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

Table of Contents

• Graphical Flowchart
• Text Version of Flowchart
• Summary of Codes

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

Graphical Flowchart

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?

• If yes:
  • Code: Y as regards clinical trials.
  • Continue on Part 2 of 2, Decision Tree for Inclusion of Minorities Plan.
• If no:
  • Code: N as regards clinical trials.
  • Continue to Step 4.

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

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