicable

  • Proposed payment(s) to research subjects as outlined in the informed consent document and the research description of the protocol application.
  • How the payment(s) will be prorated to compensate the subjects for time and participation, or if the subject withdraws before completion of the study. 
  • Costs for transportation, care, drugs, devices, or any research procedures that the subject will be responsible for as a consequence of participating in the research.
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Approval from external institutions:

The UTA IRB ensures that written approval is obtained from an authorized official of any entity or institution external to the University from where subjects may be recruited or research procedures conducted.  If the entity or institution is engaged in the research, an OHRP approved Federalwide Assurance (FWA) will be required prior to their participation.  To decide whether the institution is engaged in research, refer to the OHRP Guidance on, “Engagement of Institutions in Research.

Have Questions?

Robin Dickey

For questions regarding IRB
policies or protocol submissions
and departmental/classroom
IRB training opportunities
please contact Robin Dickey at
817-272-9329 or robind@uta.edu

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