Knowledge (XXG)

Sex as a biological variable

Source šŸ“

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and human studies. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex." The review criteria should assess the extent to which the sex of participants has been incorporated into the research plan.
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In 2003, the European Commission (EC) began influencing investigators to include sex and gender in their research methodologies. The Canadian Institutes of Health Research (CIHR) requires four approaches: sex and gender integration in research proposals, sex and gender expertise among research teams,
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Research incorporating sex as a biological variable increases the rigor and reproducibility of results. After publishing the NIH published SABV policy, there were increases in the percentage of scientists understanding and recognizing its importance. Some investigators were critical of the NIH SABV
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designs and analyses, leading to an incomplete understanding of potential sex-based differences in basic biological function, disease processes, and treatment response. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal
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Becker, Jill B.; Arnold, Arthur P.; Berkley, Karen J.; Blaustein, Jeffrey D.; Eckel, Lisa A.; Hampson, Elizabeth; Herman, James P.; Marts, Sherry; Sadee, Wolfgang; Steiner, Meir; Taylor, Jane (2005-04-01). "Strategies and Methods for Research on Sex Differences in Brain and Behavior".
57: 169: 172: 171: 167: 166: 173: 99:(NIH) established policies on sex as a biological variable (SABV). Enrolling both men and women in clinical trials can impact the application of results and permit the identification of factors that affect the course of disease and the outcome of treatment. 170: 128: 26:) is a research policy recognizing sex as an important variable to consider when designing studies and assessing results. Research including SABV has strengthened the rigor and reproducibility of findings. Public research institutions including the 621:
De Castro, Paola; Heidari, Shirin; Babor, Thomas F. (April 2016). "Sex And Gender Equity in Research (SAGER): reporting guidelines as a framework of innovation for an equitable approach to gender medicine. Commentary".
139:(APS) journals began requiring sex and gender to be reported in studies involving cells, tissues, animals, and humans. This APS editorial policy was not widely accepted by reviewers and researchers. 55: 168: 1887: 3008: 1356: 417: 3239: 38:
have instituted SABV policies. Editorial policies were established by various scientific journals recognizing the importance and requiring research to consider SABV.
200:, variability was the same among sexes. Studies following SABV policies can identify potential hormonal variability in earlier phases of biomedical research. 2545: 146:
established the gender policy committee (GPC) in 2012. The GPC published Sex and Gender Equity in Research (SAGER) guidelines in 2016. In January 2017, the
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Prendergast, Brian J.; Onishi, Kenneth G.; Zucker, Irving (March 2014). "Female mice liberated for inclusion in neuroscience and biomedical research".
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In May 2014, the NIH announced the formation of SABV policy. The policy came into effect in 2015 which specified that "SABV is frequently ignored in
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sex and gender platform in large consortiums, and starting in September 2015, the completion of sex and gender online training programs.
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McCullough, Louise D; de Vries, Geert J; Miller, Virginia M; Becker, Jill B; Sandberg, Kathryn; McCarthy, Margaret M (December 2014).
3261: 1342: 1009:"NIH initiative to balance sex of animals in preclinical studies: generative questions to guide policy, implementation, and metrics" 3201: 3143: 3104: 3031: 2948: 2763: 2460: 1853: 148: 79:. In 2001, they presented a report that sex is an important variable in designing studies and assessing results. The quality and 3168: 3131: 3079: 428: 3121: 2871: 1698: 1420: 136: 1531: 3251: 3178: 3135: 3114: 3099: 2928: 2550: 1846: 1329: 96: 35: 3234: 3148: 3071: 3036: 2943: 2726: 208: 106: 3089: 3067: 2672: 2667: 2662: 2657: 2586: 1789: 1761: 1690: 1444: 2540: 204: 3163: 2881: 2721: 2450: 2210: 1839: 1515: 193: 76: 3292: 3173: 3153: 3094: 3017: 2711: 2190: 1634: 3229: 2652: 1572: 1520: 1400: 2933: 2560: 2082: 1660: 1618: 1596: 1566: 1466: 1410: 1393: 1769: 1527: 459:
Kilkenny, Carol; Browne, William J.; Cuthill, Innes C.; Emerson, Michael; Altman, Douglas G. (2010-06-29).
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and preclinical studies can reduce costs and time requirements to test sex differences in clinical trials.
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Sandberg, Kathryn; Umans, Jason G.; Group the Georgetown Consensus Conference Work (May 2015).
