Frequently Asked Questions

  • About the IRB

    • 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.

    • 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

    • 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 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.

  • Advertisements

    • Do audio, video, print ads have to be approved by the IRB?

      Yes, Ads used to recruit participants into the research study are considered extensions of the consent process and therefore, need to be reviewed and approved by the IRB prior to use.

    • When the IRB reviews a study, do they review for compliance with other (non-IRB) UAB requirements?

      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.

  • Approvals

    • When does the "renewal clock" start ticking on my approval?

      When a protocol is subject to full review, the IRB approval begins on the date of the convened Board meeting at which the protocol was reviewed. If, at that meeting, the Board requires modifications before it will issue approval, the renewal period still begins on the date of the convened meeting.

      For example, Dr. Smith submits a protocol for full review at the December 12, 2001 IRB meeting. In that meeting, the Board approves the protocol provided that certain language is added to the consent form. Dr. Smith receives this notification on December 15, 2001, but does not submit a revised consent form until February 3, 2002. The renewal date for approval of the protocol is still December 12, 2002 because that date is one year after the Board issued its approval of the protocol.

      On the other hand, the Board may defer approval and send the application back to the researcher for resubmission. If this occurs, then the renewal period would begin on the date of the convened meeting at which the Board actually approved the protocol, with or without required modifications.

    • Who must obtain advance approval if humans are proposed as subjects of research?

      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.

  • Compliance

  • Consent

  • Datasets

  • Definitions

    • For purposes of human subjects protection, how is research defined?

      Research is defined by the regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." If you are conducting a study that you expect to publish or report in a public forum, you should consider it research and subject to IRB jurisdiction if it involves human subjects. If you are collecting data only for internal use, for example to improve customer service in your department, you are not doing research.

    • How do we assure someone is the participant’s “legally authorized representative?"

      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.

    • What does minimal risk mean?

      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).

    • What is a "phase" in a clinical trial, and which one am I in?

      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].

    • What is a human subject?

      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"

  • ePortfolio

  • Exemption

    • Can a PI, department head, or faculty mentor approve an exemption?

      No. Only the IRB can determine exemption status.

    • If my project appears to meet the requirements for an "exemption," does that mean I don't have to do anything else?

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

    • How do I know if my chart review can be classified as exempt or expedited?
      Most research involving a research question to be addressed via chart review is likely reviewable under Exempt Category 4 and should be submitted using the IRB Exemption Review Application, not the Human Subjects Protocol (HSP). These projects were previously submitted as Expedited Category 5; however, with the Revised Common Rule, this type of research is generally covered under this expanded exemption definition.
    • Can research utilizing biospecimens be conducted under Exempt Category 4?
      The use of biospecimens in Exempt 4 is limited to identifiable specimens that are publically available. Otherwise the use of biospecimens would either fall under Not Human Subjects Research (e.g., completely stripped of all identifiers prior to receipt) or Expedited (Category 5).
    • Can data registries or biorepositories be established under Exempt Category 4?
      Data Registries and Specimen Repositories (those that are created to do multiple future research projects) should be submitted for Expedited review using the HSP.
    • What types of surveys, interviews, and/or focus groups are considered exempt research?
      • Most research involving ONLY a simple survey of opinion or an interview or focus group is likely reviewable under Exempt Category 2 and should be submitted to the IRB using the Exemption Review Application, not the HSP. 
      • With the Revised Common Rule, research involving surveys, interviews, or focus groups ONLY, even if identifiable and/or sensitive, likely qualify for Exempt review as long as the privacy and confidentiality measures are adequate and thoroughly described.
      • Research under Exempt Category 2 cannot involve the following:
        • any sort of intervention
        • cannot be linked to other data sets (e.g., survey of patients linked to patient medical records)
        • minors 
      • Research under Exempt Category 2 can involve patient populations (although you may have to obtain HIPAA Authorization or request a Waiver of HIPAA Authorization)
      • Surveys involving minors, surveys surrounding an intervention (think pre/post surveys), or surveys that are extremely sensitive and identifiable and need more scrutiny may need to be submitted for Expedited review using the HSP.

  • Expedited

    • Besides the application form, what else do I need to include with my application for Expedited Review?

      Along with the Application for Expedited Review, include (as applicable)

      • If a questionnaire, survey or test is to be used, attach one copy to the application.
      • If external funding has been sought, a copy of the funding application and the Office of Sponsored Programs (OSP) Assigned Number must accompany the submission.
      • If the Investigator will be obtaining pathological or diagnostic specimens, a release form or letter is required from the Chairman of the Department responsible for providing the specimens. The specimen release form or letter of approval should be attached to the IRB exemption application form.
      • Students, Fellows and Residents must include their Faculty Advisor/Course Instructor's name, phone # and e-mail address as the contact and the advisor or instructor must sign the application, too.

    • Why does an expedited review take as long as a full review?

      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.

  • FDA (Drugs, Devices)

    • Must I submit an investigator’s brochure to the IRB when the IRB is reviewing an investigational drug study?

      ​Yes. For studies conducted under an IND the FDA requires that an investigator’s brochure be submitted. Although not mentioned specifically in 21 CFR part 56, much of the information contained in the IB is clearly required to be reviewed by the IRB such as assuring the risks to the participants are reasonable in relation to the anticipated benefits which cannot be adequately evaluated without the review of the IRB.

    • Who must obtain advance approval if humans are proposed as subjects of research?

      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."

    • What is an IND?

