References

AAMC (Association of American Medical Colleges). 2020. The State of Women in Academic Medicine 2018–2019: Exploring Pathways to Equity. Washington, DC: AAMC.

ACC (American College of Cardiology). 2022. Clinical Trials Research: Upping Your Game. Professional Development for Cardiologists and PhD Researchers Seeking to Succeed in Clinical Research. https://www.acc.org/CTR2020.

ACD (Advisory Committee to the NIH Director). 2015. “Participant Engagement and Health Equity Workshop Summary.” ACD Precision Medicine Initiative Working Group Public Workshop, July 1–2, 2015, National Institutes of Health. http://www.nih.gov/precisionmedicine/2015-07-01-workshop-summary.pdf.

Adeyemi, O. F., A. T. Evans, and M. Bahk. 2009. HIV-infected adults from minority ethnic groups are willing to participate in research if asked. AIDS Patient Care and STDs 23(10):859–865.

Agnew, B. 1998. NIH embraces citizens’ council to cool debate on priorities. Science 282(5386):18–19.

AHRQ (Agency for Healthcare Research and Quality). 2021. AHRQ Policy on the Inclusion of Priority Populations in Research. https://www.ahrq.gov/topics/individuals-special-health-care-needs.html#:~:text=The%20AHRQ%20Policy%20on%20the%20Inclusion%20of%20Priority,and%20justification%20is%20provided%20that%20inclusion%20is%20inappropriate.

AIM (Alzheimer’s Impact Movement). 2020. Race, Ethnicity, and Alzheimer’s: Fact Sheet. https://www.alz.org/aaic/downloads2020/2020_Race_and_Ethnicity_Fact_Sheet.pdf.

Aitken, M., M. Kleinrick, E. Munoz, and U. Porwal. 2019. Orphan Drugs in the United States: Rare Disease Innovation and Cost Trends Through 2019. IQVIA. https://rarediseases.org/wp-content/uploads/2021/03/orphan-drugs-in-theunited-states-NRD-2020.pdf. Published December 3, 2020.

Alcaraz, K. I., N. L. Weaver, E. M. Andresen, K. Christopher, and M. W. Kreuter. 2011. The neighborhood voice: Evaluating a mobile research vehicle for recruiting African Americans to participate in cancer control studies. Evaluation and the Health Professions 34(3):336–348.

Alhajji, M., S. B. Bass, A. Nicholson, A. Washington, L. Maurer, D. M. Geynisman, and L. Fleisher. 2020. Comparing perceptions and decisional conflict towards participation in cancer clinical trials among African American patients who have and have not participated. Journal of Cancer Education 37(2):395–404.

Alsan, M., and S. Eichmeyer. 2021. Experimental evidence on the effectiveness of non-experts for improving vaccine demand. National Bureau of Economic Research Working Paper No. 28593. https://www.nber.org/papers/w28593.

Alsan, M., O. Garrick, and G. Graziani. 2019. Does diversity matter for health? Experimental evidence from Oakland. American Economic Review 109(12):4071–4111.

Ambrosius, W. T., K. M. Sink, C. G. Foy, D. R. Berlowitz, A. K. Cheung, W. C. Cushman, L. J. Fine, D. C. Goff, K. C. Johnson, A. A. Killeen, C. E. Lewis, S. Oparil, D. M. Reboussin, M. V. Rocco, J. K. Snyder, J. D. Williamson, J. T. Wright, and P. K. Whelton. 2014. The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: The systolic blood pressure intervention trial (SPRINT). Clinical Trials 11(5):532–546.

Anderson, G. D. 2005. Sex and racial differences in pharmacological response: Where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics. Journal of Women’s Health 14(1):19–29.

Arega, A., N. J. O. Birkmeyer, J. D. N. Lurie, T. Tosteson, J. Gibson, B. A. Taylor, T. S. Morgan, and J. N. Weinstein. 2006. Racial variation in treatment preferences and willingness to randomize in the spine patient outcomes research trial (SPORT). Spine 31(19):2263–2269.

Arnegard, M. E., L. A. Whitten, C. Hunter, and J. A. Clayton. 2020. Sex as a biological variable: A 5-year progress report and call to action. Journal of Women’s Health 29(6):858–864.

Artiga, S., J. Kates, J. Michaud, L. Hill. 2021. Racial diversity within covid-19 vaccine clinical trials: Key questions and answers. KFF Health Policy. https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers.

Ashford, M.T., J. Eichenbaum, T. Williams, M. R. Camacho, J. Fockler, A. Ulbricht, D. Flenniken, D. Truran, R. S. Mackin, M. W. Weiner, and R. L. Nosheny. 2020. Effects of sex, race, ethnicity, and education on online aging research participation. Alzheimers Dementia (N Y). 6(1):e12028.

Assmann, S. F., S. J. Pocock, L. E. Enos, and L. E. Kasten. 2000. Subgroup analysis and other (mis) uses of baseline data in clinical trials. The Lancet 355(9209):1064–1069.

AuYoung, M., P. Rodriguez Espinosa, W. T. Chen, P. Juturu, M. T. Young, A. Casillas, P. Adkins-Jackson, S. Hopfer, E. Kissam, A. K. Alo, R. A. Vargas, and A. F. Brown. 2022. Addressing racial/ethnic inequities in vaccine hesitancy and uptake: lessons learned from the California alliance against COVID-19. Journal of Behavioral Medicine 22:1–14.

Azar, K. M., M. R. Moreno, E. C. Wong, J. J. Shin, C. Soto, and L. P. Palaniappan. 2012. Accuracy of data entry of patient race/ethnicity/ancestry and preferred spoken language in an ambulatory care setting. Health Services Research 47:228–240.

Azfar-e-Alam, S., A. Sikorskii, C. W. Given, and B. Given. 2008. Early participant attrition from clinical trials: Role of trial design and logistics. Clinical Trials 5(4):328–335.

Baca, E., M. Garcia-Garcia, and A. Porras-Chavarino. 2004. Gender differences in treatment response to sertraline versus imipramine in patients with nonmelancholic depressive disorders. Progress in Neuro-Psychopharmacol and Biological Psychiatry 28(1):57–65.

Bahrampour, T., and T. Mellnik. 2021. Census data shows widening diversity; number of white people falls for first time. https://www.washingtonpost.com/dc-md-va/2021/08/12/census-data-race-ethnicity-neighborhoods/.

Bano, S., S. Akhter, and M. I. Afridi. 2004. Gender based response to fluoxetine hydrochloride medication in endogenous depression. Journal of College Physicians and Surgeons Pakistan 14(3):161–165.

Barnes, L. L., and D. A. Bennett. 2014. Alzheimer’s disease in African Americans: Risk factors and challenges for the future. Health Affairs 33(4):580–586.

Bazan, I. S., and K. M. Akgün. 2021. COVID-19 healthcare inequity: Lessons learned from annual influenza vaccination rates to mitigate COVID-19 vaccine disparities. Yale Journal of Biology and Medicine 94(3):509–515.

Becker, G. S., T. J. Philipson, and R. R. Soares. 2005. The quantity and quality of life and the evolution of world inequality. American Economic Review 95(1):277–291.

Becker, J. 2021. Excluding pregnant people from clinical trials reduces patient safety and autonomy. Harvard Law “Bill of Health” (blog), posted April 16, 2021. https://blog.petrieflom.law.harvard.edu/2021/04/16/pregnant-clinical-trials-safety-autonomy/.

Beglinger, C. 2008. Ethics related to drug therapy in the elderly. Digestive Diseases 26(1):28–31.

Behringer-Massera, S., T. Browne, G. George, S. Duran, A. Cherrington, M. D. McKee, and GRADE Research Group. 2019. Facilitators and barriers to successful recruitment into a large comparative effectiveness trial: A qualitative study. Journal of Comparative Effectiveness Research 8(10):815–826.

BeLue, R., K. D. Taylor-Richardson, J. Lin, A. T. Rivera, and D. Grandison. 2006. African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender. Contemporary Clinical Trials 27(6):498–505.

Berkowitz, S. T., S. L. Groth, S. Gangaputra, and S. Patel. 2021. Racial/ethnic disparities in ophthalmology clinical trials resulting in US Food and Drug Administration drug approvals from 2000 to 2020. JAMA Ophthalmology139(6):629–637.

Bieniasz, M. E., D. Underwood, J. Bailey, and M. T. Ruffin IV. 2003. Women’s feedback on a chemopreventive trial for cervical dysplasia. Applied Nursing Research 16(1):22–28.

Bierer, B. E., S. A. White, L. Meloney, H. Ahmed, D. H. Strauss, and L. T. Clark. 2020. Achieving Diversity, Inclusion, and Equity in Clinical Research: Guidance Document and Supplementary Toolkit. Cambridge, MA: MRCT Center.

Bishop, W. P., J. A. Tiro, S. J. C. Lee, C. M. Bruce, and C. S. Skinner. 2011. Community events as viable sites for recruiting minority volunteers who agree to be contacted for future research. Contemporary Clinical Trials 32(3):369–371.

Bistricky, S. L., R. S. MacKin, J. P. Chu, and P. A. Areán. 2010. Recruitment of African Americans and Asian Americans with late-life depression and mild cognitive impairment. American Journal of Geriatric Psychiatry 18(8):734–742.

Blehar, M. C., C. Spong, C. Grady, S. F. Goldkind, L. Sahin, and J. A. Clayton. 2013. Enrolling pregnant women: Issues in clinical research. Womens Health Issues 23(1):e39–45.

Boehmer U., N. R. Kressin, D. R. Berlowitz, C. L. Christiansen, L. E. Kazis, and J. A. Jones. 2002. Self-reported vs administrative race/ethnicity data and study results. American Journal of Public Health 92(9):1471–1472.

Boise, L., L. Hinton, H. J. Rosen, and M. Ruhl. 2017. Will my soul go to heaven if they take my brain? Beliefs and worries about brain donation among four ethnic groups. Gerontologist 57(4):719–734.

Boissel, J.-P., F. Gueyffier, and M. Haugh. 1995. Response to “inclusion of women and minorities in clinical trials and the NIH revitalization act of 1993—the perspective of NIH clinical trialists.” Controlled Clinical Trials 16(5):286–288.

Bonevski, B., M. Randell, C. Paul, K. Chapman, L. Twyman, J. Bryant, I. Brozek, and C. Hughes. 2014. Reaching the hard-to-reach: A systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC Medical Research Methodology 14:42.

Borno, H., D. J. George, L. E. Schnipper, F. Cavalli, T. Cerny, and S. Gillessen. 2019. All men are created equal: Addressing disparities in prostate cancer care. American Society of Clinical Oncology Educational Book 39:302–308.

Bothwell, L. E., J. A. Greene, S. H. Podolsky, and D. S. Jones. 2016. Assessing the gold standard—lessons from the history of RCTs. New England Journal of Medicine 374(22):2175–2181.

Boyatzis, R. 1998. Transforming Qualitative Information: Thematic Analysis and Code Development. Thousand Oaks, CA: SAGE Publications.

Brandt, A. M. 1978. Racism and research: The case of the Tuskegee syphilis study. The Hastings Center Report 8(6):21–29.

Brantnell, A., E. Baraldi, T. van Achterberg, and U. Winblad. 2015. Research funders’ roles and perceived responsibilities in relation to the implementation of clinical research results: A multiple case study of Swedish research funders. Implementation Science 10(1):100.

Braunstein, J. B., N. S. Sherber, S. P. Schulman, E. L. Ding, and N. R. Powe. 2008. Race, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials. Medicine 87(1):1–9.

Brick-Hezeau, E. 2019. Who gets a say? Women and the AIDS crisis. Women Leading Change: Case Studies on Women, Gender, and Feminism 4(2). Tulane University Press.

Brown, D. R., M. N. Fouad, K. Basen-Engquist, and G. Tortolero-Luna. 2000. Recruitment and retention of minority women in cancer screening, prevention, and treatment trials. Annals of Epidemiology 10(8):S13–S21.

Brown, R. F., D. L. Cadet, R. H. Houlihan, M. D. Thomson, E. C. Pratt, A. Sullivan, and L. A. Siminoff. 2013. Perceptions of participation in a phase I, II, or III clinical trial among African American patients with cancer: What do refusers say? Journal of Oncology Practice 9(6):287–293.

Buchbinder, S. P., B. Metch, S. E. Holte, S. Scheer, A. Coletti, and E. Vittinghoff. 2004. Determinants of enrollment in a preventive HIV vaccine trial: Hypothetical versus actual willingness and barriers to participation. Journal of Acquired Immune Deficiency Syndromes 36(1):604–612.

Buck, D. S., D. Rochon, H. Davidson, and S. McCurdy. 2004. Involving homeless persons in the leadership of a health care organization. Qualitative Health Research 14(4):513–525.

Bussey-Jones, J., J. Garrett, G. Henderson, M. Moloney, C. Blumenthal, and G. Corbie-Smith. 2010. The role of race and trust in tissue/blood donation for genetic research. Genetics in Medicine 12(2):116–121.

Butler, J., S. C. Quinn, C. S. Fryer, M. A. Garza, K. H. Kim, and S. B. Thomas. 2013. Characterizing researchers by strategies used for retaining minority participants: Results of a national survey. Contemporary Clinical Trials 36(1):61–67.

Byrd, G. S., C. L. Edwards, V. A. Kelkar, R. G. Phillips, J. R. Byrd, D. S. Pim-Pong, T. D. Starks, A. L. Taylor, R. E. McKinley, Y.-J. Li, and M. Pericak-Vance. 2011. Recruiting intergenerational African American males for biomedical research studies: A major research challenge. Journal of the National Medical Association 103(6):480–487.

Byrne, J. J., A. M. Saucedo, and C. Y. Spong. 2020. Task force on research specific to pregnant and lactating women. Seminars in Perinatology 44(3):151226.

Byrne, M. M., S. L. Tannenbaum, S. Glück, J. Hurley, and M. Antoni. 2014. Participation in cancer clinical trials: Why are patients not participating? Medical Decision Making 34(1):116–126.

Calderon, J. L., R. S. Baker, H. Fabrega, J. G. Conde, R. D. Hays, E. Fleming, and K. Norris. 2006. An ethno-medical perspective on research participation: A qualitative pilot study. MedGenMed 8(2):23.

Califf, R. M., D. A. Zarin, J. M. Kramer, R. E. Sherman, L. H. Aberle, and A. Tasneem. 2012. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007–2010. JAMA 307(17):1838–1847.

Canavan, C., S. Grossman, R. Kush, and J. Walker. 2006. Integrating recruitment into eHealth patient records. Applied Clinical Trials 0(0). https://www.appliedclinicaltrialsonline.com/view/integrating-recruitment-ehealth-patient-records.

