Legislative Process Framework : Introduction to Core Concepts for the Lesson
For purposes of this lesson, "requirements" is an umbrella term that comprises laws, regulations, guidances, and policies.
In the United States, federally funded research on human subjects is conducted under a system of requirements, which may be specified in the form of laws and regulations, and further interpreted as guidances and policies. Laws and regulations now require or encourage the inclusion of women and minorities in clinical studies and data analyses to identify the differences in intervention effects for women and men.
Programs for ensuring outreach, recruitment, retention, and inclusion of women and minorities in clinical trials have been put in place to facilitate proportional biomedical and behavioral research and greater analysis of the sex-related effects of medicinal products or other interventions.
