IRB Submission and Review

All submissions to the USA IRB are made through IRBNet. For help with general IRBNet navigation such as how to create a new project, accessing required materials, etc. please refer to our IRBNet Tutorials.

The list of materials required for IRBNet submission vary greatly depending on what type of project is being conducted. 

This guide breaks down required materials by project type.

Regardless of the details of a study, ALL initial IRBNet submissions are required to contain a completed Application Part A and Application Part B. Please note there are different Application Part B’s available in IRBNet Forms and Templates including an Exempt version, Expedited/Full Board version, Biological Specimens version and a Retrospective Medical Records Review version. If you are unsure which application applies to your study, please contact the IRB Administrator at irb@southalabama.edu or 251-460-6308.

In addition to the materials listed in the above guide, the following is required for initial IRBNet submissions:

• PI signatures are required for all submissions (unless PI is individual submitting the project)
• Faculty advisor signatures are required for all student submissions
• All personnel listed within Application Part A must have their appropriate training certificate(s) linked to their User Profile or uploaded as a separate document within the IRBNet package itself
• A Letter of Support from outside organization (if proposed research site is not associated with USA). A template is available if needed.
• Vulnerable population checklists, if applicable
• Deception Debriefing form, if applicable

For information on how to access required materials, please see our guidance materials within IRBNet Basics.

All research projects submitted to the USA IRB are required to include Application Part A (also known as a Wizard). General guidance for accessing and completing Application Part A (Wizard) can be found within IRBNet Basics.

For more details on how to complete Application Part A, please see our walkthrough guidance here.

IRBNet offers varying levels of access to projects. These levels and their respective authorizations include:

• Full – Users granted Full Access can perform all functions without restriction. This includes editing project documents, sharing the project with other users, submitting document packages for review and deleting document packages. Users with Full Access will receive automatic email copies of all project notifications and alerts that are sent to the project owners.
• Read – Users granted Read Access can view project documentation, collaborate with other users and add their signature, but may not edit project documents or perform any administrative functions
• Write – Users granted Write Access can view and edit project documents, collaborate with other users and add their signature, but may not grant access to other users, submit their packages for review or perform any other administrative functions.

For IRB purposes, all PIs must be granted Full Access to their projects in IRBNet. If the PI is a USA student, their faculty advisor must also be granted Full Access.

Apart from the above, the USA IRB does not have a policy stating who must have which access level for submissions in IRBNet. It is recommended to share some level of access to all individuals listed on Application Part A.

For IRB purposes, the following applies to electronic signatures within IRBNet:

• Principal Investigators (PIs) must sign all initial submissions (package 1) within IRBNet. The only caveat to this requirement is if the PI is the individual submitting the package themselves.
• If the PI is a USA student, their faculty advisor must electronically sign the initial package (package 1) of the project.
• If a study is being transferred to a new PI, this individual must provide their electronic signature within the appropriate package.

To learn how to electronically sign a package within IRBNet, please see our “How to Sign a Project in IRBNet” guidance in IRBNet Basics.

Certain studies require additional review outside of the IRB. Some examples of these studies are those involving:

• DXA scans. These must be reviewed and approved by the USA Radiation Safety Committee.
• Human gene transfer/recombinant DNA research. These studies must be reviewed and approved by the USA Institutional Biosafety Committee (IBC). Review may be sought concurrently.
• Handling of biohazards materials at USA. These must be reviewed and approved by the USA IBC.

For assistance with these studies, please contact the IRB Administrator at irb@southalabama.edu or 251-460-6308.

To request review by an external IRB, the USA investigator / research site must first receive an acknowledgement letter from the USA IRB via IRBNet. For instructions on how to get started with IRBNet, see our IRBNet guidance page.

