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A8125Assembly2019-2020 SessionSame asS6448

Allow Human Research Under Rules

Official title

“Authorizes human research in compliance with federal law”

Sponsor Richard GottfriedAD-75Affects Health
Status
Assembly Floor Calendar
Impact
3/10
Low
Outcome
Companion signed

Bill progress

Signed via S6448

What's happening

This bill allows human research in New York that complies with federal regulations and sets an annual attestation requirement for institutions.

Why it matters

  1. Aligns New York’s human research standards with federal regulations. , reducing regulatory conflicts for institutions that already follow federal rules and making it easier to conduct research without navigating duplicative state requirements.

  2. Creates a path for non-federally funded research to be held to federal ethical standards. by allowing institutions to voluntarily attest that their studies will comply with federal protections, potentially increasing oversight and participant safety even in research not directly governed by federal law.

  3. Imposes an annual reporting/attestation requirement. , which gives the state health department ongoing visibility into which institutions are conducting human research and whether they are maintaining compliance, thereby enhancing accountability and public trust in research practices.

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Who cares

Headline styles

Allow Human Research Under Rules

Plain English, a few words. Used as the page title.

Sponsors

Primary sponsor
Richard Gottfried

Assembly Member · Assembly District 75

No co-sponsors yet.

History

  1. Substituted by S6448
  2. Ordered to third reading rules cal.429
  3. Rules report cal.429
  4. Reported
  5. Reported referred to rules
  6. Referred to health

Companion bill

The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.

S6448Senate

Allow Human Research If Safe

Signed by Governor · Sponsor Gustavo Rivera

Impact 3 · LowSigned into law

Full text

1 pageUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗

STATE OF NEW YORK

8125

2019-2020 Regular Sessions

IN ASSEMBLY

June 3, 2019

Introduced by M. of A. GOTTFRIED -- read once and referred to the Committee on Health

AN ACT to amend the public health law, in relation to authorizing human research in compliance with federal law

The People of the State of New York, represented in Senate and Assembly, do enact as follows:

Section 1. Section 2445 of the public health law, as added by chapter 450 of the laws of 1975, is amended to read as follows:

§ 2445. Applicability. 1. The provisions of this article shall not apply to the conduct of human research which is subject to, and which is in compliance with, policies and regulations promulgated by any agency of the federal government for the protection of human subjects.

2. Upon attestation, satisfactory to the commissioner, by an institution or agency that such institution or agency (a) conducts human research that is subject to and is in compliance with policies and regulations promulgated by any agency of the federal government for the protection of human subjects, and (b) conducts or proposes to conduct or authorize human research, which is not subject to but does or shall comply with federal policies and regulations, the commissioner may deem, subject to conditions, such institution or agency's human research in compliance with this article. Such attestation shall be submitted annually on or before January first to the department on a form prescribed by the commissioner.

§ 2. This act shall take effect immediately.

EXPLANATION--Matter in italics (underscored) is new; matter in brackets

[ ] is old law to be omitted.

LBD13151-01-9

Reflowed for reading: line numbers and page breaks removed. Cite the official text.

Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.