Exploring the Biological Contributions to Human Health Does Sex Matter? (2001) / Chapter Skim
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6 The Future of Research on Biological Sex Differences: Challenges and Opportunities
6 The Future of Research on Biological Sex Differences: Challenges and Opportunities
Pages 173-184
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From page 173... ...
Conducting studies that account for sex differences might require innovative designs, methods, and model systems, all of which might require additional resources. Studies that rely on biological materials would benefit from a determination and disclosure of the sex of origin of the material, and clinical researchers should attempt to identify the endocrine status of research subjects.
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From page 174... ...
As reviewed in Chapters 3 and 4, sex differences are evident and evolve across the life span; however, these differences cannot be attributed solely to sex hormones. In addition, naturally occurring variations in sexual differentiation and development can provide unique opportunities to obtain a better understanding of the basic differences and the similarities between and within the sexes.
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From page 175... ...
Food and Drug Administration rule entitled Investigational New Drug Applications and New Drug Applications establishes in law the requirement that applications for approval of new drugs contain "effectiveness and safety data for important demographic subgroups, specifically gender, age, and racial subgroups" (21 CFR Parts 312 and 314, U.S. Department of Health and Human Services, 1998, p.6854 [emphasis added]
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From page 176... ...
RESEARCH TOOLS AND RESOURCES More Complex Studies and Additional Resources for Research Differences between the sexes may be modest, yet the differences may still result in different outcomes or may point to significant and larger underlying mechanisms of sex differences. Detection of modest differences may require studies with more complex experimental designs, the use of more complex model systems, and the use of more subjects to achieve statistical power; and, thus, in some cases detection of modest differences may require additional financial resources.
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From page 177... ...
Many journals refer to the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" by the International Committee of Medical Journal Editors, which states that when writing about methods, researchers should describe their "selection of the observational or experimental subjects (patients or laboratory animals, including controls) clearly.
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From page 178... ...
RECOMMENDATION 9: Make sex-specific data more readily available. Journal editors should encourage researchers to include in their reports descriptions of the sex ratios of the research population and to specify the extent to which analyses of the data by sex were included in the study.
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From page 179... ...
(The large number of malignant immortal cell lines available from the American Type Culture Collection and similar sources are rarely identified by sex, but even if they were it would be extremely difficult to interpret differences among donor lines, as the expression of many genes is presumably abnormal by virtue of the malignant transformation process.) Few to no data are available for determination of whether cell sex matters when studying such functions as cell life span and the response to stresses.
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From page 180... ...
These studies have provided such information not only about the original participants but about their offspring as well. Those studies, however, were designed with specific disease end points, such as the risk factors for and the development of coronary artery disease, thereby precluding consideration of many other relevant developmental issues and other diseases, disorders, and conditions.
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From page 181... ...
. INTERDISCIPLINARY AND COLLABORATIVE RESEARCH Uniformity in Application of Federal Regulations Interpretation and application of federal regulations regarding protection of human subjects are at the discretion of university and industry institutional review boards (IRBs)
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From page 182... ...
that the number of researchers in the basic biomedical workforce is sufficient to meet the nation's needs. It also encouraged NIH to gradually shift the focus of its predoctoral programs from single-discipline to interdisciplinary training and increase opportunities for postdoctoral training through interdisciplinary training grants.
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From page 183... ...
Opportunities for interdisciplinary collaboration to enhance the understanding of sex differences, however, have not been fully realized. The committee recommends the continued development of interdisciplinary research programs and strategies for more effective communication and cooperation to achieve the following goals: · synergy between and among basic scientists, epidemiologists, social scientists, and clinical researchers; · enhanced collaboration across medical specialties; and · better translational or bench-to-bedside research and interlevel integration of data (cellular, to animal, to human)
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From page 184... ...
RECOMMENDATION 14: Reduce the potential for discrimination based on identified sex differences. The committee noted that, historically, studies on race, ethnicity, age, nationality, religion, and sex have sometimes led to discriminatory practices.
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