Carapinha, R., C. M. McCracken, E. T. Warner, E. V. Hill, and J. Y. Reede. 2017. Organizational context and female faculty’s perception of the climate for women in academic medicine. Journal of Women’s Health 26(5):549–559.

Carcel, C., and M. Reeves. 2021. Under-enrollment of women in stroke clinical trials. Stroke 2021 52:452–457.

Carratala, S., and C. Maxwell. 2020. Health disparities by race and ethnicity. https://cdn.americanprogress.org/content/uploads/2020/05/06130714/HealthRace-factsheet.pdf?_ga=2.194956205.1806611089.1627327183-1860413079.1627327183.

Castillo-Mancilla, J. R., S. E. Cohn, S. Krishnan, M. Cespedes, M. Floris-Moore, G. Schulte, G. Pavlov, D. Mildvan, and K. Y. Smith; the ACTG Underrepresented Populations Survey Group. 2014. Minorities remain underrepresented in HIV/AIDS research despite access to clinical trials. HIV Clinical Trials 15(1):14–26.

CDC (Centers for Disease Control and Prevention). 1995. Policy on the inclusion of women and racial and ethnic minorities in externally awarded research. Federal Register 60:47947–47951.

CDC. 1996. Inclusion of women and racial and ethnic minorities in research. C.F.R. Part 46.

CDC. 1997. CDC procedures for protection of human research participants. https://www.cdc.gov/os/integrity/hrpo/index.htm.

CDC. 2010. Inclusion of women and racial and ethnic minorities in research. CDC-GA-1996-01, C.F.R. Part 46.

CDC. 2011. Inclusion of persons under the age of 21 in research. CDC-GA-2006-01. https://www.cdc.gov/Maso/Policy/policy496.pdf.

CDC. 2020. Disparities. https://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities.

Ceballos, R. M., S. Knerr, M. A. Scott, S. D. Hohl, R. C. Malen, H. Vilchis, and B. Thompson. 2014. Latino beliefs about biomedical research participation: A qualitative study on the U.S.-Mexico border. Journal of Empirical Research on Human Research Ethics 9(4):10–21.

Census (U.S. Census Bureau). 2018. Hispanic population to reach 111 million by 2060. https://www.census.gov/library/visualizations/2018/comm/hispanic-projected-pop.html.

Census. 2019. TheAmerican Community Survey 2005–2019. https://www.census.gov/programs-surveys/acs/.

Chen, B., H. Jin, Z. Yang, Y. Qu, H. Weng, and T. Hao. 2019. An approach for transgender population information extraction and summarization from clinical trial text. BMC Medical Informatics and Decision Making 19(Suppl. 2):62.

Chen, M. S. Jr., P. N. Lara, J. H. Dang, D. A. Paterniti, and K. Kelly. 2014. Twenty years post-NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual: Renewing the case for enhancing minority participation in cancer clinical trials. Cancer 120:1091–1096.

Choi, E., G. J. Heo, Y. Song, and H.-R. Han. 2016. Community health worker perspectives on recruitment and retention of recent immigrant women in a randomized clinical trial. Family & Community Health 39(1):53–61.

Clark, H. 2013. Towards a more robust investment framework for health. Lancet 382(9908):e36–37.

Clark, L. T., L. Watkins, I. L. Piña, M. Elmer, O. Akinboboye, M. Gorham, B. Jamerson, C. McCullough, C. Pierre, A. B. Polis, G. Puckrein, and J. M. Regnante. 2019. Increasing diversity in clinical trials: Overcoming critical barriers. Current Problems in Cardiology 44(5):148–172.

Clayton, J. A. 2021. The NIH SABV policy: E-learning opportunities and a symposium provide guidance and inspiration. https://nexus.od.nih.gov/all/2021/04/12/the-nih-sabv-policy-e-learning-opportunities-and-a-symposium-provide-guidance-and-inspiration/.

Clayton, J. A., and F. S. Collins. 2014. Policy: NIH to balance sex in cell and animal studies. Nature News 509(7500):282.

CMS (Centers for Medicare & Medicaid Services). n.d. Coverage with Evidence Development. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development.

CMS. 2014b. Medicare Coverage Database: Transcatheter Mitral Valve Repair (TMVR). CAG-00438N. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=273.

CMS. 2000. 2000 National Coverage Determination (NCD). Routine Costs in Clinical Trials. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=1&ncdver=1&fromdb=true.

CMS. 2007. 2007 National Coverage Determination (NCD). Routine Costs in Clinical Trials. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=1&fromdb=true.

CMS. 2014a. Guidance for the public, industry, and CMS staff: Coverage with evidence development. https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?MCDId=27.

Coakley, M., E. O. Fadiran, L. J. Parrish, R. A. Griffith, E. Weiss, and C. Carter. 2012. Dialogues on diversifying clinical trials: Successful strategies for engaging women and minorities in clinical trials. Journal of Women’s Health 21(7):713–716.

Coburn, A., A. C. Mackinney, T. McBride, K. Mueller, R. Slifkin, and M. Wakefield. 2017. Choosing Rural Definitions: Implications for Health Policy. Issue Brief No. 2. Omaha, NE: Rural Policy Research Institute Health Panel. https://digitalcommons.usm.maine.edu/insurance/60/.

Cohen, J. C., E. Boerwinkle, T. H. Mosley, and H. H. Hobbs. 2006. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. New England Journal of Medicine 354(12):1264–1272.

Collins, F. S., and H. Varmus. 2015. A new initiative on precision medicine. New England Journal of Medicine 372(9):793–795.

COMMITTEE ON DRUGS, Kathleen A. Neville, Daniel A.C. Frattarelli, Jeffrey L. Galinkin, Thomas P. Green, Timothy D. Johnson, MMM, Ian M. Paul, John N. Van Den Anker. 2014. Off-Label Use of Drugs in Children. Pediatrics 133 (3): 563–567.

Corbie-Smith, G., S. B. Thomas, and D. M. St. George. 2002. Distrust, race, and research. Archives of Internal Medicine 162(21):2458–2463.

Cornwall, A., and R. Jewkes. 1995. What is participatory research? Social Science & Medicine 41(12):1667–1676.

Coronado, G. D., S. Ondelacy, Y. Schwarz, C. Duggan, J. W. Lampe, and M. L. Neuhouser. 2012. Recruiting underrepresented groups into the Carbohydrates and Related Biomarkers (CARB) cancer prevention feeding study. Contemporary Clinical Trials 33(4):641–646.

Cotton, P. 1990. Examples abound of gaps in medical knowledge because of groups excluded from scientific study. JAMA 263(8):1051, 1055.

Crawley, F. P., R. Kurz, and H. Nakamura. 2003. Testing medications in children. New England Journal of Medicine 348(8):763–764; author’s reply 763–764.

Crenshaw, K. 2017. On Intersectionality: Essential Writings. New York: The New Press.

Crocker, J. C., I. Ricci-Cabello, A. Parker, J. A. Hirst, A. Chant, S. Petit-Zeman, D. Evans, and S. Rees. 2018. Impact of patient and public involvement on enrolment and retention in clinical trials: Systematic review and meta-analysis. BMJ:k4738.

Cummins, N. W., J. Neuhaus, H. Chu, J. Neaton, C. Wyen, J. K. Rockstroh, D. J. Skiest, M. A. Boyd, S. Khoo, M. Rotger, A. Telenti, R. Weinshillboum, and A. D. Badley. 2015. Investigation of efravirenz discontinuation in multi-ethnic populations of HIV-positive individuals by genetic analysis. eBioMedicine 2(7):706–712.

Curry, L., and J. Jackson. 2003. The science of including older ethnic and racial group participants in health-related research. Gerontologist 43(1):15–17.

DHEW (U.S. Department of Health, Education, and Welfare). 1979. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Office for Human Research Protections, Department of Health and Human Services.

Dilworth-Anderson, P. 2011. Introduction to the science of recruitment and retention among ethnically diverse populations. Gerontologist 51(Suppl. 1):S1–S4.

DiPietro, N. A., and K. A. Liu. 2016. Women’s involvement in clinical trials: Historical perspective and future implications. Pharmacy Practice (Granada) 14(1):5.

Dohan, D., and D. Schrag. 2005. Using navigators to improve care of underserved patients. Cancer 104(4):848–855.

DOL (Department of Labor). 2020. Earnings. https://www.dol.gov/agencies/wb/data/earnings.

Domecq, J. P., G. Prutsky, T. Elraiyah, Z. Wang, M. Nabhan, N. Shippee, J. P. Brito, K. Boehmer, R. Hasan, B. Firwana, P. Erwin, D. Eton, J. Sloan, V. Montori, N. Asi, A. M. Abu Dabrh, and M. H. Murad. 2014. Patient engagement in research: A systematic review. BMC Health Services Research 14(1):89.

Drozda, K., S. Wong, S. R. Patel, A. P. Bress, E. A. Nutescu, R. A. Kittles, and L. H. Cavallari. 2015. Poor warfarin dose prediction with pharmacogenetic algorithms that exclude genotypes important for African Americans. Pharmacogenetics and Genomics 25(2):73–81.

Duma, N., J. V. Aguilera, J. Paludo, C. Haddox, M. G. Velez, Y. Wang, K. Leventakos, J. Hubbard, A. Mansfield, R. Go, and A. Adjei. 2018. Representation of minorities and women in oncology clinical trials: Review of the past 14 years. Journal of Oncology Practice 14(1).

Durant, R. W., J. A. Wenzel, I. C. Scarinci, D. A. Paterniti, M. N. Fouad, T. C. Hurd, and M. Y. Martin. 2014. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT). Cancer 120 (0 7): 1097–1105. https://doi.org/10.1002/cncr.28574.

Eggly, S., E. Barton, A. Winckles, L. A. Penner, and T. L. Albrecht. 2015. A disparity of words: Racial differences in oncologist-patient communication about clinical trials. Health Expectations 18(5):1316–1326.

Ejiogu, N., J. H. Norbeck, M. A. Mason, B. C. Cromwell, A. B. Zonderman, and M. K. Evans. 2011. Recruitment and retention strategies for minority or poor clinical research participants: Lessons from the healthy aging in neighborhoods of diversity across the life span study. Gerontologist 51(Suppl. 1):S33–S45.

Emanuel, E. J. 2005. Undue inducement: Nonsense on stilts? American Journal of Bioethics 5(5):9–13; discussion W18-11, W17.

Ermini Leaf, D., B. Tysinger, D. P. Goldman, and D. N. Lakdawalla. 2021. Predicting quantity and quality of life with the future elderly model. Health Economics 30(Suppl. 1):52–79.

Eshera, N., H. Itana, L. Zhang, G. Soon, and E. O. Fadiran. 2015. Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA from 2010 to 2012. American Journal of Therapeutics 22(6):435–455.

Evans, M. K., J. M. Lepkowski, N. R. Powe, T. LaVeist, M. F. Kuczmarski, and A. B. Zonderman. 2010. Healthy aging in neighborhoods of diversity across the life span (HANDLS): Overcoming barriers to implementing a longitudinal, epidemiologic, urban study of health, race, and socioeconomic status. Ethnicity and Disease 20(3):267–275.

Executive Office of the President. 2021. Executive Order No. 13985: Advancing racial equity and support for underserved communities through the federal government. Washington, DC: The White House.

FDA (Food and Drug Administration). n.d. Descovy prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s017lbl.pdf.

FDA. 1977. General Considerations for the Clinical Evaluation of Drugs. https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/general-considerations-clinical-evaluation-drugs.

FDA. 1979. Labeling and Prescription Drug Advertising: Content and Format for Labeling for Human Prescription Drugs. Federal Register 44(124):434–467.

FDA. 1985. Content and Format of a New Drug Application. 21 C.F.R. 314.50 (d)(5)(v).

FDA. 1987. Guideline for the Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application.

FDA. 1988. Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-and-content-nonclinical-pharmacologytoxicology-section-application.

FDA. 1989. Guideline for the Study of Drugs Likely to be Used in the Elderly. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-drugs-likely-be-used-elderly.

FDA. 1993a. Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs; Notice. Federal Register 58(139):39406–39416.

FDA. 1993b. Guidance for Industry. https://www.fda.gov/media/72504/download.

FDA. 1998. Guidance for industry on population pharmacokinetics. Federal Register 68(28): 1854–1862.

FDA. 1999. Guidance for industry on population pharmacokinetics. Federal Register 64(27): 6663–6664.

FDA. 2002. Guidance for industry on establishing pregnancy exposure registries. Federal Register 67:59528.

FDA. 2004. Guidance for industry on pharmacokinetics in pregnancy-Study design, data analysis, and impact on dosing and labeling. Federal Register 69:63402–63403.

FDA. 2011a. Dialogues on diversifying clinical trials. September 22–23, 2011, Washington, DC.

FDA. 2011b. Guidance for industry: reproductive and developmental toxicities—integrating study results to assess concerns. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reproductive-and-developmental-toxicities-integrating-study-results-assess-concerns.

FDA. 2012. FDA Safety and Innovation Act (FDASIA) Section 907: Inclusion of Demographic Subgroups in Clinical Trials. https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/fdasia-section-907-inclusion-demographic-subgroups-clinical-trials#:~:text=Sec.%20907%20of%20the%20Food%20and%20Drug%20Administration,devices%2C%20submitted%20to%20the%20agency%20for%20marketing%20approval%3A.

FDA. 2013. Collection, analysis and availability of demographic subgroup data for FDA-approved medical products. https://www.fda.gov/files/about%20fda/published/Collection--Analysis--and-Availability-of-Demographic-Subgroup-Data-for-FDA-Approved-Medical-Products.pdf. or Washington, DC: Department of Health and Human Services.

FDA. 2014a. Evaluation of sex-specific data in medical device clinical studies: Guidance for industry and FDA staff. Docket No. FDA-2011-D-0817. Washington, DC: Department of Health and Human Services.

FDA. 2014b. FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. Washington, DC: Food and Drug Administration. https://www.fda.gov/media/89307/download.

FDA. 2016. Collection of race and ethnicity data in clinical trials: Guidance for industry and Food and Drug Administration staff. Docket No. FDA-2016-D-3561. Washington, DC: Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials.

FDA. 2017. Evaluation and Reporting of Age-, Race-, and Ethnicity –Specific Data in Medical Device Clinical Studies. Federal Register 82:42819–42821.

FDA. 2018. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials. Federal Register 83:15161–15162.

FDA. 2019. Meeting of the Antimicrobial Drugs Advisory Committee. https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/2019-meeting-materials-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs for list of dates.

FDA. 2020a. 2015–2019 Drug Trials Snapshots Summary Report: Five-year Summary and Analysis of Clinical Trial Participation and Demographics. https://www.fda.gov/media/143592/download. https://www.fda.gov/media/143592/download (accessed July 8th, 2021).