Initial Submission

1. Once you are in IRBNet, create a new project. Package 1 should include the following:
   • USA IRB Application Part A (Wizard)
   • 'External Review Request' Form
   • Study Protocol
   • Informed consent with applicable USA boilerplate language included
2. All Key Personnel listed on IRB Application Part A must have completed the required applicable human subject training.
3. The Principal Investigator must electronically sign Package 1
4. An acknowledgement letter will be published in Package 1
   • Do not submit to any external IRB without receipt of USA IRB acknowledgement letter

Post-Approval Submissions

Although the USA IRB has ceded study review to the IRB of Record, there are some items that require submission to the USA IRB through IRBNet post study approval. These include:

1. Annual Check-in
   • Note, this is not the same as a continuing review and may occur at a different time than the continuing review required by the IRB of Record. The study team should pay attention to the renewal date listed on the USA IRB Acknowledgement letter and reminders sent from IRBNet. The 'Renewal - Annual Check-In' form should be submitted through IRBNet.
     
     
2. Reportable events including:
   • Change in PI/Key personnel
   • Change in funding
   • Change in study title
   • Updated local recruitment/advertising materials
   • Subject complaints
   • Conflict of Interest updates
   • Breaches of confidentiality/ HIPAA privacy or security violations
   • Protocol deviations that may represent a systematic problem requiring local evaluation by USA IRB to determine that sufficient local resources are available for safe conduct of the study
   • Study holds/suspensions from the IRB of Record or Sponsor that are not built into the study design
   • Study terminations from the IRB of Record or Sponsor
   • Any death of a participant outside of death as a result of natural disease progression
     
     
3. Study Closure
   • Once all subjects at the site have finished their final visits and follow up and there will be no further interaction with Human Subjects, the 'Closure Form' should be submitted through IRBNet.

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 IRB 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”.

All Human Subjects Research is required to be submitted to and reviewed by the IRB, regardless of level of review.

Exempt studies are considered less than minimal risk to participants and are exempt from many of the requirements in the Federal Code of Regulations. Exempt studies can include 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.

A full list of these IRB review categories can be found here.

Flowchart and explanation of exempt categories

Examples of exempt and expedited research

Visual representation of the full review process.

Studies determined to require full board review will be assigned to one of two committees:

Educational and Behavioral Research IRB

The Educational and Behavioral (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, etc.

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.

IRBNet projects and/or packages may be withdrawn for multiple reasons. These reasons include:

• No communication from the PI/study team within 90 days. Per USA IRB policy, if revisions and/or clarifications are required for your project and no communication is received by the IRB Office within 90 days of initial submission, your submission will be withdrawn.
  For new projects, this means your project has not been reviewed or approved and an entirely new submission will need to be created and submitted. Reminder: No research activities can take place until formal IRB approval has been received. For project Amendments, this means your changes have not been approved and cannot be implemented until a new package detailing all changes has been submitted and approved.
• Project duplication. All subsequent communication (e.g., Modifications/Information Required responses, Amendments, Renewals, etc.) for your project must be submitted within a new package. If a duplicate project is received, this submission will be withdrawn.
  To learn how to create a new package vs a new project, please see our guidance in IRBNet Pro.
• Submission to the incorrect committee. Please be sure to highlight the appropriate reviewing committee (IACUC, IBC, IRB) when submitting your IRBNet packages. If an item is received by the incorrect committee, this submission will be withdrawn.

Packages within IRBNet that have been formerly submitted for review can be unlocked by request. Please see our “What if My Project/Package Requires Revisions” guidance within IRBNet Pro.

Once your project has received formal IRB approval, you will receive an email notification and an alert (or “red flag”) within IRBNet. Every project is granted an initial Approval Letter (or Memorandum if you are a DNP student) that can be located within the system itself. To find this document, please follow our “How to Access Board Documents in IRBNet” guidance in IRBNet Basics.

Within your Approval Letter, there may be specific instructions or important reminders from the IRB Office. Always view your initial Approval Letter to confirm if your project does/does not have any of these details within the notes section at the bottom of this document.

In addition to your Approval Letter, your study may have stamped documents. These may include consent form(s), recruitment materials, questionnaires/surveys, etc. and are the IRB-approved versions of these materials. Stamped versions of these documents must be utilized for the duration of your study. This does not apply in certain situations, such as for studies conducting online surveys only.

