,,ii #aaith ,,congress #ast ,session ,s4 #cefd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #ah1 #bjbe,mr4 ,kim 7for himself and ,ms4 ,collins7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to direct the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health1 to take certain steps to increase clinical trial diversity1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,nih ,clinical ,trial ,integrity ,act4 #b4 ,diversity goals for clinical trials funded by the ,national ,institutes of ,health 7a7 ,applications ,beginning on the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health 7referred to in this section as the ,secretary71 shall require that a research organization or entity funded by the ,national ,institutes of ,health 7referred to in this section as an ,,nih-funded research organization or entity7 seeking to conduct a clinical trial investigating a drug or device 7as those terms are defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 or a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i777 that is funded by the ,national ,institutes of ,health or a behavioral intervention1 the protocol for which is approved by the ,national ,institutes of ,health1 submit an application 7or renewal thereof7 for such funding or approval that includes-- 7#a7 clear and measurable goals for the recruitment and retention of participants that reflect-- 7,a7 the race1 ethnicity1 age1 and sex of patients with the disease or condition being investigated2 or 7,b7 as scientifically or ethically justified and appropriate1 the race1 ethnicity1 age1 and sex of the general population of the ,united ,states if the prevalence of the disease or condition is not known2 7#b7 a rationale for the goals specified under paragraph 7#a7 that specifies-- 7,a7 how investigators will determine the number of participants for each population category that reflect the population groups specified in paragraph 7#a72 or 7,b7 strategies that will be used to enroll and retain participants across the different race1 ethnicity1 age1 and sex categories2 7#c7 a detailed plan for how the clinical trial will achieve the goals specified under paragraph 7#a7 that specifies-- 7,a7 the requirements for researchers1 in conducting the trial1 to analyze the population groups specified in paragraph 7#a7 separately2 and 7,b7 how the trial will recruit a study population that is-- 7i7 scientifically and ethically appropriate in terms of the scientific objectives and proposed study design2 and 7ii7 in sufficient numbers to obtain clinically and statistically meaningful determinations of the safety and effectiveness of the drug1 device1 or behavioral intervention being studied in the respective race1 ethnicity1 age1 and sex groups2 and 7#d7 the ,,nih-funded research organization or entity's plan for implementing1 or an explanation of why the ,,nih-funded research organization or entity cannot implement1 alternative clinical trial follow-up requirements that are less burdensome for trial participants1 such as-- 7,a7 requiring fewer follow-up visits2 7,b7 allowing phone follow-up or home visits by appropriately qualified staff 7in lieu of in-person visits by patients72 7,c7 allowing for online follow-up options2 7,d7 permitting the patient's primary care provider to perform some of the follow-up visit requirements2 7,e7 allowing for evening and weekend hours for required follow-up visits2 7,f7 allowing virtual or telemedicine visits2 7,g7 use of wearable technology to record key health parameters2 and 7,h7 use of alternate labs or imaging centers1 which may be closer to the residence of the patients participating in the trial4 7b7 ,terms 7#a7 ,in general ,as a condition on the receipt of funding through the ,national ,institutes of ,health1 as described in subsection 7a71 with respect to a clinical trial1 the ,,nih-funded research organization or entity of the clinical trial shall agree to terms requiring that-- 7,a7 the aggregate demographic information of trial participants be shared on an annual basis with the ,secretary while participant recruitment and data collection in such trial is ongoing1 and that such information is provided with respect to-- 7i7 underrepresented populations1 including populations grouped by race1 ethnicity1 age1 and sex2 and 7ii7 such populations that reflect the prevalence of the disease or condition that is the subject of the clinical trial involved 7as available and as appropriate to the scientific objective for the study1 as determined by the ,director of the ,national ,institutes of ,health72 7,b7 the ,,nih-funded research organization or entity submits to the program officer and grants management specialist of the specific institute1 center1 or office of the ,national ,institutes of ,health1 annually or as frequently as such officer or specialist determines necessary1 the retention rate of participants in the clinical trial1 disaggregated by race1 ethnicity1 age1 and sex2 7,c7 the clinical trial researchers complete education and training programs on diversity in clinical trials2 and 7,d7 at the conclusion of the trial1 the sponsor submits to the ,secretary the number of participants in the trial1 disaggregated by race1 ethnicity1 