All research involving human subjects at the University of South Alabama is required to be reviewed and approved by the USA Institutional Review Board (IRB). The USA IRB is committed to protecting the rights and welfare of those participating in human subjects research by upholding federal regulations and institutional policies.
While the nuances of the IRB review process are complex and ever-changing, the sections below detail foundational concepts that can serve as a guide for navigating both USA IRB (aka “local review”) and external IRB review.
USA IRB Review
- 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)
- 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”.
- 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.
- A human subject is a living individual about whom an investigator (whether professional or student) conducting 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 email@example.com or 251-460-6308.
- 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
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 firstname.lastname@example.org 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.
Institutional Review Boards were created as a result of instances of research misconduct throughout history. These instances caused serious harm to human subjects and has had a lasting effect within communities being recruited to participate in research studies. Some of the most infamous were the Nazi war crimes during World War II, the Willowbrook hepatitis study and the Tuskegee Syphilis study. These events have resulted in the publishing of ethical research foundations to be followed such as:
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. This commission, responsible for creating the Belmont Report, was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. These principles are as follows:
- Respect for persons establishes that all individuals should be treated as autonomous agents and those with diminished autonomy are entitled to protection.
- Beneficence is the concept that researchers should do no harm as well as maximize possible benefits and minimize possible harms.
- Justice is the fair distribution of the risks and benefits. No one group of individuals should bear the burden of research without benefiting.
IRBs follow a list of Exempt and Expedited review categories, set by federal regulations. All study activities must fit into one or more of these categories to be eligible for their respective levels of review. A full list of these IRB review categories can be found here.
Examples of Exempt Categories
Example 1 - A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, investigators will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
Example 2 – Comparing two curricula that are currently being implemented in a school. Investigators will observe classrooms and interview instructors about their experience implementing the materials (but not about specific students).
Example 1 – Anonymous surveys regarding workplace satisfaction
Example 2 – Interviews of college students about their plans after graduation
Example 3 – Focus groups with expectant mothers regarding perceptions of parenting education
Example 1 – Solving puzzles under various noise conditions taking 2 hours
Example 2 – Asking subjects to play an online game that takes 30 minutes to complete
Example 1 – Patient medical chart reviews
Example 2 – Secondary analysis of coded survey results
*Exempt category 5 only applies to research on public benefit programs such as Social Security, Medicare and Medicaid, etc. and is rarely used at universities.
Example 1 – A taste-test on different varieties of fruit to determine consumer preference when the fruits do not have any additives and subjects are asked to indicate which they prefer
Example 2 – Taste-testing of various beef products from cattle that have been given feed
Examples of Expedited Categories
Example 1 – Comparing how different over-the-counter bandages affect wound healing
Example 2 – Analysis of how well standard doses of over-the-counter NAIDs relieve headache pain in adults
Example 1 – Analysis of glucose levels in healthy adults using a finger stick glucometer
Example 2 – Analysis of human blood interactions with various types of synthetic biomaterials
Example 1 – Collection of buccal swabs to analyze enzyme function
Example 2 – Collection of saliva samples to test for markers of environmental sensitivity using genotyping techniques
Example 1 – Analyzing brain activity through Electroencephalogram (EEG) while viewing different media
Example 2 – Magnetic Resonance Imaging (MRI) scans used for recording brain signals from the motor cortex
Example 1 – Patient registry trials
Example 2 – Analysis of previously collected specimens that contain identifiable information
Example 1 – Any project involving the collection of audio/video recordings of minors
Example 2 – Audio/video recordings of vulnerable populations
Example 1 – Focus groups or interviews of a sensitive topic or that include minors as participants
The review process begins once your project is submitted to the IRB office. All IRBNet submissions are routed to the USA IRB Administrator who assigns each project a local reference number and conducts a pre-review. This pre-review includes ensuring all required documentation is included and adequately completed, all training has been provided, all required signatures have been obtained, etc.
During the pre-review stage, the IRB Administrator also determines the level of review. The level of review (Exempt, Limited, Expedited or Full Board) is determined based on the study’s level of risk. The risk level of a study is based off of the concept of minimal risk, which is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”.
Exempt studies are considered less than minimal risk such as anonymous surveys, retrospective
chart reviews, benign interventions, etc. Exempt studies are reviewed and approved
by the IRB Administrator or IRB staff.
Limited Review studies are a subset within the Exempt realm. The difference between the two is that the identity of the participant is readily ascertained by investigators within Limited Review studies. This includes, but is not limited to, audio or video recorded interviews, focus groups, or longitudinal surveys where personally identifiable information is retained. All Limited Review studies are reviewed by our EBR committee within a convened setting.
Expedited studies are considered minimal risk and include noninvasive biological specimen collection, the collection of data via physical sensors, interviews of sensitive topics, etc. Expedited studies under the purview of the EBR committee are reviewed in a convened setting; Expedited studies under the purview of the Biomedical committee are reviewed by a single IRB member.
Full Board studies are those that are greater (but not significantly greater) than minimal risk such as experimental drug or device studies, blood draws over a certain parameter, studies that require anesthesia or sedation, etc. All Full Board studies are reviewed by a full IRB committee in a convened setting.
Once the level of review is determined, the study/project is routed through the appropriate channel.
Visual representation of the full review process.
Educational and Behavioral Research IRB
The EBR IRB committee is responsible for reviewing all social, educational, behavioral and exercise science research conducted at USA. This includes survey or interview research, educational initiatives, exercise interventions/testing and non-invasive physical measurements.