FDA. 2020b. Statement: FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development. Press Announcement, November 9, 2020. https://www.fda.gov/news-events/press-announcements/fda-offers-guidance-enhance-diversity-clinical-trials-encourage-inclusivity-medical-product.

FDA. 2020c. Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs. Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial.

FDA. 2020d. Are You Concerned about Clinical Trial Enrollment and Representation? SBIA Webinar, December 16, 2020. https://sbiaevents.com/files2/Diversity-Clinical-Trials-Slides.pdf.

FDA. 2021a. Guidances. https://www.fda.gov/industry/fda-basics-industry/guidances.

FDA. 2021b. Drug Trials Snapshots. https://www.fda.gov/drugs/drug-approvals-and-databases/drugtrials-snapshots.

Findley, S., S. Matos, A. Hicks, J. Chang, and D. Reich. 2014. Community health worker integration into the health care team accomplishes the triple aim in a patient-centered medical home: A Bronx tale. Journal of Ambulatory Care Management 37(1):82–91.

Fisher, C. B., and B. Mustanski. 2014. Reducing health disparities and enhancing the responsible conduct of research involving LGBT youth. Hastings Center Report 44(Suppl. 4):S28–S31. doi:10.1002/hast.367. PMID: 25231783; PMCID: PMC4617525.

Fisher, C. B., L. I. Puri, K. Macapagal, L. Feuerstahler, J. R. Ahn, and B. Mustanski. 2021. Competence to consent to oral and injectable PrEP trials among adolescent males who have sex with males. AIDS and Behavior 25:1606–1618. https://doi.org/10.1007/s10461-020-03077-9.

Fisher, K. 2019. Academic health centers save millions of lives. American Association of Medical Colleges. https://www.aamc.org/news-insights/academic-health-centers-save-millions-lives.

Fleurence, R. L., L. H. Curtis, R. M. Califf, R. Platt, J. V. Selby, and J. S. Brown. 2014. Launching PCORnet, a national patient-centered clinical research network. Journal of the American Medical Informatics Association 21(4):578–582.

Flores, L. E., W. R. Frontera, M. P. Andrasik, C. del Rio, A. Mondríguez-González, S. A. Price, E. M. Krantz, S. A. Pergam, and J. K. Silver. 2021. Assessment of the inclusion of racial/ethnic minority, female, and older individuals in vaccine clinical trials. JAMA Network Open 4(2):e2037640–e2037640.

Fontanarosa, P. B., A. Flanagin, J. Z. Ayanian, R. O. Bonow, N. M. Bressler, D. Christakis, M. L. Disis, S. A. Josephson, M. R. Kibbe, D. Öngür, J. F. Piccirillo, R. F. Redberg, F. P. Rivara, K. Shinkai, and C. W. Yancy. 2021. Equity and the JAMA Network. JAMA 326(7):618–620.

Ford, J. G., M. W. Howerton, G. Y. Lai, T. L. Gary, S. B. Mid, M. C. Gibbons, J. Tilburt, C. Baffi, T. P. Tanpitukpongse, R. F. Wilson, N. R. Powe, and E. B. Bass. 2008. Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer 112(2):228–242.

Ford, M., L. Siminoff, E. Pickelsimer, A. Mainous, D. Smith, V. Diaz, L. Soderstrom, M. Jefferson, and B. Tilley. 2013. Unequal burden of disease, unequal participation in clinical trials: Solutions from African American and Latino community members. Health & Social Work 38(1):29–38.

Forsythe, L. P., K. L. Carman, V. Szydlowski, L. Fayish, L. Davidson, D. H. Hickam, C. Hall, G. Bhat, D. Neu, L. Stewart, M. Jalowsky, N. Aronson, and C. U. Anyanwu. 2019. Patient engagement in research: Early findings from the Patient-Centered Outcomes Research Institute. Health Affairs 38(3):359–367.

Freedman, L. S., R. Simon, M. A. Foulkes, L. Friedman, N. L. Geller, D. J. Gordon, and R. Mowery. 1995. Perspective of NIH clinical trialists. Controlled Clinical Trials 16:277–285.

Freeman, H. P., B. J. Muth, and J. F. Kerner. 1995. Expanding access to cancer screening and clinical follow-up among the medically underserved. Cancer Practice 3(1):19–30.

Frew, P., D. Saint-Victor, M. Isaacs, S. Kim, G. Swamy, J. Sheffield, K. Edwards, T. Villafana, O. Kamagate, and K. Ault. 2014. Recruitment and retention of pregnant women into clinical research trials: An overview of challenges, facilitators, and best practices. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America 59(Suppl. 7).

Frey, W. 2019. Six Maps that Reveal America’s Expanding Racial Diversity. https://www.brookings.edu/research/americas-racial-diversity-in-six-maps/.

Friedman, D. J., B. B. Cohen, A. R. Averbach, and J. M. Norton. 2000. Race/ethnicity and OMB directive 15: Implications for state public health practice. American Journal of Public Health 90(11):1714.

Friedman, S. H., C. O. Cunningham, J. Lin, L. B. Haramati, and J. M. Levsky. 2020. Having a primary care provider is the strongest predictor of successful follow-up of participants in a clinical trial. Journal of the American Board of Family Medicine 33(3):431–439.

Frosch, D. L., and M. Tai-Seale. 2014. R-e-s-p-e-c-t—what it means to patients. Journal of General Internal Medicine 29(3):427–428.

Gadegbeku, C. A., P. K. Stillman, M. D. Huffman, J. S. Jackson, J. W. Kusek, and K. A. Jamerson. 2008. Factors associated with enrollment of African Americans into a clinical trial: Results from the African American study of kidney disease and hypertension. Contemporary Clinical Trials 29(6):837–842.

GAO (Government Accountability Office). 1992. FDA needs to ensure more study of gender differences in prescription drug testing. https://www.fda.gov/media/75639/download.

GAO. 2001. Women sufficiently represented in new drug testing but FDA oversight needs improvement. https://www.fda.gov/media/75566/download.

GAO. 2015. National Institutes of Health: Better Oversight Needed to Help Ensure Continued Progress Including Women in Health Research. Report to Congressional Requesters (GAO-16-13). Washington, DC: U.S. Government Accountability Office.

GAO. 2018a. Indian Health Service: Agency Faces Ongoing Challenges Filling Provider Vacancies. Report to Congressional Requesters (GAO-18-580). https://www.gao.gov/products/gao-18-580.

GAO. 2018b. Orphan Drugs: FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue. Report to Congress. https://www.gao.gov/assets/gao-19-83.pdf.

Garber, M., B. H. Hanusa, G. E. Switzer, J. Mellors, and R. M. Arnold. 2007. HIV-infected African Americans are willing to participate in HIV treatment trials. Journal of General Internal Medicine 22(1):17–42.

Garcia, M., S. L. Mulvagh, C. N. Merz, J. E. Buring, and J. E. Manson. 2016. Cardiovascular disease in women: Clinical perspectives. Circulation Research 118(8):1273–1293.

Garrison, N. A. 2013. Genomic justice for Native Americans. Science, Technology, & Human Values 38(2):201–223.

Geller, S. E., A. Koch, B. Pellettieri, and M. Carnes. 2011. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: Have we made progress? Journal of Women’s Health 20(3):315–320.

Geller, S. E., A. R. Koch, P. Roesch, A. Filut, E. Hallgren, and M. Carnes. 2018. The more things change, the more they stay the same: A study to evaluate compliance with inclusion and assessment of women and minorities in randomized controlled trials. Academic Medicine: Journal of the Association of American Medical Colleges 93(4):630.

Genetech Inc. 2020. A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants with Mild to Moderate Alzheimer’s Disease Treated with Crenezumab. https://www.clinicaltrials.gov/ct2/show/results/NCT01723826.

George, S., N. Duran, and K. Norris. 2014. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. American Journal of Public Health 104(2):e16–e31.

Giarelli, E., D. W. Bruner, E. Nguyen, S. Basham, P. Marathe, D. Dao, T. N. Huynh, J. Cappella, and G. Nguyen. 2011. Research participation among Asian American women at risk for cervical cancer: Exploratory pilot of barriers and enhancers. Journal of Immigrant and Minority Health 13(6):1055–1068.

Gilbert, A. L., Knopf, A. S., Fortenberry, J. D., Hosek, S. G., Kapogiannis, B. G., Zimet, G. D. 2015. Adolescent self-consent for biomedical human immunodeficency virus prevention research. Journal of Adolescent Health 57(1): 113-119.

Gilmore-Bykovskyi, A., J. D. Jackson, and C. H. Wilkins. 2021. The urgency of justice in research: Beyond COVID-19. Trends in Molecular Medicine 27(2):97–100.

Gilmore-Bykovskyi, A., Y. Jin, C. Gleason, S. Flowers-Benton, L. Block, P. Dilworth-Anderson, L. Barnes, M. Shah, and M. Zuelsdorff. 2019. Recruitment and retention of underrepresented populations in Alzheimer’s disease research: A systematic review. Alzheimer’s & Dementia (N Y) 5:751–770.

Giuliano, A., M. Papenfuss, J. D. de Zapien, S. Tilousi, and L. Nuvayestewa. 1998. Breast cancer screening among southwest American Indian women living on-reservation. Preventive Medicine 27(1):135–143.

Giuliano, A. R., N. Mokuau, C. Hughes, G. Tortolero-Luna, B. Risendal, R. C. S. Ho, T. E. Prewitt, and W. J. McCaskill-Stevens. 2000. Participation of minorities in cancer research: The influence of structural, cultural, and linguistic factors. Annals of Epidemiology 10(8):S22–S34.

Glantz, L. H. 1998. Research with children. American Journal of Law & Medicine 24(2–3):213–244.

Glasgow, R., A. Huebschmann, and R. Brownson. 2018. Expanding the consort figure: Increasing transparency in reporting on external validity. American Journal of Preventive Medicine 55(3):422–430.

GlobalData. 2021. Increased use of virtual trials has contributed to improved patient accrual rates, says GlobalData. https://www.globaldata.com/increased-use-virtual-trials-contributedimproved-patient-accrual-rates-says-globaldata/.

Gluck, M. A., A. Shaw, and D. Hill. 2018. Recruiting older African Americans to brain health and aging research through community engagement: Lessons from the African-American brain health initiative at Rutgers University-Newark. Generations 42(2):78–82.

Goldman, D., P.-C. Michaud, D. Lakdawalla, Y. Zheng, A. Gailey, and I. Vaynman. 2010. The fiscal consequences of trends in population health. National Tax Journal 63(2):307.

Goldman, D. P., D. Cutler, J. W. Rowe, P. C. Michaud, J. Sullivan, D. Peneva, and S. J. Olshansky. 2013. Substantial health and economic returns from delayed aging may warrant a new focus for medical research. Health Affairs (Millwood) 32(10):1698–1705.

Goldman, D. P., and P. R. Orszag. 2014. The growing gap in life expectancy: Using the future elderly model to estimate implications for Social Security and Medicare. American Economic Review 104(5):230–233.

Goldman, D. P., B. Shang, J. Bhattacharya, A. M. Garber, M. Hurd, G. F. Joyce, D. N. Lakdawalla, C. Panis, and P. G. Shekelle. 2005. Consequences of health trends and medical innovation for the future elderly: When demographic trends temper the optimism of biomedical advances, how will tomorrow’s elderly fare? Health Affairs 24(Suppl. 2):W5-R5–W5-R17.

Goldman, D. P., Y. Zheng, F. Girosi, P.-C. Michaud, S. J. Olshansky, D. Cutler, and J. W. Rowe. 2009. The benefits of risk factor prevention in Americans aged 51 years and older. American Journal of Public Health 99(11):2096–2101.

Gollin, L. X., R. C. Harrigan, J. L. Calderon, J. Perez, and D. Easa. 2005. Improving Hawaiian and Filipino involvement in clinical research opportunities: Qualitative findings from Hawai’i. Ethnicity & Disease 15(4 Suppl. 5):S5-111–119.

Gong, I., N. Tan, S. Ali, G. Lebovic, M. Mamdani, S. Goodman, D. Ko, A. Laupacis, and A. Yan. 2019. Temporal trends of women enrollment in major cardiovascular randomized clinical trials. Canadian Journal of Cardiology 35(5).

Green-Harris, G., S. L. Coley, R. L. Koscik, N. C. Norris, S. L. Houston, M. A. Sager, S. C. Johnson, and D. F. Edwards. 2019. Addressing disparities in Alzheimer’s disease and African-American participation in research: An asset-based community development approach. Frontiers in Aging Neuroscience 11:125.

Greer, T. 2015. Landmark study shows intensive blood pressure management may save lives. UAB News, Research & Innovation, September 11, 2015. https://www.uab.edu/news/research/item/6486-landmark-study-shows-intensive-blood-pressure-management-may-save-lives.

Griffith, D. M., E. M. Bergner, A. S. Fair, and C. H. Wilkins. 2021. Using mistrust, distrust, and low trust precisely in medical care and medical research advances health equity. American Journal of Preventive Medicine 60(3):442–445.

Group, S. R. 2015. A randomized trial of intensive versus standard blood-pressure control. New England Journal of Medicine 373(22):2103–2116.

Guadagnolo, B. A., D. G. Petereit, P. Helbig, D. Koop, P. Kussman, E. F. Dunn, and A. Patnaik. 2009. Involving American Indians and medically underserved rural populations in cancer clinical trials. Clinical Trials 6(6):610–617.

Guthrie, S., J. Krapels, C. A. Lichten, and S. Wooding. 2016. 100 Metrics to Assess and Communicate the Value of Biomedical Research: An Ideas Book. Santa Monica, CA: RAND Corporation.

Haidich, A., and J. Ioannidis. 2001. Patterns of patient enrollment in randomized controlled trials. Journal of Clinical Epidemiology 54(9):877–883.

Hamad, R., T. T. Nguyen, J. Bhattacharya, M. M. Glymour, and D. H. Rehkopf. 2019. Educational attainment and cardiovascular disease in the United States: A quasi-experimental instrumental variables analysis. PLoS Med. 16(6):e1002834.

Hamad, R., J. Penko, D. S. Kazi, P. Coxson, D. Guzman, P. C. Wei, A. Mason, E. A. Wang, L. Goldman, K. Fiscella, and K. Bibbins-Domingo. 2020. Association of low socioeconomic status with premature coronary heart disease in US adults. JAMA Cardiology 5(8):899–908.