When individuals are being added to and/or removed from study personnel, this must be reported to the USA IRB in real time. To document this update, please follow these steps:

• Step 1 – Complete a Change of Study Team form, located in IRBNet Forms and Templates.
• Step 2 – Create a new package to the appropriate project within IRBNet and attach your completed Change of Study Team form via the Designer
• Step 3 – Provide an updated Application Part A that reflects the change in personnel. Be sure to select Save and Exit when finished.
• Step 4 – Attach / link any additional personnel’s required training.
• Step 5 – Submit your new package to the IRB for review. This can be submitted as “Other”.

If the PI of a study is changing, please follow these steps (in order):

• Step 1 – Complete a Change of Study Team form, located in IRBNet Forms and Templates.
• Step 2 – Create a new package to the appropriate project within IRBNet.
• Step 3 – Select Project Overview (on the left-hand navigational panel) and click Edit at the top of your screen to update the PI name. Be sure to Save when finished.
• Step 4 – Navigate to the Designer page (left-hand panel) and attach your completed Change of Study Team form.
• Step 5 - Provide an updated Application Part A that reflects the change in personnel. Be sure to select Save and Exit when finished.
• Step 6 – Attach / link the new PI’s required training.
• Step 7 – Share Full Access with the new PI and obtain their electronic signature.
• Step 8 – Submit your new package to the IRB for review. This can be submitted as “Other”.

If needed, please refer to our provided guidance materials within IRBNet Basics & Pro for assistance to complete these steps.

Any change to your currently approved project is considered an Amendment. This includes adding survey questions, adding/removing/modifying a research procedure, revising a consent form, updating recruitment materials, etc. All Amendments must be submitted to the IRB for review and approval prior to implementation.

To submit an Amendment, follow these steps:

• Step 1 – Complete an Amendment Form, located in IRBNet Forms and Templates.
• Step 2 – Create a new package to the appropriate project within IRBNet.
• Step 3 – Attach your completed Amendment Form along with all revised materials via the Designer
• Step 4 – Submit your new package to the IRB for review. This should be submitted as an “Amendment/Modification”.

Please note that if your study is considered Expedited or Full Board it may require review by a single committee member or the full board if the Amendment submitted is significant. This includes, but is not limited to, any modification that may affect participants’ willingness to participate, increases risk, or adds scientific procedures that require expert review. Please plan accordingly.

Personnel changes may be submitted in addition to an Amendment; however, Amendments cannot be reviewed and/or approved at the same time as a study renewal/check-in. These must be submitted in separate packages. Please plan accordingly.

All USA IRB-approved studies, at a minimum, require an annual status update. This applies to all Exempt/Limited Review studies, most Expedited studies, and studies where the USA IRB does not serve as the IRB of Record. These projects are given a Next Report Due date within IRBNet and require a completed Annual Check-In form* to be submitted for review before the given date.

All Full Board and certain Expedited studies are given an Expiration date within IRBNet and require more in-depth review at the time of annual renewal. These projects require, at a minimum, a completed Continuing Review form* to be submitted for review before the given Expiration date. Please note that if your study falls within this category it must be reviewed by either a single committee member or the full board to be approved for an additional year. It is highly recommended to submit your project renewal at least 30 days before your date of expiration.

*These forms are located within IRBNet Forms and Templates. To access these fillable forms, please view our “How to Access Required Documents for IRBNet Submission” guidance in IRBNet Basics. Once complete, they must be submitted within a new package to your existing project. To learn how to do this, please see our “How to Create a New Package in IRBNet” guidance in IRBNet Pro.

Individuals with Full Access to a project will receive an email notification and alert (or “red flag”) within IRBNet 90 days, 60 days, and 30 days before AND one day after the study’s Expiration or Next Report Due date. If your project exceeds this date, it may be administratively closed due to failure to respond.