At the University of South Alabama, all Limited Review and Expedited status studies under the purview of the EBR committee are reviewed in a convened setting.
The EBR committee meets every 3 weeks. Submission deadlines for these convened meetings can be found on the IRB Calendar.
Biomedical Research IRB
The Biomedical IRB committee is responsible for reviewing all biomedical research conducted at USA. This includes all FDA regulated research, medically invasive procedures, retrospective and prospective medical chart reviews, and the collection/storage of biological specimens.
The Biomedical IRB committee meets every second Tuesday of the month. Submission deadlines for these convened meetings can be found on the IRB Calendar.
Projects requiring review by a single committee member or the full board are voted on for an approval determination. The following are voting options granted to committee members and their respective meanings:
- Approve – The study is approved as is and can begin once the investigator receives written documentation of IRB approval.
- Modifications Required – The study requires minor changes or clarifications. Revisions are reviewed by IRB administrative staff and, once satisfactory, the research may proceed once the investigator receives their letter of IRB approval.
- Information Required – The study requires more than minor changes or clarifications. Revisions are reviewed by the primary and/or secondary reviewer and, once satisfactory, the research may proceed once the investigator received their letter of approval.
- Defer – Substantial changes are necessary before approval can be granted. The investigator’s response, along with and revised materials, must be reviewed at the next convened IRB meeting.
- Suspension/Termination – This determination may be made due to an adverse event, noncompliance, or other danger to human subjects. The IRB Chair or the convened IRB may suspend a study at any time. Once a study has been suspended, the convened IRB reviews the study and either requires changes to the protocol, allows the study to restart, or terminates the study. While the IRB Chair may suspend a study, only the convened IRB can make the decision to terminate a study.
- Disapprove – The study requires major changes that are not likely to be feasible without a complete reassessment of the protocol by the investigator and/or sponsor. Disapproval is only permissible through a majority vote at a convened meeting of the IRB.
The timeline between submitting your project and receiving approval from the IRB has
many variables including how well put-together your initial submission is, the number
of currently pending submissions, how quickly the PI/study team is able to respond
to revision requests, the timing of when a project requiring committee review is submitted,
For studies requiring Limited, Expedited (EBR), or Full Board review, we highly encourage planning your IRBNet submission around the respective IRB committee’s submission deadlines and meeting dates listed on the IRB Calendar.
Exempt studies with zero required modifications are typically reviewed and approved within 1-2 weeks after submission. This timeline is extended should your study require modifications such as missing or inconsistent documentation, electronic signatures, etc.
Expedited studies under the purview of the Biomedical committee are typically reviewed and approved within 2-3 weeks after submission. This timeline is extended should your study require modifications before and/or after being sent to a single committee member for their review. All committee members are granted 5 business days to complete Expedited reviews.
Studies that require revisions (Modifications Required or Information Required) are heavily dependent on how timely these revisions are received by the IRB Office. If your study received a:
- Modifications Required letter, your submitted revisions are reviewed by the IRB Administrator. If all revisions are satisfactory, the new timeline for approval is within an additional week. If additional revisions are required, this timeline is extended.
- Information Required letter, your submitted revisions are sent back to the primary reviewer for their additional review. If all revisions are satisfactory, the new timeline for approval is within an additional 5 business days. If additional revisions are required, this timeline is extended.
USA DNP Program
All 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.
To learn what materials are required for DNP project submissions, please see our IRBNet Specifics site.
To learn what training is required for DNP students, please see our Training site.
External IRB Review
Investigators may partner with two or more institutions to conduct human subjects
research or be involved in multi-site research studies. To enhance and streamline
the IRB review process when such collaborations occur, regulations allow institutions
to “enter into a joint review arrangement, rely upon the review of another qualified
IRB, or make similar arrangements for avoiding duplication of effort” (45 CFR 46.114).
If a non-USA owned IRB is chosen as the reviewing IRB, it is called an “External IRB”, as it is external to our organization. The following are different types of external IRB models:
- Central IRB: A reviewing IRB provides the ethical review for all sites participating in more than one multi-site study. The relying sites are usually in a network, consortium, or particular program such as the National Cancer Institute Adult Cooperative Groups and Children’s Oncology Group.
- Single Independent or Commercial IRB: The IRB is independent, established for commercial purposes, developing products and services to support the research industry. Pharmaceutical companies conducting multi-site studies may rely on ‘Single Independent (Commercial) IRBs to coordinate IRB review services (e.g., WCG).
- Single IRB, or sIRB: A reviewing IRB, selected on a study-by-study basis by partner institutions, provides the ethical review for all relying sites participating in that multi-site study (two or more sites).
For each model, the USA IRB enters into a Reliance Agreement (also referred to as an 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.
The USA IRB does not require reliance agreements for studies with Exempt status; however,
these arrangements are necessary for all non-Exempt research studies where the USA
IRB will rely on an external IRB.
If you believe you will potentially be involved in a study where the USA IRB will need to rely on an external IRB, please contact the IRB Administrator at email@example.com or 251-460-6308.
NIH Single IRB Policy Announcement
NIH Revised Implementation Date Announcement
NIH Single IRB Frequently Asked Questions
NIH Guidance about Single IRB Costs
NIH Guidance on Implementation of the Single IRB Policy
NIH Guidance on Requesting an Exception to the Single IRB
PHS Human Subjects and Clinical Trials Information Form Application Guide