Standard Operating Procedures of the Institutional Review Board

I. Overview of the Institutional Review Board

A. The Mission of the Institutional Review Board


The University of North Florida Institutional Review Board (IRB) has the responsibility for protecting the rights and welfare of human participants in all studies and research carried out by University faculty, staff, and students or studies conducted under the auspices of UNF. To achieve this, all studies involving human research participants must be conducted in accordance with the Federalwide Assurance (FWA). This legally binding document with the federal government “assures” that all of the institutions under the FWA are guided by the Department of Health and Humans Services (HHS) regulations for the protection of human participants, 45 CFR Part 46 (the Common Rule), and are guided by the ethical principles set forth in the Belmont Report, regardless of whether the research is publicly or privately sponsored. In addition to the Public Health Service Regulations 45 CFR 46, the UNF IRB is also guided by regulations of the Family Education Rights and Privacy Act (FERPA), the Health Insurance Portability and Accountability Act (HIPAA), the International Conference of Harmonization (ICH), Good Clinical Practice (GCP), and other applicable laws and regulations.

The Belmont Report was completed on April 18, 1979, and the drafters of the document included consideration of rules like the Nuremberg Code in the identification of the broad ethical principles under which human subject research is conducted. The three principles of the Belmont Report, which help guide human subject research at UNF:

  • Respect for persons;
  • Beneficence; and
  • Justice.

The principle of respect for persons means that each individual should be treated as autonomous, capable of making decisions about themselves and their personal goals. Potential research participants should be given sufficient time and information upon which to base their decisions about participation. Research should be explained so that it is comprehensible to potential participants. Participants should be volunteers who participate without being subject to coercion or undue influence. Beneficence means that researchers should maximize the benefits of participating in research studies and minimize the possible risks.  Research should be well-designed so that the results are warranted and credible. The principle of justice revolves around the question of who ought to receive benefits of research and who ought to bear the burden of possible risks. Vulnerable populations or populations of convenience must not be exploited or coerced into participating.

 

These three principles of the Belmont Report are implemented through the processes of informed consent, risk/benefit assessment, and fair subject selection.

 

The Belmont Report and the Code of Federal Regulations regarding human subjects research (45 CFR 46) may be found on the web page of the HHS Office for Human Research Protections (OHRP). Information about the Federalwide Assurance is also posted on the OHRP web site.



B. Role of the IRB in Ethical Review


The purpose of the University of North Florida IRB is to protect the rights and welfare of human research participants and to ensure that research involving human participants is conducted in compliance with applicable federal and state regulations. To achieve this purpose, the IRB must advise investigators in designing research projects that minimize potential harm to participants, review all research involving human participants prior to initiation of the work, approve research that meets established criteria for protection of human participants, and monitor approved research to ensure that the welfare of human participants is appropriately safeguarded.

 

Guided by the principles set forth in the Belmont Report, OHRP rules and regulations, and ICH, the IRB assures that all of the following stipulations are met:

  • Risks to subjects are minimized.
  • Risks to subjects are reasonable in relation to the anticipated benefits.
  • Selection of subjects is equitable.
  • Documented, informed consent is obtained from each prospective subject or the subject’s legal guardian or healthcare decision-maker.
  • Informed consent will be sought from each prospective subject or the subject’s legally authorized representative to the extent required by 45 CFR 46.116.
  • Informed consent is appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
  • When appropriate, provisions are made for the protection of the privacy of subjects and confidentiality of data is maintained.
  • Provisions are made for monitoring the data collected to ensure the safety of subjects.
  • Safeguards are included to protect members of vulnerable population groups (45 CFR 46.111).

The IRB consists of scientists, non-scientists, and at least one member unaffiliated with UNF who come from varying backgrounds to promote complete and adequate review of research activities commonly conducted at UNF. The IRB membership includes professional persons knowledgeable in the areas of institutional commitments, law, welfare of vulnerable participants, and standards of professional conduct and practice. The required diversity of members includes adequate representation from scientific disciplines, non-scientific disciplines, the appropriate minority and gender groups, the academic units of the institution, and the local community though the inclusion of at least one member from outside of the institution. When possible, the IRB will include at least one member from each of the academic colleges within the university. The representative from an academic college should be a tenured faculty member.

 

No member participating in initial or continuing review may have a conflict of interest in the proposed research.  The IRB is responsible for assuring that it has the required competence to review protocols, and may add expertise as required.

 

In exercising its responsibility to ensure that human participants are protected in research conducted by institutional faculty, staff, and students or otherwise under the auspices of the institution, the IRB shall have the responsibility and authority to:

  • Review all planned research that involves human participants, including the determination that planned research is exempt from further IRB review (45 CFR 46.101).
  • Review and have the authority to approve, require modifications in, or disapprove research activities involving human participants.
  • Oversee all research involving human participants that is not exempt from IRB review including the authority to observe or have third parties observe the consent process and the conduct of research.
  • Suspend or terminate approval of research that is not conducted as approved or that has been associated with serious unexpected harm to participants. An IRB decision to disapprove, suspend, or terminate a project may not be reversed by any officer or agency of the University of North Florida. However, University officials may, in certain cases, decide that a research study approved by the IRB may not be conducted.

Report to the institutional official unanticipated problems involving risks to participants and others and serious or continuing noncompliance by investigators.



C. Federalwide Assurance System


Under the FWA system, each IRB must register with Office for Human Research Protection (OHRP) within the U. S. Department of Health and Human Services (DHHS). Each legally separate entity engaged in human subject research must apply for its own FWA. Under federal policy, awardees and their collaborating institutions become engaged in human research whenever their employees or agents intervene or interact with living individuals for research purposes. Although each legally separate institution or entity must file its own Assurance, the institutions are free to designate IRBs under the Assurance that are operated by other institutions or entities.

 

The FWA requires the development and adoption of policies and procedures for conducting human subject research and the appointment of an institutional official to oversee the University’s compliance with federal regulations pertinent to human participants in research. The institutional official at the University of North Florida, as designated by the Vice President for Academic Affairs of the University, is the Associate Vice President for Research.