Nevada § 439.263 - Policy of State concerning clinical trials; duties of Division to carry out policy; acceptance of gifts, grants and donations

§ 439.263. Policy of State concerning clinical trials; duties of Division to carry out policy; acceptance of gifts, grants and donations

1. It is the policy of this State to: (a) Improve the completeness and quality of data concerning diverse demographic groups

that is collected, reported and analyzed for the purposes of clinical trials of drugs

and medical devices; (b) Identify barriers to participation in clinical trials by persons who are members

of demographic groups that are underrepresented in such trials and employ strategies

recognized by the United States Food and Drug Administration to encourage greater

participation in clinical trials by such persons; and (c) Make data concerning demographic groups that is collected, reported and analyzed

for the purposes of clinical trials more available and transparent. 2. To assist in carrying out this policy: (a) The Division shall review the most recent version of “Collection of Race and Ethnicity

Data in Clinical Trials--Guidance for Industry and Food and Drug Administration Staff,”

published by the United States Food and Drug Administration, and establish, using

existing infrastructure and tools, a program to encourage participation in clinical

trials of drugs and medical devices by persons who are members of demographic groups

that are underrepresented in such clinical trials. The program must include, without limitation: (1) Collaboration with medical facilities, health authorities and other local governmental

entities, nonprofit organizations and scientific investigators and institutions that

are performing research relating to drugs or medical devices to assist such investigators

and institutions in identifying and recruiting persons who are members of underrepresented

demographic groups to participate in clinical trials; and (2) The establishment and maintenance of an Internet website that: (I) Provides information concerning methods recognized by the United States Food and

Drug Administration for identifying and recruiting persons who are members of underrepresented

demographic groups to participate in clinical trials; and (II) Contains links to Internet websites maintained by medical facilities, health

authorities and other local governmental entities, nonprofit organizations and scientific

investigators and institutions that are performing research relating to drugs or medical

devices in this State. (b) With the assistance of the Office of Federal Assistance, the Division shall apply

for grants from any source, including, without limitation, the Federal Government,

to fund the program established pursuant to paragraph (a). (c) Not later than May 1 of each even-numbered year, the Division shall submit to

the Director of the Legislative Counsel Bureau for transmittal to the Legislature

a report concerning the status and results of the program established pursuant to

paragraph (a). (d) Each state or local governmental entity that conducts clinical trials of drugs

or medical devices, including, without limitation, the Board of Regents of the University

of Nevada, shall adopt a policy concerning the identification and recruitment of persons

who are members of underrepresented demographic groups to participate in those clinical

trials. Such a policy must include, without limitation, requirements that investigators

who are conducting clinical trials collaborate with community-based organizations

and use methods recognized by the United States Food and Drug Administration to identify

and recruit such persons to participate in those clinical trials. 3. For the purposes of this section, demographic groups that are underrepresented

in clinical trials may include, without limitation, persons who are underrepresented

by race, sex, sexual orientation, socioeconomic status and age. 4. The Division may accept gifts, grants and donations from any source for the purpose

of carrying out the provisions of this section. 5. As used in this section, “medical facility” has the meaning ascribed to it in NRS 449.0151 .