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Research Law Certificate
About Research Law
The "theory of everything" (TOE) is a hypothetical theory studied in theoretical physics that is intended to fully explain and link together all known physical phenomena. The Research Law certificate 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. The Research Law certificate is for both new research administrators who need a basic approach for recognizing the legal issues that they will face daily and for the more experienced administrator who works with general counsel and outside attorneys on a daily basis. Because there are so many legal issues in research, the curriculum is very broad and constantly changing to address new issues confronting scientists, research administrators and their attorneys.
Research Law Certificate Course Requirements
Research Law is comprised of one full-day workshop, four required sessions and one elective session. The required courses are listed below; the electives will vary meeting-to-meeting.
Required Workshop (full-day)
- Introduction to Research Law
Sessions:
Five (5) concurrent sessions (must take one (1) session within each of the first four (4) required categories; one (1) elective any category)
- Parties and Players (Formerly Working with Office of General Counsel)
- Intellectual Property
- Contract and Grants
- Public Policy, Compliance and Ethics (Formerly Compliance and Ethics)
- Other Legal Issues (Elective only)
Sessions vary from meeting to meeting.
About the Certificate Tracking Booklet
The tracking booklet allows members to easily record their progress. Obtain a stamp at the conclusion of each workshop or session. Once all coursework has been completed turn in your documentation to the Registration Desk at the meeting or e-mail it to Certificates@srainternational.org to receive your certificate of completion. If you attended a workshop or session at a previous SRA meeting, list the meeting on the line next to the course. SRA staff will verify your attendance at previous meetings. The blank lines under electives are for future meetings where new sessions may be held.
Courses given over the past three years (Fall 2009 - Fall 2012)
2012 Annual Meeting - Orlando, FL
Required Workshop
Introduction to Research Law
Required Sessions
1. Parties and Players
Negotiating with National Labs: Why are They So Different?
NSF-OIG Case Studies: Best and Worst Practices of Federal Grantees
Social Media and The FDA Regulated Entity
European Union Research Programme Fundamentals
Clinical Research Consortia: Challenges and Lessons Learned Along the Way
From Chaos to Control: Surviving a False Claims Act Investigation
2. Intellectual Property
Regulatory Research for the Research Administration Professional
Faculty Consulting, Intellectual Property and Living with Stanford v Roche
Social Media and The FDA Regulated Entity
Intellectual Property Basics for the Research Administrator
Biological Specimens in Industry Sponsored Research
America Invents Act
Disclosure and Privacy Issues in a Digital Age
3. Contract and Grants
Negotiating Clinical Trial Agreements with For-Profit Companies
Regulatory Research for the Research Administration Professional
Clinical Trials: Rules and More Rules
Faculty Consulting, Intellectual Property and Living with Stanford v Roche
FAR, FAR Away with the Federal Acquisition Regulations
4. Public Policy, Compliance and Ethics
Export Controls: What You Need to Know in Changing Times
Compliance Issues in the Social and Behavioral Sciences
Is it Worth the Risk?
Research Compliance, Part 1
Research Compliance, Part 2
Conflict of Interest: The Year in Review
Mitigating Financial Fraud in Sponsored Research
A Hard Look at Research Misconduct: Is Academia the Problem?
Responding to Serious Wrongdoing in Research
From Chaos to Control: Surviving a False Claims Act Investigation
Research Misconduct Review and Update
FAR, FAR Away with the Federal Acquisition Regulations
Elective Session
Managing Investigator Initiated Studies Managing Risks and Developing Best Practices
Subcontracting Under Federal Research Grants and Contracts
2012 Midwest/Southern Section Meeting - Cincinnati, OH
Required Sessions
1. Parties and Players
The FDA is Coming: Who Will You Coordinate With Your Sponsor?
Faculty Consulting: Institutional Policies, Intellectual Proposer, Private Plans and the Impact of Stanford vs. Roche
3. Contract and Grants
Clinical Trials: Rules and More Rules
Consulting for Academics
Negotiating Clinical Trial Agreements with For-Profit Companies
Faculty Consulting: Institutional Policies, Intellectual Proposer, Private Plans and the Impact of Stanford vs. Roche
4. Public Policy, Compliance and Ethics
Consulting for Academics
The FDA is Coming: Who Will You Coordinate With Your Sponsor?
2012 Western/Northeast Section Meeting - San Francisco, CA
Required Sessions
2. Intellectual Property
Understanding Intellectual Property Policy Changes and the Implication for Research Agreements
3. Contract and Grants
FAR, FAR Away with the Federal Acquisition Regulations
4. Public Policy, Compliance and Ethics
Recent Developments in U.S. Export Controls
Authorship: Role of Institutional Guidelines and RCR Training
for International Collaborations
Washington Update
2011 Annual Meeting - Montréal, Canada
Workshop
Introduction to Research Law
Required Sessions
1. Parties and Players (Formerly Working with Office of General Counsel)
The Defensive IRB: Lessons to be Learned from the Practice of Defensive Medicine
Contents of a Clinical Trial Agreement
The FDA is Coming - How Will You Coordinate With Your Sponsor
National Security Law for the Research Administrator
Addressing Subject Injury: Informed Consent, Contract Language and the Interplay with Third Party Payers
Sub-contracting and Sub-recipient Monitoring - Best Practices
Recent Developments in U.S. Export Controls
Negotiating Clinical Trial Agreements with For-Profit Companies
Faculty Consulting: Institutional Policies, Interllectual Property, Private Practice Plans and the Impact of Stanford vs. Roche
2. Intellectual Property
BioBanking Basics: An Overview of Current Legal and Compliance Issues Related to Human Specimens Collected in Research
Data Acquisition, Management, Ownership and Sharing
Copyright and Data Rights under Government Contracts and Grants
Canadian/International Intellectual Property Issues
Canadian Copyright Issues
Faculty Consulting: Institutional Policies, Interllectual Property, Private Practice Plans and the Impact of Stanford vs. Roche
Publication of Research vs. Protection of Sensitive Data and Agreements
3. Contracts and Grants
A FAR Clause Database: Managing and Negotiating FAR Clauses Based on Historical Decision-making OR "Have We Ever Agreed to This Before?"
