,,ii #aagth ,,congress #ast ,session ,s4 #bgjf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,august #aj1 #bjba,mr4 ,menendez 7for himself and ,mr4 ,scott of ,south ,carolina7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve diversity in clinical trials and data collection for ,,covid-#ai and future public health threats to address social determinants of health4 #a4 ,short title ,this ,act may be cited as the ,diversifying ,investigations ,via ,equitable ,research ,studies for ,everyone ,trials ,act or the ,,diverse ,trials ,act4 #b4 ,guidance on decentralized clinical trials 7a7 ,definitions ,in this section1 the term decentralized clinical trials includes clinical trials that are executed through a broad spectrum of options1 such as telemedicine or other mobile or digital technologies1 to allow for the remote collection and assessment of clinical trial data from participants1 including in the home or office setting4 7b7 ,guidance ,not later than #f months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this ,act as the ,secretary71 acting through the ,commissioner of ,food and ,drugs 7referred to in this ,act as the ,commissioner71 shall issue a draft guidance that addresses how to conduct decentralized clinical trials with meaningful demographic diversity1 including racial1 ethnic1 age1 gender1 and geographic diversity in patient engagement1 enrollment1 and participation1 including how to appropriately use digital health technologies or other remote assessment options1 such as telemedicine1 to support such trials4 ,not later than #f months after the date the public comment period for the draft guidance ends1 the ,secretary shall issue a final guidance4 7c7 ,content of guidance ,the guidance under subsection 7b7 shall address the following3 7#a7 ,strategies to engage with prospective clinical trial participants and community partners1 such as patient advocacy groups with diverse representation1 to incorporate input of such patients and partners into the design of decentralized clinical trials4 7#b7 ,recommendations for-- 7,a7 protocol design approaches2 7,b7 appropriate clinical endpoints2 7,c7 institutional review board composition and ensuring that such boards include members with expertise in decentralized clinical trials2 7,d7 delegation of clinical research organization responsibilities and suitable proxies for clinical research organizations2 and 7,e7 simplifying informed consent4 7#c7 ,recommendations for how digital health technology or other remote assessment options1 such as telemedicine1 could support decentralized clinical trials1 including guidance on appropriate technological platforms and mediums1 data collection and use1 data integrity1 and communication to study participants through digital technology4 7#d7 ,recommendations for appropriate methods of patient recruitment and retention1 including institutional review board oversight1 patient communication1 and the role of study participants and community partners as advocates to facilitate clinical trial recruitment1 particularly with respect to underrepresented populations4 7#e7 ,information regarding when and how a study sponsor may solicit a meeting with the ,secretary regarding the issues described in paragraphs 7#a7 through 7#d74 7d7 ,international ,harmonization ,after issuing the final guidance under subsection 7b71 the ,secretary1 acting through the ,commissioner1 may work with foreign regulators pursuant to existing memoranda of understanding governing exchange of information to facilitate international harmonization of the regulation of decentralized clinical trials and use of digital health technology or other remote assessment options4 #c4 ,encouragement of clinical trial enrollment by racially and ethnically diverse populations 7a7 ,no cost provision of digital health technologies ,the free provision of digital health technologies by drug or device manufacturers to their clinical trial participants shall not be considered a violation of section #aabh;,a of the ,social ,security ,act 7commonly known as the ,civil ,monetary ,penalties ,law7 7#db ,u4,s4,c4 #acbj;a-#g;a71 section #aabh;,b of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b71 or sections #cgbi through #cgcc of title #ca1 ,united ,states ,code1 7commonly known as the ,false ,claims ,act71 provided that-- 7#a7 the use of digital health technologies will facilitate in any phase of clinical development the inclusion of diversity of patient populations1 such as underrepresented racial and ethnic minorities1 low-income populations1 and the elderly2 7#b7 the digital health technologies will facilitate individuals participation1 or are necessary to such participation2 7#c7 all features of the digital health technologies that are unrelated to use in the clinical trial are disabled or only allowed to remain activated to model real-world usage of the digital technology2 and 7#d7 the clinical trial sponsor requires participants to return1 purchase1 or disable the digital health technologies by the conclusion of the trial4 7b7 ,grants and contracts 7#a7 ,in general ,the ,secretary may issue grants to and enter into contracts with entities to support community education1 outreach1 and recruitment activities for clinical trials with respect to drugs1 including vaccines for diseases or conditions which have a disproportionate impact on underrepresented populations 7including on racial and ethnic minority populations71 including for the diagnosis1 prevention1 or treatment of ,,covid-#ai4 ,such activities may include-- 7,a7 working with community clinical trial sites1 including community health centers1 academic health centers1 and other facilities2 