Hamel L.M., L. A. Penner, T. L. Albrecht, E. Heath, C. K. Gwede, and S. Eggly. 2016. Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. Cancer Control 23(4):327–337. doi:10.1177/107327481602300404. PMID: 27842322; PMCID: PMC5131730. Hamilton, B. E., J. A. Martin, and M. J. K. Osterman. 2021. Births: Provisional Data for 2020. National Center for Health Statistics, Division of Vital Statistics. NVSS Vital Statistics Rapid Release, Report No. 012. https://stacks.cdc.gov/view/cdc/104993.

Hardie, G., R. Liu, J. Darden, and W. M. Gold. 2010. Ethnic differences in methacholine responsiveness and word descriptors in African Americans, Hispanic-Mexican Americans, Asian-Pacific Islanders, and Whites with mild asthma. Journal of Asthma 47(4):388–396.

Hardie, G. E., R. Liu, J. Darden, and W. M. Gold. 2011. Recruitment of asthmatic ethnic minorities into a methacholine research study: Factors influencing participation. Journal of the National Medical Association 103(2):138–149.

Harrington, R., M. Hanna, E. Oehrlein, R. Camp, R. Wheeler, C. Cooblall, T. Tesoro, A. Scott, R. Gizycki, F. Nguyen, A. Hareendran, D. Patrick, and E. Perfetto. 2020. Defining patient engagement in research: Results of a systematic review and analysis: Report of the ISPOR patient-centered special interest group. Value in Health 23(6):677–688.

Harris, D. J., and P. S. Douglas. 2000. Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute. New England Journal of Medicine 343(7):475–480.

Hattam, V. 2005. Ethnicity & the boundaries of race: Rereading Directive 15. Daedalus 134(1):61–69.

Haynes-Maslow, L., P. Godley, L. Dimartino, B. White, J. Odom, A. Richmond, and W. Carpenter. 2014. African American women’s perceptions of cancer clinical trials. Cancer Medicine 3(5):1430–1439.

Helmuth, L. 2000. Reports see progress, problems, in trials. Science 288(5471):1562–1563.

Hersh, W. R., M. G. Weiner, P. J. Embi, J. R. Logan, P. R. Payne, E. V. Bernstam, H. P. Lehmann, G. Hripcsak, T. H. Hartzog, J. J. Cimino, and J. H. Saltz. 2013. Caveats for the use of operational electronic health record data in comparative effectiveness research. Medical Care 51(8 Suppl. 3):S30–S37.

HHS (Department of Health and Human Services). 1983. Additional protections for children involved as subjects in research—Department of Health and Human Services. Final rule. Federal Register 48(46):9814–9820.

HHS. 1985. Office on Women’s Health. Report of the Public Health Service Task Force on Women’s Health Issues. Washington, DC: Department of Health and Human Services.

HHS. 1994. Part R. Statement of organization, functions, and delegations of authority. 86 FR 48737. https://www.federalregister.gov/documents/2021/08/31/2021-18075/statement-of-organization-functions-and-delegations-of-authority.

HHS. 2010. Office of Inspector General. Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials. Washington, DC: Department of Health and Human Services.

HHS. 2017. Federal policy for the protection of human subjects. Federal Register 82:7149–7274.

HHS. 2020. Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. Washington, DC: Department of Health and Human Services.

HHS. 2022a. Office of Minority Health. Profile: American Indian/Alaska Native. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=62.

HHS. 2022b. Breastfeeding: Surgeon General’s Call to Action Fact Sheet. https://www.hhs.gov/surgeongeneral/reports-and-publications/breastfeeding/factsheet/index.html.

Hill, C., E. Pérez-Stable, N. Anderson, and M. Bernard. 2015. The National Institute on Aging health disparities research framework. Ethnicity & Disease 25(3).

Hillyer, G. C., M. Beauchemin, D. L. Hershman, M. Kelsen, F. L. Brogan, R. Sandoval, K. M. Schmitt, A. Reyes, M. B. Terry, A. B. Lassman, and G. K. Schwartz. 2020. Discordant attitudes and beliefs about cancer clinical trial participation between physicians, research staff, and cancer patients. Clinical Trials 17(2):184–194.

Hooper, M. W., T. Asfar, M. Unrod, A. Dorsey, J. B. Correa, K. O. Brandon, V. N. Simmons, M. A. Antoni, T. Koru-Sengul, D. J. Lee, and T. H. Brandon. 2019. Reasons for exclusion from a smoking cessation trial: An analysis by race/ethnicity. Ethnicity & Disease 29(1):23–30.

Hoppe, T. A., A. Litovitz, K. A. Willis, R. A. Meseroll, M. J. Perkins, B. I. Hutchins, A. F. Davis, M. S. Lauer, H. A. Valantine, J. M. Anderson, and G. M. Santangelo. 2019. Topic choice contributes to the lower rate of NIH awards to African-American/Black scientists. Science Advances 5(10):eaaw7238.

Hoyo, C., M. L. Reid, P. A. Godley, T. Parrish, L. Smith, and M. Gammon. 2003. Barriers and strategies for sustained participation of African-American men in cohort studies. Ethnicity & Disease 13(4):470–476.

HRSA (Health Resources and Services Administration). 2020a. National Health Center Program Uniform Data System (UDS) Awardee Data. https://data.hrsa.gov/tools/data-reporting/program-data/national.

HRSA. 2020b. National Health Center Program Uniform Data System (UDS) Look-Alike Data. https://data.hrsa.gov/tools/data-reporting/program-data/national-lookalikes.

HRSA. 2022. Health Center Data and Reporting. https://bphc.hrsa.gov/datareporting/index.html.

Huamani, K. F., B. Metch, G. Broder, M. Andrasik. A demographic analysis of racial/ethnic minority enrollment into HVTN preventive early phase HIV vaccine clinical trials conducted in the United States, 2002-2016. 2019 Public Health Reports 134(1):72–80. doi: 10.1177/0033354918814260. Epub 2018 Dec 5. PMID: 30517057; PMCID: PMC6304725.

Huang, B., D. De Vore, C. Chirinos, J. Wolf, D. Low, R. Willard-Grace, S. Tsao, C. Garvey, D. Donesky, G. Su, and D. H. Thom. 2019. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Medical Research Methodology 19(1).

Huang, H.-Y., M. O. Ezenwa, D. J. Wilkie, and M. K. Judge. 2013. ResearchTracking: Monitoring gender and ethnic minority recruitment and retention in cancer symptom studies. Cancer Nursing 36(3):E1–E6.

Hudson, K. L., M. S. Lauer, and F. S. Collins. 2016. Toward a new era of trust and transparency in clinical trials. JAMA 316(13):1353–1354.

Hudson, S. V., D. Memperousse, and H. Leventhal. 2005. Physician perspectives on cancer clinical trials and barriers to minority recriutment. Cancer Control: Journal of the Moffitt Cancer Center 12(Suppl. 2):93–96.

Hughes, T. B., V. R. Varma, C. Pettigrew, M. S. Albert, and B. J. Bowers. 2017. African Americans and clinical research: Evidence concerning barriers and facilitators to participation and recruitment recommendations. Gerontologist 57(2):348–358.

Hume, M., L. L. Lewis, and R. M. Nelson. 2017. Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies. Journal of Medical Ethics 43(12):857–860.

Hurley, E. A. 2017. From the director: “Vulnerability” in the revised Common Rule. Ampersand, PRIMER (blog), posted September 12, 2017. https://blog.primr.org/vulnerability-revised-common-rule/.

IHS (Indian Health Service). 2021. Statement from the IHS acting director Elizabeth Fowler on the president’s fiscal year 2022 budget. Press Release, May 28, 2021. https://www.ihs.gov/newsroom/pressreleases/2021-press-releases/statement-from-the-ihs-acting-director-elizabeth-fowler-on-the-presidents-fiscal-year-2022-budget/.

Iltis, A. S. 2004. Costs to subjects for research participation and the informed consent process: Regulatory and ethical considerations. IRB: Ethics & Human Research 26(6): 9–13. https://doi.org/10.2307/3564097.

Indorewalla, K. K., M. K. O’Connor, A. E. Budson, C. Guess DiTerlizzi, and J. Jackson. 2021. Modifiable barriers for recruitment and retention of older adults participants from underrepresented minorities in Alzheimer’s disease research. Journal of Alzheimer’s Disease 80(3):927–940.

IOM (Institute of Medicine). 1990. Broadening the Base of Treatment for Alcohol Problems. Washington, DC: The National Academies Press.

IOM. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers, A. C. Mastroianni, R. Faden, and D. Federman, eds. Washington, DC: The National Academies Press.

IOM. 2001. Exploring the Biological Contributions to Human Health: Does Sex Matter? T. M. Wizemann and M.-L. Pardue, eds. Washington, DC: The National Academies Press.

IOM. 2011. “Introduction,” chap. 1 in The Health of Lesbian, Gay, Bisexual and Transgender People: Building a Foundation for Better Understanding. Washington, DC: The National Academies Press. https://www.nap.edu/read/13128/chapter/1.

IRS (Internal Revenue Service). n.d. Patient-Centered Outcomes Research Trust Fund Fee (IRC 4375, 4376 and 4377): Questions and Answers. https://www.irs.gov/affordable-care-act/patient-centered-outcomes-research-trust-fund-fee-questions-and-answers.

Ix, J. H., M. A. Allison, J. O. Denenberg, M. Cushman, and M. H. Criqui. 2008. Novel cardiovascular risk factors do not completely explain the higher prevalence of peripheral arterial disease among African Americans. The San Diego population study. Journal of the American College of Cardiology 51(24):2347–2354.

Jackson, J. L., C. Bates, S. M. Asch, R. Roberts, and J. R. Clarkson. 2021. How can medical journals promote equity and counter racism? Journal of General Internal Medicine 36(10):2919–2921.

Jacobs, E. A., I. Ganguli, and S. K. Inouye. 2021. Increasing representation of women as editors in medical journals. JAMA Network Open 4(9):e2123364–e2123364.

Jamerson, K., and V. DeQuattro. 1996. The impact of ethnicity on response to antihypertensive therapy. American Journal of Medicine 101(3A):22S–32S.

James, D. C. S., C. Harville II, O. Efunbumi, I. Babazadeh, and S. Ali. 2017. “You have to approach us right”: A qualitative framework analysis for recruiting African Americans into mHealth research. Health Education and Behavior 44(5):781–790.

Jamison, D. T., L. H. Summers, G. Alleyne, K. J. Arrow, S. Berkley, A. Binagwaho, F. Bustreo, D. Evans, R. G. Feachem, J. Frenk, G. Ghosh, S. J. Goldie, Y. Guo, S. Gupta, R. Horton, M. E. Kruk, A. Mahmoud, L. K. Mohohlo, M. Ncube, A. Pablos-Mendez, K. S. Reddy, H. Saxenian, A. Soucat, K. H. Ulltveit-Moe, and G. Yamey. 2013. Global health 2035: A world converging within a generation. Lancet 382(9908):1898–1955.

Javid, S. H., J. M. Unger, J. R. Gralow, C. M. Moinpour, A. J. Wozniak, J. W. Goodwin, P. N. Lara, P. A. Williams, L. F. Hutchins, C. C. Gotay, and K. S. Albain. 2012. A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316). Oncologist 17(9):1180–1190.

Jones, N. C., A. K. Otto, D. E. Ketcher, J. B. Permuth, G. P. Quinn, and M. B. Schabath. 2020. Inclusion of transgender and gender diverse health data in cancer biorepositories. Contemporary Clinical Trials Communications 19(10).

Jonsen, A. R. 1978. Research involving children: Recommendations of the national commission for the protection of human subjects of biomedical and behavioral research. Pediatrics 62(2):131–136.

Joosten, Y. A., T. L. Israel, N. A. Williams, L. R. Boone, D. G. Schlundt, C. P. Mouton, R. S. Dittus, G. R. Bernard, and C. H. Wilkins. 2015. Community engagement studios: A structured approach to obtaining meaningful input from stakeholders to inform research. Academic Medicine 90(12):1646–1650.

Joseph, G., and D. Dohan. 2009. Diversity of participants in clinical trials in an academic medical center: The role of the ‘good study patient?’. Cancer 115(3):608–615.

Kalliainen, L. K., I. Wisecarver, A. Cummings, and J. Stone. 2018. Sex bias in hand surgery research. The Journal of Hand Surgery 43(11):1026–1029.

Kalt, J. P., and J. W. Singer. 2004. Myths and Realities of Tribal Sovereignty: The Law and Economics of Indian Self-rule. Faculty Research Working Paper Series. John F. Kennedy School of Government, Harvard University. https://scholar.harvard.edu/files/jsinger/files/myths_realities.pdf.

Ka’opua, L. S., D. Mitschke, and J. Lono. 2004. Increasing participation in cancer research: Insights from Native Hawaiian women in medically underserved communities. Pacific Health Dialog 11(2):170–175.

Kaplan, C. P., A. M. Nápoles, S. Narine, S. Gregorich, J. Livaudais-Toman, T. Nguyen, Y. Leykin, M. Roach, and E. J. Small. 2015. Knowledge and attitudes regarding clinical trials and willingness to participate among prostate cancer patients. Contemporary Clinical Trials 45:443–448.

Karris, M. Y., K. Dubé, and A. A. Moore. 2020. What lessons it might teach us? Community engagement in HIV research. Current Opinion in HIV and AIDS 15(2):142–149. https://doi.org/10.1097/COH.0000000000000605.

Kass, N. E., L. Chaisson, H. A. Taylor, and J. Lohse. 2011. Length and complexity of US and international HIV consent forms from federal HIV network trials. Journal of General Internal Medicine 26(11):1324–1328.

Katz, R. V., S. S. Kegeles, N. R. Kressin, B. L. Green, S. A. James, M. Q. Wang, S. L. Russell, and C. Claudio. 2008. Awareness of the Tuskegee Syphilis Study and the US presidential apology and their influence on minority participation in biomedical research. American Journal of Public Health 98(6):1137–1142.

Katz, R. V., S. S. Kegeles, N. R. Kressin, B. L. Green, M. Q. Wang, S. A. James, S. L. Russell, and C. Claudio. 2006. The Tuskegee Legacy Project: Willingness of minorities to participate in biomedical research. Journal of Health Care for the Poor and Underserved 17(4):698–715.

Kessler Foundation. 2011. Kessler foundation receives grants to study health disparities in people with disabilities. Press Release, November 26, 2011. https://kesslerfoundation.org/press-releases/kessler-foundation-receives-grants-study-health-disparities-people-disabilities.

KFF (Kaiser Family Foundation). 2019. Poverty Rate by Race/Ethnicity. https://www.kff.org/other/stateindicator/poverty-rate-by-raceethnicity/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D.

