Decision Tree for Inclusion of Minorities Plan, Part 1 of 2

Table of Contents

See the main index of Decision Trees or Research Using Human Subjects

Graphical Flowchart

Decision Tree for Inclusion of Minorities

Text Version of Flowchart

Step 1. Are Human Subjects involved (even if exempted under 45 CFR 46)?

  • If yes, policy applies despite exemption. Continue to Step 2.
  • If no:
    • Policy does not apply.
    • Code: 10, Code: X as regards clinical trials.
    • End.

Step 2. Is information on minority representation provided? 

  • If yes, continue to Step 3.
  • If no:
    • Absent (Negative impact on score, bar to award, or application not reviewed.)
    • End.

Step 3. Is a NIH-Defined Phase III Clinical Trial proposed?

Step 4.

  • What is the actual minority representation?
    1. U.S. minority individuals ARE included in scientifically appropriate numbers (non-minorities may or may not be included)? (Code M1: both U.S. minorities and non-minorities, or Code M2: U.S. minorities only) or
    2. Some or all U.S. minority groups are excluded or poorly represented because any of the following applies?
      • inclusion is inappropriate with respect to their health
      • research question is relevant to only one racial/ethnic group
      • prior evidence strongly suggests no racial/ethnic difference in outcome variables
      • proposal is for a single minority group study to fill a research gap
      • data exists for excluded minority group(s); duplicative studies are unnecessary
      • geographical location has too few eligible minorities and exclusion has been well justified (e.g., based on study size, disease characteristics, unfeasibility of collaboration)
      • purpose of research constrains subject selection in regard to race/ethnicity (Code M3: U.S. non-minorities only; or Code M2: U.S. minorities only; or Code M1: both included) or
    3. Racial or ethnic origin of specimens/datasets cannot be accurately determined and this does not compromise scientific objectives? (Code M4: minority representation unknown)
    4. Only foreign (non-U.S.) subjects are involved and study design addresses any known scientific reasons for examining in-country minority group or subgroup differences? (Code M5: no U.S. subjects involved)
  • Is minority representation acceptable?
    • If yes:
      • Acceptable.
      • Code M1A, M2A, M3A, M4A, or M5A.
      • End.
    • If no:
      • Unacceptable.
      • Code M1U, M2U, M3U, M4U, or M5U.
      • Negative impact on score.
      • End.

Summary of Codes

Minority Representation Representation is scientifically...
Acceptable Unacceptable (bar to award)
both minorities and non minorities are included M1A M1U
minorities only M2A M2U
non-minorities only M3A M3U
unknown (cannot be known) M4A M4U
only foreign (non-U.S subjects) in the study M5A M5U

Clinical Trial Status

  • X—Human subjects not involved (not clinical research)
  • N—Clinical research, not an NIH-defined Phase III clinical trial
  • Y—Clinical research, an NIH-defined Phase III clinical trial
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