Decision Tree for Inclusion of Women 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 Part 46)?

• If yes, continue to Step 2.
• If no:
  • The policy does not apply.
  • Human Subjects Code: 10. X as regards clinical trials.
  • End.

Step 2. Is information on gender 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, continue to Decision Tree for Inclusion of Women Plan, Part 2 of 2.
• If no:
  • Human Subjects Code: N as regards clinical trials.
  • Proceed to Step 4.

Step 4.

• What is the actual gender representation?
  1. Both genders are included in scientifically appropriate numbers? (Code G1) or
  2. One gender is excluded because one of the following applies (Code G2: females only, G3: males only)
     • Inclusion is appropriate with respect to their health
     • Research question is relevant to only one gender
     • Prior evidence strongly suggests no gender difference
     • Data exists for excluded gender; duplicative studies are unnecessary; or
  3. One gender excluded or limited because subject selection is constrained due to purpose of research? (Code G2: females only, G3: males only) or
  4. Gender representation of specimens or datasets cannot be accurately determined and this does not compromise the scientific objectives? (Code G4: gender representation unknown)
• Is gender representation acceptable?
  • If yes:
    • Acceptable.
    • Code G1A, G2A, G3A, or G4A.
    • End.
  • If no:
    • Unacceptable
    • Code G1U, G2U, G3U, or G4U.
    • 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