7,b7 training health care personnel including potential clinical trial investigators1 with a focus on significantly increasing the number of underrepresented racial and ethnic minority healthcare personnel who are clinical trial investigators at the community sites for ongoing clinical trials2 7,c7 engaging community stakeholders to encourage participation in clinical trials1 especially in underrepresented racial and ethnic minority communities2 and 7,d7 fostering partnerships with community-based organizations serving underrepresented racial and ethnical minority populations1 including employee unions and frontline health care workers4 7#b7 ,priority for grant and contract awards ,in awarding grants and contracts under this subsection1 the ,secretary shall prioritize entities that-- 7,a7 develop educational1 recruitment1 and training materials in multiple languages2 or 7,b7 undertake clinical trial outreach efforts in more diverse racial and ethnic communities that are traditionally underrepresented in clinical trials1 such as tribal areas4 7#c7 ,authorization of appropriations ,there is authorized to be appropriated for fiscal years #bjbj and #bjba such sums as may be necessary to carry out this subsection4 #d4 ,enhancement of ,,covid-#ai data collection to address demographic data gaps and social determinants of health 7a7 ,data collection ,to address demographic data gaps 7#a7 ,in general ,the ,secretary shall require laboratories that are subject to the reporting requirements under section #ahaae7;a7 of the ,coronavirus ,aid1 ,relief1 and ,economic ,security ,act 7,public ,law #aaf-acf71 to include with reports made under such section #ahaae7;a7 information to enhance such existing ,,covid-#ai data collection activities and to advance policies to address social determinants of health1 including additional identifiers1 such as those identified by the ,commissioner1 including building on guidance existing on the date of enactment of this ,act1 for the collection of race and ethnicity data in clinical trials1 as determined appropriate by the ,secretary4 7#b7 ,additional use of data ,the data collected under paragraph 7#a7 may be used to inform-- 7,a7 clinical trial recruitment2 7,b7 resource allocations2 7,c7 treatment strategies2 and 7,d7 other public health activities4 7#c7 ,collection via grants or contracts 7,a7 ,in general ,the ,secretary may issue grants to1 and enter into contracts with1 ,states1 local public health departments1 or other entities supplying data to the ,secretary as required under this subsection1 to support the activities under this subsection4 7,b7 ,guidance for use of funds ,in issuing grants or contracts under subparagraph 7,a71 the ,secretary may issue guidance regarding best practices for collecting data pursuant to paragraph 7#a7 and track the performance of entities receiving grants or contracts4 7#d7 ,use and disclosure for public health activities ,the submission and use of data collected pursuant to this subsection shall be considered a permitted disclosure and use for public health activities as set forth in section #afd4eab7;b77#a77;i7 of #de1 ,code of ,federal ,regulations 7or any successor regulations74 7b7 ,data collection regarding enhanced risk for ,,covid-#ai ,the ,secretary shall-- 7#a7 conduct a study on best practices for laboratories that are subject to the reporting requirements under section #ahaae7;a7 of the ,coronavirus ,aid1 ,relief1 and ,economic ,security ,act 7,public ,law #aaf-acf7 to aid such laboratories in collecting data elements related to enhanced risk for ,,covid-#ai1 such as data1 with respect to a patient1 regarding income1 education1 employment1 disability1 community resources1 and social support2 7#b7 consider which governmental entities 7including ,federal1 ,state1 and local governmental entities7 would be best suited to aiding in collecting such data elements in coordination with such laboratories2 and 7#c7 issue guidance on such best practices4 #e4 ,clarification that certain remuneration related to participation in clinical trials does not constitute remuneration under the ,federal civil money penalties law 7a7 ,in general ,section #aabh;,a7i77#f77;,f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7i77#f77;,f77 is amended by inserting 7including remuneration offered or transferred to an individual to promote the participation in an approved clinical trial1 as defined in subsection 7d7 of the first section #bgji of the ,public ,health ,service ,act1 that is registered with the database of clinical trials maintained by the ,national ,library of ,medicine 7or any successor database71 so long as such remuneration facilitates equitable inclusion of patients from all relevant demographic and socioeconomic populations and is related to patient participation in the approved clinical trial7 after promotes access to care4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply to remuneration provided on or after the date of the enactment of this ,act4 #f4 ,national academy of medicine study 7a7 ,in general ,the ,secretary shall enter into an arrangement with the ,national ,academy of ,medicine under which the ,national ,academy agrees to study and propose a design for a national interoperable data platform to improve access to health data1 and other relevant data needs1 during public health emergencies4 7b7 ,report ,the arrangement under subsection 7a7 shall provide for submission by the ,national ,academy of ,medicine to the ,secretary and ,congress1 not later than #abj days after the date of enactment of this ,act1 of a report on the results of the study under subsection 7a7 and the design proposed based on such study4