WHICH FORMS DO I USE?
Everyone must fill out the required Cover Sheet. There are 2 Cover Sheets to choose from:
- Faculty & Staff
- Student Cover Sheet
- All signatures and approvals on the Cover Sheet must be obtained before submitting a protocol.
- Signatures can be submitted with Adobe automatic signatures.
- A typed name can be accepted, too, WHEN ACCOMPANIED BY AN EMAIL sent to the IRB with the statement, “My typed name indicates my signature.”
PROTOCOL (Research) FORM:
There are 3 protocol forms to choose from based on your study parameters:
- 1) QI/QA (Quality Improvement/Quality Assurance)
- 2) Exempt (See guidelines below)
- 3) Non-exempt (See guidelines below)
Access the Cover-Sheet-FACULTY-STAFF
Access the Student Cover Sheet
Access the QI/QA Form
Access the Exempt Form | >>> Exempt Example (Faculty) | >>> Exempt Example (Students)
Access the Exempt Form | >>> Bulk Class Exemption Example (for instructors with multiple student research projects)
Access the Non-Exempt Form | >>> Non-Exempt Example
Access the Informed Consent Form
Access the Study Information Sheet Form
COVID Addendum to Informed Consent
Exempt Example (Faculty) | >>>Exempt Example (Students)
Alternative Informed Consent Example
Quality Improvement / Process Improvement / Quality Assurance
➢ Designed to have its findings applicable to the local institution and bring about immediate improvements
- Not designed to generalize to other settings
- Quality assurance procedures fit here (e.g., data collected to monitor implementation or effectiveness of a program…and the data are only examined by administrators at the institution)
➢ If you see your work as QI, pay attention to your claims.
- Call your project “Quality Improvement” in the title and throughout the protocol. And be aware that you can NEVER call it research at any stage of your data collection or dissemination of findings.
- Limit your conclusions and don’t generalize
➢ Also have a letter of support from the agency that speaks to the ways the project will help them improve their processes or outcomes OR have the local IRB approve it as QI
➢ Quality Improvement or Process Improvement: You may choose to use the exempt form for quality improvement or process improvement projects. In this case, the federal definition of research does not apply.
This table shows key distinctions between QI and research.
Research is EXEMPT when it fits into one of the federally-defined categories:
Category 1: Your research will be conducted in established educational settings on normal educational practices
Category 2: Your research will:
• Use educational tests with children or adults
• Use surveys with adults on non-sensitive topics
• Use interviews with adults on non-sensitive topics
Category 3: The researcher manipulates individuals or their environment in benign ways
Category 4: Uses data originally collected for non-research purposes – does not need to exist prior to the start of the study
Category 5: Your research will focus on public benefit or service program
Category 6: Your research will focus on taste and food quality evaluation and consumer acceptance studies
EXEMPT RESEARCH FOR BULK EXEMPTION:
Bulk Exemption – If you are an instructor with a class that encourages multiple student research projects as part of the course work, and the projects will meet the criteria for Exempt or QI/QA, you may be able to submit a bulk Exemption. Please follow the link for more information about the process and example forms. See the Bulk Exemption submission process.
• Choose the NON-EXEMPT form in the following situations:
➢Low-risk behavioral research (e.g., non-invasive physical or behavioral tasks; manipulation of the subject's environment and similar methods commonly used in cognitive, behavioral, social, ethnographic, educational, health, and epidemiologic research)
➢ Video, digital, or image recordings made for research purposes. (e.g., Using video recordings to examine communication styles between professors and college students)
➢ Noninvasive procedures routinely employed in clinical practice (e.g., Weighing, muscular strength testing, body composition assessment, and flexibility testing).
➢ Minimally invasive procedures routinely employed in clinical practice (e.g., Physical sensors that are applied either to the surface of the body or at a distance).
➢ Non-invasive measures of performance on:
• other related tasks
FULL BOARD REVIEW RESEARCH:
Plan enough time for a full board review when:
➢ Your study involves more risk than would be ordinarily encountered in daily life or during routine physical or psychological examinations/tests
➢ Any of the subjects are confined in a correctional or detention facility.
➢ Pregnancy is a prerequisite for serving as a subject.
➢ Any subjects are presumed not to be legally competent.
➢ The research involves children and the investigator will
• interview the children
• manipulate the environment or interact with the child as part of the data gathering
See Full Board Operating Procedures.
Regulations and References
DHHS 45 CFR 46.110
FDA 21 CFR 56.110
FDA 21 CFR 56.111(a)(1-2)
OHRP IRB Guidebook, Chapter 3: Basic IRB Review, Section A, Risk/Benefit Analysis