Endpoints

Commentary from the Academic and Clinical Research Group

Research law is what Verrill Dana's Academic and Clinical Research Group does, and this blog is where the Group shares its musings and breaking news alerts in the research arena. If your days involve digesting and implementing the complex regulatory framework that governs the conduct of research, and grappling with underlying ethical considerations, this blog will serve as a helpful resource.

Latest from Endpoints

We are pleased to welcome attorney Nadine Peters to our nationally-recognized Health Care Group. Nadine comes to Verrill Dana with more than 15 years of experience as a health care and privacy attorney and focuses on clients within the health care and life sciences industries. Most recently, Nadine served as Deputy General Counsel at the Patient-Centered Outcomes Research Institute (PCORI), an independent non-profit organization authorized under the Affordable Care Act to fund comparative effectiveness research.…
Introduction On June 28, a new law took effect in California that gives California residents greater control over the collection and processing of their personal information. The law, called The California Consumer Privacy Act of 2018 (the “Act”), incorporates principles similar to those in the European Union’s General Data Protection Regulation (GDPR), which took effect in May of this year. Businesses collecting personal information of California residents should assess their obligations under the Act and…
How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal “Right to Try” As discussed in our Alert of June 4, “Right to Try” Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers, patients, providers and IRBs are now grappling with two alternative federal pathways through which manufacturers may (but are not required) to provide investigational drugs for treatment purposes outside of an FDA-overseen clinical investigation. As manufacturers, treating physicians,…
On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (S. 204), which had passed the Senate on August 3, 2017 and then the House of Representatives on May 22, 2018 (following an unsuccessful attempt by the House to get an alternative bill, H.R. 5247, passed by the Senate this…
In an 11th hour—but nonetheless anticipated—move, the sixteen federal departments and agencies responsible for the Common Rule Final Rule that was slated to become effective tomorrow, January 19, 2018 (“Revised Common Rule”), have issued an Interim Final Rule (“IFR ”) delaying the effective date and the general compliance date of the Revised Common Rule for six months, until July 19, 2018. The IFR does not alter the compliance date for the Revised Common Rule’s…
On September 7, 2017, the National Institutes of Health (“NIH”) released a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109) (“the Policy”). This Policy flows from the Cures Act’s changes to when and how a Certificate of Confidentiality (“Certificate”) is issued, see Pub. Law 114-255, Section 2012 (December 13, 2016), and applies to research “in which identifiable, sensitive information is collected.” The Policy goes into effect on October 1, 2017, with…
As many of you know, most of the provisions of the Final Rule updating the Common Rule (“2018 Common Rule”) will go into effect, and compliance is required, on January 19, 2018. Notwithstanding some uncertainty with respect to the current Administration’s regulatory plans, as of now institutions should be taking stock of what needs to be done to bring IRBs and human research protection programs into timely compliance with the revised regulations. To…
Portions of Kate Gallin Heffernan’s presentation at the American Health Lawyers Association conference on legal issues affecting academic medical centers and teaching institutions were quoted in a March 15, 2017 Bloomberg Law: Medical Research Law & Policy Report article entitled “Early Adoption Not an Option For Research Rule Changes.” Kate and her co-presenter, Laura Odwazny, commented on recent changes to human subject protection regulations known as the Common Rule published on January 19, 2017. The…
As many of you know, the long-awaited final rule updating the Common Rule (“Final Rule”) was issued officially January 19 (after an unofficial release to the public yesterday). Like many of you, we are in the process of digesting and analyzing the new regulations and how they alter the current Common Rule, as well as how they differ from the Notice of Proposed Rulemaking (“NPRM”) for the Common Rule that was published sixteen months ago.…
Whether or not you agree with its position, there is no denying that in its recently released report, “Dead on Arrival,” the Goldwater Institute takes a passionate stance on the current status of the federal “Compassionate Use” program and its counterpart, the increasingly vigorous state-led initiative known as the “Right to Try” movement, a statutory phenomenon initially ignited by the Goldwater Institute, a private think-tank. “Compassionate Use”, formally referred to as “Expanded Access”, is a…