Nevada Code § 439.263

Policy of State concerning clinical trials; duties of Division to carry out policy; acceptance of gifts, grants and donations
Open in Lexace · Ask the AI about this section
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 .

‹ Prev All Nevada sections Next ›


Lexace provides legal information, not legal advice, and no attorney–client relationship is created. Statute text is provided for general information and may not reflect the most recent amendments; verify against the official state code.