The information in this section applies to all types of research reviewed by the UAB IRB and to all types of application for IRB review. Because this information is general in nature, it includes directions to several sources of further information. The specific requirements for each type of IRB application are described in separate sections of this guidebook.
Before Applying for IRB Review
Scientific, Scholarly Integrity (Protocol Oversight Review Form)
Conflict of Interest
Subcontracts
Material Transfer Agreements (MTAs)
Devices, Inventions and Patent Policy, and Protocol-Specific Approvals
Advertisements
Data Safety Monitoring Information
Women and Minorities
Pregnant Women, Fetuses, Neonates and Non-Viable Neonates
Prisoners
Children, Minors
Additional Regulatory Requirements
The documents linked below contain details on regulations specific to research under the following categories:
Funded by the Department of Defense (DOD) - GUI339
Funded by the Department of Energy (DOE) - GUI338
Funded by the Department of Justice (DOJ)/National Institute of Justice (NIJ) - GUI341
Conducted within the Bureau of Prisons (BOP) - GUI341
Generating clinical trial data that is intended to be submitted to regulatory authorities – ICH-GCP (E6) applies - GUI 344 UAB Investigator ICH-GCP Checklist
No work may begin until formal IRB approval has been issued by the OIRB.
IRB Review—Outcomes and Approval Details
Outcomes of IRB Review
Approval Period
Approval of Informed Consent Documents
Consent forms used with participants must bear the IRB approval stamp.
No Modifications Without Prior IRB Approval
Notify OIRB of all Reportable Problems
Provide OIRB with Copies of All Monitoring Reports
Participant Withdrawal from Research—Guidance for Investigators
RadioisotopesRecombinant DNA Molecules
Ionizing Electromagnetic Radiation
NIH GuidelinesVaccine Trials Project Review Panel
Exemption from NIH Guidelines
Institutional Biosafety Committee Approval
Members of the UAB Vaccine Trials Project Review Panel
The Comprehensive Cancer Center Protocol Review Committee (PRC)
The Center for Clinical and Translational Science (CCTS)
Jefferson County Department of Health (JCDH)
Release of Pathologic MaterialsUAB Department of Pathology: AnatomicalResearch Involving Participants with Contagious Infections
UAB Department of Pathology: Clinical
Children's of AlabamaPolicies Concerning Drugs for Research Use
UA Hospital
Children's of AlabamaParticipants and Resources from Other Institutions, Facility Notifications
UAB Hospital
Birmingham Veterans Affairs Medical Center (BVAMC)
The terms in this section apply to all human research activities at UAB. Additional terms that apply to specific aspects of those activities are defined in the applicable sections (e.g., Compliance & Monitoring).
Agent— Person authorized to act on behalf of UAB. This includes an individual performing UAB designated activities or exercising UAB-delegated authority or responsibility.
Clinical Investigation— See definition for "Research (as defined by FDA regulations)."
Code of Federal Regulations (CFR)— A codification of federal agency regulations which has the force and effect of law.
Coded private information or biological specimens— For related definitions, please see http://www.hhs.gov/ohrp/policy/cdebiol.html
Federal Guidance— Information published by federal agencies on the topic that represents the agency’s current thinking or view but does not have the effect or force of law.
Federalwide Assurance (FWA)— A document filed with the Office for Human Research Protections (OHRP) of the Department of Health and Human Services expressing an institution‘s commitment to comply with the department’s regulations for the protection of human subjects.
Human Subject (as defined by DHHS regulations)— A living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Human Subject (as defined by FDA regulations)— An individual who becomes a participant in research regulated by the Food and Drug Administration (FDA), either as a recipient of a test article or as a control. A subject may be either a healthy human or a patient. In the case of research involving medical devices, a human subject includes an individual on whose specimen a medical device is used.
Human Subjects Research— Any activity that is either (a) “research” as defined by DHHS regulations that involves “human subjects” as defined by DHHS regulations or (b) "research” as defined by FDA regulations that involves “human subjects” as defined by FDA regulations.
IRB— Institutional Review Board established in accord with and for the purposes expressed in federal regulations to protect the rights and welfare of human research subjects.
Research (as defined by DHHS regulations)— A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.
Research (as defined by FDA regulations) (synonymous with the term Clinical Investigation)— Any experiment that involves a test article and one or more human subjects that is subject to the IND or IDE regulations or that is not subject to the IND or IDE regulations but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
- An experiment subject to the IND regulations is defined as any use of a drug other than the use of a marketed drug in the course of medical practice.
- An experiment subject to the IDE regulations is defined as any evaluation of the safety or efficacy of a medical device.
UAB Facilities— Facilities owned and operated by UAB; does not include facilities leased by the Board of Trustees of the University of Alabama to private entities.
UAB Institutional Official— Individual authorized to act for UAB and, on its behalf, obligates UAB to the Terms of its Federalwide Assurance with the Department of Health and Human Services and OHRP.
UAB-Affiliated Entities— UAB Health System, University of Alabama Health Services Foundation, UAB Highlands, and Callahan Eye Foundation Hospital and Ophthalmology Services Foundation and their wholly or majority owned subsidiaries.
All protocols reviewed by the IRB are subject to regulatory monitoring by the IRB and OIRB personnel. Studies are selected at random as well as according to criteria listed in the UAB Policy and Procedure for Compliance Issues with Human Subjects Regulations or IRB Requirements or Determinations.
As detailed in the UAB Policy on the Protection of Human Subjects in Research, investigators and other study personnel involved in human subjects research are required to comply with all laws and regulations governing their research activities, as well as with requirements and determinations of the IRB. Study personnel includes the principal investigator and any staff members directly involved with participants or the informed consent process.
