FAQs

FAQs

FAQs

IRB Frequently Asked Questions (FAQs) are provided here organized by general topic.  Click on a Topic at right to view the FAQs in that category.  To view the Answer portion of the FAQ, simply click on the question, and the answer will slide into view. 
 
  • 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.

    • 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 "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 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.

       

       
  • 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
  • Copies
  • 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"
  • Exemption
  • 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 Grants and Contracts (OGCA) Tracking # 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.

    • What is an IDE?

      ​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 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 The Office of the IRB or call 205-934-3789, or 855-860-3789 

    • 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 The Office of the IRB 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 The Office of the IRB 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 The Office of the IRB.

       

    • 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 The Office of the IRB 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: irb@uab.edu; Fax: 934-1301).

    • Do I have to have a BlazerID to do IRB training?

      The courses in the UAB Learning Management System (Healthstream) require a BlazerID. You can register for the CITI and NIH training courses without one. However, please use your BlazerID for your CITI email address and CITI username to help the OIRB identify you and assign your training credit properly.

      About Receiving E-Mail From the IRB

      If you are a UAB student or employee, the OIRB will always use your BlazerID as your e-mail address (i.e., YOURBlazerID@uab.edu).

      If you are not affiliated with UAB, the OIRB prefers to have an email address associated with your research work (e.g., @childresnal.org).

      Each student and employee configures his or her BlazerID alias to receive e-mail. To ensure yours is set up properly, follow these simple steps:

      Go to https://padlock.dpo.uab.edu/cgi-bin/bp/chginfo.cgi

      Sign in with your BlazerID and strong password

      Enter your "real, host-based e-mail address" (e.g., drjones@ccc.uab.edu, joesmith@yahoo.com) where indicated.

      If you do not know your host-based address, contact your IT specialist.

      Scroll down and click "Change!"

      Why is it important that I receive e-mail from the OIRB?

      You could miss vital information about your research.

      If you are not able to receive e-mail through your BlazerID alias, you will not receive courtesy reminders about continuing review of protocols, IRB training news, and other issues related to UAB's Human Research Protection Program.

      You can avoid having to update your address.

      If you change positions within the university, you can change your BlazerID alias to point to your new email account.

      Account? Alias? I'm confused!

      An e-mail "account" is attached to an e-mail host server, with storage space for incoming and outgoing email and other features. Examples at UAB include _____@path.uab.edu, _____@mail.ad.uab.edu, ______@peds.uab.edu, and many others.

      An e-mail "alias" is a shortcut to an e-mail account. At UAB, your BlazerID can be used as an alias with the format of YOURBlazerID@uab.edu. That alias automatically forwards e-mail messages to the account you have configured. For example, messages sent to the alias irb@uab.edu are forwarded to the account at irb@mail.ad.uab.edu.

       

    • Does a person have to be a UAB employee or student to do IRB training?

      Usually yes, but not always

      People who are employees of an institution that has its own IRB should not complete training for the UAB IRB. Instead, their work on the research should be reviewed by their "IRB of record." These individuals should be named, and their work described, in the Human Subjects Protocol form, but they should not be listed as protocol staff members.

      People who are not affiliated with an institution that has an IRB may need to complete training for the UAB IRB. However, before they do, the UAB IRB may need to document its role as the IRB of record for that work.

      Please contact the Office of the IRB at 934-3789 or irb@uab.edu for guidance if you aren't sure.

      About Receiving E-Mail From the IRB

      If you a UAB student or employee, the OIRB will always use your BlazerID as your e-mail address (i.e., YOURBlazerID@uab.edu).

      If you are not affiliated with UAB, the OIRB prefers to have an email address associated with your research work (e.g., @chsys.org).

      Each student and employee configures his or her BlazerID alias to receive e-mail. To ensure yours is set up properly, follow these simple steps:

      Go to https://padlock.dpo.uab.edu/cgi-bin/bp/chginfo.cgi

      Sign in with your BlazerID and strong password

      Enter your "real, host-based e-mail address" (e.g., drjones@ccc.uab.edu, joesmith@yahoo.com) where indicated.