830:"Does sex matter?: an update on the implementation of sex as a biological variable in research" 3246: 2903: 2689: 2618: 2343: 1998: 1983: 1810: 1774: 1741: 1666: 1588: 1365: 1304: 1286: 1247: 1239: 1185: 1150: 1142: 1107: 1089: 1048: 1030: 989: 971: 924: 916: 867: 849: 810: 792: 745: 737: 688: 647: 639: 603: 585: 546: 538: 500: 482: 461:"Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research" 399: 300:"NOT-OD-15-102 Guidance: Consideration of Sex as a Biological Variable in NIH-funded Research" 278: 260: 132: 80: 1265:
Arnegard, Matthew E.; Whitten, Lori A.; Hunter, Chyren; Clayton, Janine Austin (2020-06-01).
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impacting findings in animal studies. Other studies using mice models found that despite the
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Sandberg, Kathryn; Verbalis, Joseph G.; Yosten, Gina L. C.; Samson, Willis K. (2014-08-15).
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of biomedical research depends on the consideration of key biological variables, such as
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Mannon, Elinor C.; Ray, Sarah C.; Ryan, Michael J.; Sullivan, Jennifer C. (2020-02-01).
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National Centre for the Replacement, Refinement and Reduction of Animals in Research
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American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
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policy, saying it would increase cost and labor requirements. Including SABV in
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Wald, C.; Wu, C. (2010-03-26). "Of Mice and Women: The Bias in Animal Models".
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Shah, Kalpit; McCormack, Charles E.; Bradbury, Neil A. (2014-01-01).
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American Journal of Physiology. Gastrointestinal and Liver Physiology
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in 2015 speaking on the importance of SABV in preclinical research.
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which promotes incorporating SABV in animal studies. In 2012, the
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This article incorporates text from this source, which is in the
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This article incorporates text from this source, which is in the
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Khosla, Sundeep; Amin, Shreyasee; Orwoll, Eric (2008-06-01).
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began requiring the consideration of SABV. The December 2017
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Historically, there were concerns among researchers of the
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established a committee on understanding the biology of
370:"Policy: NIH to balance sex in cell and animal studies" 2571: 215:: Integrating Sex and Gender to Improve Human Health. 211:
Office of Women's Health created an educational tool,
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The NIH 4 Cs of Studying Sex to Strengthen Science.
834:American Journal of Physiology. Renal Physiology 570:American Journal of Physiology. Cell Physiology 3002: 2587: 1881: 1350: 8: 2546:Sexuality and gender identity-based cultures 952:"Sex and basic science. A Title IX position" 418:"Sex & Gender: Questions & Answers" 156:encouraged the use of SABV by researchers. 3009: 2995: 2987: 2594: 2580: 2572: 2258: 1916: 1888: 1874: 1866: 1562: 1357: 1343: 1335: 180:in 2016 explaining SABV in clinical trials 1298: 1233: 1101: 1083: 1042: 1024: 983: 910: 861: 804: 731: 682: 597: 494: 476: 393: 272: 1649:Preventable fraction among the unexposed 1645:Attributable fraction for the population 1170:Neuroscience & Biobehavioral Reviews 624:Annali dell'Istituto Superiore di SanitĆ  1653:Preventable fraction for the population 1641:Attributable fraction among the exposed 224: 144:European Association of Science Editors 93:Canadian Institutes of Health Research 32:Canadian Institutes of Health Research 7: 1816:Correlation does not imply causation 1732:Animal testing on non-human primates 566:"Do you know the sex of your cells?" 