Research Law

About Research Law

The law related to the administration and management of research is incredibly broad, diverse and dynamic. While research administrators frequently work with in-house counsel and sometimes with outside counsel, the Research Law certificate is designed to give research administrators an overview of the magnitude of the multiple legal issues associated with research. Research administrators taking this certificate will be provided with sufficient information and substance to effectively identify legal issues and communicate effectively regarding potential solutions to such issues. Lawyers working with research institutions work on cases and policy relating to a broad range of topics that include access to artificial intelligence, confidential information, insurance coverage, conflicts of interest and other ethical issues, drugs safety and international relations. In part because of the breadth of the field, the law related to research activities also cuts across and involves doctrine and practice from an even wider area ranging from tax law, criminal law and even issues that involve freedom of speech implications.

Law related to research administration is practiced in multiple settings: federal, state and local government; mediation; universities, health care, business, and legal services organizations; advocacy nonprofits; and private law firms, to name a few. Some research administrators may hold a juris doctor (JD) although they may not serve as lawyers for their organization. They may serve in roles such as compliance, contract negotiation, policy drafting or advocacy work. This diversity makes the law related to research a field where almost anyone can find an area of interest, and where those working within the field can find new challenges in an ever-changing landscape.

Because of the foregoing, the Research Law certificate is broadly structured to cover an array of topics with concentrations in those areas of most common concern. The certificate is based on an intensive workshop survey of the various aspects of the law that will touch almost every research administrator and lawyer working with research institutions.

Requirements

Research Law is comprised of one full-day workshop, five required sessions and one elective session. The required categories are listed below; the electives will vary meeting-to-meeting.

Required Workshop

Full-day workshop.

Introduction to Research Law

Content Level: All Levels

The 'theory of everything' (TOE) is a hypothetical theory studied in physics whose intent is to fully explain and link together all known physical phenomena. The Introduction to Research Law workshop is similar to TOE in that it attempts to explain and link together all known issues of research administration. Legal issues arise throughout research, starting with intellectual property issues, continuing through contract and grant matters, and living on in post research licensing, 'derivative works disputes,' and post-clinical trial liability questions. This workshop is for new research administrators who need a 'boot camp' approach to recognizing the legal issues that they will face daily.

Learning Objectives:

Identify the parties and players involved in common research activities and indicate their legal rights and responsibilities.
Identify common issues that arise requiring the application of legal processes and procedures to research activities.

Prerequisites: None

Required Sessions

Must take 5 sessions from the categories below, with no more than 1 required from a given category.

Intellectual Property (IP)
The sessions include information regarding intellectual property including copyright, trademark, patent and/or trade secrets. They could include how to identify different types of IP and implications of inclusion of certain IP clauses and the impact on research projects

The Players (the Personnel and Organizations that play a role in research)
The sessions include descriptions or information about the various individuals or organizations that may be involved in research and how their roles impact research projects.

Public Policy Issues
Sessions include discussions about past, current and evolving public policy issues. While Public Policy issues may or may not be included in the terms of an agreement, they can still influence expectations and the success of the project as well as provide additional requirements.

Compliance and Ethics
This category includes statutory and regulatory requirements and guidance. Sessions provide details about particular compliance and ethical requirements in carrying out the research and may focus on a particular regulation or provide an overview of multiple compliance obligations and how to address them.

Grants and Contracts
Sessions provide discussion and information about the nature of the research project (e.g., is it a grant or is it a contract) and what requirements flow from the type of research agreement.

Evolving/Hot Topics
Sessions include topics which are currently still evolving and impacting research administration or are anticipated to impact research administration in the future

Elective Sessions

Must take one additional session from the categories above.