老司机福利网

• 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 鈥渞esearch鈥�.

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鈥檚 important to understand what types of studies require IRB review, it鈥檚 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 鈥渋ntent to publish is an insufficient criterion for determining whether a QI [Quality Improvement] activity involves research.鈥�

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.

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鈥檚 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 鈥� 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 鈥� 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 鈥� 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 鈥淗ow to Sign a Project in IRBNet鈥� guidance in IRBNet Basics.

Please refer to the College of Nursing Instruction/Guidance/Checklist provided within IRBNet Forms and Templates. The USA IRB has also provided a 鈥淗ow To鈥� guide for completing Application Part A in the same location. For instructions on how to access IRBNet Forms and Templates, please see our 鈥淗ow to Access Required Documents for IRBNet Submission鈥� step-by-step guidance within IRBNet Basics.

For additional guidance, please contact your faculty advisor.

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.

For studies targeting the recruitment of PASSAGE USA students, there are specific guidelines to follow in addition to the list of required materials above. Please see our provided guidance within the Vulnerable Populations page.

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.

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

For details on IRB approval timelines, please see the IRB Review section.

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.

Once your project has received formal IRB approval, you will receive an email notification and an alert (or 鈥渞ed flag鈥�) 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 鈥淗ow to Access Board Documents in IRBNet鈥� 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 鈥� Complete a Change of Study Team form, located in IRBNet Forms and Templates.
• Step 2 鈥� Create a new package to the appropriate project within IRBNet and attach your completed Change of Study Team form via the Designer
• Step 3 鈥� Provide an updated Application Part A that reflects the change in personnel. Be sure to select Save and Exit when finished.
• Step 4 鈥� Attach / link any additional personnel鈥檚 required training.
• Step 5 鈥� Submit your new package to the IRB for review. This can be submitted as 鈥淥ther鈥�.

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

• Step 1 鈥� Complete a Change of Study Team form, located in IRBNet Forms and Templates.
• Step 2 鈥� Create a new package to the appropriate project within IRBNet.
• Step 3 鈥� 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 鈥� 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 鈥� Attach / link the new PI鈥檚 required training.
• Step 7 鈥� Share Full Access with the new PI and obtain their electronic signature.
• Step 8 鈥� Submit your new package to the IRB for review. This can be submitted as 鈥淥ther鈥�.

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

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鈥� 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 鈥淗ow to Access Required Documents for IRBNet Submission鈥� 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 鈥淗ow to Create a New Package in IRBNet鈥� guidance in IRBNet Pro.

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