Research Law (RL)

Courses center around: patents; copyrights; intellectual property; technology transfer; undue influence and conflict of interest; Stark, Safe Harbors, Anti Kickback, HIPAA; institutional liability assessment and corrective action planning; FAR/DFAR; OMB Circulars and CFR’s; emerging regulations and statutes; interrelationship of federal, state and local law; international issues; import/export and licensing issues; data sharing, monitoring, management, and ownership.

Sunday, February 28, 2016

WS4: Publisher, Purse, Prison, Patent
Sunday, February 28, 2016 - 9:00am to 12:30pm

Content level: Intermediate

This half-day workshop will look at the fallout from a finding of research misconduct and explore the implications for affected publications, the financial implications of making a misconduct finding, criminal sanctions in misconduct cases and implications for patents associated with misconduct findings.

Learning objectives:

Understand the implications for an institutional misconduct finding. Manage institutional reputational and financial risk.

Prerequisites: None

Speaker(s):

Debra Parrish, JD, Founder, Parrish Law Offices

WS8: The Implications of US Export Control Regulations on Academic Research Knowledge Sharing
Sunday, February 28, 2016 - 1:30pm to 5:00pm

Content level: Intermediate

The purpose of this paper is to discuss some of the important factors related to the effectiveness of the current legislative, institutional and administrative processes within the realms of export control and the implications of US export control regulations on academic research institutions and research knowledge sharing. The stringent and rigid export control regulations often times hinder productive knowledge sharing among US and international academic and research institutions, as well as negatively affect US industry and commercial sector. Several important issues addressed by this research paper are: how US export control affects universities and research activity in the US, whether knowledge is "re-defined" as a result of stringent export control limitations, and does the existing export control mechanism (particularly in educational sector) really serve the purpose to prevent technological and intellectual piracy, or does it create an unnecessary policy church for research institutions and industry, comparative analysis on measuring the effectiveness of the post 9/11 US export control laws vs. the "real dollar" value lost in revenue to the industry and academic institutions? There is a comparative analysis of Research and Development (R&D) increase vs. decrease nationwide in the last decade in correlation with the increased export control regulations.  Interesting case studies are included.

 

Learning objectives:

  1. Have a better understanding of US export control mechanism and its implications on research activity. 
  2. Be able to understand the implications of export regulations on a larger scale, including financial, legal and policy levels.

Prerequisites: None

Speaker(s):

Gloria Greene, CRA, Director, Office of Sponsored Programs and Tanta Myles, Director and Research Compliance Officer, University of Alabama, Huntsville

Monday, February 29, 2016

M104: The Impact of the Physician Payments Sunshine Act on Clinical Research
Monday, February 29, 2016 - 9:30am to 10:45am

Content level: Intermediate

Established by Section 6002 of the Affordable Care Act, the Physician Payments Sunshine Act (“Act”) requires pharmaceutical and medical device manufacturers to report annually to the Department of Health and Human Services payments and other transfers of value furnished to physicians and teaching hospitals. The Act was designed to encourage greater transparency in the relationships between manufacturers and physicians. The Centers for Medicare & Medicaid Services (CMS) is charged with implementing the Act and has attempted to clarify how the Act applies to clinical research.

Learning objectives:

  1. Identify payments or transfers of value that must be reported. 
  2. Discuss the specific research reporting requirement.

Prerequisites: None

Speaker(s):

Penny Smith, JD, Attorney, Life Science Law Group; LLC; Michelle Sercye, JD, Attorney, Life Science Law Group, LLC; Meena Nayak, Vertex Pharmaceuticals Incorporated USA

M204: Dealing with Conflicts of Commitment and Financial Interest
Monday, February 29, 2016 - 11:00am to 12:15pm

Content level: Intermediate

Participants will be provided with an overview of the financial disclosure process required by the federal government. Many researchers are still not aware of the necessity for them to fully disclose all outside interests related to their faculty research role. These strict requirements have led to concerns that the institution is invading their privacy or preventing them from working with pharma to conduct research or establish public partnerships. Participants will be provided with the notification process that was created and is being utilized between the Research Office and the Institutional Review Board (IRB) for the financial review process. This session will provide the audience with real case scenarios, the process of review and resolution, as well as a sample of the management plan that was created.

