What is the "Common Rule?"

What is the "Common Rule?"

Institutional Review Board (IRB) FAQs What is the "Common Rule?"

What is the "Common Rule?"

​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

Related FAQs
  • About the IRB: How often does the IRB meet?

    ​At UAB, one of the two IRBs meets each week.
  • Do I need IRB approval to interview people or observe their behavior?

    ​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.

  • How do I determine which review process is right for a project?

    ​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

     
  • How will the IRB review my research?

    ​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:

    • Full Review
    • Expedited Review

    However, at its initial review, the IRB may assign one of two categories that do not require further review:

    • Exemption from Review
    • No Humans Designation.

    Full 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.

    Expedited Review

    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.

    • Certain types of clinical studies on medical drugs and devices... [see application].
    • Collection of certain amounts of blood when the collection meets specified criteria... [see application].
    • Prospective collection of biological specimens for research purposes by noninvasive means such as hair and nail clippings, permanent teeth if routine patient care indicates a need for extraction, or cells collected on swabs or mouth washings... [see application].
    • Collection of data through noninvasive, nonradiological procedures (not involving general anesthesia or sedation) that are routinely employed in clinical practice. One example is a test given to assess one's ability to walk... [see application].
    • Research involving materials that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)... [see application].
    • Collection of data from voice, video, digital, or image recordings made for research purposes... [see application].
    • Research on the characteristics or behavior of an individual or group (such as research on perception, cognition, or motivation) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies... [see application].

    Exemption from Review

    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.

    • Research conducted in established or commonly accepted educational settings, involving normal educational practices … [see application].
    • Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior, unless (i) human subjects can be identified and (ii) any disclosure of the responses could place subjects at risk… [see application].
    • Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under category (2), if
      the human subjects are public officials or candidates for public office; or
      federal statute(s) require(s) without exception the maintenance of confidentiality… [see application].
    • Research involving the collection or study of pre-existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the Investigator in such a manner that subjects cannot be identified… [see application].
    • Research and demonstration projects that (a) are conducted by or must be approved by department or agency heads, and that (b) examine public benefit or service programs… [see application].
    • Taste and food quality evaluation and consumer acceptance studies, if
      wholesome foods without additives are consumed or foods are consumed that contain levels judged safe… [see application].

    No Humans Designation

    The IRB may assign a proposal to this category if it includes the use of only

    • Cadaveric materials
    • Outdated blood products (from the Red Cross or other blood banks)
    • Commercially available cell lines provided by nonfederal funding (Use Exemption Application if requesting funding from a federal agency to purchase cell lines.)

    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.

  • What is the IRB?

    ​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.

     
  • What kinds of studies are common at UAB?

    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)

     

  • Who makes up the IRB?

     

    ​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

     

  • Who will review my research?

    ​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.

  • Why does the title of my protocol have to match the title of the funding application?

    ​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. 

    1. The research protocol and funded project can share the same exact title, as in “A Study to Determine the Safety of Drug A.”           
    2. The title of the research protocol can be followed by the title of the funded project in parentheses, as in “A Study to Determine the Safety of Drug A (UAB Drug Program for Hypertension).” This is usually the case, for example, in program project grants when many protocols are covered by one funded project.  In most cases, each funded award involving human subjects must have its own IRB approval. 
     
  • Why is my research subject to review by 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 
  • Will I be paid to participate?

    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.

     

     
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