Specifically, study personnel are required to
- Notify the IRB when a protocol is changed to eliminate an apparent immediate hazard to one or more human subjects—as soon as possible and not later than 5 working days after the change.
- Notify the IRB of any information related to non-compliance with federal regulations, state laws, institutional policies, or IRB requirements and determinations—as soon as possible and not later than 10 working days from the date of learning the information.
- Respond in a timely manner to all IRB requests regarding compliance.
In cases where serious or continuing non-compliance has occurred, the IRB may exercise its authority to monitor, suspend, or terminate the research. (See Definitions, below.)
Monitoring IRB Protocols
After a protocol has been selected for monitoring and usually 2 to 4 days before the planned visit, the OIRB Regulatory Manager or designee contacts the investigator, and study coordinator if applicable, to schedule the monitoring appointment. A written follow-up message from the OIRB confirms the appointment and lists materials that should be available for the reviewer, as well as any issues that need to be specifically addressed.
The monitor inspects the general maintenance of study records, including the following specific documents as applicable:
- Original IRB Protocol approval
- Amendments
- Consent Forms
- IRB Continuing Review materials (this would include Final Report)
- Final Report
- Adverse Events or Unanticipated Problems
- Sponsor Correspondence
- Investigator Brochure
- FDA Form 1572, if applicable
- Participant Screening and Enrollment Logs
- Monitoring Report
Within 2 weeks of completing the monitoring visit, the OIRB Regulatory Compliance Manager completes the monitoring report and provides a copy to the IRB Chair and to the principal investigator. The OIRB puts a copy of the report in the protocol file and schedules the report for review by the convened IRB.
The convened IRB reviews all monitoring reports in accordance with its scheduled deadlines and meetings. After the review is completed, the OIRB sends the principal investigator a copy of the IRB's determinations and puts a copy in the protocol file.
Classifying, Correcting, and Reporting Non-compliance
The UAB IRB is responsible for determining whether alleged activities constitute non-compliance and, if so, whether the non-compliance is serious and/or continuing.
When the IRB determines non-compliance in the conduct of a protocol, it may request one or more corrective actions before considering the protocol for approval such as increasing its oversight through more frequent continuing reviews or completing additional human subjects training.
An allegation of non-compliance that is potentially serious or continuing will be referred to the Compliance Review Subcommittee of the IRB for further evaluation and fact finding. The subcommittee recommendation is forwarded to the IRB. Before making any determination of serious or continuing non-compliance, the IRB will review the subcommittee recommendation at a convened board meeting to which the investigator will have the opportunity to attend. When the IRB finds non-compliance that is determined to be serious or continuing, the IRB reports its findings to UAB's Institutional Official (IO). The IO then reports the finding to other appropriate institutional officials and external agencies including the sponsor (e.g., UAB personnel, OHRP, FDA) in accordance with UAB policy.
All such IRB determinations and requested corrective actions are communicated in writing to the principal investigator.
Definitions Related to Non-compliance
Allegation of non-compliance:- Falsifying IRB documents
- Conducting human subjects research without IRB approval
- Deviating from the IRB-approved protocol or consent process
- Modifying the protocol or consent process without prior IRB approval
- Failing to maintain regulatory documents
- Inadequately overseeing research
In 2000, the NIH enacted a policy (NOT-OD-00-039) requiring that study or "key" personnel involved in human subjects research complete education in the protection of those subjects. At UAB, study personnel are required to complete an approved “initial’ training option and to complete an approved "continuing" option once during every 3-year period.
The training requirement applies to all key personnel, including
- all investigators—principal, co-principal, or other investigators;
- all persons involved in the consent process—discussing participation or obtaining consent;
- all persons engaged in the design, conduct, analysis, or reporting of the research.
The IRB will not approve a protocol unless all study personnel have completed the required training. Although some human subjects research is exempt from IRB review, NIH requires investigators conducting such research to complete training in the protection of human subjects.
Training is available in languages other than English for non-UAB staff and community workers on protocols conducted outside the United States. Before using non-English training, investigators should contact the OIRB for guidance and then clearly describe the training plan in the HSP.
Initial IRB Training
The initial training requirement may be met in several ways. The most popular options are listed below:
- CITI Basic Course in Human Research Protections
- NIH Protecting Human Research Participants
- Investigator 101 WebCT Course
Instructions for course registration and IRB certification are posted on the Initial IRB Training web page.
New faculty members or researchers may begin or continue their research if they provide certification of completing (a) the CITI biomedical or behavioral course or (b) a training course intended to meet the federal IRB training requirements that is offered by another institution that holds a Federalwide Assurance (FWA). Persons submitting certification of a training course other than the CITI course should also submit a description of the course (e.g., syllabus, course objectives and outline). Depending on the date when the "transferred" training was completed, continuing IRB training may also be required.
Continuing IRB Training
Continuing IRB training is required once every 3 years. The Continuing IRB Training web page lists approved options. Individuals who plan to attend events not in that list but related to human subjects research may submit an agenda or synopsis of the event before attending so the IRB may determine if training credit can be given for that event.
Certification and Record-Keeping
Depending upon the event, the person completing the training may have to send the training completion certificate to the OIRB. Currently, the OIRB is automatically notified of courses completed through CITI or through UAB WebCT. All other online options require filing the verification, as described on the IRB Training web site.
Individuals are required to keep accurate and up-to-date records of their IRB training. The OIRB maintains records of individuals´ IRB training for protocols reviewed by the IRB. These records can be viewed online from any on-campus computer through the IRB e-reports system.
To certify IRB training to sponsors, investigators use the information in IRB e-reports to complete a form that is available from the Office of Sponsored Programs. That form and instructions can be found at the OSP Forms web page.
Please direct any questions about IRB training to the OIRB (934-3789,