LegalFix

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

NV Rev Stat § 439.263 (2019) (N/A)
Copy with citation
Copy as parenthetical citation

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 Grant Procurement, Coordination and Management of the Department of Administration, 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.

(Added to NRS by 2017, 630)

LegalFix

Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal plans you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.

LegalFix provides its members with easy access to affordable legal services through a network of independent law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.

The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our network law firms.

You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your network law firm.

The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.

Use of this website, the purchase of legal plans, and access to the LegalFix networks of law firms are subject to the LegalFix Terms of Service and Privacy Policy.

We have updated our Terms of Service, Privacy Policy, and Disclosures. By continuing to browse this site, you agree to our Terms of Service, Privacy Policy, and Disclosures.
NRS 439.263 - Policy of State concerning clinical trials; duties of Division to carry out policy; acceptance of gifts, grants and donations.