Khan, M., I. Shahid, T. Siddiqi, S. Khan, H. Warraich, S. Greene, J. Butler, and E. Michos. 2020. Ten-year trends in enrollment of women and minorities in pivotal trials supporting recent US Food and Drug Administration approval of novel cardiometabolic drugs. Journal of the American Heart Association 9(11):e015594.

Khan, S. U., M. Z. Khan, A. N. Lone, C. R. Subramanian, S. Talluri, J. K. Han, N. Isakadze, A. S. Volgman, and E. D. Michos. 2020. Abstract 14171: Association of women authors with women enrollment in the clinical trials of atrial fibrillation. Circulation 142(Suppl. 3).

Kibbe, M. R., and J. Freischlag. 2020. Call to action to all surgery journal editors for diversity in the editorial and peer review process. JAMA Surgery 155(11):1015–1016.

Kim, E. S., T. P. Carrigan, and V. Menon. 2008. Enrollment of women in National Heart, Lung, and Blood Institute-funded cardiovascular randomized controlled trials fails to meet current federal mandates for inclusion. Journal of the American College of Cardiology 52(8):672–673.

Kimminau, K. S., C. Jernigan, J. LeMaster, L. S. Aaronson, M. Christopher, S. Ahmed, A. Boivin, M. DeFino, R. Greenlee, G. Salvalaggio, D. Hendricks, C. Herbert, N. M. Mabachi, A. Macaulay, J. M. Westfall, and L. R. Waitman. 2018. Patient vs. Community Engagement: Emerging Issues. Medical Care 10 (Suppl. 1):S53–S57.

King, A. C., D. Cao, C. C. Southard, and A. Matthews. 2011. Racial differences in eligibility and enrollment in a smoking cessation clinical trial. Health Psychology 30(1):40–48.

King, W. D., D. Defreitas, K. Smith, J. Andersen, L. P. Perry, T. Adeyemi, J. Mitty, J. Fritsche, C. Jeffries, M. Littles, M. Fischl, G. Pavlov, and D. Mildvan. 2007. Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: A descriptive study. AIDS Patient Care and STDs 21(8):551–563.

King, J. B., L. C. Pinheiro, J. B.Ringel, A. P. Bress, D. Shimbo, P. Mutner, K. Reynolds, M. Cushman, G. Howard, J. J. Manly, and M. M. Safford. 2021. Multiple social vulnerabilities to health disparities and hypertension and death in the regards study. Hypertension 79(1):196–206.

Kneipp, S. M., T. A. Schwartz, D. J. Drevdahl, M. K. Canales, S. Santacroce, H. P. Santos Jr., and R. Anderson. 2018. Trends in health disparities, health inequity, and social determinants of health research: A 17-year analysis of NINR, NCI, NHLBE, and NIMHD funding. Nursing Research 67(3):231–241.

Knopf, A., M. A. Ott, C. B. Draucker, J. D. Fortenberry, D. H. Reirden, R. Arrington-Sanders, J. Schneider, D. Straub, R. Baker, G. Bakoyannis, and G. D. Zimet. 2020. Innovative approaches to obtain minors’ consent for biomedical HIV prevention trials: Multi-site quasi-experimental study of adolescent and parent perspectives. JMIR Research Protocols 9(3):e16509.

Knopf A. S., M. A. Ott, N. Liu, B. G. Kapogiannis, G. D. Zimet, J. D. Fortenberry, and S. G. Hosek. 2017. Minors’ and young adults’ experiences of the research consent process in a phase II safety study of pre-exposure prophylaxis for HIV. Journal of Adolescent Health 61(6):747–754.

Knowler, W. C., E. Barrett-Connor, S. E. Fowler, R. F. Hamman, J. M. Lachin, E. A. Walker, and D. M. Nathan. 2002. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. New England Journal of Medicine 346(6):393–403.

Kopelman, L. M. 2000. Children as research subjects: A dilemma. The Journal of Medicine and Philosophy 25(6):745–764.

Kornstein, S. G., A. F. Schatzberg, M. E. Thase, K. A. Yonkers, J. P. McCullough, G. I. Keitner, A. J. Gelenberg, S. M. Davis, W. M. Harrison, and M. B. Keller. 2000. Gender differences in treatment response to sertraline versus imipramine in chronic depression. American Journal of Psychiatry 157(9):1445–1452.

Kost, R. G., A. Leinberger-Jabari, T. H. Evering, P. R. Holt, M. Neville-Williams, K. S. Vasquez, B. S. Coller, and J. N. Tobin. 2017. Helping basic scientists engage with community partners to enrich and accelerate translational research. Academic Medicine 92(3):374–379.

Kretzmann, J. P., and J. L. McKnight. 1993. Building Communities from the Inside Out : A Path Toward Finding and Mobilizing a Community’s Assets. The Asset-Based Community Development Institute. Chicago: DePaul University Steans Center. https://resources.depaul.edu/abcd-institute/publications/Documents/Chapter 5 - PROVIDING SUPPORT FOR ASSET-BASED DEVELOPMENT- POLICIES AND GUIDELINES.pdf.

Krieger, N., and S. Sidney. 1996. Racial discrimination and blood pressure; The CARDIA study of young black and white adults. American Journal of Public Health 86: 1370-1378.

Kripalani, S., W. J. Heerman, N. J. Patel, N. Jackson, K. Goggins, R. L. Rothman, V. M. Yeh, K. A. Wallston, D. T. Smoot, and C. H. Wilkins. 2019. Association of health literacy and numeracy with interest in research participation. Journal of General Internal Medicine 34(4):544–551.

Kuhn, N. S., M. Parker, and C. Lefthand-Begay. 2020. Indigenous research ethics requirements: An examination of six tribal institutional review board applications and processes in the United States. Journal of Empirical Research on Human Research Ethics 15(4):279–291. doi:10.1177/1556264620912103.

Lakdawalla, D. N., D. P. Goldman, and B. Shang. 2005. The health and cost consequences of obesity among the future elderly. Health Affairs 24(Suppl. 2):W5-R30–W35-R41.

Langford, A. T., K. Resnicow, E. P. Dimond, A. M. Denicoff, D. S. Germain, W. McCaskill-Stevens, R. A. Enos, A. Carrigan, K. Wilkinson, and R. S. Go. 2014. Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute’s Community Cancer Centers Program. Cancer 120(6):877–884.

Largent, E. A., C. Grady, F. G. Miller, and A. Wertheimer. 2012. Money, coercion, and undue inducement: Attitudes about payments to research participants. IRB: Ethics & Human Research 34(1):1–8.

Largent, E. A., and H. F. Lynch. 2017. Paying research participants: The outsized influence of “undue influence.” IRB: Ethics & Human Research 39(4):1–9.

Larkey, L. K., J. A. Gonzalez, L. E. Mar, and N. Glantz. 2009. Latina recruitment for cancer prevention education via community based participatory research strategies. Contemporary Clinical Trials 30(1):47–54.

Las Nueces, D., K. Hacker, A. Digirolamo, and L. S. Hicks. 2012. A systematic review of community-based participatory research to enhance clinical trials in racial and ethnic minority groups. Health Services Research 47(3pt2):1363–1386.

Lauer, M. 2020. Some thoughts following the NIH inclusion across the lifespan 2 workshop. National Institutes of Health, Extramural Nexus (blog), posted December 10, 2020. https://nexus.od.nih.gov/all/2020/12/10/some-thoughts-following-the-nih-inclusion-across-the-lifespan-2-workshop/.

Lawrence, J. 2000. The Indian Health Service and the sterilization of Native American women. American Indian Quarterly 24(3):400–419.

Leaf, D. E., B. Tysinger, D. P. Goldman, and D. N. Lakdawalla. 2020. Predicting quantity and quality of life with the future elderly model. Health Economics. Special Issue Paper, Wiley Online Library. https://onlinelibrary.wiley.com/doi/abs/10.1002/hec.4169.

Levitan, B., K. Getz, E. L. Eisenstein, M. Goldberg, M. Harker, S. Hesterlee, B. Patrick-Lake, J. N. Roberts, and J. Dimasi. 2018. Assessing the financial value of patient engagement: A quantitative approach from CTTI’s patient groups and clinical trials project. Therapeutic Innovation & Regulatory Science 52(2):220–229.

Lewis, J. H., M. L. Kilgore, D. P. Goldman, E. L. Trimble, R. Kaplan, M. J. Montello, M. G. Housman, and J. J. Escarce. 2003. Participation of patients 65 years of age or older in cancer clinical trials. Journal of Clinical Oncology 21(7):1383–1389.

Lewison, D. 1997. Retailing. Hoboken, NJ: Prentice Hall.

Liu, K. A., and N. A. Dipietro Mager. 2016. Women’s involvement in clinical trials: Historical perspective and future implications. Pharmacy Practice (Granada) 14(1):708.

Lockett, J. 2017. Let’s talk about inclusion of all ages in research. National Institute on Aging, Research and Funding (blog), posted April 26, 2017. https://www.nia.nih.gov/research/blog/2017/04/lets-talk-about-inclusion-all-ages-research.

Lor, M., and B. J. Bowers. 2018. Hmong older adults’ perceptions of insider and outsider researchers: Does it matter for research participation? Nursing Research 67(3):222–230.

Lowsky, D. J., S. J. Olshansky, J. Bhattacharya, and D. P. Goldman. 2014. Heterogeneity in healthy aging. Journals of Gerontology, Series A: Biological Sciences and Medical Sciences 69(6): 640–649.

Lucero, J. E., B. Boursaw, M. M. Eder, E. Greene-Moton, N. Wallerstein, and J. G. Oetzel. 2020. Engage for equity: The role of trust and synergy in community-based participatory research. Health Education & Behavior 47(3):372–379.

Ludmir, E. B., W. Mainwaring, T. A. Lin, A. B. Miller, A. Jethanandani, A. F. Espinoza, J. J. Mandel, S. H. Lin, B. D. Smith, G. L. Smith, N. A. VanderWalde, B. D. Minsky, A. C. Koong, T. E. Stinchcombe, R. Jagsi, D. R. Gomez, C. R. Thomas Jr., and C. D. Fuller. 2019. Factors associated with age disparities among cancer clinical trial participants. JAMA Oncology 5(12):1769–1773.

MacLeod, S. 2010. Therapeutic drug monitoring in pediatrics: How do children differ? Therapeutic Drug Monitoring 32(3):253–256.

Maixner, S. M., A. M. Mellow, and R. Tandon. 1999. The efficacy, safety, and tolerability of antipsychotics in the elderly. Journal of Clinical Psychiatry 60 (Suppl. 8):29–41.

Mak, W. W. S., R. W. Law, J. Alvidrez, and E. J. Pérez-Stable. 2007. Gender and ethnic diversity in NIMH-funded clinical trials: Review of a decade of published research. Administration and Policy in Mental Health and Mental Health Services Research 34(6):497–503.

Malzbender, K., L. Lavin-Mena, L. Hughes, N. Bose, D. Goldman, D. Patel. 2020. Key barriers to clinical trials for Alzheimer’s disease. White Paper. Leonard D. Schaeffer Center for Health Policy and Economics. Los Angeles: University of Southern California.

Manders, D. B., A. Paulsen, D. L. Richardson, S. M. Kehoe, D. S. Miller, and J. S. Lea. 2014. Factors associated with clinical trial screening failures in gynecologic oncology. Gynecologic Oncology 134(3):450–454.

Martin, A. R., M. Kanai, Y. Kamatani, Y. Okada, B. M. Neale, and M. J. Daly. 2019. Clinical use of current polygenic risk scores may exacerbate health disparities. Nature Genetics 51(4):584–591.

Maxwell, A. E., R. Bastani, P. Vida, and U. S. Warda. 2005. Strategies to recruit and retain older Filipino-American immigrants for a cancer screening study. Journal of Community Health 30(3):167–179.

McCarthy-Keith, D., S. Nurudeen, A. Armstrong, E. Levens, and L. Nieman. 2010. Recruitment and retention of women for clinical leiomyoma trials. Contemporary Clinical Trials 31(1).

McCormick, R. A. 1974. Proxy consent in the experimentation situation. Pp. 297–309 in Biomedical Ethics and the Law, J. M. Humber and R. F. Almeder, eds. Boston: Springer.

McElfish, P. A., C. R. Long, J. P. Selig, B. Rowland, R. S. Purvis, L. James, A. Holland, H. C. Felix, and M. R. Narcisse. 2018. Health research participation, opportunity, and willingness among minority and rural communities of Arkansas. Clinical and Translational Science 11(5):487–497.

McKee, M., D. Schlehofer, and D. Thew. 2013. Ethical issues in conducting research with deaf populations. American Journal of Public Health 103(12):2174–2178.

McMurdo, M. E. T., H. Roberts, S. Parker, N. Wyatt, H. May, C. Goodman, S. Jackson, J. Gladman, S. O’Mahony, K. Ali, E. Dickinson, P. Edison, and C. Dyer. 2011. Improving recruitment of older people to research through good practice. Age and Ageing 40(6):659–665.

Medicare advantage: Reforms needed to ensure access to clinical trials. 2009. Journal of Oncology Practice 5(3):144–145.

Meeker-O’Connell, A., and J. Menikoff. 2021. The role of institutional review boards: National Academies of Sciences, Engineering, and Medicine. https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/D3A0C8EA19ED6783B1E59A8D5ED5A7607F3E15C782BC.

Michos, E. D., T. K. Reddy, M. Gulati, L. C. Brewer, R. M. Bond, G. P. Velarde, A. L. Bailey, M. R. Echols, S. A. Nasser, H. E. Bays, A. M. Navar, and K. C. Ferdinand. 2021. Improving the enrollment of women and racially/ethnically diverse populations in cardiovascular clinical trials: An ASPC practice statement. American Journal of Preventive Cardiology 8:100250.

Michos, E. D., and H. G. C. Van Spall. 2021. Increasing representation and diversity in cardiovascular clinical trial populations. Nature Reviews Cardiology 18(8):537–538.

Mistretta, A. 2016. NIH outreach toolkit: How to engage, recruit, and retain women in clinical research. Paper presented at APHA 2016 Annual Meeting & Expo (October 29–November 2, 2016). https://orwh.od.nih.gov/toolkit.

Moher, D., S. Hopewell, K. F. Schulz, V. Montori, P. C. Gøtzsche, P. J. Devereaux, D. Elbourne, M. Egger, and D. G. Altman. 2010. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. BMJ 340:c869.

Moher, D., S. Hopewell, K. Schulz, V. Montori, P. Gøtzsche, P. Devereaux, D. Elbourne, M. Egger, and D. Altman. 2012. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. International Journal of Surgery 10(1):28–55.

Moreno-John, G., A. Gachie, C. M. Fleming, A. Napoles-Springer, E. Mutran, S. M. Manson, and E. J. Perez-Stable. 2004. Ethnic minority older adults participating in clinical research: Developing trust. Journal of Aging and Health 16(5 Suppl.):93S–123S.

