[updated 22 February 2017]
Who We Are
Every institution that is engaged in research involving human subjects that is supported by the federal government or falls under federal policy must establish a committee for the protection of human subjects to review and approve all research or use another approved IRB for this review. Cal Poly Pomona has chosen to establish its own Institutional Review Board (IRB), and has obtained a Federalwide Assurance from the federal Office of Human Research Protections (OHRP) authorizing itself. Under the terms of our agreement, all research involving human subjects (including samples, data sets, etc.) performed by Cal Poly Pomona faculty, staff or students, or performed on this campus, must be reviewed by the IRB for the applicability of federal policy. Almost all federal agencies have adopted the Department of Health and Human Services regulations concerning human subjects research (the Food and Drug Administration has made slight changes due to its pharmaceutical company applicants), hence the term "Common Rule" is used when federal policy (Title 45 Code of Federal Regulations part 46 (PDF)) is cited.
The IRB functions because of the three groups of persons involved: 1) the volunteers also known as subjects or participants, 2) the researchers aka principal investigators (PI), and 3) the members of the IRB committee. Click at the upper right to view the current list of members. View this document of "position descriptions" for the responsibilities of the members and of PIs.
Why We Exist
While the atrocities committed by the Nazis under the guise of medical research during (and before) World War II are well known, and often taught in high schools and colleges, less well studied are the medical research scandals that have been discovered in the United States over the past 50 years. These include the Jewish Chronic Hospital Disease case, in which live cancer cells were injected into elderly patients without informed consent; the Tuskegee Syphilis Study, where the United States Public Health Service conducted a natural history study of syphilis in the "Negro male" for 40 years, specifically withholding knowledge of and treatment for the disease from the participants; and the Willowbrook Institution case, in which mentally retarded children were injected with hepatitis virus without their parent's or guardian's consent. That these were not isolated incidents at that time (the 1960s and 1970s) can be seen in an article from the New England Journal of Medicine (NEJM, 274(24):1354-1360).
The evidence that unethical medical research was being performed in the United States led to the creation by the Federal Government of a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which produced a report on the “Ethical Principles and Guidelines for the Protection of Human Subjects in Research" (the "Belmont Report" http://ohsr.od.nih.gov/guidelines/belmont.html). This report forms the basis for current Federal Policy for the protection of human subjects in research.
This timeline is succinct in giving an overview of the History of Human Subjects Protection (PDF) in the United States (credit is given to the State of Washington from one of its publications). And here is an article about bioethics (DOC).
What We Do
All institutions at which research involving human subjects is conducted are required by law to have an institutional review board (IRB) to oversee those projects when the research is supported by a federal agency. It is Cal Poly Pomona’s policy that a review of compliance with ethical guidelines be completed on all research involving human subjects conducted at Cal Poly Pomona. Similarly, reviews must be done of all off-campus research on human subjects carried out by Cal Poly Pomona faculty, staff, and students when they are conducting the research as an aspect of their roles as faculty, staff, or students of the University. The Committee is not responsible for reviewing research on human subjects that is conducted by a University employee or student as a function of their independent consulting work or their work with another institution.The expertise of the IRB membership is reflective of the type of applications submitted to the IRB. The IRB meets about once each month during the fall, winter, and spring quarters, and as needed during the summer quarter.
How We Do It
Not all human subject research falls under Federal Policy, and there may be differences in the types of review required based on the potential risk to the subjects. However, only an IRB can determine if a given research project falls under Federal Policy, or which aspects of the policy apply. Under Federal Policy, an authorized IRB can decide on policy that is more restrictive than Federal Policy, though never more lenient.
The policies of Cal Poly’s IRB are fully described in the PDF "Policies and Procedures of the Institutional Review Board (IRB) (aka Policies and Procedures for Human Research Protection)" as first published on September 11, 2007. It is updated periodically with a date notation in applicable sections. See the tab "Policy & Procedures". Hard copies are available upon request from the Office of Research Compliance.
In some studies, medical records are part of the data collected. The regulations of the Health Insurance Portability and Accountability Act may then apply for privacy protections of the subjects. This is a list of the identifiers (DOC) which must be evaluated in HIPAA-type research.
The following chart explains how protocols are reviewed once they have been submitted by investigators: