Yes. There's a good chance such research may qualify for "exempt" or "expedited" review, but only the IRB can make that decision. Detailed information about these categories of review can be found in the application forms for the Exemption Review and Expedited Review.

The Common Rule refers to regulations that govern human subjects of research and have been adopted by seventeen federal agencies. The Common Rule is delineated in Title 45 of the Code of Federal Regulations Part 46 Subpart A

45 CFR 46 Subpart A

IRB is an acronym for Institutional Review Board for Human Use. UAB has two IRBs. Together, they review all research conducted at UAB or by UAB faculty, staff and students research procedures that involves human subjects.

The IRB also has jurisdiction over research involving UAB data on human subjects. The IRB can approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.

The aim of the IRB review is to ensure that research involving human participants is conducted in an ethical manner. This includes ensuring that risks to participants are minimized, the selection of participants is equitable, and participants are informed fully of what their participation will entail and of the potential risks and benefits.

Researchers at UAB conduct many different kinds of studies that involve human subjects. Some are biomedical; that is, they involve tests of medical treatments, drugs, or medical devices. These studies are usually conducted at one of the hospitals or clinics associated with UAB. Others are social or behavioral, such as studies in education, health promotion, and psychology. These studies may be conducted in schools, hospitals, or a variety of other places. Because there are so many different studies at UAB, it's important for you, as a participant, to understand what to expect from any study you might enroll in.

Listing of UAB Research Projects (UAB Reporter)

The membership in the IRB is selected based on the requirements of the federal regulations. In general IRB members are people on the faculty or staff at UAB who have expertise in the areas of research that the IRB reviews. There are also members who are not employed by UAB who are members of the community. People on the UAB IRBs include physicians, scientists, nurses, bioethicists, lawyers, and members of the clergy. You can find a list of current IRB board members online.

IRB Members

Your application will be reviewed by one of the two IRBs at UAB. Each board consists of 15 members, and at least 8 of them must be present at the review for a vote to be taken. The members have various backgrounds and specialties. All are appointed to serve by the Institutional Official for UAB's Federalwide Assurance (FWA) and are reported to the U.S. Secretary of Health and Human Services.

In addition, at least one member is always a person not affiliated with UAB and able to review applications according to community, rather than academic, standards. If a study involves the use of prisoners as human subjects, a prisoners' advocate must sit on the board for review of that study's application to the IRB.

The University has negotiated a Federalwide Assurance (FWA) with the Federal Office for Human Research Protections (OHRP). Under this assurance—and under federal law—the University must reasonably ensure that human subjects are adequately protected in research conducted under its auspices. IRB review of all research involving human subjects is required for the university to uphold its assurance with the federal government.

UAB's Current Federal Assurance

Participants in some studies are compensated for their time or inconvenience. Such payment is not intended to encourage participation but rather to compensate for time spent doing activities related to the study, such as completing a series of exercises during a doctor visit, or inconvenience, such as being at a specific place at a specific time.

No, the IRB does not review for all UAB requirements. The IRB’s mission is to protect human subjects in research. As such, it is important for the IRB to remain focused on compliance with IRB requirements. While the IRB may point out other issues, the IRB can’t be expected to review for compliance with all UAB requirements.

For example, when reviewing recruitment materials, the IRB will focus on preventing undue influence on participants by balancing the ad’s emphasis on compensation. The IRB will not, however, review for compliance with UAB branding standards.

For questions regarding other institutional requirements, the investigator should contact the responsible UAB office.

For UAB branding standards, see https://www.uab.edu/brand/home/standards.

Faculty, staff, postdoctoral fellows, and students (undergraduate or graduate) must obtain IRB approval before involving humans (or data collected about or from humans) as subjects of research. If you are unsure whether your research needs approval, contact the IRB for clarification. If you are a student, your advisor may have obtained IRB approval for the study that you are conducting. If you think that this is the case, it is important to verify it before you start.

Principal investigators are responsible for the actions of the people that they engage to perform studies. If a member of a research team fails to follow the approved protocol, fails to maintain required documentation, engages in activities that violate federal regulations, or put subjects at risk, the principal investigator and the research team member may be subject to disciplinary action up to and including suspension.

More information on possible consequences of noncompliance can be found under Compliance Oversight" at the web site of the Office for Human Research Protections. The UAB Human Subjects Advisory Committee (HSAC) determines corrective actions.

Parents are legally authorized representatives for their children. If someone other than the parents asserts that he or she is the legally authorized representative, you should obtain a copy of the court documents naming the individual as guardian or conservator.

The Common Rule defines minimum risk—for non-prisoners—as risk in which "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (45 CFR 46.102).

For prisoners, minimal risk is defined as risk in which "the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons" (45 CFR 46.303).

Phase 1 trials include the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers; sometimes, where the drug is intended for use in patients with a particular disease, however, such patients may participate as subjects. Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness; they are typically closely monitored. The ultimate goal of Phase 1 trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies. Other examples of Phase 1 studies include studies of drug metabolism, structure-activity relationships, and mechanisms of actions in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. The total number of participants involved in Phase 1 investigations is generally in the range of 20-80.

PHASE 2 DRUG TRIAL Phase 2 trials include controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well-controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred participants.

PHASE 3 DRUG TRIAL Phase 3 trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide an adequate basis for physician labeling. In Phase 3 studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to the FDA for approval to market the drug. Phase 3 trials usually involve several hundred to several thousand patient-subjects.

PHASE 4 DRUG TRIAL Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time [21 CFR §312.85].

The definition of a "human subject" is contained in POL001: UAB Policy on the Protection of Human Subjects in Research.

OHRP Human Subject Regulations Decision Charts. Charts from the Office for Human Research Protections to determine whether research uses "human subjects"

All research involving human subjects must be submitted to the IRB. Only the IRB Office can grant exemption.

The term expedited review refers to the categories of research that may be reviewed through an expedited review procedure as outlined in the IRB's Policy and Procedure Manual. It does not refer to the length of time required for the review process.

Expedited review is applicable for research activities which involve no more than minimal risk to the human participants and which can be placed in one or more of the nine (9) categories. Categories one (1) through seven (7) pertain to both initial and continuing review. The definition of minimal risk for the purpose of IRB application is defined as the amount of risk encountered in daily life.

IDE refers to investigational device exemption. A device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

IND refers to Investigational New Drug. Investigation New Drug Applications are submitted to the FDA prior to the product’s approval and marketing for that indication.

Yes, the Code of Federal Regulations requires “prompt reporting to the IRB of changes in the research activity.” The completion of the study is a change in activity and should be reported to the IRB. A final report to the IRB allows it to close its files as well.