IRB Policies and Procedures

Section 1: Introduction

1.0 Background

Federal regulation of human subjects research began in 1971. With the background of the Nuremberg Code, shown in Appendix A, in 1974 the National Research Act created the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. This law required every institution applying for federal funds for the conduct of human research to establish an Institutional Review Board (IRB) to protect the rights of the human subjects involved in biomedical and behavioral research.

After meetings at the Smithsonian Institution’s Belmont Conference Center in 1976 and extensive deliberations over the next three years, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued a 1979 statement, “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” (The Belmont Report, Appendix B), laying out basic ethical principles to assist individuals in resolving ethical issues in the conduct of research with human subjects. In 1981, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) set forth the regulatory standards for the protection of human subjects and for the operation of Institutional Review Boards. In 1983, the U.S. Department of Health and Human Services (DHHS) issued new regulations and mandated special protection for vulnerable populations such as prisoners and children. In 1989, the National Institutes of Health became the coordinator of all the human subjects protection activity of the federal government through what is now known as the Office for Human Research Protections (OHRP). In 1991, OHRP issued regulations to protect human subjects in research (Title 45 of the Code of Federal Regulations, Part 46, Appendix C). It is these regulations, also known as 45 CFR 46 or the Common Rule, that govern human research activity at Texas Tech University.

To certify that Texas Tech complies with these federal regulations, the university has filed a Federalwide Assurance (FWA 00001568; expires 11-09-2015). The assurance commits the university, the Institutional Review Board, and research investigators to the ethical principles of The Belmont Report and an institutional policy of compliance with the regulations. Importantly, as part of its assurance, Texas Tech is committed to reviewing all research involving human subjects regardless of sponsorship.

1.1 Institutional Review Board

1.1.1 Administration of Research Ethics at Texas Tech University

The Vice President for Research is responsible for the application of policies and procedures governing the use of human subjects in research. The HRPP Manager (742-2064) is responsible for coordinating IRB activities. The HRPP office maintains all IRB records including meeting agendas and minutes, policies, regulations, forms, reference materials, and protocols. Active IRB-approved individual protocol files are maintained for the life of the project. When notification is received that a project has been completed, the files are archived for three years and then destroyed.

1.1.2 Composition of the Institutional Review Board

The Protection of Human Subjects Committee (O.P. 74.09) serves as the IRB for Texas Tech University. It operates under the DHHS regulations for the protection of human research subjects (45 CFR 46), the university’s Federalwide Assurance (FWA), and is guided by the ethical principles regarding human subjects research as set forth in The Belmont Report. Within the scope of these documents, the IRB is charged with applying both the letter and the spirit of regulations designed to protect the rights and welfare of human subjects.

The IRB members represent diverse backgrounds in order to provide the professional competency necessary to review research and to provide an understanding of the ethical, legal, and community contexts in which research takes place. The Vice President for Research is responsible for the appointment of members for the IRB. Members are selected on the basis of their experience and expertise and their sensitivity to issues such as community attitudes. One member is appointed specifically to represent the interests of prisoners. Two members who are not affiliated with the university represent the larger community. Two additional members are from the faculty of the Texas Tech University School of Medicine. The rest of the IRB consists of Texas Tech University faculty members who represent expertise in a wide variety of areas of human research. The ex-officio members include the Associate Vice President for Research, a representative from Environmental Health and Safety, a representative from the Information Technology Division, and a representative from the Office of Research Services. There are also alternate members who may replace a regular voting member unable to attend a meeting. Members and alternates are appointed for staggered three-year terms and may be reappointed so that the Board maintains a large number of experienced members. The IRB can and does enlist the help of outside experts whenever review of a proposal requires specialized knowledge concerning research procedures or populations. These outside experts do not have voting privileges.

The Institutional Review Board for the Protection of Human Subjects Committee meets monthly on the last Tuesday of each month at 3:00 p.m.