      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.

  • Participants

    • 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)
    • 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.

    • What are the risks of participating in a study?

      The risks of participating in a study always depend on the nature of the study itself. The IRB helps to ensure that risks are minimized in all studies, but it is very important that participants understand the risks and benefits associated with participating in any study. Both the risks and the benefits should be explained to you through the Informed Consent process before you begin to participate in the study. If you have a question about risks associated with a particular study, ask someone conducting the study or contact the Office of the IRB.

      Send e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it.or call 205-934-3789, or 855-860-3789

    • Whom can I ask a question about the study?

      You can ask anyone conducting the study a question at any time. If you signed an Informed Consent document, then it may include more specific information about whom to contact with questions about the study.

      If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact the Office of the IRB (OIRB) at 205-934-3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m to 5:00 p.m. CT, Monday through Friday. You may also call this number in the event the research staff cannot be reached or you wish to talk to someone else.

      You may also send and e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it.

    • What if I don't want to enroll in the study?

      If you don't want to participate in a particular study, then don't. Regardless of why you might choose to not participate, it is against federal guidelines and University policy to offer preferential treatment to people who participate in studies or to discriminate against people who do not. If you feel that you are being pressured to participate in a study, please contact the UAB Office of the IRB (OIRB).

      In some cases, students must participate in a certain number of research studies as part of their coursework. You should always have an alternative to participation. In these cases, students who have a question about their participation should contact the course instructor or department chair.

      Send e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it. or call 205-934-3789, or 855-860-3789

    • What if I want or need to stop participating?

      If you have enrolled in a study and want or need to stop participating for any reason, you are free to do so. However, you should always notify the researchers if you decide to do so. If you are receiving a treatment as part of the study, it may be important to your safety. You can withdraw by telling the contact person on the Informed Consent document (if applicable). If you do not know the name of the contact person, you can contact the UAB Office of the IRB (OIRB) for information on how to withdraw from a particular study.

      Send e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it. or call 205-934-3789, or 855-860-3789

    • Will it cost me any money to participate in a trial?

      In some studies, you may be responsible for the cost of drugs or devices used. The cost may be reimbursable from your insurance company, or it may not. Whether or not there are financial costs to you or your insurance agency should be explained to you during the informed consent process. If you have questions, ask the contact person for the study or contact the UAB Office of the IRB (OIRB). Send e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it. or call 205-934-3789, or 855-860-3789

  • Reporting

    • Do I need to report to the IRB when a study has been completed?

      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.

  • Training

    • Do I get CME or Nursing Contact Hours for IRB training?
      In general, no. However, with prior approval from the IRB, some events that offer such credits may also serve for IRB training at UAB. Send a program schedule to the OIRB before attending the event, and the staff will evaluate the event for possible IRB training credit (Email: This email address is being protected from spambots. You need JavaScript enabled to view it.; Fax: 934-1301).
    • Does training for OH&S, Effort Reporting, or HIPAA count as IRB training?
      OH&S and Effort Reporting, no. HIPAA, rarely. Only the events and courses listed on the IRB Training page are approved for IRB training
    • I can't find my old IRB training certificate. Can I get another copy?
      The Office of the IRB no longer issues certificates for training. You can document your IRB training through the IRB e-reports system.
    • I completed initial IRB training, but it lapsed, so what should I do?
      Unless the IRB has specifically directed you to redo the initial training, complete one of the options for continuing training.
    • I completed training, so why haven't I received my certificate from the IRB?
      The Office of the IRB no longer issues certificates for training. You can document your IRB training through the IRB e-reports system.
    • What other training is required?
      Some IRB protocols require completion of ICH-GCP training. This can be done through CITI, as described on our training page. For information on other types of training (e.g., Effort Reporting, HIPAA) Log into BlazerNET Choose the Research tab Scroll down to Compliance Courses.
    • Which IRB training course should I take?
      Each option listed for Initial IRB Training will satisfy the initial UAB IRB requirement for training. Click the course names for more details at https://www.uab.edu/research/home/initial-irb-training.

      For continuing IRB training, you need to complete the UAB course currently described at https://www.uab.edu/research/home/continuing-irb-training.
    • Who should complete UAB IRB training?
      You need UAB IRB training if you are an employee or student at UAB or TCHA and you
      • are listed as an Investigator or "key personnel" (see Key Personnel Flowchart for guidance); or
      • screen potential participants and/or obtain informed consent; or
      • have IRB-related responsibilities.
      You need UAB IRB training if you are not affiliated with UAB or TCHA and you
      • Have an Individual Investigator Agreement whereby the UAB IRB is your "IRB of record."
      You do not need UAB IRB training if you
      • are not affiliated with UAB or TCHA in any way (e.g., student, employee, consultant); and
      • work at another institution that has its own IRB.
      In these cases, you should have your research work reviewed by your IRB.
    • Why is IRB training required?
      The NIH requires training in the protection of human research participants for all investigators receiving awards for research involving human subjects (NIH Notice).

      As part of its Federalwide Assurance, UAB has extended the training requirement to all research that involves human subjects, regardless of the funding source for the research.

      All individuals involved in research on human subjects must complete an initial, approved training course on human subjects protection and must update their training once in every 3 year period. This requirement applies to Principal Investigators, key personnel, and any study personnel. Key personnel are those engaged in the design, conduct, analysis, or reporting of research. The IRB will not approve any protocol unless all listed Principal Investigators have completed or updated their training, as applicable.