Lara Jean Ancona
Partner/Director
516-393-2245
Clinical Trial/Research
- Overview
- Attorneys
- Insights
Garfunkel Wild’s Clinical Trial/Research Practice Group is comprised of attorneys with extensive experience in advising clients on clinical research-related matters. We provide advice on the legal and regulatory requirements and concerns raised by and related to participation in research and research-related activities, including compliance issues, reporting obligations, misconduct issues, and conflict of interest concerns. We have worked extensively with health care facilities, research institutions, institutional review boards (IRBs), principal investigators, academic institutions, and sponsors/grantors regarding structuring research-related relationships and facilitating the ongoing operation of such research relationships by addressing their continuing legal concerns and issues. Our attorneys are well versed in the requirements for drafting and negotiating research-related agreements, including clinical trial agreements, registry agreements, data sharing agreements, and material transfer agreements. Our attorneys have extensive knowledge of the multitude of laws, rules, and regulations that affect any potential data-sharing relationship and provide advice on the regulatory requirements and limitations that need to be considered.
We have assisted entities with the initial creation and structuring of a research program (including IRB formation), including the creation of research-related policies and programs as well as research registries and databases. Our client support may vary from providing day-to-day services to support the daily research activities to supporting in-house counsel in addressing research-related issues. We have knowledge of and provide advice regarding issues of human subject protection; compliance with federal, state, and local laws and regulations regarding the collection, transfer, and sharing of data; compliance with applicable laws regarding regulatory review and approvals in the research process; and the negotiation and execution of research agreements, including clinical trial, data sharing, material transfer, data use, and other related agreements. We further provide counsel on intellectual property rights resulting from research data and activities as well as intellectual property transfer issues. We advise and have participated in intellectual review board activities and related compliance concerns.
As always, our attorneys provide practical advice to allow our clients to navigate the complex legal requirements surrounding clinical and data research.
AREAS OF FOCUS:
- Research Contracting
- Human Subject Protection
- Institutional Review Boards
- Data Sharing
Practice Group Contacts
Team
OIG Allows Subsidies for Clinical Trials
The U.S. Department of Health and Human Services, Office of Inspector General recently issued a favorable advisory opinion (26-05) in which it approved a medical device company’s proposal to subsidize certain Federal health care program cost-sharing obligations for a clinical trial that evaluated Company’s U.S. Food & Drug Administration-approved device in a new patient population with heart failure. Company proposed to pay in full the cost-sharing obligations that eligible participating patients would owe to Medicare for reimbursable items and services furnished during the trial.
An Appellate Win for Skin Substitute Providers
David Traskey recently secured a fully favorable decision in a client’s skin substitute case at hearing before an Administrative Law Judge.
NJ Enacts “Magic Mushroom” Law
In his final days as Governor, Phil Murphy signed the “magic mushroom” bill into law. The law establishes a pilot program for three, to be selected, hospitals in the state to participate regarding administration of psilocybin to qualified patients.
New Jersey Mandates Electronic Employee Separation Reporting
Every employee separation in New Jersey, from resignations to layoffs, must now be reported electronically through the Department of Labor’s Employer Access Portal. This means employers must proactively report separations, including terminations, resignations, layoffs, retirements, and other forms of job separation – regardless of whether the employee files for unemployment benefits.
Florida Allows Use of Unapproved Stem Cell Therapies
Effective July 1, 2025, however, the State of Florida passed legislation allowing physicians to use non-FDA approved stem cell therapies for certain treatments or procedures related to orthopedics, wound care, or pain management, provided that the performance of such is within the physician’s scope of practice.
FTC Bans Non-Competes Across the Nation
On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).
Garfunkel Wild’s Clinical Trial/Research Practice Group is comprised of attorneys with extensive experience in advising clients on clinical research-related matters. We provide advice on the legal and regulatory requirements and concerns raised by and related to participation in research and research-related activities, including compliance issues, reporting obligations, misconduct issues, and conflict of interest concerns. We have worked extensively with health care facilities, research institutions, institutional review boards (IRBs), principal investigators, academic institutions, and sponsors/grantors regarding structuring research-related relationships and facilitating the ongoing operation of such research relationships by addressing their continuing legal concerns and issues. Our attorneys are well versed in the requirements for drafting and negotiating research-related agreements, including clinical trial agreements, registry agreements, data sharing agreements, and material transfer agreements. Our attorneys have extensive knowledge of the multitude of laws, rules, and regulations that affect any potential data-sharing relationship and provide advice on the regulatory requirements and limitations that need to be considered.
We have assisted entities with the initial creation and structuring of a research program (including IRB formation), including the creation of research-related policies and programs as well as research registries and databases. Our client support may vary from providing day-to-day services to support the daily research activities to supporting in-house counsel in addressing research-related issues. We have knowledge of and provide advice regarding issues of human subject protection; compliance with federal, state, and local laws and regulations regarding the collection, transfer, and sharing of data; compliance with applicable laws regarding regulatory review and approvals in the research process; and the negotiation and execution of research agreements, including clinical trial, data sharing, material transfer, data use, and other related agreements. We further provide counsel on intellectual property rights resulting from research data and activities as well as intellectual property transfer issues. We advise and have participated in intellectual review board activities and related compliance concerns.
As always, our attorneys provide practical advice to allow our clients to navigate the complex legal requirements surrounding clinical and data research.
AREAS OF FOCUS:
- Research Contracting
- Human Subject Protection
- Institutional Review Boards
- Data Sharing
Practice Group Contacts
Team
OIG Allows Subsidies for Clinical Trials
The U.S. Department of Health and Human Services, Office of Inspector General recently issued a favorable advisory opinion (26-05) in which it approved a medical device company’s proposal to subsidize certain Federal health care program cost-sharing obligations for a clinical trial that evaluated Company’s U.S. Food & Drug Administration-approved device in a new patient population with heart failure. Company proposed to pay in full the cost-sharing obligations that eligible participating patients would owe to Medicare for reimbursable items and services furnished during the trial.
An Appellate Win for Skin Substitute Providers
David Traskey recently secured a fully favorable decision in a client’s skin substitute case at hearing before an Administrative Law Judge.
NJ Enacts “Magic Mushroom” Law
In his final days as Governor, Phil Murphy signed the “magic mushroom” bill into law. The law establishes a pilot program for three, to be selected, hospitals in the state to participate regarding administration of psilocybin to qualified patients.
New Jersey Mandates Electronic Employee Separation Reporting
Every employee separation in New Jersey, from resignations to layoffs, must now be reported electronically through the Department of Labor’s Employer Access Portal. This means employers must proactively report separations, including terminations, resignations, layoffs, retirements, and other forms of job separation – regardless of whether the employee files for unemployment benefits.
Florida Allows Use of Unapproved Stem Cell Therapies
Effective July 1, 2025, however, the State of Florida passed legislation allowing physicians to use non-FDA approved stem cell therapies for certain treatments or procedures related to orthopedics, wound care, or pain management, provided that the performance of such is within the physician’s scope of practice.
FTC Bans Non-Competes Across the Nation
On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).