Blue Chip Clients

Beth Israel Deaconess Medical Center
Cape Cod Healthcare
Dana Farber Cancer Institute
Harvard Medical School
Harvard Pilgrim Health Care
Massachusetts General Hospital
South Shore Hospital
Tufts Health Plan

Strategic and Scientific Expertise

Biotechnology
Cardiology
Diagnostics
Drug delivery
Genomics
Immunology
Medical devices
Nanotechnology
Neuroscience
Oncology
Pharmaceuticals
Proteomics

 

Human Subjects Research

"unique ability to handle [novel situations], providing rapid advice on request at any time of day"

Chambers USA


Healthcare

 

We routinely advise hospitals and universities on human subjects protection program regulations, policies and procedures and assist institutions and individuals in resolving allegations of scientific misconduct or violations of the False Claims Act resulting from misconduct or the failure to comply with federal grant requirements.  We also draft, review and negotiate clinical trial agreements on behalf of institutional providers and pharmaceutical and biotech companies.  

Representative Scientific Misconduct and False Claims Act engagements
include assisting:

  • a leading university in making a voluntary self disclosure arising out of a professor's alleged mishandling of various federal grants, resulting in a favorable civil settlement with the Department of Justice
  • a research university in a federal investigation arising out of allegations of scientific misconduct and the use of federal grant monies
  • an academic medical center in making a self-disclosure and repayment to NIH based on the discovery of a laboratory worker's falsification of study results
  • an institution in a federal investigation of one of its researchers which alleged that he failed to disclose adverse events during a clinical study.
  • a professor affiliated with a major research institution against allegations that she falsified data results, resulting in the professor being cleared of all misconduct allegations
  • a professor affiliated with a major research institution against allegations that he falsified data results, resulting in the professor being cleared of all misconduct allegations    

Representative Human Subjects Protection and Ethical Issue engagements
include advising: 

  • a leading medical school and academic medical center in achieving AAHRPP accreditation, including a comprehensive review of their human subjects protection  program policies and procedures
  • a leading contract research organization in achieving AAHRPP accreditation, including a comprehensive review of their human subjects protection program policies and procedures
  • a community hospital in negotiating the relative responsibilities of the IRBs of three institutions in connection with cancer research to be conducted by a jointly-operated facility and its physician staff
  • a major multi-national pharmaceutical firm in the negotiation of its Phase III clinical trial agreements, related informed consent forms, investigator-sponsored clinical trial agreements and indemnification agreements, both in the United States and abroad
  • major multi-national pharmaceutical firms in the development and negotiation of agreements and arrangements related to clinical trials, including agreements with clinical research organizations, laboratory services, and clinical services
  • a clinical-stage biopharmaceutical company in the development of investigator-initiated clinical trial agreements
 

Thank you for reaching out to contact Choate. Before you send your message, we wanted to make sure you are aware of the following. Please do not send any confidential information in response to this link. Sending an e-mail to Choate does not give rise to an attorney-client relationship, and will not be deemed to disqualify Choate from undertaking any engagement for a current or future client.  Before any attorney-client engagement may be formed, Choate will need to check for possible conflicts of interest, you will need to consider whether you wish to retain Choate as counsel, and we will need to consider whether we wish to accept the potential engagement. In the meantime, Choate reserves the right to represent parties with interests adverse to you.

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