Gender, Racial, and Ethnic Disclosure in NIH K-Award Funded Diabetes and Obesity Clinical Trials

TitleGender, Racial, and Ethnic Disclosure in NIH K-Award Funded Diabetes and Obesity Clinical Trials
Publication TypeJournal Article
Year of Publication2006
AuthorsGuevara, C, Cook, C, Herback, N, Pietrobon, R, Jacobs, DO, Vail, TP
JournalAccountability in Research: Policies & Quality Assurance
Volume13
Issue4
Pagination311-324
Type of ArticleArticle
Publication Languageeng
ISSN Number08989621
Accession Number23220217
KeywordsClinical , DIABETES , Die , Diversity , gender , Human , Human Research Subjects , K , MEDICINE , MINORITY , National , OBESITY , Racial , SCIENCE , United
AbstractIn 1993, the National Institutes of Health (NIH) passed The Revitalization Act (Subtitle B) which mandated that all NIH funded clinical trials have “appropriate representation” of minority and women subjects. The authors aim was to evaluate the impact of the mandate by examining the reporting and inclusion of minority and female subjects into NIH K-Award funded clinical trials, addressing the minority predominant diagnoses of diabetes and clinical obesity. Of the 165 papers studied, only 37% disclosed race, a number that did not improve over time (p = .15), whereas 92% disclosed gender. Clinical trials that focused on females increased for diabetes studies but not obesity studies. Overall, disclosure of race declined over the 3 timeframes whereas individually, the disclosure of African Americans improved.
NotesGUEVARA, CARLOS 1; COOK, CHAD 1; Email Address: chad.cook@duke.edu; HERBACK, NATALIE 2; PIETROBON, RICARDO 3; JACOBS, DANNY O. 4; VAIL, THOMAS PARKER 5; Affiliations: 1: Duke University Medical Center, Durham, NC; 2: Duke University Physical Therapy, Department of Community and Family Medicine, Durham, NC; 3: Department of Orthopaedic Surgery, Center for Excellence in Surgical Outcomes, Duke University Medical Center, Durham, NC; 4: Department of Surgery, Duke University Medical Center, Durham, NC; 5: Adult Reconstructive Surgery, Duke University Medical Center, Durham, NC; Issue Info: Oct2006, Vol. 13 Issue 4, p311; Subject Term: CLINICAL trials; Subject Term: CLINICAL medicine; Subject Term: OBESITY; Subject Term: DIABETES; Subject Term: RACIAL minorities; Subject: UNITED States; Author-Supplied Keyword: gender; Author-Supplied Keyword: K grant; Author-Supplied Keyword: minority; Author-Supplied Keyword: obesity ; Company/Entity: NATIONAL Institutes of Health (U.S.); Number of Pages: 14p; Illustrations: 3 Charts; Document Type: Article
DOI10.1080/08989620601003380
Short TitleGender, Racial, and Ethnic Disclosure in NIH K-Award Funded Diabetes and Obesity Clinical Trials*
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