Decision Tree for Inclusion of Women 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 Women Plan, Part 1 of 2.

Decision Tree for Inclusion of Women 2

Text Version of Flowchart

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

Step 1. Is a NIH-defined phase III clinical trial proposed?

Step 2.

  • Is gender representation acceptable?
    1. Strong evidence exists for significant gender differences in intervention effect and study design or analysis can answer primary question(s) separately for each gender and can detect significant differences in intervention effect? (Code G1: both genders included) or
    2. Strong evidence exists for NO significant gender differences in intervention effect? (Code G1: both genders included, or Code G2: females only, or Code G3: males only) or
    3. No clear evidence exists for or against significant gender differences in intervention effect and study design and analysis plans will permit valid analysis of a differential intervention effect? (Code G1: both genders included) or
    4. One gender is excluded because inclusion is inappropriate with respect to their health or because the research question is relevant to only one gender? (Code G2: females only, or Code G3: males only)
  • 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

Gender Representation Representation is scientifically...
Acceptable Unacceptable (bar to award)
Both genders included G1A G1U
Females only G2A G2U
Males only G3A G3U
Unknown (cannot be known) G4A G4U

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