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Student research projects that are conducted solely for in-class work are not required to have IRB review. However, if the results of a student research project that involves human subjects will be presented or otherwise disseminated to the public, then IRB review is required.

Many student projects meet the criteria for the Not Human Subjects Research (NHSR), Exempt, or Expedited review categories. See the HRPP Guidebook for Investigators for more information on IRB Review Types.
 
 
Virtual UAB HRPP Office Hours 
 
Students who are planning to submit an IRB application can visit the UAB Human Research Protection Virtual Office Hours to meet with an experienced member of the HRPP staff for a preliminary protocol review.
In advance of the office hours session, students should:
  • ​have completed most of the preliminary work in preparation for submission and
  • have specific questions regarding their application or need review of draft documents.

Office hours are offered bi-weekly on Thursdays between 11:00 AM - 12:30 PM. Students, researchers and research staff are able to drop in, at their convenience during the two-hour window, to have an HRPP staff member answer specific questions about human subjects research.
If Faculty Advisors are unable to answer specific questions, we encourage their participation in the Virtual Office Hours with the student. are intended to last approximately 15 minutes.

 

Prerequisites

To prepare for their appointment, students are asked to

To attend the next UAB HRPP Virtual Office Hours, visit the UAB Campus Calendar for the virtual meeting information. If you have any questions, contact the Office of the IRB at 205-934-3789 or This email address is being protected from spambots. You need JavaScript enabled to view it..

 

Consent

Describes required and as-applicable information that must be included in the informed consent process
 
FDA, Drugs, Device Studies

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

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

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 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)

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

The Human Research Protection Program (HRPP) offers researchers guidance documents to help them conduct human subjects research in compliance with regulatory and policy requirements. These documents are available online through the links at the left.

If you can't find the answer to your question, please feel free to contact the HRPP at (205) 934-3789, or send an email to This email address is being protected from spambots. You need JavaScript enabled to view it..

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