Murphy, E., and A. Thompson. 2009. An exploration of attitudes among Black Americans towards psychiatric genetic research. Psychiatry 72(2):177–194.

Murphy, E. J., P. Wickramaratne, and M. M. Weissman. 2009. Racial and ethnic differences in willingness to participate in psychiatric genetic research. Psychiatric Genetics 19(4):186–194.

Murthy, V. H., H. M. Krumholz, and C. P. Gross. 2004. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 291(22):2720–2726.

Nadel, M. V. 1990. “National Institutes of Health: Problems in Implementing Policy on Women in Study Populations.” Statement of Mark V. Nadel, Associate Director, National and Public Health Issues, Human Resources Division, before the Subcommittee on Housing and Consumer Interest, Select Committee on Aging, U.S. House of Representatives. Released July 24, 1990. Washington, DC: U.S. General Accounting Office. http://archive.gao.gov/d48t13/141859.pdf.

Nanna, M. G., S. T. Chen, A. J. Nelson, A. M. Navar, and E. D. Peterson. 2020. Representation of older adults in cardiovascular disease trials since the inclusion across the lifespan policy. JAMA Internal Medicine 180(11):1531–1533.

NARHC (National Association of Rural Health Clinics). 2022. Mission Statement. https://www.narhc.org/narhc/Mission_Statement.asp.

NASEM (National Academies of Sciences, Engineering, and Medicine). 2015. The Growing Gap in Life Expectancy by Income: Implications for Federal Programs and Policy Responses. Washington, DC: The National Academies Press.

NASEM. 2018. The Next Generation of Biomedical and Behavioral Sciences Researchers: Breaking through, R. Daniels and L. Beninson, eds. Washington, DC: The National Academies Press.

NASEM. 2020a. Promising Practices for Addressing the Underrepresentation of Women in Science, Engineering, and Medicine: Opening Doors, R. Colwell, A. Bear, and A. Helman, eds. Washington, DC: The National Academies Press.

NASEM. 2020b. Understanding the Well-Being of LGBTQI+ Populations, M. J. Sepulveda, C. J. Patterson, and J. White, eds. Washington, DC: The National Academies Press.

Nature Medicine. 2018. Diversifying clinical trials. 24(1779). https://doi.org/10.1038/s41591-0180303-4.

Nazha, B., M. Mishra, R. Pentz, and T. Owonikoko. 2019. Enrollment of racial minorities in clinical trials: Old problem assumes new urgency in the age of immunotherapy. American Society of Clinical Oncology Educational Book, Vol. 39. Alexandria, VA: American Society of Clinical Oncology.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html.

NCAI (National Congress of American Indians). 2016. Reducing Disparities in the Federal Healthcare Budget. https://www.ncai.org/resources/ncai-publications/08_FY2017_health_care.pdf.

NCPHS. 1978. Research Involving Children: Report and Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (45 C.F.R. 46.). Federal Register 43:2083.

NCUIH (National Council of Urban Indian Health). 2019. Advance Appropriations: Protecting Tribal Communities from the Effects of Government Shutdowns Hearing, House Committee on Natural Resources Subcommittee for Indigenous Peoples of the United States. Statement of Maureen Rosette, President, NCUIH, September 25, 2019. https://docs.house.gov/meetings/II/II24/20190925/110050/HHRG-116-II24-20190925-SD013.pdf.

NEJM. 2021. Striving for diversity in research studies. Editorial, October 7, 2021. New England Journal of Medicine 385(15):1429–1430.

Nelson, L. A., S. E. Williamson, L. M. LeStourgeon, and L. S. Mayberry. 2021. Retaining diverse adults with diabetes in a long-term trial: Strategies, successes, and lessons learned. Contemporary Clinical Trials 105:106388.

Newman, P. A., N. Duan, K. J. Roberts, D. Seiden, E. T. Rudy, D. Swendeman, and S. Popova. 2006. HIV vaccine trial participation among ethnic minority communities: Barriers, motivators, and implications for recruitment. Journal of Acquired Immune Deficiency Syndromes 41(2):210–217.

Nguyen, T., N. Wallerstein, R. Das, M. Sabado-Liwag, B. Bird, T. Jacob, T. Cannady, L. Martinez, U. Ndulue, A. Ortiz, A. Stubbs, L. Pichon, S. Tanjarsiri, J. Pang, and K. Woo. 2021. Conducting community-based participatory research with minority communities to reduce health disparities. Pp. 171–186 in The Science of Health Disparities Research, I. Dankwa-Mullan, E. J. Pérez-Stable, K. L. Gardner, X. Zhang, and A. M. Rosariok, eds. Hoboken, NJ: John Wiley & Sons, Inc.

Nguyen, T. T., C. P. Somkin, Y. Ma, L. C. Fung, and T. Nguyen. 2005. Participation of Asian-American women in cancer treatment research: A pilot study. Journal of the National Cancer Institute (Monograph) (35):102–105.

Nielsen, M. W., J. P. Andersen, L. Schiebinger, and J. W. Schneider. 2017. One and a half million medical papers reveal a link between author gender and attention to gender and sex analysis. Nature Human Behaviour 1(11):791–796.

Night, S. 2009. History of NIH Revitalization Act of 1993 and current relevance to inclusion of women and minorities in clinical research. SoCRA Source August 2009:20–23. https://nebula.wsimg.com/3809b19c768db79eb0d57d86d4940699?AccessKeyId=4ECD43F4A65F6DBF7F21&disposition=0&alloworigin=1.

NIH. 1987. NIH Guide for Grants and Contracts. https://grants.nih.gov/grants/guide/historical/1987_01_09_Vol_16_No_01.pdf.

NIH. 1989. NIH Guide for Grants and Contracts. https://grants.nih.gov/grants/guide/historical/1989_08_11_Vol_18_No_27.pdf.

NIH. 1998. NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects. https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

NIH. 2001a. NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm.

NIH. 2001b. Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html.

NIH. 2010. NIH announces institute on minority health and health disparities. News Release, September 27, 2010. https://www.nih.gov/news-events/news-releases/nih-announces-institute-minority-health-health-disparities.

NIH. 2013. Draft Report of the Advisory Committee to the Director Working Group on Diversity in the Biomedical Research Workforce. https://www.acd.od.nih.gov/documents/reports/Diversity-BiomedicalResearchWorkforceReport.pdf.

NIH. 2015a. National Institutes of Health FY2012 Sexual and Gender Minority Health Research Portfolio Analysis Report. https://dpcpsi.nih.gov/sgmro/reports.

NIH. 2015b. NIH Precision Medicine Initiative. https://www.nimhd.nih.gov/about/legislative-info/clips/pmi.html.

NIH. 2015c. Request for information: NIH precision medicine cohort. Notice Number: NOT-OD-15-096, Release Date, April 20, 2015. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-096.html.

NIH. 2016. Era Commons – User Registration. https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/registration/investigators-and-other-users/era-commons-user-registration.htm.

NIH. 2017a. Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Notice Number NOT-OD-18-014. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-014.html.

NIH. 2017b. Revision: NIH Policy and Guidelines on the Inclusion of Individuals across the Lifespan as Participants in Research Involving Human Subjects, Notice Number NOT-OD-18-116. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-116.html.

NIH. 2017c. Information about NIH Clinical Trial Stewardship. https://grants.nih.gov/policy/clinical-trials/why-changes.htm.

NIH. 2018a. Post-Award Monitoring and Reporting. https://grants.nih.gov/grants/post-award-monitoring-and-reporting.htm.

NIH. 2018b. Task Force on Research Specific to Pregnant Women and Lactating Women: Report to Secretary, Health and Human Services and Congress. https://www.nichd.nih.gov/sites/default/files/2018-09/PRGLAC_Report.pdf.

NIH. 2019a. Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). https://www.nichd.nih.gov/about/advisory/PRGLAC.

NIH. 2019b. Guidelines for the review of inclusion on the basis of sex/gender, race, ethnicity, and age in clinical research. https://grants.nih.gov/grants/peer/guidelines_general/Review_Human_subjects_Inclusion.pdf.

NIH. 2020a. NIH Inclusion Across the Lifespan II Workshhop Report. https://grants.nih.gov/sites/default/files/IAL-II-Workshop-Report.pdf.

NIH. 2020b. Center for Scientific Review. https://public.csr.nih.gov/

NIH. 2021a. FDAAA 801 and the Final Rule. https://clinicaltrials.gov/ct2/manage-recs/fdaaa.

NIH. 2021b. Strategic Plan to Advance Research on the Health and Well-being of Sexual & Gender Minorities: Fiscal Years 2021–2025. https://dpcpsi.nih.gov/sites/default/files/SGMStrategic-Plan_2021_2025.pdf.

NIH. 2021c. Faculty Institutional Recrtuiment for Sustainable Transformation (FIRST). https://commonfund.nih.gov/first/programhighlights.

NIH. 2021d. FAQs About Research Supplements to Promote Diversity in Health-Related Research (Diversity Supplements). https://nida.nih.gov/about-nida/organization/offices/office-nida-director-od/office-research-training-diversity-disparities-ortdd/odhd/faqs-about-research-supplements-to-promote-diversity-in-health-related.

NIH. 2022. NIH RCDC Inclusion Statistics Report. https://report.nih.gov/risr/#/.

NIHB (National Indian Health Board). 2020. Reclaiming Tribal Health: A National Budget Plan to Rise above Failed Policies and Fufill Trust Obligation to Tribal Nations. https://www.nihb.org/communications/nihb_publications.php.

NIMHD (National Institute of Minority Health and Health Disparities). 2022. History. https://www.nimhd.nih.gov/about/overview/history/.

Nipp, R. D., K. Hong, and E. D. Paskett. 2019. Overcoming barriers to clinical trial enrollment. American Society of Clinical Oncology Educational Book (39):105–114.

Nipp, R. D., H. Lee, E. Powell, N. E. Birrer, E. Poles, D. Finkelstein, K. Winkfield, S. Percac-Lima, B. Chabner, and B. Moy. 2016. Financial burden of cancer clinical trial participation and the impact of a cancer care equity program. Oncologist 21(4):467–474.

Nours, S. 2021. Improving the representation of women and underrepresented minorities in clinical trials and research. In NASEM Report Interviews, L. Bothwell, ed. https://nap.nationalacademies.org/resource/26479/Bothwell_Assessing_Federal_Policies_on_the_Inclusion_of_Women_and_Minorities-Clinical_Trials.pdf.

NRC (National Research Council). 2005. Assessment of NIH Minority Research and Training Programs: Phase 3. Washington, DC: The National Academies Press.

NSF (National Science Foundation). 2021. Women, Minorities, and Persons with Disabilities in Science and Engineering. National Center for Science and Engineering Statistics. Arlington, VA: National Science Foundation.

O’Brien, E. C., S. R. Raman, A. Ellis, B. G. Hammill, L. G. Berdan, T. Rorick, S. Janmohamed, Z. Lampron, A. F. Hernandez, and L. H. Curtis. 2021. The use of electronic health records for recruitment in clinical trials: A mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study. Trials 22(1):465.

Occa, A., S. E. Morgan, and J. N. E. Potter. 2018. Underrepresentation of Hispanics and other minorities in clinical trials: Recruiters’ perspectives. Journal of Racial and Ethnic Health Disparities 5(2):322–332.

Odierna, D., and L. Bero. 2009. Systematic reviews reveal unrepresentative evidence for the development of drug formularies for poor and nonwhite populations. Journal of Clinical Epidemiology 62(12):1268–1278.

Ofili, E. O., L. E. Schanberg, B. Hutchinson, F. Sogade, I. Fergus, P. Duncan, J. Hargrove, A. Artis, O. Onyekwere, W. Batchelor, M. Williams, A. Oduwole, A. Onwuanyi, F. Ojutalayo, J. A. Cross, T. B. Seto, H. Okafor, P. Pemu, L. Immergluck, M. Foreman, E. A. Mensah, A. Quarshie, M. Mubasher, A. Baker, A. Ngare, A. Dent, M. Malouhi, P. Tchounwou, J. Lee, T. Hayes, M. Abdelrahim, D. Sarpong, E. Fernandez-Repollet, S. O. Sodeke, A. Hernandez, K. Thomas, A. Dennos, D. Smith, D. Gbadebo, J. Ajuluchikwu, B. W. Kong, C. McCollough, S. R. Weiler, M. D. Natter, K. D. Mandl, and S. Murphy. 2019. The Association of Black Cardiologists (ABC) Cardiovascular Implementation Study (CVIS): A research registry integrating social determinants to support care for underserved patients. International Journal of Environmental Research and Public Health 16(9):1631.

Oh, S. S., J. Galanter, N. Thakur, M. Pino-Yanes, N. E. Barcelo, M. J. White, D. M. de Bruin, R. M. Greenblatt, K. Bibbins-Domingo, and A. H. Wu. 2015. Diversity in clinical and biomedical research: A promise yet to be fulfilled. PLOS Medicine 12(12):e1001918.

Olin, J. T., K. S. Dagerman, L. S. Fox, B. Bowers, and L. S. Schneider. 2002. Increasing ethnic minority participation in Alzheimer disease research. Alzheimer Disease and Associated Disorders 16:A82–S85.

Olshansky, S. J., T. Antonucci, L. Berkman, R. H. Binstock, A. Boersch-Supan, J. T. Cacioppo, B. A. Carnes, L. L. Carstensen, L. P. Fried, D. P. Goldman, J. Jackson, M. Kohli, J. Rother, Y. Zheng, and J. Rowe. 2012. Differences in life expectancy due to race and educational differences are widening, and many may not catch up. Health Affairs (Millwood) 31(8):1803–1813.

Olshansky, S. J., D. P. Goldman, Y. Zheng, and J. W. Rowe. 2009. Aging in america in the twenty-first century: Demographic forecasts from the MacArthur Foundation Research Network on an Aging Society. Milbank Q 87(4):842–862.

O’Mara-Eves, A., G. Brunton, D. McDaid, S. Oliver, J. Kavanagh, F. Jamal, T. Matosevic, A. Harden, and J. Thomas. 2013. Community engagement to reduce inequalities in health: A systematic review, meta-analysis and economic analysis. Public Health Research 1(4):1–526.

Ong, M. 2021. Single digits: Black, Hispanic scientists strikingly underrepresented at NCI among senior workforce and grantees. The Cancer Letter 47(26).

Ortman, J. M., and C. E. Guarneri. 2009. United States population projections: 2000 to 2050. United States Census Bureau 1(15):1–19.

