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

Table of Contents

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

Graphical Flowchart

Continued from Decision Tree for Inclusion of Minorities Plan, Part 1 of 2.

Decision Tree for Inclusion of Minorities 2
Credit: NIAID

Text Version of Flowchart

Step 1. Is a NIH-Defined Phase III Clinical Trial proposed?

Step 2.

  • Consider these questions:
    1. Strong evidence exists for significant racial or ethnic differences in intervention effect and study design or analysis can answer primary question(s) separately for each relevant subgroup and can detect significant differences in intervention effect? (Code M1: both U.S. minorities and non-minorities included) or
    2. Strong evidence exists for NO significant racial or ethnic differences in intervention effect? (Code M1: both U.S. minorities and non-minorities, or Code M2: U.S. minorities only, or Code M3: U.S. non-minorities only) or
    3. No clear evidence exists for or against significant racial or ethnic differences in intervention effect and study design and analysis plans will permit valid analysis of a differential intervention effect? (Code M1: both U.S. minorities and non-minorities) or
    4. Some or all minority groups or subgroups are excluded because inclusion is inappropriate with respect to their health or because the research question is not relevant to them? (Code M1: both U.S. minorities and non-minorities, or Code M2: U.S. minorities only, or Code M3: U.S. non-minorities only) or
    5. 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 gender 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, bar to award.
      • 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
Content last reviewed on April 19, 2016