Forms

Need More Info?  See The Training Handout and Presentation

Which Form Do I Choose?

Everyone must fill out the required Cover Sheet. Then, choose one of the two protocol forms: 1) Exempt, or 2) Non-exempt.

Important: all cover sheet signatures, approvals and letters of support must be obtained before submitting a protocol.

Access the Faculty & Staff Cover Sheet
Access the Student Investigator Cover Sheet
Access the Exempt Form
Access the Non-Exempt Form
Access the Informed Consent Form

Other Forms

Amendment or Modification of Protocol
Continuing Review Form
Child Assent Form Ages 12-17
Child Assent Script Ages 5-11


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.

 

Exempt 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: Your research will involve observation of public behavior of adults

Category 4: Your research will collect only existing data

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

Non-Exempt Research

• 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:
     • cognitive
     • perceptual
     • neuropsychological
     • behavioral
     • other related tasks

 

Full Board Review

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

 

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