Otado, J., J. Kwagyan, D. Edwards, A. Ukaegbu, F. Rockcliffe, and N. Osafo. 2015. Culturally competent strategies for recruitment and retention of African American populations into clinical trials. Clinical and Translational Science 8(5):460–466.

Paskett, E. D., M. R. Cooper, N. Stark, T. C. Ricketts, S. Tropman, T. Hatzell, T. Aldrich, and J. Atkins. 2002. Clinical trial enrollment of rural patients with cancer. Cancer Practice 10(1):28–35.

Passmore, S. R., D. Farrar Edwards, C. A. Sorkness, S. Esmond, and A. R. Brasier. 2020. Training needs of investigators and research team members to improve inclusivity in clinical and translational research participation. Journal of Clinical and Translational Science 5(1):e57.

Patterson, C. H. 1985. Respect (unconditional positive regard). Pp. 59–63 in The Therapeutic Relationship. Monterey, CA: Brooks/Cole.

PCORI (Patient-Centered Outcomes Research Institute). n.d. Diversity and Inclusion in PCORnet: Need and Recommendations. https://www.pcori.org/sites/default/files/3928-PCORnet-Engagement-Committee-Diversity-Inclusion-Needs-Recommendations.pdf.

PCORI. 2019. PRIDEnet: A Participant-Powered Research Network of Sexual and Gender Minorities. https://www.pcori.org/research-results/2015/pridenet-participant-powered-research-network-sexual-and-gender-minorities.

PCORI. 2020. 2020 Annual Report. Washington DC: Patient-Centered Outcomes Research Institute.

Penberthy, L. T., B. A. Dahman, V. I. Petkov, and J. P. DeShazo. 2012. Effort required in eligibility screening for clinical trials. Journal of Oncology Practice 8(6):365–370.

Pinho-Gomes, A.-C., A. Vassallo, K. Thompson, K. Womersley, R. Norton, and M. Woodward. 2021. Representation of women among editors in chief of leading medical journals. JAMA Network Open 4(9):e2123026–e2123026.

Pinn, V. W. 2003. Sex and gender factors in medical studies: Implications for health and clinical practice. JAMA 289(4):397–400.

Pearson, C. Schapiro, L., Pearson, S.D. 2022. The next generation of rare disease drug policy: Ensuring both innovation and affordability. Institute for Clinical and Economic Review. https://icer.org/wp-content/uploads/2022/04/ICER-White-Paper_The-Next-Generation-of-Rare-Disease-Drug-Policy_040722.pdf.

Pratt, B. M., L. Hixson, and N. A. Jones. Measuring race and ethnicity across decades, 1790–2010. 2010. Population Division, U.S. Census Bureau. https://www.census.gov/data-tools/demo/race/MREAD_1790_2010.html.

Priddy, F. H., A. C. Cheng, L. F. Salazar, and P. M. Frew. 2006. Racial and ethnic differences in knowledge and willingness to participate in HIV vaccine trials in an urban population in the southeastern US. International Journal of STD and AIDS 17(2):99–102.

Protheroe, J., D. Nutbeam, and G. Rowlands. 2009. Health literacy: A necessity for increasing participation in health care. British Journal of General Practice 59(567):721–723.

Quinn, S. C. 2004. Ethics in public health research. American Journal of Public Health 94(6):918–922. https://doi.org/10.2105/ajph.94.6.918.

Quinn, S. C., J. Butler, C. S. Fryer, M. A. Garza, K. H. Kim, C. Ryan, and S. B. Thomas. 2012. Attributes of researchers and their strategies to recruit minority populations: Results of a national survey. Contemporary Clinical Trials 33(6):1231–1237.

Quinn, S. C., A. Jamison, J. An, V. S. Freimuth, G. R. Hancock, and D. Musa. 2018. Breaking down the monolith: Understanding flu vaccine uptake among African Americans. SSM – Population Health 4:25–36.

Quiñones, A. R., S. L. Mitchell, J. D. Jackson, M. P. Aranda, P. Dilworth-Anderson, E. P. McCarthy, and L. Hinton. 2020. Achieving health equity in embedded pragmatic trials for people living with dementia and their family caregivers. Journal of the American Geriatric Society 68(Suppl. 2):S8–S13.

Ramamoorthy, A., M. A. Pacanowski, J. Bull, and L. Zhang. 2015. Racial/ethnic differences in drug disposition and response: Review of recently approved drugs. Clinical Pharmacology & Therapeutics 97(3):263–273.

Ramsey, P. 1976. The enforcement of morals: Nontherapeutic research on children. Hastings Center Report 6(4):21–30.

Reihl, S. J., N. Patil, R. A. Morshed, M. Mehari, A. Aabedi, U. N. Chukwueke, A. B. Porter, V. Fontil, G. Cioffi, K. Waite, C. Kruchko, Q. Ostrom, J. Barnholtz-Sloan, and S. L. HerveyJumper. 2021. A population study of clinical trial accrual for women and minorities in neurooncology following the NIH Revitalization Act. medRxiv. https://www.medrxiv.org/content/10.1101/2021.05.28.21258034v1.

Reza, N., A. S. Tahhan, N. Mahmud, E. M. DeFilippis, A. Alrohaibani, M. Vaduganathan, S. J. Greene, A. H. Ho, G. C. Fonarow, J. Butler, C. O’Connor, M. Fiuzat, O. Vardeny, I. L. Piña, J. Lindenfeld, and M. Jessup. 2020. Representation of women authors in international heart failure guidelines and contemporary clinical trials. Circulation: Heart Failure 13(8):e006605.

Rhea, B. W., E. G. Lindo, L. D. Weeks, and M. R. McLemore. 2020. On racism: A new standard for publishing on racial health inequities. Health Affairs, Health Affairs Blog, posted July 2, 2020. https://www.healthaffairs.org/do/10.1377/forefront.20200630.939347.

Riley, W., M. Riddle, and M. Lauer. 2018. NIH policies on experimental studies with humans. Nature Human Behavior 2(2):103–106.

Rivara, F. P., S. M. Bradley, D. V. Catenacci, A. N. Desai, I. Ganguli, S. J. P. A. Haneuse, S. K. Inouye, E. A. Jacobs, K. Kan, H. S. Kim, A. M. Morris, O. Ogedegbe, E. N. Perencevich, R. H. Perlis, E. Powell, G. D. Rubenfeld, L. N. Shulman, N. S. Trueger, and S. D. Fihn. 2021. Structural racism and JAMA Network Open. JAMA Network Open 4(6):e2120269–e2120269.

Rosende-Roca, M., C. Abdelnour, E. Esteban, J. Tartari, E. Alarcon, J. Martínez-Atienza, A. González-Pérez, M. Sáez, A. Lafuente, M. Buendía, A. Pancho, N. Aguilera, M. Ibarria, S. Diego, S. Jofresa, I. Hernández, R. López, M. Gurruchaga, L. Tárraga, S. Valero, A. Ruiz, M. Marquié, and M. Boada. 2021. The role of sex and gender in the selection of Alzheimer patients for clinical trial pre-screening. Alzheimer’s Research & Therapy 13(1):95.

RSC (Royal Society for Chemistry). n.d. Talent. Joint commitment for action on inclusion and diversity in publishing. https://www.rsc.org/new-perspectives/talent/joint-commitmentfor-action-inclusion-and-diversity-in-publishing/.

Rubin, R. 2021. Pregnant people’s paradox—excluded from vaccine trials despite having a higher risk of covid-19 complications. JAMA 325(11):1027–1028.

Rucker-Whitaker, C., K. J. Flynn, G. Kravitz, C. Eaton, J. E. Calvin, and L. H. Powell. 2006. Understanding African-American participation in a behavioral intervention: Results from focus groups. Contemporary Clinical Trials 27(3):274–286.

Sadler, G. R., J. Gonzalez, M. Mumman, L. Cullen, S. F. Lahousse, V. Malcarne, V. Conde, and N. Riley. 2010. Adapting a program to inform African American and Hispanic American women about cancer clinical trials. Journal of Cancer Education 25(2):142–145.

SAMHSA (Substance Abuse and Mental Health Services Administration). 2012. Top Health Issues for LGBT Populations: Information & Resource Kit. Washington, DC: U.S. Department of Health and Human Services.

Sanderson, S. C., M. A. Diefenbach, R. Zinberg, C. R. Horowitz, M. Smirnoff, M. Zweig, S. Streicher, E. W. Jabs, and L. D. Richardson. 2013. Willingness to participate in genomics research and desire for personal results among underrepresented minority patients: A structured interview study. Journal of Community Genetics 4(4):469–482.

Sauceda, J. A., K. Dubé, B. Brown, A. E. Pérez, C. E. Rivas, D. Evans, and C. B. Fisher. 2021. Framing a consent form to improve consent understanding and determine how this affects willingness to participate in HIV cure research: An experimental survey study. Journal of Empirical Research on Human Research Ethics 16(1–2):78–87.

Sausa, L., J. Sevelius, J. Keatley, J. R. Iñiguez, and M. Reyes. 2009. Policy Recommendations for Inclusive Data Collection of Trans People in HIV Prevention, Care & Services. San Francisco: Center of Excellence for Transgender HIV Prevention, University of California, San Francisco.

Scaffidi, J., B. W. Mol, and J. A. Keelan. 2017. The pregnant women as a drug orphan: A global survey of registered clinical trials of pharmacological interventions in pregnancy. BJOG 124(1):132–140.

Scharff, D. P., K. J. Mathews, P. Jackson, J. Hoffsuemmer, E. Martin, and D. Edwards. 2010. More than Tuskegee: Understanding mistrust about research participation. Journal of Health Care for the Poor and Underserved 21(3):879–897.

Scott, P. E., E. F. Unger, M. R. Jenkins, M. R. Southworth, T.-Y. McDowell, R. J. Geller, M. Elahi, R. J. Temple, and J. Woodcock. 2018. Participation of women in clinical trials supporting FDA approval of cardiovascular drugs. Journal of the American College of Cardiology 71(18):1960–1969.

Sedrak, M. S., R. A. Freedman, H. J. Cohen, H. B. Muss, A. Jatoi, H. D. Klepin, T. M. Wildes, J. G. Le-Rademacher, G. G. Kimmick, W. P. Tew, K. George, S. Padam, J. Liu, A. R. Wong, A. Lynch, B. Djulbegovic, S. G. Mohile, and W. Dale; Cancer and Aging Research Group. 2021. Older adult participation in cancer clinical trials: A systematic review of barriers and interventions. CA: A Cancer Journal for Clinicians 71(1):78–92.

Shepherd, A., D. Hewick, T. Moreland, and I. Stevenson. 1977. Age as a determinant of sensitivity to warfarin. British Journal of Clinical Pharmacology 4(3):315–320.

Shields, K. E., and A. D. Lyerly. 2013. Exclusion of pregnant women from industry-sponsored clinical trials. Obstetrics & Gynecology 122(5):1077–1081.

Shirkey, H. 1968. Therapeutic orphans. The Journal of Pediatrics 72(1):119–120.

Sirugo, G., S. M. Williams, and S. A. Tishkoff. 2019. The missing diversity in human genetic studies. Cell 177(1):26–31.

Siskind, R. L., M. Andrasik, S. T. Karuna, G. B. Broder, C. Collins, A. Liu, J. P. Lucas, G. W. Harper, and P. O. Renzullo. 2016. Engaging transgender people in NIH-funded HIV/AIDS clinical trials research. Journal of Acquired Immune Deficiency Syndromes (1999) 72(Suppl. 3):S243.

Siskind, R. L., M. Andrasik, S. T. Karuna, G. B. Broder, C. Collins, A. Liu, J. P. Lucas, G. W. Harper, and P. O. Renzullo. 2016. Engaging transgender people in nih-funded hiv/aids clinical trials research. Journal of Acquired Immune Deficiency Syndromes (1999) 72(Suppl. 3):S243.

Skirrow, H., S. Barnett, S. Bell, S. L. Riaposova, S. Mounier-Jack, B. Kampmann, and B. Holder. 2022. Women’s views on accepting COVID-19 vaccination during and after pregnancy, and for their babies: a multi-methods study in the UK. BMC Pregnancy Childbirth 22:33. https://doi.org/10.1186/s12884-021-04321-3.

Slomka, J., E. A. Ratliff, S. A. McCurdy, S. Timpson, and M. L. Williams. 2008. Decisions to participate in research: Views of underserved minority drug users with or at risk for HIV. AIDS Care 20(10):1224–1232.

Smirnoff, M., I. Wilets, D. F. Ragin, R. Adams, J. Holohan, R. Rhodes, G. Winkel, E. M. Ricci, C. Clesca, and L. D. Richardson. 2018. A paradigm for understanding trust and mistrust in medical research: The community voices study. AJOB Empirical Bioethics 9(1):39–47.

Smith, S. K., W. Selig, M. Harker, J. N. Roberts, S. Hesterlee, D. Leventhal, R. Klein, B. Patrick-Lake, and A. P. Abernethy. 2015. Patient engagement practices in clinical research among patient groups, industry, and academia in the United States: A survey. PLOS One 10(10):e0140232.

Soejima K., H. Sato, and A. Hisaka. 2022. Age-related change in hepatic clearance inferred from multiple population pharmacokinetic studies: Comparison with renal clearance and their associations with organ weight and blood flow. Clinical Pharmacokinetics 61(2):295–305. doi: 10.1007/s40262-021-01069-z. Epub 2021 Sep 13. PMID: 34514537.

Spong, C. Y., and D. W. Bianchi. 2018. Improving public health requires inclusion of underrepresented populations in research. JAMA 319(4):337–338.

Sprague, D., J. Russo, D. L. Lavallie, and D. Buchwald. 2013. Barriers to cancer clinical trial participation among American Indian and Alaska Native tribal college students. Journal of Rural Health 29(1):55–60.

Stadnick N. A., K. L. Cain, W. Oswald, P. Watson, M. Ibarra, R. Lagoc, L. O. Ayers, L. Salgin, S. L. Broyles, L. C. Laurent, K. Pezzoli, and B. Rabin. Co-creating a Theory of Change to advance COVID-19 testing and vaccine uptake in underserved communities. Health Serv Res. 2022 Mar 4. doi:10.1111/1475-6773.13910.

Stefanoudis, P. V., W. Y. Licuanan, T. H. Morrison, S. Talma, J. Veitayaki, and L. C. Woodall. 2021. Turning the tide of parachute science. Current Biology 31(4):R184–R185.

Stephenson, J. 2020. FDA offers guidance for boosting diversity in clinical trials. JAMA Health Forum 1(11):e201434.

