The University of Texas at Arlington

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. 

The UTA IRB initial review application is located in the Investigators Handbook.  The IRB forms are designed to address these criteria and thereby, assist the IRB in collecting enough information to make a determination of approval. 

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)]:: 

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)]: 

Documentation of informed consent is also important.  The SOP regarding Informed Consent includes guidance for reviewing the informed consent document as does the model consent form (CF) available on the UTA IRB website.  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. 

No informed consent, whether oral or written, may 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. 

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.

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).

See also “Privacy vs. Confidentiality, What’s the Difference?” and the “Certificate of Confidentiality Summary Sheet” documents for additional guidance. 
 
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. 

The UTA IRB requires that the Department Chairperson, Faculty Advisor or other appropriate immediate supervisor sign the protocol submission form (#1 or #1A): 

By signing the protocol submission, a Department Chairperson (or other representative as indicated above) signifies that the study has scientific validity, that the research staff is qualified to perform research activities and has completed HSP Training or some other equitable compliance education in the responsible conduct of human subject research, adequate facilities and resources are available, and the Department Chairperson or authorized designee will mentor the Investigator as needed. 

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)

Advertisements and Recruitment Incentives:

The IRB reviews the recruitment procedures according to DHHS and, if applicable, FDA recommendations found in the FDA Information Sheets.   Refer to the “Investigator’s Guide to Identification and Recruitment of Human Subjects for Research” document” located in the Investigators Toolbox. 

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.

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.”