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5 " NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research Amended October, women_min/guidelines_amended_10 _2001.htm 5

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7 &!! (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; 7

8 &!! 78 (2) Epidemiologic and behavioral studies; (3) Outcomes research and health services research. 8

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15 #$ "! ) &.?.//@ &,!%$: * $ C Question 1: Ask about Ethnicity Question 2: Ask about Race WITH OPTION to select more than one racial designation 15

16 "! OMB Directive 15 Issued 1997 Ethnic Categories: Hispanic or Latino Not Hispanic or Latino Racial Categories: American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander White 16

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22 P rincipal Investigator/P rogram D irector (Last, first, m iddle): Stud y T itle: Inclusion E nrollm ent R eport Table T his report form at should N O T be used for data collection from study participants. T otal Enrollm ent: G rant N um ber: Proto col N u m b er: P AR T A. TO T AL E N R O LLM E N T R E P O R T: N um ber of S ubjects E nrolled to D ate (C um ulative) b y E thnicity and R ace Sex/G end er E thnic C ategory U nkn ow n or Fem ales M ales N ot R epo rted T otal H ispanic or Latino ** N ot H ispanic or Latino U nknow n (Individ uals not reporting ethnicity) E thnic C ategory: Total o f All S ub jects* * R acial C ategories Am erican Indian/Alaska N ative Asian N ative H aw aiian or O ther P acific Islander B lack or African Am erican W hite M ore than one race U nknow n or not reported R acial C ategories: Total o f All S ubjects* * P AR T B. H IS P AN IC E N R O LLM E N T R E P O R T: N um ber of H ispanics or Latinos E nrolled to D ate (C um ulative) U nkn ow n or R acial C atego ries Fem ales M ales T otal N ot R epo rted Am erican Indian or Alaska N ative Asian N ative H aw aiian or O ther P acific Islander B lack or African Am erican W hite M ore Than O ne R ace U nknow n or not reported R acial C ategories: Total o f H ispanics or Latino s** ** * These totals m ust agree. ** These totals m ust agree. P H S 398/2590 (R ev. 05/01) P age Inclusion Enrollm ent R eport Form at P age 22

23 4/98 INCLUSION TABLE This report format should NOT be used for data collection from study participants. Principal Investigator/Project Director (Last, First, Middle) Grant Number (if known): STUDY TITLE: Total Enrollment: Protocol Number: American Indian or Asian or Alaskan Native Pacific Islander Black, not of Hispanic Origin Hispanic White, not of Hispanic Origin Other or Unknown Total Female Male Unknown Total 23

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25 Requirements for NIH-Defined Phase III Clinical Trials $ (!! : Prior studies support significant differences between subgroups: Need plans to conduct valid analyses to detect significant differences between sex/gender and/or racial/ethnic subgroups For the purpose of this policy, Significant Difference is defined as a difference that is of clinical or public health importance based on substantial scientific data. This is not the same as statistically significant difference. 25

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27 D(! % &! " * =$$ : Prior studies neither support nor negate significant differences in intervention effect between subgroups: Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (Does not require high statistical power) 6 $$! $- E =(, ( D $,!, ( ; 27

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34 $ Inclusion of Women and Minorities Implementation Page ing/women_min/women_min.h tm CONTACT PROGRAM STAFF! 34