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
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.
Several factors must be considered when deciding whether to file for Exempt Review, Expedited Review, or Full Review. The IRB has built a flowchart to help new researchers and staff—who may be unfamiliar with the IRB or with UAB—navigate the options.
Flowchart for Types of IRB Review
The IRB reviews proposals for research and assigns them into one of four categories.
Two of the categories require at least annual renewal of IRB approval:
However, at its initial review, the IRB may assign one of two categories that do not require further review:
Full Review is required for protocols involving investigational drugs or devices and where certain vulnerable subject populations will be participating. Full review is also required if the protocol involves more than minimal risk to particicpants. See Section 11 of the IRB Guidebook and the Application for Full Review for complete information.
See Section 10 of the IRB Guidebook and the Application for Expedited Review for complete information.
Expedited review is applicable for research activities which (a) involve no more than minimal risk to the human participants and which (b) can be placed in one or more of the nine (9) categories listed on the application form. The first seven (7) categories are for new applications; the last two apply only to renewals.
See Section 9 of the IRB Guidebook and the Exemption Review Application for complete descriptions of the following 6 categories that may be eleigible for exemption from further IRB review.
The IRB may assign a proposal to this category if it includes the use of only
See Section 8 of the IRB Guidebook for more information on the No Humans Designation. Contact the IRB before submitting any No Humans proposal that does not clearly meet the three requirements listed above.
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.
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 IRB coordinates its review with several other offices and must be able to link the research protocol with the funded project, where applicable. Therefore, the title of the research protocol submitted to the IRB must either (1) match the title of the funded project or (2) contain the title of the funded project in parentheses that follow the protocol title.
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.