424:Office of Research on Women's Health 294: 292: 234: 232: 230: 228: 2690:Heterogametic sex / Homogametic sex 1328:from websites or documents of the 887:"NIH policy: Mandate goes too far" 14: 714:Clayton, Janine A. (2018-04-01). 3057: 2971: 2970: 2764:Evolution of sexual reproduction 2461:Attraction to transgender people 1324: This article incorporates 1319: 885:Fields, R. Douglas (June 2014). 671:Journal of Neuroscience Research 440: 318: 149:Journal of Neuroscience Research 1182:10.1016/j.neubiorev.2014.01.001 3192:Age disparity in relationships 2872:Sexual reproduction in animals 1699:Pre- and post-test probability 1421:Patient and public involvement 239:Lee, Suk Kyeong (April 2018). 137:American Physiological Society 1: 2551:Social construction of gender 1330:National Institutes of Health 1139:10.1126/science.327.5973.1571 733:10.1016/j.physbeh.2017.08.012 665:Prager, Eric M (2017-01-02). 307:National Institutes of Health 97:National Institutes of Health 36:National Institutes of Health 2744:Sex as a biological variable 2727:Simultaneous hermaphroditism 2536:Sex as a biological variable 1826:Sex as a biological variable 478:10.1371/journal.pbio.1000412 257:10.5483/BMBRep.2018.51.4.034 209:Food and Drug Administration 47:Public research institutions 20:Sex as a biological variable 1790:Intention-to-treat analysis 1762:Analysis of clinical trials 1691:Specificity and sensitivity 1445:Randomized controlled trial 846:10.1152/ajprenal.00575.2019 3314: 2882:Penile-vaginal intercourse 2722:Sequential hermaphroditism 2451:Androphilia and gynephilia 1013:Biology of Sex Differences 968:10.1152/ajpregu.00251.2014 582:10.1152/ajpcell.00281.2013 194:female reproductive system 77:sex and gender differences 3298:Sex differences in humans 3055: 3018:Sex differences in humans 2966: 2712:Testis-determining factor 1834: 1799:Interpretation of results 1532:Nested caseā€“control study 1271:Journal of Women's Health 1026:10.1186/s13293-014-0015-5 720:Physiology & Behavior 2653:Sex-determination system 1999:Non-binary / genderqueer 1401:Academic clinical trials 535:10.1152/ajpgi.00101.2012 205:Office on Women's Health 2561:Transgender archaeology 1619:Relative risk reduction 1467:Adaptive clinical trial 1411:Evidence-based medicine 1394:Adaptive clinical trial 3159:Emotional intelligence 3032:Sexual differentiation 2636:Sexual differentiation 2556:Split attraction model 2541:Sexā€“gender distinction 1607:Number needed to treat 1326:public domain material 181: 111: 68: 2678:Temperature-dependent 2531:Queer heterosexuality 1611:Number needed to harm 1498:Cross-sectional study 1450:Scientific experiment 1406:Clinical study design 1283:10.1089/jwh.2019.8247 773:"Osteoporosis in Men" 178:Janine Austin Clayton 176: 154:ICMJE recommendations 109: 73:Institute Of Medicine 63: 2511:Anti-gender movement 2486:Romantic orientation 1577:Cumulative incidence 1226:10.1210/en.2004-1142 1085:10.1096/fj.14-269548 789:10.1210/er.2008-0002 636:10.4415/ANN_16_02_05 2894:Hormonal motivation 2867:Fungal reproduction 2786:Reproductive system 2263:Sexual orientations 1994:Masculine of center 1484:Observational study 1416:Real world evidence 1370:experimental design 1133:(5973): 1571ā€“1572. 903:2014Natur.510..340F 519:Miller, Virginia M. 366:Collins, Francis S. 123:Scientific journals 89:European Commission 28:European Commission 2899:Human reproduction 2877:Sexual intercourse 2862:Plant reproduction 2384:Same gender loving 2295:Alternative labels 1770:Riskā€“benefit ratio 1737:First-in-man study 1687:Case fatality rate 1528:Caseā€“control study 1502:Longitudinal study 362:Clayton, Janine A. 182: 112: 69: 3275: 3274: 3247:Gender inequality 2984: 2983: 2904:Lordosis behavior 2619:Sexual dimorphism 2569: 2568: 2516:Gender assignment 2499: 2498: 2244: 2243: 1984:Gender neutrality 1863: 1862: 1811:Survivorship bias 1775:Systematic review 1742:Multicenter trial 1705: 1704: 1695:Likelihood-ratios 1667:Clinical endpoint 1635:Population impact 1589:Period prevalence 1366:Clinical research 1072:The FASEB Journal 777:Endocrine Reviews 684:10.1002/jnr.23979 203:In 2020, the NIH 174: 133:ARRIVE guidelines 61: 3305: 3293:Medical research 3090:Mental disorders 3061: 3011: 3004: 2997: 2988: 2974: 2973: 2934:Animal sexuality 2857:Sexual selection 2596: 2589: 2582: 2573: 2359:Non-heterosexual 2259: 1917: 1890: 1883: 1876: 1867: 1710:Trial/test types 1585:Point prevalence 1563: 1506:Ecological study 1489:EBM II-2 to II-3 1460:Open-label trial 1455:Blind experiment 1431:Controlled study 1359: 1352: 1345: 1336: 1323: 1322: 1313: 1312: 1302: 1262: 1256: 1255: 1237: 1220:(4): 1650ā€“1673. 