Sec. 2038. COLLABORATION AND COORDINATION TO ENHANCE RESEARCH

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## SEC. 2038 COLLABORATION AND COORDINATION TO ENHANCE RESEARCH ###

(a)Research Priorities; Collaborative Research Projects Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended— ####

(1)by amending paragraph

(4)to read as follows: > > #### “(4) > > shall assemble accurate data to be used to assess research priorities, including— > > > ##### “(A) > > information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; and > > > ##### “(B) > > data on study populations of clinical research, funded by or conducted at each national research institute and national center, which— > > > ###### “(i) > > specifies the inclusion of— > > > ###### “(I) > > women; > > > ###### “(II) > > members of minority groups; > > > ###### “(III) > > relevant age categories, including pediatric subgroups; and > > > ###### “(IV) > > other demographic variables as the Director of the National Institutes of Health determines appropriate; > > > ###### “(ii) > > is disaggregated by research area, condition, and disease categories; and > > > ###### “(iii) > > is to be made publicly available on the Internet website of the National Institutes of Health;” > ; and ####

(2)in paragraph (8)— #####

(A)in subparagraph (A), by striking “and” at the end; and #####

(B)by adding at the end the following: > > ##### “(C) > > foster collaboration between clinical research projects funded by the respective national research institutes and national centers that— > > > ###### “(i) > > conduct research involving human subjects; and > > > ###### “(ii) > > collect similar data; and > > > ##### “(D) > > encourage the collaboration described in subparagraph

(C)to— > > > ###### “(i) > > allow for an increase in the number of subjects studied; and > > > ###### “(ii) > > utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities;” > . ###

(b)Reporting Section 492B(f) of the Public Health Service Act (42 U.S.C. 289a-2(f)) is amended— ####

(1)by striking “biennial” each place such term appears and inserting “triennial”; ####

(2)by striking “ The advisory council ” and inserting the following: > > #### “(1) In general > > The advisory council” > ; and ####

(3)by adding at the end the following: > > #### “(2) Contents > > Each triennial report prepared by an advisory council of each national research institute as described in paragraph

(1)shall include each of the following: > > > ##### “(A) > > The number of women included as subjects, and the proportion of subjects that are women, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease, and accounting for single-sex studies. > > > ##### “(B) > > The number of members of minority groups included as subjects, and the proportion of subjects that are members of minority groups, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease and accounting for single-race and single-ethnicity studies. > > > ##### “(C) > > For the applicable reporting period, the number of projects of clinical research that include women and members of minority groups and that— > > > ###### “(i) > > have been completed during such reporting period; and > > > ###### “(ii) > > are being carried out during such reporting period and have not been completed. > > > ##### “(D) > > The number of studies completed during the applicable reporting period for which reporting has been submitted in accordance with subsection (c)(2)(A).” > . ###

(c)Coordination Section 486(c)(2) of the Public Health Service Act (42 U.S.C. 287d(c)(2)) is amended by striking “designees” and inserting “senior-level staff designees”. ###

(d)In general Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.), as amended by section 2021, is further amended by adding at the end the following: > > ## “SEC. 404N POPULATION FOCUSED RESEARCH > > **[**[42 U.S.C. 283p](/us/usc/t42/s283p)**]** > > “The Director of the National Institutes of Health shall, as appropriate, encourage efforts to improve research related to the health of sexual and gender minority populations, including by— > > > #### “(1) > > facilitating increased participation of sexual and gender minority populations in clinical research supported by the National Institutes of Health, and reporting on such participation, as applicable; > > > #### “(2) > > facilitating the development of valid and reliable methods for research relevant to sexual and gender minority populations; and > > > #### “(3) > > addressing methodological challenges.” > . ###

(e)Reporting **[**[42 U.S.C. 283p note](/us/usc/t42/s283p)**]** ####

(1)In general The Secretary, in collaboration with the Director of the National Institutes of Health, shall as appropriate— #####

(A)continue to support research for the development of appropriate measures related to reporting health information about sexual and gender minority populations; and #####

(B)not later than 2 years after the date of enactment of this Act, disseminate and make public such measures. ####

(2)National academy of medicine recommendations In developing the measures described in paragraph (1)(A), the Secretary shall take into account recommendations made by the National Academy of Medicine. ###

(f)Improving Coordination Related to Minority Health and Health Disparities Section 464z-3 of the Public Health Service Act (42 U.S.C. 285t) is amended— ####

(1)by redesignating subsection (h), relating to interagency coordination, that follows subsection

