SACHRP Meeting

July 31, 2019

On July 31, health care attorney Kate Heffernan will be speaking at the SACHRP Meeting on deceased donor intervention research (DDIR). The topic of Kate’s discussion focuses on using a staged consent process to overcome the logistical barriers to obtaining informed consent from organ recipients for research participation when they are offered an organ that has been part of a deceased donor intervention protocol.

For more information, visit the event page here.

Firm Highlights


Research Non-Compliance Investigations


Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new  guidance  (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for Protection of Human...


One Month Left to Submit Comments on HIPAA Request For Information

Last month, the Office for Civil Rights (“OCR”) within the U.S. Department of Health and Human Services (“HHS”) published a   Request for Information   (“RFI”) looking for recommendations and public input regarding the...


Is Cybersecurity on Your 2019 Work Plan?

On December 28, 2018, the U.S. Department of Health and Human Services (“HHS”) closed out the year by releasing long-awaited voluntary  cybersecurity guidelines  for the health care industry.[ 1 ] The four-volume publication, developed...


Research Misconduct

Represented various hospital systems in connection with research misconduct investigations, including advising on the internal investigation, assisting with the drafting of required reports, and communicating with federal regulators and respondents’ legal counsel.


Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the “Common Rule”), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.


European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...


Institutional Review Board

Assisted a prominent university with the development of a NIH-funded national IRB reliance model in facilitation of NIH’s Single IRB Review Policy.


Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...


Conflicts of Interest

Reviewed medical center’s systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.