1208: 1202: 1201: 1165: 1159: 1158: 1122: 1116: 1115: 1105: 1087: 1078:(5): 1646ā€“1652. 1063: 1057: 1056: 1046: 1028: 1004: 998: 997: 987: 962:(4): R361ā€“R365. 947: 941: 940: 914: 882: 876: 875: 865: 840:(2): F329ā€“F331. 825: 819: 818: 808: 768: 762: 761: 735: 711: 705: 704: 686: 662: 656: 655: 618: 612: 611: 601: 561: 555: 554: 529:(9): G907ā€“G908. 515: 509: 508: 498: 480: 456: 450: 444: 443: 439: 437: 436: 427:. Archived from 414: 408: 407: 397: 358: 352: 351: 349: 348: 334: 328: 322: 321: 317: 315: 314: 304: 296: 287: 286: 276: 236: 213:Bench-to-Bedside 175: 81:generalizability 65:Gillian Einstein 62: 3313: 3312: 3308: 3307: 3306: 3304: 3303: 3302: 3278: 3277: 3276: 3271: 3218: 3126: 3110:Substance abuse 3085:Life expectancy 3062: 3053: 3020: 3015: 2985: 2980: 2962: 2949:Differentiation 2939:Human sexuality 2929:Plant sexuality 2915: 2811:Spermatogenesis 2755: 2748: 2611: 2605: 2600: 2570: 2565: 2495: 2446:Analloeroticism 2429: 2425:Heterosociality 2393: 2290: 2253: 2251: 2240: 2055: 2047: 1989:Gender variance 1979:Gender fluidity 1911: 1904: 1894: 1864: 1859: 1830: 1794: 1756: 1701: 1655: 1629: 1603:Risk difference 1591: 1552: 1486: 1478: 1433: 1425: 1389:Trial protocols 1372: 1363: 1333: 1320: 1317: 1316: 1264: 1263: 1259: 1210: 1209: 1205: 1167: 1166: 1162: 1124: 1123: 1119: 1065: 1064: 1060: 1006: 1005: 1001: 949: 948: 944: 912:10.1038/510340a 884: 883: 879: 827: 826: 822: 770: 769: 765: 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2296: 2292: 2291: 2289: 2288: 2283: 2278: 2273: 2267: 2265: 2256: 2246: 2245: 2242: 2241: 2239: 2238: 2233: 2228: 2226:Vakasalewalewa 2223: 2218: 2213: 2208: 2203: 2198: 2193: 2188: 2183: 2178: 2173: 2168: 2163: 2158: 2153: 2148: 2143: 2138: 2133: 2128: 2123: 2118: 2117: 2116: 2106: 2101: 2096: 2095: 2094: 2091: 2088: 2080: 2075: 2070: 2065: 2059: 2057: 2049: 2048: 2046: 2045: 2040: 2039: 2038: 2033: 2028: 2018: 2013: 2012: 2011: 2001: 1996: 1991: 1986: 1981: 1976: 1971: 1966: 1961: 1956: 1951: 1946: 1941: 1936: 1931: 1925: 1923: 1914: 1906: 1905: 1895: 1893: 1892: 1885: 1878: 1870: 1861: 1860: 1858: 1857: 1854:List of topics 1850: 1843: 1835: 1832: 1831: 1829: 1828: 1823: 1818: 1813: 1808: 1806:Selection bias 1802: 1800: 1796: 1795: 1793: 1792: 1787: 1782: 1777: 1772: 1766: 1764: 1758: 1757: 1755: 1754: 1749: 1744: 1739: 1734: 1729: 1727:Animal testing 1724: 1719: 1713: 1711: 1707: 1706: 1703: 1702: 1679:Mortality rate 1665: 1663: 1657: 1656: 1639: 1637: 1631: 1630: 1601: 1599: 1593: 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2756:reproduction 2743: 2705:Y chromosome 2700:X chromosome 2646:Virilization 2641:Feminization 2535: 2521:Gender roles 2466:Kinsey scale 2456:Aromanticism 2332:Gray asexual 2281:Heterosexual 2206:Sworn virgin 2176:Mukhannathun 2078:Binabinaaine 1852: 1845: 1838: 1825: 1627:Hazard ratio 1511:Cohort study 1274: 1270: 1260: 1217: 1213: 1206: 1173: 1169: 1163: 1130: 1126: 1120: 1075: 1071: 1061: 1016: 1012: 1002: 959: 955: 945: 894: 890: 880: 837: 833: 823: 780: 776: 766: 723: 719: 709: 674: 670: 660: 627: 623: 616: 573: 569: 559: 526: 522: 513: 468: 465:PLOS Biology 464: 454: 433:. 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Index

European Commission
Canadian Institutes of Health Research
National Institutes of Health
Gillian Einstein
Institute Of Medicine
sex and gender differences
generalizability
sex
European Commission
Canadian Institutes of Health Research
National Institutes of Health

animal study
National Centre for the Replacement, Refinement and Reduction of Animals in Research
ARRIVE guidelines
American Physiological Society
European Association of Science Editors
Journal of Neuroscience Research
ICMJE recommendations
Janine Austin Clayton
basic research
female reproductive system
estrous cycle
Office on Women's Health
Food and Drug Administration
Bench-to-Bedside



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