What's happening
This bill allows institutions conducting human research in compliance with federal standards to be deemed compliant with New York law.
Why it matters
Reduces Red Tape for Research Institutions. By allowing institutions that follow federal human subject protection standards to be considered compliant with New York law, the bill streamlines administrative requirements for research organizations, potentially making it easier to conduct studies in the state.
Encourages National Consistency. This alignment with federal standards helps ensure that rules for human research are consistent across state and federal levels, reducing confusion or conflicts for multi-state or federally funded research projects.
Checks and Oversight Remain. Institutions must annually attest to the state health department that they comply with federal protections, meaning oversight is maintained and the state can set conditions for accepting federal compliance as sufficient.
May Promote More Research Activity in NY. By lowering bureaucratic barriers for compliant institutions, New York could become a more attractive location for research, possibly increasing innovation and access to clinical trials for residents.
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Who cares
Institutions and agencies conducting human research
Those conducting federally regulated, compliant research could seek state recognition of compliance for research outside federal jurisdiction that follows federal protections.
State Department of Health and health commissioner
The commissioner would review annual attestations due by January 1 and could deem an institution or agency’s human research compliant with the state article, subject to conditions.
Human research participants
Participants in research not subject to federal rules could be covered by federal protections voluntarily followed under this state compliance pathway.
Headline styles
Allow Human Research If Safe
Plain English, a few words. Used as the page title.
Sponsors
No co-sponsors yet.
History
- Signed chap.309
- Delivered to governor
- Returned to senate
- Passed assembly
- Ordered to third reading rules cal.429
- Substituted for A8125
- Referred to health
- Delivered to assembly
- Passed senateVote 62–0
- Ordered to third reading cal.1465
- Referred to rules
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.
Allow Human Research Under Rules
Assembly Floor Calendar · Sponsor Richard Gottfried
Full text
1 pageUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
6448
2019-2020 Regular Sessions
IN SENATE
June 11, 2019
Introduced by Sen. RIVERA -- read twice and ordered printed, and when printed to be committed to the Committee on Rules
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.
Sponsor's memo
Title of bill
An act to amend the public health law, in relation to authorizing human research in compliance with federal law
Purpose or general idea of bill
To enable human research that complies with Federal Law.
Summary of specific provisions
Amends Public Health Law section 2445 to provide that upon attestation, satisfactory to the Commissioner of Health, human subject research conducted in compliance with federal law may be deemed in compliance with PHL Article 24-A.
Justification
An institution conducting federally funded human research is required to provide a Federal wide Assurance (FWA) to the federal Office of Human Research Protections (OHRP) that all the institution's federally funded human research will comply with the relevant federal policies and regu- lations. Prior to 2019, an institution was given the option to "check the box" to subject all their human research, even research that is not federally funded, to OHRP oversight. An exemption in PHL § 2445 allows human research in New York to be conducted under federal policies and regulations when an institution is subject to federal policies and regu- lations, including when the institution checks the box. Due to a recent change in federal policy, this "check the box" option will no longer be part of the FWA and certain non-federally funded research will no longer be "subject to" OHRP oversight. Without the "check the box" assurance, human research not federally supported will need to meet the require- ments of PHL Article 24-A.
Subjecting thousands of studies per year at hundreds of New York insti- tutions to a whole new system of oversight by the state IRB would be costly, redundant, and unnecessary. The Department is not aware of any significant problems with the current system of allowing institutions to self-regulate their human subject research under federal laws, regu- lations, and policies. This legislation would allow the current system to remain in place.
Prior legislative history
New bill.
Fiscal implications
None
Effective date
Immediately.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.