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Feb2020

Women are two-thirds of the world’s blind population, and there is no clear evidence for the cause of this alarming statistic. Dr. Janine Austin Clayton’s keynote address, "It’s About Quality Construction—Advancing a Foundational Framework for Rigorous Research Relevant to the Health of Women," at the 2019 Advancing Ethical Research Conference (AER19) began with this disturbing fact as she described her path from being an ophthalmologist to the Director for NIH’s Office of Research on Women’s Health (ORWH). As she discussed this, and other startling statistics regarding women’s health in the United States, it caused me to wonder why gender and sex are not routinely considered in study design. How are studies ensuring that women (and sex as a biological variable) are integrated into the design of animal and human research studies so that knowledge and treatments gained from these studies can be generalizable and effective for both men and women?

The integration of sex as a biological variable begins at the cellular and animal research level. Yet surprisingly, the majority of preclinical studies, from which human studies receive their foundation, only include male animals. Why? Is female biology such a confusing variable that researchers choose not to include females in their research? Maybe females are excluded from research to reduce variables in the name of “good science”, but is it really "good science" if practical applications of that research are then uncertain for half the population? Is research inherently a patriarchal system designed to protect females from the risks due to the physiological processes that occur in their bodies?

It is apparent that historically, women and women’s health have been secondary focuses of research, and often adult women, who should have the ability to consent for their own treatment, were still seen as vulnerable in research. Pregnant women in particular have been, until recently, considered a population vulnerable to coercion in research, solely based upon their ability to carry another human being.

Dr. Clayton’s discussion regarding ORWH’s focus on multidimensional research was fascinating and caused me to examine the IRB review process. Are Institutional Review Boards assessing sex and gender as they relate to the Belmont Report principle of justice? The principle of justice is meant to ensure that both the burdens and benefits of research are distributed equally and the application of justice states, “equals ought to be treated equally.” It is accepted in our country and many cultures that men and women are equal; but are women equals in human research?

Are women (sex as a biological variable) being considered and included within study design and review? While IRB applications and protocols request information regarding exclusion of women, are they asking enough probing questions to stimulate thought and discussion regarding how sex as a biological variable will be specifically included? Are the physiological differences that occur within men and women accounted for in the research and in the resulting medical treatments? During the continuing review process, do IRBs challenge investigators who have designed multidimensional studies but have enrolled a majority male population?

Dr. Clayton’s address caused me to pause and truly examine this problem and examine my own thoughts on inclusion and multidimensional research. If the research through which we achieve life-saving treatments and scientific breakthroughs does not include women, these treatments and breakthroughs may not benefit women to the same degree. Addressing issues of women’s health through sound, multidimensional research design should be an imperative. For those of us actively involved in the administration of human research protection programs, where do we start to address this issue? Do we challenge the investigators designing and conducting studies? On the other hand, do we challenge the IRBs and scientific boards who review the studies? Wherever we choose to start, the time is now, and leaders like Dr. Clayton and the ORWH provide the proper framework for investigators and IRBs.

Ivy Tillman, MS, CCRC, CIP, joined the Augusta University IRB Office in 2005 and is currently the Director. She serves as the primary liaison for the Augusta University Human Research Protection Program (HRPP), which is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Augusta University’s IRBs review research for Augusta University, Augusta University Medical Center, and the Charlie Norwood VA Medical Center. Ivy is responsible for overseeing the missions of the IRB Office, which include administrative support to the IRB committees, compliance and oversight of human research studies, and education and training for research team members and the IRB Committee members.

Ivy received her Master of Science in Management with a concentration in Healthcare Management from Troy University and her Bachelor of Arts in Biological Sciences and Modern Languages from Clemson University. A former educator, Ivy’s past roles in human research include working as a clinical research coordinator in pediatric sickle cell and adult neurology studies, and serving as the IRB Office Training Coordinator. She obtained certification as a Certified Clinical Research Coordinator in 2005 and Certified IRB Professional in 2008.

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

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