Introduction to Core Concepts for the Lesson

Lesson 2: Page 2 of 17

Legislative Process Framework : Introduction to Core Concepts for the Lesson

This lesson presents the human subjects research requirements specified by the U.S. Department of Health and Human Services (HHS) and two of its agencies, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Each agency's requirements reflect and apply to the mission of that agency. For example, FDA's regulations and guidances are applicable only to research involving FDA-regulated products.

The lesson focuses primarily on the requirements for the inclusion of women and minority population groups in clinical research. Informed consent is required of all participants in clinical research; the lesson also describes those requirements. An introductory section presents four types of instruments that constitute the system of requirements: laws, regulations, guidances, and policies.

Lesson Two Learning Objectives

Upon completing this lesson, the participant will be able to:

Gain a broad knowledge of the requirements that researchers must follow in proposing and conducting HHS-funded clinical research, and will know how to access specific resources explaining those requirements
Name four types of instruments that can be used to establish Federal research regulations
Explain where all regulations regarding research funded by HHS, FDA, and NIH can be accessed
Give examples of appropriate applications of the terms "sex" and "gender" in biomedical research
State the current FDA requirement for subgroup data in new drug applications
State the inclusion conditions under which FDA may impose a clinical hold on proposed or ongoing clinical trials
Summarize the provisions for assessing sex/gender-related variations in FDA's 1993 Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs
State the four major provisions of the NIH Revitalization Act of 1993 that strengthened NIH policy regarding inclusion of women and minorities in clinical research
State the NIH requirement for reporting subset analyses by sex/gender and racial/ethnic groups
State the categories of information required for NIH Phase III clinical trial applications
Name three resources for understanding more about the requirements for inclusion of women and minorities in NIH-funded clinical research