Stevens, K. R., K. S. Masters, P. I. Imoukhuede, K. A. Haynes, L. A. Setton, E. Cosgriff-Hernandez, M. A. Lediju Bell, P. Rangamani, S. E. Sakiyama-Elbert, S. D. Finley, R. K. Willits, A. N. Koppes, N. C. Chesler, K. L. Christman, J. B. Allen, J. Y. Wong, H. El-Samad, T. A. Desai, and O. Eniola-Adefeso. 2021. Fund Black scientists. Cell 184(3):561–565.

Strauss, R. P., S. Sengupta, S. C. Quinn, J. Goeppinger, C. Spaulding, S. M. Kegeles, and G. Millett. 2001. The role of community advisory boards: Involving communities in the informed consent process. American Journal of Public Health. 91(12):1938–1943. doi:10.2105/ajph.91.12.1938.

Strong, B., V. Howard, and M. Reeves. 2020. Sex differences in enrollment among contemporary acute stroke trials: Differences by trial type. Paper presented at ESO-WSO 2020 Virtual Conference, November 7–9, 2020. ESO-WSO Joint Meeting Abstracts. International Journal of Stroke. https://journals.sagepub.com/doi/full/10.1177/1747493020963387.

Sullivan, J. 2004. Subject recruitment and retention: Barriers to success. Applied Clinical Trials 13(4).

Szabo, L. 2022. Why pregnant people were left behind while vaccines moved at ‘warp speed’ to help the masses. Kaiser Health News. https://khn.org/news/article/why-pregnant-people-were-leftbehind-while-vaccines-moved-at-warp-speed-to-help-the-masses/.

Tahhan A. S., M. Vaduganathan, S. J. Greene, G. C. Fonarow, M. Fiuzat, M. Jessup, J. Lindenfeld, C. M. O’Connor, and J. Butler. 2018. Enrollment of older patients, women, and racial and ethnic minorities in contemporary heart failure clinical trials: A systematic review. JAMA Cardiology 3(10):1011–1019. doi: 10.1001/jamacardio.2018.2559. PMID: 30140928.

Tahhan A. S., M. Vaduganathan, S. J. Greene, A. Alrohaibani, M. Raad, M. Gafeer, R. Mehran, G. C. Fonarow, P. S. Douglas, D. L. Bhatt, and J. Butler. 2020. Enrollment of older patients, women, and racial/ethnic minority groups in contemporary acute coronary syndrome clinical trials: A systematic review. JAMA Cardiology 5(6):714–722. doi:10.1001/jamacardio.2020.0359. PMID: 32211813.

Takvorian, S. U., C. E. Guerra, and W. L. Schpero. 2021. A hidden opportunity — Medicaid’s role in supporting equitable access to clinical trials. New England Journal of Medicine 384(21): 1975–1978.

Tamargo, J., G. Rosano, T. Walther, J. Duarte, A. Niessner, J. C. Kaski, C. Ceconi, H. Drexel, K. Kjeldsen, and G. Savarese. 2017. Gender differences in the effects of cardiovascular drugs. European Heart Journal–Cardiovascular Pharmacotherapy 3(3):163–182.

Tauer, C. A. 2002. Central ethical dilemmas in research involving children. Accountability in Research: Policies and Quality Assurance 9(3–4):127–142.

Tay, T., J. Pham, and M. Hew. 2020. Addressing the impact of ethnicity on asthma care. Current Opinion in Allergy and Clinical Immunology 20(3):274–281.

Taylor, H. A. 2008. Implementation of NIH inclusion guidelines: Survey of NIH study section members. Clinical Trials 5(2):140–146.

TCFHA (The Center for Health Affairs). 2012. The emerging field of patient navigation: A golden opportunity to improve healthcare. Issue Brief, December 20, 2012. https://www.neohospitals.org/thecenterforhealthaffairs/mediacenter/newsreleases/2012/December/12-12_Patient-Navigation-Publication.

Thetford, K., T. W. Gillespie, Y. I. Kim, B. Hansen, and I. C. Scarinci. 2021. Willingness of Latinx and African Americans to participate in nontherapeutic trials: It depends on who runs the research. Ethnicity and Disease 31(2):263–272.

The White House. 2000. Office of the Press Secretary. Medicare will reimburse for all routine patient care costs for those in clinical trials. Press Announcement, June 7, 2000. https://clintonwhitehouse5.archives.gov/WH/New/html/20000607.html.

Torgersen J., S. L. Bellamy, B. Ratshaa, X. Han, M. Mosepele, A. F. Zuppa, M. Vujkovic, A. P. Steenhoff, G. P. Bisson, and R. Gross. 2019. Impact of efavirenz metabolism on loss to care in older HIV+ africans. European Journal of Drug Metabolism and Pharmacokinetics 44(2):179–187.

Trant, A. A., L. Walz, W. Allen, J. DeJesus, C. Hatzis, and A. Silber. 2020. Increasing accrual of minority patients in breast cancer clinical trials. Breast Cancer Research and Treatment 184(2):499–505.

Trantham, L. C., W. R. Carpenter, L. D. DiMartino, B. White, M. Green, R. Teal, G. Corbie-Smith, and P. A. Godley. 2015. Perceptions of cancer clinical research among African American men in North Carolina. Journal of the National Medical Association 107(1):33–41.

Tu, S. P., H. Chen, A. Chen, J. Lim, S. May, and C. Drescher. 2005. Clinical trials: Understanding and perceptions of female Chinese-American cancer patients. Cancer 104(12 Suppl.):2999–3005.

UCSF Accelerate. 2022. How can I best work with community members to enhance my research and its impact on the community?, University of California, San Francisco. https://accelerate.ucsf.edu/files/CE/communityFAQ.pdf.

UNC (University of North Carolina at Chapel Hill). 2022. Atherosclerosis risk in communities study description. https://sites.cscc.unc.edu/aric/desc.

Unger, J. M., J. R. Gralow, K. S. Albain, S. D. Ramsey, and D. L. Hershman. 2016. Patient income level and cancer clinical trial participation. JAMA Oncology 2(1):137.

USPSTF (U.S. Preventive Services Task Force). 2021. Screening for colorectal cancer: U.S. Preventive Services Task Force recommendation statement. JAMA 325(19):1965–1977.

van der Kolk, B. A. 2014. The Body Keeps the Score: Brain, Mind, and Body in the Healing of Trauma. New York: Viking.

Van Nuys, K. E., Z. Xie, B. Tysinger, M. A. Hlatky, and D. P. Goldman. 2018. Innovation in heart failure treatment: Life expectancy, disability, and health disparities. JACC: Heart Failure 6 (5):401–409.

Van Spall, H. G. C. 2021. Exclusion of pregnant and lactating women from COVID-19 vaccine trials: A missed opportunity. European Heart Journal 42(28):2724–2726.

Vargesson, N. 2015. Thalidomide-induced teratogenesis: History and mechanisms. Birth Defects Research Part C: Embryo Today: Reviews 105(2):140–156.

Vigil, D., N. Sinaii, and B. Karp. 2021. American Indian and Alaska Native enrollment in clinical studies in the National Institutes of Health’s Intramural Research Program. Ethics & Human Research 43(3):2–9.

Vitale, C., M. Fini, I. Spoletini, M. Lainscak, P. Seferovic, and G. Rosano. 2017. Under-representation of elderly and women in clinical trials. International Journal of Cardiology 232:216–221.

Vitale, C., G. Rosano, and M. Fini. 2016. Are elderly and women under-represented in cardiovascular clinical trials? Implication for treatment. Wiener klinische Wochenschrift 128(Suppl. 7).

Voytek, C. D., K. T. Jones, and D. S. Metzger. 2011. Selectively willing and conditionally able: HIV vaccine trial participation among women at “high risk” of HIV infection. Vaccine 29(36): 6130–6135.

Waheed, W., A. Hughes-Morley, A. Woodham, G. Allen, and P. Bower. 2015. Overcoming barriers to recruiting ethnic minorities to mental health research: A typology of recruitment strategies. BMC Psychiatry 15(1).

Wallace, J., K. Jiang, P. Goldsmith-Pinkham, and Z. Song. 2021. Changes in racial and ethnic disparities in access to care and health among US adults at age 65 years. JAMA Internal Medicine 181(9):1207–1215.

Wallerstein, N. B., and B. Duran. 2006. Using community-based participatory research to address health disparities. Health Promotion Practice 7(3):312–323.

Wallerstein, N., B. Duran, J. Oetzel, and M. Minkler, eds. 2018. Community-based Participatory Research for Health: Advancing Social and Health Equity. 3rd ed. San Francisco, CA: Jossey-Bass.

Wang, R., S. W. Lagakos, J. H. Ware, D. J. Hunter, and J. M. Drazen. 2007. Statistics in medicine—reporting of subgroup analyses in clinical trials. New England Journal of Medicine 357(21):2189–2194.

Ward, E., A. Jemal, V. Cokkinides, G. K. Singh, C. Cardinez, A. Ghafoor, and M. Thun. 2004. Cancer disparities by race/ethnicity and socioeconomic status. CA: A Cancer Journal for Clinicians 54(2):78–93.

Warden, B. A., S. Fazio, and M. D. Shapiro. 2020. The PCSK9 revolution: Current status, controversies, and future directions. Trends in Cardiovascular Medicine 30(3):179–185.

Webb, D. A., J. C. Coyne, R. L. Goldenberg, V. K. Hogan, I. T. Elo, J. R. Bloch, L. Mathew, I. M. Bennett, E. F. Dennis, and J. F. Culhane. 2010. Recruitment and retention of women in a large randomized control trial to reduce repeat preterm births: The Philadelphia Collaborative Preterm Prevention Project. BMC Medical Research Methodology 10.

Webb, F. J., J. Khubchandani, C. W. Striley, and L. B. Cottler. 2019. Black–white differences in willingness to participate and perceptions about health research: Results from the population-based healthstreet study. Journal of Immigrant and Minority Health 21(2):299–305.

Wendler, D., R. Kington, J. Madans, G. Van Wye, H. Christ-Schmidt, L. A. Pratt, O. W. Brawley, C. P. Gross, and E. Emanuel. 2006. Are racial and ethnic minorities less willing to participate in health research? PLOS Medicine 3(2):201–210.

Wennberg, D. E., F. L. Lucas, J. D. Birkmeyer, C. E. Bredenberg, and E. S. Fisher. 1998. Variation in carotid endarterectomy mortality in the Medicare population: Trial hospitals, volume, and patient characteristics. JAMA 279(16):1278–1281. doi:10.1001/jama.279.16.1278.

Wesp, L. M., V. Scheer, A. Ruiz, K. Walker, J. Weitzel, L. Shaw, P. M. Kako, and L. Mkandawire-Valhmu. 2018. An emancipatory approach to cultural competency: The application of critical race, postcolonial, and intersectionality theories. Advances in Nursing Science 41(4):316–326.

Westergaard, R. P., M. C. Beach, S. Saha, and E. A. Jacobs. 2014. Racial/ethnic differences in trust in health care: HIV conspiracy beliefs and vaccine research participation. Journal of General Internal Medicine 29(1):140–146.

Whitelaw, S., K. Sullivan, Y. Eliya, M. Alruwayeh, L. Thabane, C. W. Yancy, R. Mehran, M. A. Mamas, and H. G. C. Van Spall. 2021. Trial characteristics associated with under-enrolment of females in randomized controlled trials of heart failure with reduced ejection fraction: A systematic review. European Journal of Heart Failure 23(1):15–24.

Wilcox, A., K. Natarajan, and C. Weng. 2009. Using personal health records for automated clinical trials recruitment: The ePaIRing Model. Summit on Translational Bioinformatics 2009:136–140.

Wilkins, C. H. 2018. Effective engagement requires trust and being trustworthy. Medical Care 56(10 Suppl. 1):S6–S8.

Wilkins, C. H., and P. M. Alberti. 2019. Shifting academic health centers from a culture of community service to community engagement and integration. Academic Medicine 94(6):763–767.

Winkfield, K. M., J. K. Phillips, S. Joffe, M. T. Halpern, D. S. Wollins, and B. Moy. 2018. Addressing financial barriers to patient participation in clinical trials: ASCO policy statement. Journal of Clinical Oncology 6(33):3331–3339. doi:10.1200/JCO.18.01132.

Winter, S. S., J. M. Page-Reeves, K. A. Page, E. Haozous, A. Solares, C. Nicole Cordova, and R. S. Larson. 2018. Inclusion of special populations in clinical research: Important considerations and guidelines. Journal of Clinical and Translational Research 4(1):56–69.

Wissing, M.D., Kluetz, P.G., Ning, Y.-M., Bull, J., Merenda, C., Murgo, A.J. and Pazdur, R. 2014. Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013. Cancer 120: 3025–3032.

WMA (World Medical Association). 2008. Declaration of Helsinki. https://www.wma.net/wp-content/uploads/2018/07/DoH-Oct2008.pdf.

Woitowich, N. C., and T. K. Woodruff. 2019. Opinion: Research community needs to better appreciate the value of sex-based research. Proceedings of the National Academy of Sciences 116(15):7154–7156.

Women’s health. 1985. Report of the Public Health Service Task Force on Women’s Health Issues. Public Health Reports 100(1):73–106.

Wood, S. 2021. Improving the representation of women and underrepresented minorities in clinical trials and research. In NASEM Report Interviews, L. Bothwell, ed.

Woodall, A., C. Morgan, C. Sloan, and L. Howard. 2010. Barriers to participation in mental health research: Are there specific gender, ethnicity and age related barriers? BMC Psychiatry 10(1):103.

Yancey, A. K., A. N. Ortega, and S. K. Kumanyika. 2006. Effective recruitment and retention of minority research participants. Annual Review of Public Health 27(1):1–28.

Yearby, R. 2014. When is a change going to come. Separate and unequal treatment in health care fifty years after Title VI of the Civil Rights Act of 1964. SMU Law Review 67(2):287–337.

Yin, W. 2008. Market incentives and pharmaceutical innovation. Journal of Health Economics 27(4). https://doi.org/10.1016/j.jhealeco.2008.01.002.

Zissimopoulos, J. M., B. C. Tysinger, P. A. St. Clair, and E. M. Crimmins. 2018. The impact of changes in population health and mortality on future prevalence of Alzheimer’s disease and other dementias in the united atates. The Journals of Gerontology: Series B 73(Suppl. 1):S38–S47.

Zulman, D. M., J. B. Sussman, X. Chen, C. T. Cigolle, C. S. Blaum, and R. A. Hayward. 2011. Examining the evidence: A systematic review of the inclusion and analysis of older adults in randomized controlled trials. Journal of General Internal Medicine 26(7):783–790.

Zunzunegui, M., B. Alvarado, R. Guerra, J. Gómez, A. Ylli, J. Guralnik, and I. R. Group. 2015. The mobility gap between older men and women: The embodiment of gender. Archives of Gerontology and Geriatrics 61(2):140–148.

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