age1 and sex4 7#b7 ,privacy protections ,any data shared under paragraph 7#a7 may not include any individually identifiable information or protected health information with respect to clinical trial participants and shall only be disclosed to the extent allowed under ,federal privacy laws and by ,national ,institutes of ,health policy4 7c7 ,exception ,in lieu of submitting an application under subsection 7a7 and documentation of goals as required by paragraph 7#a7 of such subsection1 an applicant may provide reasoning for why the recruitment of each of the population groups specified in paragraph 7#a7 of subsection 7a7 is not necessary and why such recruitment is not scientifically justified or possible4 #c4 ,eliminating cost barriers ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health1 shall conduct and complete a study on-- 7#a7 the need for review of human subject regulations specified in part #df of title #de1 ,code of ,federal ,regulations 7or successor regulations71 and related guidance2 7#b7 the modernization of such regulations and guidance to establish updated guidelines for reimbursement of out-of-pocket expenses of human subjects1 compensation of human subjects for time spent participating in the clinical trial1 and incentives for recruitment of human subjects2 and 7#c7 the need for updated safe harbor rules under section #ajja4ieb of title #db1 ,code of ,federal ,regulations 7or successor regulations71 and section #aabh;,b of the ,social ,security ,act 7commonly referred to as the ,federal ,anti-,kickback ,statute 7#db ,u4,s4,c4 #acbj;a-#g;b77 with respect to the assistance provided under this section4 #d4 ,public awareness and education campaign 7a7 ,national campaign ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in consultation with the stakeholders specified in subsection 7e71 shall carry out a national campaign to increase the awareness and knowledge of individuals in the ,united ,states1 including health care professionals1 patients1 and others1 with respect to the need for diverse clinical trials among the demographic groups identified pursuant to section #b7;a77#a74 7b7 ,requirements ,the national campaign conducted under this section shall include-- 7#a7 7,a7 the development and distribution of written educational materials2 7,b7 the development and placing of public service announcements that are intended to encourage individuals who are members of the demographic groups identified pursuant to section #b7;b77#a77;,a77i7 to seek to participate in clinical trials2 and 7,c7 the development of curricula for health care professionals on-- 7i7 how to participate in clinical trials as an investigator2 and 7ii7 how such professionals can enroll patients in trials2 7#b7 such efforts as are reasonable and necessary to ensure meaningful access by consumers with limited ,english proficiency2 and 7#c7 the development and distribution of best practices and training for recruiting underrepresented study populations1 including a method for sharing such best practices among clinical trial sponsors1 providers1 community-based organizations who assist with recruitment1 and with the public4 7c7 ,health disparities ,in developing the national campaign under subsection 7a71 the ,secretary shall recognize and address-- 7#a7 health disparities among individuals who are members of the population groups specified in section #b7;b77#a77;,a7 with respect to access to care and participation in clinical trials2 and 7#b7 any barriers in access to care and participation in clinical trials that are specific to individuals who are members of such groups4 7d7 ,grants ,the ,secretary shall establish a program to award grants to nonprofit private entities 7including community-based organizations and faith communities1 institutions of higher education eligible to receive funds under section #cga of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajfgq71 national organizations that serve underrepresented populations1 and community pharmacies7 to enable such entities-- 7#a7 to test alternative outreach and education strategies to increase the awareness and knowledge of individuals in the ,united ,states1 with respect to the need for diverse clinical trials that reflect the race1 ethnicity1 age1 and sex of patients with the disease or condition being investigated2 and 7#b7 to cover administrative costs of such entities in assisting in diversifying clinical trials subject to section #b4 7e7 ,stakeholders specified ,the stakeholders specified in this subsection are the following3 7#a7 ,representatives of the ,food and ,drug ,administration1 the ,health ,resources and ,services ,administration1 the ,office on ,minority ,health of the ,department of ,health and ,human ,services1 the ,centers for ,disease ,control and ,prevention1 and the ,national ,institutes of ,health4 7#b7 ,community-based resources and advocates4 7f7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #aj1jjj1jjj for each of fiscal years #bjbf through #bjbi4 #e4 ,definition ,in this ,act1 the term clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions 7which may include placebo or other control7 to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes4