Basic Science and the Biological Basis for Sex- and Gender-Related Differences
Course Introduction

The Basic Science and the Biological Basis for Sex- and Gender-Related Differences course is a six lesson course designed to give the student a basic scientific understanding of the major physiological differences between the sexes, the influence these differences have on illness and health outcomes, and the implications for policy, medical research, and health care. The course was peer-reviewed during its development and will be revised in response to ongoing evaluation by students and experts. The content is updated to keep pace with changes in the body of knowledge.

The course format is self-paced and the student’s mastery of the course content is measured by quizzes.

Each lesson can be completed in approximately 30-40 minutes. The entire course can be completed in less than 4 hours.

Up to four AMA PRA Category I Credits™ can be awarded for successful completion of this course. Please refer to the Continuing Education page for more information.

Learning Objectives
Intended Students
Lesson Quizzes and Continuing Medical Education Units
References and Resources
Written Disclosure
Course Writers
Course Planning Committee

Learning Objectives

Contrast and compare key regulatory U.S. Department of Health and Human Services policies significant to inclusion of women in clinical research and human subject protection.
Better evaluate appropriate design and analysis of preclinical and clinical research studies to detect and quantify potential sex and gender differences.
Understand the scientific basis of known sex and gender differences.
Identify known sex and gender differences with regard to disease, and differences in response to or effects of drugs and other medical interventions in the treatment and management of these conditions.

Intended Students

This course has been designed to meet the training needs of:

Staff of the Food and Drug Administration divisions (CDER, CBER, CDRH).
NIH staff and scientists and researchers and clinicians supported by the NIH.
Students and faculty members in all science and health professional schools.
Researchers and clinicians in the pharmaceutical industry.
Allied health professionals.

Lesson Quizzes and Continuing Medical Education Units

Quizzes are included at the end of each lesson to assess the student’s mastery of the lesson content. Students who are interested in receiving continuing medical education units are required to successfully complete each lesson quiz within a course. Those who are not interested in receiving CME are not required to complete the quizzes, but will need to do so in order to receive a certificate of completion.

References and Resources

The references used in the development of the course, included in the order they appear in the lesson content, can be found on the references page. Users may also view reference items by selecting the reference links included in the lesson content. Some reference links will link directly to the reference online, while others will link to the references page where the citations are located. Links to PubMed are included where available. Reference links are distinguishable from other links by a superscript indicating the number in which the reference is listed on the references page.

The resources, available from the left navigation bar, serve as supplemental reading materials that complement the course content. Some of the resources included on the resources page are available online and those that are not will include a citation on the resources page.

Written Disclosure

In compliance with the Standards of the Accreditation Council for CME, it is the policy of the NIH/FAES CME Committee to ensure balance, independence, objectivity, and scientific rigor in all of its educational activities and to include information free of commercial bias and based on the best evidence available. All individuals in a position to influence the activity content have disclosed relevant financial interests or relationships of their own, their spouse/partner, or their worksite, with any manufacturer or provider of a commercial product, service, technology, or program; and also disclosed relationships with any non-governmental supporters of this course. There were no non-governmental supporters involved in the development of this course.

Course Writers

Name	Degree	Title	Organization
Eleanor Hanna (NIH Activity Director)	Ph.D.	Associate Director for Special Projects and Centers	NIH, Office of Research on Women’s Health
Angela Bates	M.B.A.	Program Analyst	NIH, Office of Research on Women’s Health
Susan Wood	Ph.D.	Former Director	FDA, Office of Women’s Health
Deborah Kallgren	B.S.	Health Programs Coordinator	FDA, Office of Women’s Health
Pamela Scott	Ph.D.	Health Programs Coordinator	FDA, Office of Women’s Health
Carmen Sapienza	Ph.D.	Professor of Pathology and Laboratory Medicine; Associate Director of the Fels Institute for Cancer Research and Molecular Biology	Temple University School of Medicine
Joseph Kaczmarczyck	D.O., M.P.H.	Medical Officer	FDA, Office of Women’s Health
Myong-Jin Kim	Pharm.D.	Senior Clinical Pharmacologist	FDA, Division of Clinical Pharmacology 3
Gurvaneet Randhawa	M.D., M.P.H.	Senior Fellow	Center for Primary Care, Prevention and Clinical Partnerships, Agency for Healthcare Research and Quality

Course Planning Committee

Name	Degree	Title	Organization
Vivian Pinn	M.D.	Director	NIH, Office of Research on Women’s Health
Eleanor Hanna (NIH Activity Director)	Ph.D.	Associate Director for Special Projects and Centers	NIH, Office of Research on Women’s Health
Angela Bates	M.B.A.	Program Analyst	NIH, Office of Research on Women’s Health
Florence Haseltine	Ph.D., M.D.	Director	NIH, Center for Population Research
Patrice Desvigne-Nickens	M.D.	Leader, Cardiovascular Medicine Scientific Review Group	NIH, National Heart, Lung, and Blood Institute
Susan Wood	Ph.D.	Former Director	FDA, Office of Women’s Health
Deborah Kallgren	B.S.	Health Programs Coordinator	FDA, Office of Women’s Health
Pamela Scott	Ph.D.	Health Programs Coordinator	FDA, Office of Women’s Health
Joseph Kaczmarczyk	D.O, M.P.H.	Medical Officer	FDA, Office of Women’s Health

Basic Science and the Biological Basis for Sex- and Gender-Related DifferencesCourse Introduction