Contents of a Clinical Trials Agreement
Copyright and Data Rights under Government Contracts and Grants
Addressing Subject Injury: Informed Consent, Contract Language and the Interplay with Third Party Payers
Sub-contracting and Sub-recipient Monitoring - Best Practices
Negotiating Clinical Trial Agreements with For-Profit Companies
Faculty Consulting: Institutional Policies, Interllectual Property, Private Practice Plans and the Impact of Stanford vs. Roche
Successfully Conducting Multinational Research Activities to Ensure Compliance and Operational Efficiency
Publication of Research vs. Protection of Sensitive Data and Agreements
4. Public Policy, Compliance and Ethics
Foreign Corrupt Practices Act: The Impact of the FCPA on International Research Collaboration and Other International Activities
Conflict of Interest and Ethics
Research Integrity: The Institutional Perspective
BioBanking Basics: An Overview of Current Legal and Compliance Issues Related to Human Specimens Collected in Research
The Defensive IRB: Lessons to be Learned from the Practice of Defensive Medicine
The FDA is Coming - How Will You Coordinate With Your Sponsor
National Security Law for the Research Administrator
How Fraud Happens (And How to Prevent It at Your Institution)
Recent Developments in U.S. Export Controls
Faculty Consulting: Institutional Policies, Interllectual Property, Private Practice Plans and the Impact of Stanford vs. Roche
Successfully Conducting Multinational Research Activities to Ensure Compliance and Operational Efficiency
Electives
Human Research Protection Program: Beyond the IRB
Managing Advanced Compliance Issues with Subcontracts
2011 WE/MW - Long Beach, CA
Electives
Washington Update
Deal Maker or Deal Taker: Contract Essentials
Export Controls/Security Issues in Research Administration
IRB Review - Informed Consent
2011 SO/NE - New Orleans, LA
Workshop
Introduction to Research Law
Required Sessions
1. Parties and Players
Charging the Hill: How to Handle Government Relations and Lobbying Issues
Sub-recipient Monitoring: The Continuous Collection of Relevant Information about a Sub-recipient and Its Performance
2. Intellectual Property
Publication of Research vs. Protection of Sensitive Data in Agreements
Identifying Institutional Risks in Privacy, Confidentiality, and Data Security
3. Contract and Grants
Contract Law 101
Contract Complexities .
Sub-recipient Monitoring: The Continuous Collection of Relevant Information about a Sub-recipient and Its Performance
4. Public Policy, Compliance and Ethics
National Security Law for the Research Administrator
Identifying Institutional Risks in Privacy, Confidentiality, and Data Security
Research Ethics: The History of U.S. Policy of Informed Consent
Recent Developments in U.S. Export Controls
Electives
Washington Update
2010 Annual Meeting - Chicago, IL
Workshop
Introduction to Research Law
Required Sessions
1. Parties and Players
Is there a Lawyer in the House: Working with the Office of General Counsel
Counsel vs. Counsel - There are Sharks in Them-thar Waters
Multiparty Complex Agreements
2. Intellectual Property
Intellectual Property Basics for Research Administrator
3. Contract and Grants
Sub-contracting and Sub-recipient Monitoring: Best Practices
Material Transfer Agreements - What's All the Fuss
Industry Participation in Federal Grants and Cooperative Agreements: Special Issues Associated with Sub-Awards to Commercial Organizations
4. Public Policy, Compliance and Ethics
The Foreign Corrupt Practices Act (FCPA): Issues and Obligations in International Research Collaboration
Recent Developments in U.S. Export Controls
Research Misconduct - Dark Times in the Ivory Tower
Increasing Importance of Conflicts in Research Regulatory Landscape
Ethical Issues in International Human Research Protections
Human Subject Protection: A Collaborative Approach
The Gist on GINA
HIPAA Breach Notification Analysis: How to Determine Whether Notification is Required in the Event of a Privacy Breach
Subject Injury and Research Contracts
Electives
Establishing Authorship Agreements in Research Collaborations: Charting a Pathway to Success
The Pack Rat Syndrome-Databases, Bio-banks of Documents and Records
2009 Annual Meeting - Seattle, WA
Workshop
Introduction to Research Law
Required Sessions
1. Parties and Players
Issues Involving University Spin-Off Companies
Counsel vs. Counsel - There are Sharks in Them-thar Waters
2. Intellectual Property
IP Basics: Copyright, Trademark, Trade Secret, Patent etc.
Privacy, Confidentiality, and Data Security
3. Contract and Grants
Sub-contracting and Sub-recipient Monitoring: Best Practices
Working with National Laboratories and Other Federally Funded Research and Development Centers 4. Public Policy, Compliance and Ethics
Challenges Facing Investigators and Institutional Review Boards
Research Misconduct Investigations without Borders
Electives
Clinical Trials: Rules and More Rules
DoD Road Map: Unique Requirements in Human Research Protections
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