Learning objectives:

  1. Utilize the notification process that was created between the Research & IRB Offices to assist investigators in items needed for potential disclosures of conflicts of interest (COIs). 
  2. Provide the audience with a sample of the management plan as a template to use in communicating to investigators what is needed and how to report.

Prerequisites: None

Speaker(s):

Carlotta Rodriguez, CIP, CHRC, Director and Deborah Lazzarino, PhD, Assistant Dean for Research, Rutgers New Jersey Medical School

M304: The Journal’s Role in Research Misconduct Cases
Monday, February 29, 2016 - 2:15pm to 3:30pm

Content level: Intermediate

Journals are taking an increasing role in research misconduct cases from reporting misconduct allegations to taking corrective actions.  This session will improve understanding of how journals process these allegations, how they respond to information about a researcher who has fabricated data, what they will let a retraction or correction notice state and when they will post such a notice.

Learning objectives:

  1. Understand journals handle allegations of misconduct allegations. 
  2. Understand issues with retraction and correction.

Prerequisites: None

Speaker(s):

Debra Parrish, JD, Founder, Parrish Law Offices

M404: The America Invents Act and Its Effect on Universities
Monday, February 29, 2016 - 3:45pm to 5:00pm

Content level: Intermediate

The America Invents Act (AIA) was signed into law in September of 2011 and went into effect between September of 2012 and March of 2013. Since going into effect, the law has changed patenting in the US so that instead of a patent being awarded to the first person to make an invention, the patent is now awarded to the first inventor to file a patent application in the US Patent Office. This change has a number of implications on universities, such as putting more pressure on researchers to file applications expeditiously and calling into question the value of the one year “grace period” between the first public disclosure of an invention and the filing of a patent application on that invention. In addition, the law creates a new filing status for “micro-entities” that may benefit universities, greatly decreases penalties for failing to disclose the “best mode” of implementing an invention and provides new means for third parties to challenge patents both before and after they are issued. This talk is directed towards individuals who already know at least a little about patent law and will highlight how these changes are affecting American universities.

Learning objectives:

  1. Identify the difference between a “first to invent” patent regime and a “first inventor to file” patent regime. 
  2. Evaluate whether the AIA is successful in improving the quality of issued patents as a result of pre-issuance submissions from third parties and whether costs are likely to increase for universities as a result of “post-grant review.”

 

Prerequisites: None

Speaker(s):

Carl Mahler, JD, Executive Director, Office of Technology Transfer, University of North Carolina, Charlotte

Tuesday, March 1, 2016

T104: Negotiating Clinical Trial Agreements with Industry - The Key Issues
Tuesday, March 1, 2016 - 9:00am to 10:15am

Content level: Basic

This session addresses the four key issues in clinical trial agreements between academic medical institutions and industry sponsors: Confidentiality, Publication, Intellectual Property Rights and Indemnification. The session will include discussion of the perspectives of both parties and practical solutions to streamline the negotiation process and achieve terms that are acceptable to both parties.

Learning objectives:

  1. Understand the importance of the four key provisions in clinical trial agreements between academic medical institutions and industry sponsors. 
  2. Gain practical knowledge of how to negotiate these challenging issues.

 

Prerequisites: None

Speaker(s):

Karen Mullin, JD, LLM, Chief General Counsel, Director of Technology Development, The Forsyth Institute

T204: Grants and Contracts Language: What A Department Administrator Should Watch out and Question
Tuesday, March 1, 2016 - 10:30am to 11:45am

Content level: Basic

This session will address some of the problematic grants and contracts language that a Department Research Administrator encounters, such as intellectual property clauses, Principal Investigator (PI) questions on export control, confidentiality provisions, publications/publicity rights and associated problematic Federal Acquisition Regulation (FAR) clauses.