(j)as subsection (k); and ####

(2)in subsection

(k)(as so redesignated)— #####

(A)in the subsection heading, by striking “Interagency” and inserting “Intra-National Institutes of Health”; #####

(B)by striking “as the primary Federal officials” and inserting “as the primary Federal official”; #####

(C)by inserting a comma after “review”; #####

(D)by striking “Institutes and Centers of the National Institutes of Health” and inserting “national research institutes and national centers”; and #####

(E)by adding at the end the following: “The Director of the Institute may foster partnerships between the national research institutes and national centers and may encourage the funding of collaborative research projects to achieve the goals of the National Institutes of Health that are related to minority health and health disparities.”. ###

(g)Basic Research **[**[42 U.S.C. 284r](/us/usc/t42/s284r)**]** ####

(1)Developing policies Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health (referred to in this section as the “Director of the National Institutes of Health”), taking into consideration the recommendations developed under section 2039, shall develop policies for projects of basic research funded by National Institutes of Health to assess— #####

(A)relevant biological variables including sex, as appropriate; and #####

(B)how differences between male and female cells, tissues, or animals may be examined and analyzed. ####

(2)Revising policies The Director of the National Institutes of Health may update or revise the policies developed under paragraph

(1)as appropriate. ####

(3)Consultation and outreach In developing, updating, or revising the policies under this section, the Director of the National Institutes of Health shall— #####

(A)consult with— ######

(i)the Office of Research on Women’s Health; ######

(ii)the Office of Laboratory Animal Welfare; and ######

(iii)appropriate members of the scientific and academic communities; and #####

(B)conduct outreach to solicit feedback from members of the scientific and academic communities on the influence of sex as a variable in basic research, including feedback on when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals. ####

(4)Additional requirements The Director of the National Institutes of Health shall— #####

(A)ensure that projects of basic research funded by the National Institutes of Health are conducted in accordance with the policies developed, updated, or revised under this section, as applicable; and #####

(B)encourage that the results of such research, when published or reported, be disaggregated as appropriate with respect to the analysis of any sex differences. ###

(h)Clinical Research **[**[42 U.S.C. 289a-2 note](/us/usc/t42/s289a-2)**]** ####

(1)In general Not later than 1 year after the date of enactment of this Act, the Director of the National Institutes of Health, in consultation with the Director of the Office of Research on Women’s Health and the Director of the National Institute on Minority Health and Health Disparities, shall update the guidelines established under section 492B(d) of Public Health Service Act (42 U.S.C. 289a-2(d)) in accordance with paragraph (2). ####

(2)Requirements The updated guidelines described in paragraph

(1)shall— #####

(A)reflect the science regarding sex differences; #####

(B)improve adherence to the requirements under section 492B of the Public Health Service Act (42 U.S.C. 289a-2), including the reporting requirements under subsection

(f)of such section; and #####

(C)clarify the circumstances under which studies should be designed to support the conduct of analyses to detect significant differences in the intervention effect due to demographic factors related to section 492B of the Public Health Service Act, including in the absence of prior studies that demonstrate a difference in study outcomes on the basis of such factors and considering the effects of the absence of such analyses on the availability of data related to demographic differences. ###

(i)Appropriate Age Groupings in Clinical Research **[**[42 U.S.C. 282 note](/us/usc/t42/s282)**]** ####

(1)Input from experts Not later than 180 days after the date of enactment of this Act, the Director of the National Institutes of Health shall convene a workshop of experts on pediatric and older populations to provide input on— #####

(A)appropriate age groups to be included in research studies involving human subjects; and #####

(B)acceptable justifications for excluding participants from a range of age groups from human subjects research studies. ####

(2)Policy updates Not later than 180 days after the conclusion of the workshop under paragraph (1), the Director of the National Institutes of Health shall make a determination with respect to whether the policies of the National Institutes of Health on the inclusion of relevant age groups in clinical studies need to be updated, and shall update such policies as appropriate. In making the determination, the Director of the National Institutes of Health shall take into consideration whether such policies— #####

(A)address the consideration of age as an inclusion variable in research involving human subjects; and #####

(B)identify the criteria for justification for any age-related exclusions in such research. ####

(3)Public availability of findings and conclusions The Director of the National Institutes of Health shall— #####

(A)make the findings and conclusions resulting from the workshop under paragraph

(1)and updates to policies in accordance with paragraph (2), as applicable, available to the public on the Internet website of the National Institutes of Health; and #####

(B)ensure that age-related data reported in the triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032) are made available to the public on the Internet website of the National Institutes of Health.

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Sec. 2038

COLLABORATION AND COORDINATION TO ENHANCE RESEARCH

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