About the IRB

Modern research compliance regulations were created in response to historical instances of ethical misconduct in human experimentation. Events such as the biomedical experiments performed during World War II, the Willowbrook hepatitis studies, and the Tuskegee Syphilis Study resulted in profound harm to human participants and eroded public trust in scientific endeavors. 

These injustices highlight the imperative need for independent oversight, leading to international codes of ethics, federal legislation, and the establishment of IRBs to ensure that research participants are treated with dignity, respect, and adequate protections. 

These events resulted in the publication of ethical research foundations such as:

• The Nuremberg Code
• The Declaration of Helsinki

In 1974, the National Research Act was passed in the United States which brought about the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979,  this commission published The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research. The Belmont Report serves as the foundational cornerstone for human subject protection regulations in the United States and outlines three primary ethical principles: 

• Respect for Persons: Acknowledges the personal autonomy and dignity of individuals. This principle requires that participation in research be entirely voluntary and supported by a robust informed consent process. It also mandates additional protections for individuals with diminished autonomy.
• Beneficence: The concept that researchers should do no harm as well as maximize possible benefits and minimize possible harms.
• Justice: The fair distribution of the risks and benefits of research. Selection of research participants must be equitable, ensuring that no one group or vulnerable population bears an undue burden of research participation while others receive the benefits.

This document summarizes key points and principles set forth in each of these foundational documents.

IRB authority and oversight are governed primarily by the U.S. Department of Health and Human Services (DHHS) regulations under 45 CFR 46 (commonly known as the Common Rule), alongside Food and Drug Administration (FDA) regulations under 21 CFR 50 and 56 for studies involving investigational drugs, biologics, or medical devices.

Under these regulatory frameworks, the IRB has the authority to:

• Approve, require modifications in, or disapprove all human subjects research activities.
• Conduct ongoing oversight and periodic continuing reviews of active studies.
• Suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to subjects.

Institutional Review Boards review and approve projects that meet the federal definition of Human Subjects Research, which can be broken down into multiple parts:

• A human subject is a living individual about whom an investigator (whether professional or student) conducting research:Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyses the information or biospecimens; or
  Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
• Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • A systematic investigation is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
    Examples of systematic investigations include surveys/questionnaires, interviews and focus groups, analyses of existing data or biological specimens, epidemiological studies, cognitive and perceptual experiments, medical chart review studies, etc.
  • Generalizable knowledge is information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
    • Results that are applicable to a larger population beyond the site of data collection or the specific subjects studies
    • Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study
    • Note that publication or other dissemination of findings alone does not in and of itself make the activity “research."

Examples of activities that are not generalizable include:

• Classroom exercises that solely fulfill a course requirement (please see Classroom Assignments below for more information)
• Service or course evaluations
• Services, courses, or concepts where it is not the intention to share results beyond the USA community
• Quality assurance activities designed to continuously improve the quality or performance of a department or program

If your study/project meets all of the above definitions, it requires review and approval through the USA IRB.

While it’s important to understand what types of studies require IRB review, it’s equally important to understand what types of studies do not. You can find a list of examples of projects that do and do not require IRB review here.

If it is questioned whether your study/project requires IRB review or approval, please contact the IRB Administrator at irb@southalabama.edu or 251-460-6308.

Quality Improvement (QI) and Evidence Based Practice (EBP) projects always involve human subjects, but only require IRB submission if they meet the definition of research as defined above. 

Characteristics and definitions of Research, Quality Improvement, and Program Evaluation Activities are outlined here to help make the determination for how to categorize your project. 

Characteristics of Evidence Based Practice (EBP), Quality Improvement (QI), and Research Projects are outlined here for further guidance.

Per the U.S. Department of Health & Human Services (HHS), the “intent to publish is an insufficient criterion for determining whether a QI [Quality Improvement] activity involves research.”

If your project does not meet the federal definition of human subjects research yet you wish to publish your findings, the USA IRB office is able to generate an IRB Determination Letter. This is a formal letter stating your project has been evaluated by the USA IRB and no IRB approval is required. A Determination Letter serves in place of an Approval letter for publishing purposes to alleviate the administrative burden of reviewing and approving non-HSR studies unnecessarily. 

