Research Compliance

Responsible Conduct of Research:
The Imbalance Between Ethics and Compliance

February 28, 2013 - 10:30 AM-Noon

We live in a more demanding and competitive era. Research institutions are not immune to the effects of the ongoing struggle for resources and financing. With that in mind the cultivation of research compliance and integrity structures within institutions has become a forthright rather than presumed endeavor. And very often the pressure is on to apply minimal compliance standards which are thought of as beneficial to short-term goals as opposed to inculcating higher levels of responsibility which go beyond legal requisites. However, science generally flourishes when the public, with whom it has a social contract, supports it. The public has a hope for future knowledge and security and generally depends on science and research, its more methodological arm, to provide the ways and means to that goal. Therefore, every effort must be made to bolster the invaluable commodities of respect and trust. This module will review the evolution of the interest in the responsible conduct of research over the last half century.

Learning Objectives:

a. Discuss the nature of the ongoing dialectic within research institutions between compliance and ethics as it relates to responsible conduct in research.
b. Explain the importance of a solid research compliance and integrity foundation to the perceptions and aspirations of the global general public and the practice and coherence of the community of science.
c. Describe the evolution of responsible conduct of research standards and outreach efforts over the last half century.

Fraud – Falsification – Fabrication: The Role of the RIO and Other Prevention Mechanisms

February 28, 2013 - 1:00-2:30 PM

As an institutional research compliance official, what do I need to know about research misconduct? How can I help my institution prevent cases of misconduct? If we put “successful” prevention measures in place, what do those measures look like and how do we measure that success? We all know cases of misconduct are on the increase and the numbers of retracted publications are skyrocketing. How can we create a cultural of integrity before the federal funders impose additional compliance burdens? Join us for a lively discussion.

Research Subject Protections: Humans, Animals and Stem Cells

February 28, 2013 - 3:00-4:30 PM

As a grants and contracts administrator why do I need to know about research subjects protection? Don’t they have those ethical review groups to take care of that? What impact does all that have on my responsibility to get grants out the door and funds set up and rolling? The reality is clear – more and more regulators and funding agencies are becoming very specific about what approvals need to be in place during all phases of grant submission and acceptance. Without effective communication between committees, departments and central offices these important reviews and approvals can fall through the cracks. It is not enough to have an IRB, IACUC or ESCRO at your institution, you must be able to make the connections between these approvals and your grants management systems in order to be completely in compliance and audit ready.

Learning Objectives:
• Identify areas of research subject protections that are essential to successful grants and contracts management and identify research integrity/compliance allies within their institution
• Strategize ways to establish open lines of communication between the various constituents responsible for research protections and compliance
• Establish policy and procedures for sharing timely protocol compliance information within your grants management system to support effective record keeping and reporting to sponsors

Financial Conflicts of Interest and Commitment: Conflicted Over Conflict

March 1, 2013 - 10:30 AM-Noon

Investigators and research institutions alike constantly work to balance the altruistic and entrepreneurial pursuits of research with the conflicts of interest and commitment that inevitably arise. As a significant portion of research funding is provided by federal sources (e.g, the NIH, NSF, DOD), researchers and institutions must also factor in the regulatory COI terms and conditions that flow down with federal research dollars. Increasingly rigorous conflict of interest and financial conflict of interest regulations have resulted from growing concerns that institutions’ commitment to profit has trumped academic and research integrity, coupled with increased demand for transparency in federal expenditures. What does this mean for higher education and research institutions? Additional efforts are required to address disclosure and reporting requirements, and administrative oversight. This session will outline the various types of conflicts of interest and provide examples of each, discuss current federal regulations guiding COI in sponsored research, and provide tips and techniques for improving, or implementing, a COI program.

Learning Objectives:
• Define and categorize conflict of interest (e.g., financial conflicts, conflicts of

conscience, conflicts of commitment)

• Understand the current regulatory landscape, including federal COI

regulations
• Identify questions to assess the effectiveness of your own COI program
• Learn techniques and best practices for implementing a COI program at your institution

Compliance and Grants Management:
Keeping the Records Straight

March 1, 2013 - 1:00-2:30 PM

Federal research funding, while providing researchers with the resources to further their scientific endeavors, exposes institutions to myriad of new risks compliance elements. The Principal Investigator is officially the institutional employee responsible for how those funds are spent, institutions may provide resources to assist in the management, financial oversight, and monitoring of awards. While there are a variety of models, processes, and practices used to provide this assistance, which depend on many factors unique to the institution, there are common areas where all institutions face challenges.

Learning Objectives:

• Identify areas in grants management and financial compliance that regularly

pose challenges to research administrators
• Discuss the importance of process and documentation
• Discuss key controls for financial monitoring
• Illustrate cost charging and compliance through case studies
• Provide examples of best practices for the design of oversight processes

SPEAKERS

Research Compliance is multi-faceted and at times overwhelming. Whether your institution’s research is basic, clinical or translational in nature, there are rules, regulations, guidelines and sometimes just plain old best practices that need to be learned and followed. If not, the consequences can be dire for researchers, staff, institutions, and the public at large. This two day track is geared for those who need to learn how to best handle and manage regulatory compliance aspects of grants and contracts administration or want a more in-depth understanding of relevant regulatory compliance topics.

Day One will focus on how to administer and track compliance of Responsible Conduct of Research training, how to recognize the threat of research misconduct and what prevention mechanisms can be put in place, and how to establish effective communication and sharing of information with research subject protection committees (i.e., IRB, IACUC, IBC, ESCRO).

Day Two will focus on financial conflicts of interest and commitment and how to stay compliant with the latest PHS rules and how best to record and track compliance information within your grants management system.

Sheila Rose Garrity, JD, MPH, MBA

Director, Research Integrity
Johns Hopkins University School of Medicine

Kimberly Ginn, CIA
Principal

Baker Tilly

Adrienne Larmett

Senior Consultant

Baker Tilly

Debra Schaller-Demers, MSOM
Director, Research Outreach and Compliance
Memorial Sloan-Kettering Cancer Center

Daniel Vasgird, PhD
Director, Office of Research Integrity and Compliance
West Virginia University

Each day begins at 8:30 AM with a Plenary Session and ends at 5:00 PM with Question and Answers. Please see Schedule for more details.

Recap with Questions and Answers

March 1, 2013 - 3:00-5:00 PM