      If you do not know your host-based address, contact your IT specialist.

      Scroll down and click "Change!"

      Why is it important that I receive e-mail from the OIRB?

      You could miss vital information about your research.

      If you are not able to receive e-mail through your BlazerID alias, you will not receive courtesy reminders about continuing review of protocols, IRB training news, and other issues related to UAB's Human Research Protection Program.

      You can avoid having to update your address.

      If you change positions within the university, you can change your BlazerID alias to point to your new email account.

      Account? Alias? I'm confused!

      An e-mail "account" is attached to an e-mail host server, with storage space for incoming and outgoing email and other features. Examples at UAB include _____@path.uab.edu, _____@mail.ad.uab.edu, ______@peds.uab.edu, and many others.

      An e-mail "alias" is a shortcut to an e-mail account. At UAB, your BlazerID can be used as an alias with the format of YOURBlazerID@uab.edu. That alias automatically forwards e-mail messages to the account you have configured. For example, messages sent to the alias irb@uab.edu are forwarded to the account at irb@mail.ad.uab.edu.

       
    • 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

    • How do I complete (or update) IRB training?

      ​That depends on whether we have a record of your initial training.

      Initial IRB training credit is required before credit can be granted for continuing IRB training.

      If you completed training in human subjects protection at another university, or you completed approved training that isn't reflected in the IRB records, please contact the OIRB at 205-934-3789 or irb@uab.edu so that we can update our record of your training.

      Initial and Continuing IRB training are described on our training page at www.uab.edu/irb/training.

      Go to IRB Training Records in IRAP

    • 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.

    • My name isn't listed in RA Workspace, so how can I check my training?

      ​If your name isn't listed, that usually means one of two things: either we don't have any IRB training on record for you, or we have your training listed under another "version" of your name. Try typing in only your last name, a previous name (e.g., a maiden name), or type in alternative spellings (e.g., without punctuation).

      If the tips above don't turn up your name, send an e-mail to irb@uab.edu and describe your request.

      Go to UAB IRB Training Records 

       
    • What are my username and password for the online course?

      ​We don't know, but we may be able to help you find out:

      What course are you trying to take?

      CITI: The CITI courses are not tied to BlazerIDs, so you have to register and choose a username and password. If you registered previously but don't remember your username or password, you can contact the OIRB at 934-3789 and a staff member will assist you.

      NIH: The NIH courses are not tied to BlazerIDs, so you have to register and choose a username and password. If you registered previously but don't remember your username or password, simply register again, as described in the course description.

      Investigator 101: This course is tied to your BlazerID, but you still must register, as described in the course description for the initial or continuing training version.

    • 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.
       

       

       

       

    • When do I have to update my IRB training?

      IRB training should be updated once in each two-year training period. The training periods are 2009-2010, 2011-2012, 2013-2014, and so on.

      Initial and continuing IRB training are "good" until December 31 of the next two-year training period. Continuing training does not have to be completed in the same two-year period in which you completed your first initial training on record with UAB.

      Examples:

      • Your first initial training on record with UAB was completed in 2011 or later. Your training is up to date until December 31, 2014. Before that date, you will need to complete the 2013-2014 course (which was not available as of today, February 21, 2013).
      • You have initial training on record with UAB in 2010 or earlier. You need to take the Financial Conflict of Interest in Research course before becoming involved in human subjects research. Registration is described in detail at www.uab.edu/irb/training/continuing.

      NOTE: Courses offered through CITI and NIH are not valid for continuing training—they are valid only for initial training.

    • 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 www.uab.edu/irb/training/initial.

      For continuing IRB training, you need to complete the UAB course currently described at www.uab.edu/irb/training/continuing.  

       
    • 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" (i.e., engaged in the design, conduct, analysis, or reporting of research) on the IRB protocol or funding application; 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

      • work at another institution that has an IRB Authorization Agreement whereby the UAB IRB is the "IRB of record"; or
      • work at another institution and hold 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 annually. 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.