Consent

Sample Consent Changes

Detailed description of sample consent form changes effective 5/29/2014.

Describes required and as-applicable information that must be included in the informed consent process
 
Consent, Assent, HIPAA Authorizations, and Waivers

Authorization to Use/Disclosure of Health Information for Research (FOR209)

If applicable, include as a stand-alone document. Version: January 15, 2019

Boilerplate 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)

Concise Summary Tables

Samples of the Concise Summary to be used at the beginning of the consent form. Version: January 15, 2019

Sample Assent Form (FOR207)

Used as a guide for obtaining assent from participants 7-13 years of age. Version: February 25, 2013

Sample Consent Form with HIPAA Authorization (FOR206)

Used as a guide for obtaining consent from participants 14 years of age and older. Version: August 27, 2019.

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, 2019

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
 
FDA, Drugs, Device Studies
 

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).
 
General

Definitions Comparison Chart.docx

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.

Draft Guidance for Expedited Status Update

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 Reports

Describes UAB IRB policy for review of case reports.

Key Personnel Flowchart

Key Personnel for IRB

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 https://www.uab.edu/research/home/irb-guidance-faqs). 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

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.
 
Outside IRBs

Institution Review Form

Used to apply to rely on an external IRB. Version: December 5, 2019
 
Policies and Procedures