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
Credit: NIAID

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