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Decision Tree for Protection of Human Subjects from Research Risk

Table of Contents

See the main index of Decision Trees or the NIAID Human Subjects Application and Grant Handbook.

Graphical Flowchart

Image map. There is a text-only version available below these images. Click to see the definition in the glossaryClick to see the definition in the glossary

Text Version of Flowchart

Step 1. Are human subjects involved? (even if exempted under 45 CFR Part 46)?

Step 2. Does the study claim an exemption to regulations?

Step 3. Does the study fit an allowed exemption?

Step 4. Are these issues adequately and appropriately addressed? Risk to subjects, adequacy of protection against risks, potential benefits of the research to subjects and others, importance of knowledge to be gained

  • If yes:
  • If no:
    • Concerns. Unacceptable risks and/or inadequate protections.
    • Negative impact on score, bar to award.
    • Human Subjects Code: 44.
    • End.

Summary of Codes

  • Human subjects protection codes
    • 10—Human subjects not involved (not clinical research)
    • 30—Human subjects involved, No Concerns (or only minor problems)
    • 44—Human subjects involved, Concerns
  • Exemption codes: Research involves...
    • E1—Instructional strategies in established educational settings
    • E2—Educational tests unlinkable to individuals, with no risks from disclosure
    • E3—Educational tests on public officials, or absolute confidentiality federally mandated
    • E4—Existing data/specimens, publicly available or unlinkable to individuals
    • E5—Demonstration projects concerning public benefit or service programs
    • E6—Taste and quality evaluation of foods without additives exceeding regulated levels

See the main index of Decision Trees or the NIAID Human Subjects Application and Grant Handbook.

Last Updated April 19, 2016

Last Reviewed April 19, 2016