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Applications and Checklist
Application for Request for Documentation Regarding Use of Established Human Cell Lines Not Requiring IRB Review (FOR239)Used to request documentation from the IRB (or designated reviewer) of whether an activity using established human cell line(s) does/did not require IRB review. Version: April 5, 2011
Expedited Category Review Sheet (FOR231)
Used to indicate the applicable federal category when a protocol is submitted for expedited review. Version: January 14, 2019Public Dataset Nomination Form (FOR240)
Used to nominate a public dataset, the use of which does not constitute research with human subjects (as described at https://www.uab.edu/research/home/irb-guidance-faqs). Version: November 5, 2012 -
Consent, Assent, HIPAA Authorizations, and Waivers
Sample Information Sheet (Consent) for Exempt Research
Used as a guide for obtaining consent from participants in exempt research projects. Version: September 16, 2019
Authorization to Use/Disclosure of Health Information for Research (FOR209) (English)
If applicable, include as a stand-alone document. Version: January 15, 2019Authorization to Use/Disclosure of Health Information for Research (FOR209) (Spanish)
If applicable, include as a stand-alone document. Version: April 21, 2025Boilerplate Consent Form Language (English)
Standard language used in all consent forms. Version: February 20, 2017 (updated version coming soon)Boilerplate Consent Form Language (Spanish)
Standard language used in all consent forms. Version: February 20, 2017 (updated version coming soon)Certification of Spanish Translation
Certification of Spanish Translation from Apex TranslationsSamples of the Concise Summary to be used at the beginning of the consent form. Version: January 15, 2019Used as a guide for obtaining assent from participants 7-13 years of age. Version: February 25, 2013Sample Consent Form with HIPAA Authorization (FOR206)
Used as a guide for obtaining consent from participants 14 years of age and older. Version: June 21, 2023.Sample Consent Form without HIPAA Authorization (FOR206)
Used as a guide for obtaining consent from participants 14 years of age and older. Version: August 27, 2019Sample 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 -
Departmental Forms
Clinical Vaccine Trials Protocol Oversight Review Form (FOR201)Used to document departmenal review of clinical vaccine trials, also to document exemption from NIH Guidelines for Human Gene Transfer Experiments. Version: April 9, 2009
Health Information Management Research Guidelines (FOR219)
Used to request medical charts for research-review purposes. Version: March 3, 2015Release of Drugs for Human Research Use - Children's of Alabama (FOR218)
Used to describe Children's of Alabama Pharmacy handling of drugs used or studied in human subjects. Version: February 10, 2015Release of Drugs for Human Research Use - UAB Pharmacy (FOR217)
Used to describe UAB Pharmacy handling of drugs used or studied in human subjects. Version: October 29, 2010Release of Pathologic Materials - Clinical (FOR216)
Used to document approval from the Division of Laboratory Medicine (e.g., Clinical Pathology). Version: October 10, 2007Release of Pathologic Materials (FOR215)
Used to document of approval from Anatomic Pathology. Version: January 17, 2023Report of the Project Review (FOR214)
One of the IRB-approved forms used to document departmental review for scientific and scholarly merit; required for gene therapy and some other projects. Version: September 22, 2011Sample Protocol Oversight Review Form (FOR205)
One of the IRB-approved forms used to document departmental review of protocols for scientific and scholarly merit. Version: July 24, 2007- FDA, Drugs, Device Studies
Investigational Agent Accountability Record (FOR236)Used by sponsor-investigators in FDA-regulated research to track investigational drugs. Version: October 4, 2007Investigational Device Accountability Record (FOR238)
Used to track investigational devices when there is no sponsor-provided form. Version: October 4, 2007Summary of Overall Drug Accountability (FOR237)
Used to track overall accountability for investigational agents when the investigator is the sponsor. Version: October 4, 2007- Outside IRBs
- Reportable Events, Unanticipated Problems
Problem Report (FOR226)Used to notify the IRB of events that meet the criteria—listed on the form—for a "reportable problem." Version: July 24, 2007Problem Summary Sheet (FOR234)Used at continuing review to notify IRB of events that do not meet the criteria for a "reportable problem." Version: April 18, 2007- QI Self Determination Tool
A self-declaration tool developed for certain projects categorized as quality improvement. While not all cases of quality improvement studies will be able to use this tool, several projects will benefit from the ability to self-determine that a project does not require IRB review. This tool provides documentation that may be used to support requirements for journals at the time of publication.
QI Self Determination Tool - FDA, Drugs, Device Studies