To request an IRB Determination Letter, please reach out to the USA IRB Administrator at irb@southalabama.edu or 251-460-6308.

While classroom research assignments generally do not contribute to generalizable knowledge and, thus, are not considered human subjects research, there are certain parameters for when IRB review and approval of these assignments are necessary. Please see USA IRB guidance.

If it is determined a classroom research assignment does not require IRB review, there are still ethical considerations while interacting with human participants. The USA IRB has created a Student Class Project Consent Letter template that should be utilized for this purpose.

Pilot activities that involve recruiting individuals and collecting information from them—regardless of whether the data will be published, analyzed, or retained—are considered human subjects research when conducted to develop or refine a study intended for future research dissemination.

In such cases, IRB approval or an official IRB determination is required prior to initiating any pilot activities.

IRB review is required when pilot testing involves having individuals complete the same or substantially similar procedures planned for the IRB reviewed study. Pilot sessions meeting these criteria may not be conducted without prior IRB approval.

Pilot activities may fall outside IRB oversight only when they are strictly limited to internal development or operational purposes, such as:

• Research assistant training
• Testing equipment, software, or room setup
• Activities that do not involve recruiting participants
• Activities that do not involve collecting participant responses or data

Once individuals are engaged as participants and asked to complete study tasks, IRB review is required, regardless of whether the data are retained, analyzed, or used in the final study.

The USA IRB considers a case report to be a retrospective analysis of three (3) or fewer clinical cases describing a clinical presentation, treatment, or outcome. Because activities involving data from three or fewer patients do not meet the federal definition of "research" (a systematic investigation designed to develop generalizable knowledge), they carry automatic "Not Human Subjects Research" (NHSR) status. Investigators preparing case reports or reviewing medical records for three or fewer patients do not need to contact or submit an application to the IRB. When publishing, authors are responsible for verifying whether the targeted journal requires a formal "IRB Exemption / Non-Human Subjects Research" determination letter; this can be provided by the USA IRB upon request.

Projects involving four (4) or more patients constitute human subjects research and require formal IRB review and approval prior to initiating data collection or record reviews.

Although IRB review is not required for case reports involving three or fewer patients, HIPAA Privacy Rule requirements strictly apply if Protected Health Information (PHI) or unique identifying characteristics are involved:

• De-identified Reports: Specific patient authorization is not required if the report contains none of the 18 HIPAA identifiers and no unique patient characteristics.
• Internal Presentations: Presenting cases containing PHI within USA or affiliated institutions for local educational programs is considered part of standard healthcare operations and does not require patient authorization.
• External Presentations & Publications: Presenting a case containing PHI outside of USA/affiliated institutions or submitting it for publication is not part of standard healthcare operations. These activities strictly require explicit written authorization from the patient or their Legally Authorized Representative (LAR) prior to presentation or submission. Note: External presentations and publications containing PHI do not qualify for a HIPAA waiver.
  
  

Additional guidance on writing case reports, including guidelines and a checklist used by many medical journals can be found on the CARE (CAse REport) website.

All Doctor of Nursing Program (DNP) students are required to complete a quality improvement (QI) project during the course of the DNP program. While QI projects do not meet the federal definition of human subjects research, the USA IRB and the DNP Program has partnered over many years to establish an educational pathway for DNP students to exercise creating and submitting their projects within IRBNet.

IRB submissions from College of Nursing DNP students must be reviewed and approved by the assigned DNP Faculty Advisor.

• Students should reference this Checklist of Instructions for DNP submissions when submitting a project.
• For instructions on how to navigate IRBNet, please reference the IRBNet Basics section of our website.
• For in-depth guidance on how to complete IRBNet Part A, please reference these DNP Application Part A Instructions.
• A letter of support is required from your proposed DNP project site. A template is available if needed.

For additional guidance, please contact your faculty advisor.

Overview & Regulatory Framework

When University of South Alabama Investigators participate in collaborative or multi-site research, federal regulations allow institutions to enter into joint review arrangements or rely on an external IRB to avoid duplication of effort (45 CFR 46.114).

