IRB’s Criteria for approval

All researchers who intend to submit protocol(s) seeking approval to enroll human subjects must meet approval criteria before the research can be initiated.  The criteria are based on federal regulations (45 CFR 46; 21 CFR 50 and 56) 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.

Note that for studies that are not federally funded or supported nor FDA regulated, IRB Staff is designated with the responsibility and authority to review and approve such research, with consultation from the IRB when deemed necessary. The following criteria for IRB approval will be used as a guideline by IRB Staff in these cases.

1. Identification and Minimization of Risks

The protocol application must identify the risks associated with participating in the research and differentiate them from the risks that the subjects would encounter if they were not in the study.  The risks may include physical, psychological, emotional, economical/financial risks, and those related to a loss of privacy or a breach of confidentiality. 

The study design and study procedures delineated in the protocol application will be evaluated to determine whether risks have been minimized to the fullest extent possible that will still permit the ethical conduct of the study and that study objectives can be met. Whenever possible, procedures should be utilized that would otherwise be performed on subjects if they were not enrolled in the study (e.g., in cases of biomedical research, using diagnostics or treatments that would already be conducted in the course of standard medical practice).

2. Benefits and the Risk/Benefit Ratio

The protocol application must describe the probable benefits to be derived from the research and whether the risks are reasonable in relation to the anticipated benefits. The IRB should not consider the possible long-term effects of potential knowledge that may be gained from the study when considering whether to approve the study (e.g., the possible effects of the research on public policy).

3. Equitable (Fair) Selection of Subjects

The protocol must describe plans for the equitable (fair) selection of subjects. The IRB will review the purpose of the study, the setting in which the research will be conducted and inclusion and exclusion criteria for selection of subjects.  The IRB will also consider the settings and/or communities from which subjects will be recruited and review the recruitment plan, recruitment materials, and even the informed consent document(s) from this perspective.

4. Informed Consent

The IRB must ensure that protocols have plans to obtain legally-effective informed consent from potential participants or the subjects’ Legally Authorized Representative (LAR), unless informed consent is specifically waived by the IRB. Informed consent documents must provide the elements of informed consent required by federal regulations, including an accurate and fair description of the risks and/or discomforts associated with study participation and procedures.

To minimize the possibility of undue influence or 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. 

5. Documentation of Informed Consent

The IRB must ensure that the informed consent process is documented appropriately by a signed, written (hard-copy) consent form to ensure legally-effective consent, unless this requirement is specifically waived by the IRB.  The IRB template informed consent document (ICD) provided to investigators on the Forms page is designed to ensure that documentation of informed consent includes federally mandated basic and additional elements of informed consent.

6. Monitoring of Collected Data

Where appropriate, The IRB must determine that adequate provisions are in place for monitoring the collected data to ensure the safety and well-being of subjects. 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.

7. Privacy and Confidentiality

The IRB must determine the adequacy of the provisions to protect subject privacy and maintain data confidentiality, as outlined in the protocol application.  If a breach of confidentiality would present additional risk to the subjects, a data protection plan may be required for review by the IRB.

8. Special Considerations for Projects Including Vulnerable Study Populations

The IRB considers certain groups of human participants to be particularly vulnerable in a research setting or susceptible to coercion or undue influence.  The IRB considers additional protections for research activities involving:

• pregnant women
• human fetuses and neonates
• prisoners
• children
• cognitively impaired persons

In reviewing these research projects, the IRB ascertains that the inclusion of the vulnerable population is adequately justified and that safeguards are implemented to minimize risks unique to each population. Addition safeguards should be implemented in the recruitment and informed consent processes when enrolling these vulnerable populations and therefore should be outlined in the protocol application.

Exempt Research

For certain types of research, federal regulations allow for research activities to be “Exempt” from federal requirements and the approval criteria above, however, this determination must be made by the UTA IRB. Although exempt from the federal requirements, Exempt research is still human subjects research and must be conducted in accordance with the approved protocol, ethical principles found in the Belmont report, the UTA IRB SOPs, and applicable institutional policies.