University of New Mexico Health Sciences Center
Welcome to the Human Research Review Committee (HRRC), the Institutional Review Board (IRB) for the University of New Mexico Health Sciences Center (UNMHSC). HRRCs are established under federal law to ensure the rights, welfare, and protection of all human subjects. Research involving human subjects to be conducted at or sponsored by the UNMHSC, or that is conducted by or under the direction of a faculty, staff, or student of the UNMHSC, or which uses any confidential information of patients at the UNMHSC, cannot commence until it has been reviewed and approved by an HRRC. In addition to reviewing all biomedical and behavioral research at the UNMHSC, the HRRCs will review biomedical research proposals, or other research proposals requiring access to the UNMHSC patient population submitted by main campus faculty, staff, and students as well. The HRRCs at UNMHSC are overseen and operated by the School of Medicine.
The UNMHSC has four HRRCs. Each HRRC meets one time a month, so that there are four meetings a month at which UNMHSC research protocols may be reviewed. Once a project is assigned to one of the HRRCs, all subsequent matters related to the initial approval of that project will be reviewed by that HRRC. At each of their meetings, the HRRCs review new projects, conduct continuing review, and any problems or difficulties encountered in studies under their auspices.
This Manual is intended to serve as a guide for investigators and their staff who conduct human subject research. While the Manual provides a general overview of the HRRC process and the main regulatory requirements designed to protect human subjects of research, the field of human subject research is continually evolving. Therefore, investigators should ensure that they and their staff understand the information contained in this manual and follow any mandatory requirements, obtain additional information on any regulatory requirements or expectations relevant to their specific research, and contact the HRRC Support Office with any questions. As a policy evolves, and rules change, the manual will be updated. Please make sure you have the latest information by checking the HRRC Website.
The HRRCs oversee "human subject research" and "clinical investigations" at the UNMHSC.
“Human subject research” means a research activity that involves one or more human subjects as defined below:
“Clinical Investigation” means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be submitted to, or held for inspection by the FDA as part of an application for research or marketing permit. 21 CFR 56.102(c)
In their review of human subject research, the HRRCs have jurisdiction over all aspects of research involving human subjects, including:
These activities cannot be carried out without prior HRRC review and written approval.
The basic ethical principles on which the federal regulations for the protection of human subjects are founded are set forth in The Belmont Report. This Report was submitted on September 30, 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was established in 1974 under the National Research Act. The Commission was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. The Report sets forth three principles that are basic to the protection of human subjects: Respect for persons, Beneficence, and Justice.
Respect for Persons: Respect for persons involves the recognition of the personal autonomy and dignity of individuals, and the need for special protection of individuals with diminished autonomy. Under this principle, individuals must be given sufficient information to decide whether to participate in a study, they must be able to comprehend the information, and their consent must be voluntarily given, free from coercion and undue influence. IRBs are expected to be particularly sensitive to these factors when vulnerable subjects are involved, to ensure that extra measures are taken to protect the immature and incapacitated, and may even require that they be excluded from participating in certain research. Respect for persons also means honoring the subjects’ privacy and confidentiality.
Beneficence: This principle entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. This principle requires assessing the nature and scope of the risks and benefits, and systematically assessing the risks and benefits. All possible harms must be considered not only physical and psychological injury. All possible benefits, including societal benefits that might be gained from research, must also be considered. Benefits to the subjects, or generalizable knowledge to be gained from the research, should always outweigh the risks. In assessing the risks and benefits, the appropriateness of involving vulnerable populations is considered.
Justice: The principle of justice requires that the benefits and burdens of research be distributed fairly. Subjects must be fairly selected, and may not be selected either because they are favored by a researcher or held in disdain. Social justice requires an order of preference in the selection of classes of subjects, for example, adults before children. The principle cautions that researchers should not systematically select subjects because of their easy availability, their compromised position, or their social, racial, sexual, or economic position, or because of cultural biases institutionalized in society. Investigators should base inclusion criteria on those factors that most appropriately address the research problem.
FederalWide Assurance. Federal government agencies, such as the United States Department of Health and Human Services (HHS), require institutions and persons who apply for federal funding to conduct human subject research to sign an assurance that they will comply with federal human subject research regulations and requirements. A "Federal Wide Assurance" (FWA), which is approved by the Office for Human Research Protections (OHRP) at the Department of Health and Human Services (HHS), allows an institution to conduct federally funded research without obtaining a single project assurance for each separate project. The UNMHSC has an FWA, which sets forth a number of conditions with which it, the HRRCs, and UNMHSC investigators are required to comply. In this assurance, the UNMHSC has agreed that it will apply these standards to all human subject research, whether or not it is federally funded. Therefore, all UNMHSC research falls under the requirements of our FWA. The Albuquerque VA Medical Center and its research organization--the Biomedical Research Institute of New Mexico—also have signed FWAs..
Federal Regulations. Various federal regulations also contain requirements for the review and conduct of human subject research. Those regulations include 45 C.F.R. Part 46, entitled "Protection of Human Research Subjects" (HHS regulation), 21 C.F.R. Part 50, entitled "Protection of Human Subjects" (FDA regulation), and 21 C.F.R. Part 56, entitled "Institutional Review Boards" (FDA regulation). Other applicable FDA regulations, which the HRRC and the investigator must follow, depending on the study, include 21 C.F.R. Part 312, "Investigational Drugs" and 21 C.F.R. Part 812, "Investigational Devices." In addition, the NIH and FDA disseminates guidelines for the conduct of certain types of research from time to time.
Under federal regulations and the UNMHSC FWA, the UNMHSC must establish IRB(s) that meet certain requirements and follow specific criteria for reviewing and approving human subject research. These IRBs--the HRRCs--are required under the law to review all human subject research before it may begin, and may approve only that research that meets the established regulatory and ethical criteria. In conducting their reviews and providing feedback to investigators on required changes, etc., the HRRCs serve to educate UNMHSC investigators on important human subject research issues.