When a non-USA entity serves as the reviewing authority, it is designated as the IRB of Record and assumes primary IRB oversight responsibilities for the study. It is vital that research teams know who the IRB of Record is for their studies, as IRBs may have differing policies and reporting procedures.

The USA IRB conducts an administrative (ceded) review to authorize the use of an external IRB, ensuring that local context, state laws, study team qualifications, and institutional policies are properly addressed.

At this time, the USA IRB will not serve as the IRB of Record for research conducted at external sites.

External IRB Models & Supported Platforms

• National Cancer Institute IRB (NCI CIRB): Required for USA Investigators participating in NCI-sponsored cooperative group clinical trials. The Cancer Trials Support Unit (CTSU) website lists CIRB approved trials.
  Step-by-step guidance on NCI CIRB Submissions
  USA CIRB Policy and Procedures
• WCG IRB: WCG IRB is an independent, commercial IRB that USA investigators may utilize for specified studies when conducting multi-site research facilitated by an outside sponsor. 
  Step-by-step guidance on WCG Submissions
  USA WCG Policy and Procedures
• Single IRB (sIRB) / Other Institutional IRBs: USA Investigators may rely on an outside Institution's IRB or another commercial IRB when conducting multi-site research. 

Reliance Agreements

Before non-Exempt research using an external IRB can begin, the USA IRB must establish a formal Reliance Agreement (or Authorization Agreement) with the reviewing IRB. A reliance agreement is a formal, written document that provides a mechanism for institutions partnering in research to rely on one IRB to be responsible for multi-site IRB review. These agreements clearly delineate the roles of the Reviewing IRB (study oversight) and the Relying IRB (local context, training, resources, conflicts of interest). Reliance processes are typically coordinated through national platforms such as SMART IRB. These portals do not serve IRB functions, rather act as a platform to connect various IRBs. 

If your study requires a Reliance Agreement, The Office of Research Compliance and Integrity will need to facilitate review and completion. Please contact dlayton@southalabama.edu 

Submitting & Managing External IRB Studies

While the External IRB handles protocol review and continuing reviews / amendments, USA study teams must submit an administrative package in IRBNet to receive formal local acknowledgement before any study activities begin. USA also requires local post-approval tracking for annual check-ins, personnel updates, and local reportable events.

Ready to submit an External IRB protocol or manage a post-approval update? For step-by-step instruction on assembling your IRBNet package, required forms, and local reporting requirements, visit the IRB Submission and Review Page.

NIH Guidance and Policy on the use of Single IRBs

Federal regulations require that IRBs give special consideration to protecting the welfare of individuals belonging to one or more vulnerable populations. Potentially vulnerable populations include research participants who are:

• Children / minors
• Pregnant
• Susceptible to coercion or undue influence (e.g., homeless, prisoners, institutionalized, terminally ill, socially or economically disadvantaged)
• Unable to comprehend the research and its potential risks (e.g., educationally disadvantaged or suffering mental illness, dementia, etc.)
• At higher risk for harm and/or economic, social, or legal consequences (e.g., individuals answering survey questions about their HIV status, drug use, sexual assault, etc.)

Increased protections for certain populations (pregnant women, prisoners, and children) have been established by federal regulations which are highlighted here along with an additional University-specific population.

Research Involving Pregnant Women, Human Fetuses, and Neonates

45 CFR 46 Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research

Research Involving Prisoners

Guidance on Research Involving Prisoners

Research Involving Children

Guidelines: Requirements for Research Involving Children

Ambulatory Pediatric Association Policy Statement

PASSAGE USA Students

Investigators wishing to recruit PASSAGE USA students must follow specific guidelines to ensure adequate protections are in place for this vulnerable population. These guidelines are detailed here.

If you have any questions regarding this guidance, please contact the IRB Administrator at irb@southalabama.edu or 251-460-6308.

College of Nursing Students as Participants

If your project will be recruiting students from the USA College of Nursing specifically, a letter of support from Dr. Sharon Fruh will be required before approval can be granted.