UTA's Criteria for Approval
Guidance to Criteria for Institutional Review Board (IRB) Criteria
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)]::
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 consent 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:
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:
For studies which require limited IRB review under Revised Common Rule exemption categories 7 & 8, the IRB does not need to make the above determinations; instead, the IRB must make the following determinations: [§46.111(a)(8)]:
(i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
(ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with §46.117; and
(iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
When appropriate, additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence. [§46.111(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)
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:
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.”
Since there are many considerations for collaborative research studies, for additional information please visit the UTA web page for Collaborative Research.