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Institutional Review Board (IRB)
Give to UAB
2014 Deadline and Meeting Schedule
IRB Information and Current Roster
Assurance and IRB Registration
Past IRB Rosters
IRB Policies and Procedures
Initial IRB Training
Continuing IRB Training
ICH-GCP Training through CITI
Training Records in IRB e-reports
Fees Charged by UAB for Industry-Sponsored Protocols
WIRB Fee Schedule
IRB Policies and Procedures
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Sample Assent Form (FOR207)
Used as a guide for obtaining assent from participants 7-13 years of age. Version: February 25, 2013
Sample Consent Changes
Detailed description of sample consent form changes effective 5/29/2014.
Sample Consent Form (FOR206)
Used as a guide for obtaining consent from participants 14 years of age and older. Version: May 29, 2014
Sample Consent Form (Spanish) (FOR206)
Used as a guide for obtaining consent from Spanish-speaking participants 14 years of age and older. Version: August 8, 2011
Sample Short Form Written Consent Document (FOR223)
Used as an example when obtaining consent when the consent form is not translated into the participant's language. Version: November 9, 1995
Statement on Elements and Disclosures for Informed Consent Process (GUI304)
Describes required and as-applicable information that must be included in the informed consent process
FDA, Drugs, Device Studies
FDA Sponsor Requirements for Investigators Serving as Sponsors of Investigational Device or Test Article Studies (GUI306)
Requirements for a sponsor-investigator on a device study.
FDA Sponsor Requirements for Investigators Who are Serving as Sponsors of Investigational Drug or Biologic Studies (GUI307)
Requirements for a sponsor-investigator on an investigational drug or biologic study
Investigator Responsibilities for Drug Supplies (GUI336)
Highlights responsibilities of investigators who sign FDA Form 1572.
Investigator Responsibilities for Handling, Inventory, and Disposing of Devices (GUI337)
Highlights the responsibilities of investigators conducting FDA-regulated research involving devices.
Responsibilities of Investigators Under FDA Regulations (GUI331)
Outlines responsibilities for investigators conducting research that is subject to FDA regulations (e.g., drugs, devices, biologics).
IRB Guidebook for Investigators (GUI300)
Basic guidance for investigators working with human subjects.
DOE Guidance: Department of Energy (DOE) Requirements for DOE-Sponsored Protocols (GUI338)
Outlines regulations and directives that specifically address the protection of human subjects in DOE-sponsored research.
Family Educational Rights and Privacy Act (FERPA) and Pupil Rights Amendment (PPRA) Guidance (GUI345)
Outlines requirements for consideration when research will involve the use of educational records (FERPA) and/or programs receive funding from the U.S. Department of Education (PPRP).
Guidance on Additional Requirements for Protocols Conducted by UAB and Sponsored by a Department of Defense (DoD) Component (GUI339)
Outlines regulations and directives that specifically address the protection of human subjects in research sponsored by any component of the US Department of Defense (DoD).
Guidance on Additional Requirements for Protocols Conducted by UAB and Sponsored by the Department of Department of Justice (DOJ)/National Institute of Justice (NIJ) and Research Conducted with the Bureau of Prisons (BOP) (GUI341)
Outlines requirements for the conduct of research sponsored by DOJ, NIJ, or BOP.
Guide to Mandatory Reporting Laws Affecting Research Conducted in Alabama (GUI326)
A survey of relevant statues requiring disclosure to public health officials and/or other individuals under law.
IRB Guidance for Case Report
Describes UAB IRB policy for review of case reports.
Organizational Statement on Calculation of Approval Periods, With Examples (GUI327)
Defines "approval period" and describes how this period is determined.
Organizational Statement on the IRBs of Record for UAB (GUI305)
Describes existing arrangements for IRB review of human subjects research conducted by UAB investigators.
Public Dataset Nomination - Sample (FOR240-sample)
SAMPLE of form used to nominate a public dataset for use as not constituting research with human subjects (as described at http://www.uab.edu/research/administration/offices/IRB/FAQs/Pages/PublicDatasets.aspx). Version: November 5, 2012
Special Approval Requirements for Research Undergoing IRB Review (GUI303)
Outlines requirements for approval from other UAB areas (e.g., radiation safety, Clinical Research Unit).
Statement on Institutional Conflicts of Interest (SUP401)
Preliminary guidelines for UAB's management of institutional conflict of interest.
Summary of Reporting Requirements for Investigators to the IRB (GUI325)
Requirements for investigator reporting of events, issues, changes, etc.
UAB Investigator Checklist ICH-Good Clinical Practice (GCP) Guidance (GUI344)
Details additional investigator responsibilities that are required when the study is being conducted to comply with ICH-GCP guidance.
Which Review Is for Me?
Used as a guide in deciding whether to apply for Exempt, Expedited, or Convened IRB review.
HIPAA Handbook for Researchers at UAB (GUI302)
Outlines research requirements related to the Health Insurance Portability and Affordability Act (HIPAA)
Recruitment and HIPAA
Describes effects of HIPAA on use of PHI in seeking participants for studies.
Sample HIPAA Authorization (FOR209)
Used as a guide for obtaining HIPAA authorization. Usually included as the last page of the consent form, as shown in the sample consent form. Version: May 29, 2014
"Dear Sponsor" Letter for WIRB reviews
Describes UAB fees for protocols reviewed by WIRB.
Organizational Chart for the Office of the IRB
OIRB Organizational Chart effective 07/01/14
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Policies and Procedures
IRB Policies and Procedures
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