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• 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 吃瓜爆料 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 吃瓜爆料 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 吃瓜爆料 IRB office is able to generate an IRB Determination Letter. This is a formal letter stating your project has been evaluated by the 吃瓜爆料 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 吃瓜爆料 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 吃瓜爆料 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 吃瓜爆料 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 吃瓜爆料). 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 吃瓜爆料 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 吃瓜爆料 student, their faculty advisor must also be granted Full Access.

Apart from the above, the 吃瓜爆料 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 吃瓜爆料 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 吃瓜爆料 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 吃瓜爆料 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 吃瓜爆料 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 吃瓜爆料 Radiation Safety Committee.
• Human gene transfer/recombinant DNA research. These studies must be reviewed and approved by the 吃瓜爆料 Institutional Biosafety Committee (IBC). Review may be sought concurrently.
• Handling of biohazards materials at 吃瓜爆料. These must be reviewed and approved by the 吃瓜爆料 IBC.

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