Learning objectives:

  1. Learn how to identify potential problematic grants and contracts language.  
  2. Understand how to highlight and question common legal problematic language.

Prerequisites: None

Speaker(s):

Lori Benjamin, CRA, Senior Research Administrator, Massachusetts General Hospital; Geraldine M. Pierre, MSc, JD, Grant and Contract Manager, Department of Health Policy and Management, School of Public Health, Boston University

T404: Master Research Agreements: Some Lessons from the Trenches
Tuesday, March 1, 2016 - 3:15pm to 4:30pm

Content level: Basic

Master Research Agreements are becoming increasingly popular as universities' attempt to establish deeper connections with for-profit research sponsors. A well-constructed Master Research Agreement specifies many of the legal terms and conditions under which research will be conducted so that individual projects can be processed quickly and with significantly decreased burden on the contract negotiators. However, a poorly constructed Master Agreement can create unrealistic expectations, impose unexpected burdens on one or both of the parties and generally create more problems than they are worth. This talk addresses when it is appropriate to establish a Master Research Agreement (and some situations when it is not), what the agreement should contain, how to build in maximum flexibility and some of the less obvious pitfalls awaiting the unwary negotiator.

Learning objectives:

  1. Learn how to maximize flexibility in Master Research Agreements by using a good template for "Task Orders." 
  2. Establish better control of the use of Master Research Agreements by using "opt in" language rather than "one size fits all" language.

 

Prerequisites: None

Speaker(s):

Carl Mahler, JD, Executive Director, Office of Technology Transfer, University of North Carolina, Charlotte 

Wednesday, March 2, 2016

W104: Indemnification: It's not Me, it's You
Wednesday, March 2, 2016 - 9:00am to 10:15am

Content level: Intermediate

An in-depth discussion of the types of indemnity required and the justification for both commercially funded and grant funded research agreements. This presentation will address investigator and sponsor initiated trials, pre-clinical research agreements and what you should be indemnifying.

Learning objectives:

  1. Evaluate the use of unilateral sponsor vs. standard bilateral indemnity. 
  2. Analyze indemnification related to drugs and devices vs. results and intellectual property (IP) only.

 

Prerequisites: None

Speaker(s):

Nicole Leonard, JD, Director and Carlos Braxton, JD, MA, Assistant Director, Office of Research Administration, School of Medicine, The Johns Hopkins University

 

W204: Policy and Procedure: What we Really Need to Comply with Federal Regulations
Wednesday, March 2, 2016 - 10:30am to 11:45am

Content level: Intermediate

Developing and implementing solid policies and procedures is imperative to complying with federal regulations when conducting business with the federal government – that is, conducting research through grants, contracts or co-operative agreements, or providing or delivering other services. While there is a consistency among federal agencies on the basic requirements, some agencies have additional requirements that need frequent updates or monitoring. This session will review the requirements, starting with National Institutes of Health (NIH), which has 57 basic policy requirements, and compare these with other agencies, especially Department of Defense, National Science Foundation (NSF) and Center for Disease Control and Prevention (CDC). The successful implementation of these policies and procedures not only keeps an institution compliant, it also increases efficiency and productivity. This session will also address barriers to developing and implementing policies and show ways to overcome these impediments to improve efficiency and productivity.  

Learning objectives:

  1. Learn the basic policy requirements for conducting federally-funded projects. 
  2. Understand the complexities of the policy implementations and learn ways to develop and implement policies successfully to improve productivity.

 

Prerequisites: None

Speaker(s):

Dhanonjoy Saha, PhD, Director, Office of Grant Support, Albert Einstein College of Medicine; John Scarfone, JD Associate General Counsel and Director of Compliance, Albert Einstein College of Medicine