Responsible Conduct of Research: A Framework for Research Administrators and Organizations

Responsible Conduct of Research : A Framework for Research Administrators and Organizations

Presented by: Contributions from: Denise McCartney, Washington University Geoff Grant, Partners Health System Lynne Chronister, Assistant Vice Provost University of Washington Denver, 2008

Conduct of Research Principle: Ensures validity of results/ Maximizes return on public investment Conflict of Interests Research Integrity Conflict of Commitment Data, Resource Sharing, Cyber Security (new) Public Access to Publications (new) Public Policy Requirements Principle: Meets National Social, Economic, Security Interests SEVIS/Visas (new) Export controls (new) Title IX Lobbying Debarment Drug Use Protections/Safeguards Principle: Provides safety/welfare of subjects and environment Human Subjects Animal Welfare HIPAA (new) Environmental Health & Safety Select Agents (new) Cost Policy/Financial Management Principle: Ensures fair and reasonable costs to the Government Reasonable Allocation of Costs Salary Charges/Effort Reporting Indirect Costs Cost Sharing Geoff Grant, May, 2005 Ensuring Research Protections Principles and Responsibilities

Research Compliance – Why?

Universities have an obligation to maintain the public’s trust by:

Conducting research ethically and responsibly

Ensuring proper stewardship of research funds

Protecting animal and human subjects

Assuring compliance with federal regulations

Why is there so much emphasis on this topic now?

The Academic Culture is at risk for compliance failures due to

Decentralized organizations

Potential for conflicts of interest

Undefined roles and responsibilities

Lack of comprehensive training

Expanded Requirements

Recent, significant compliance failures at large, research institutions

Increased funding for biomedical research resulting in greater scrutiny, increased inspections

4. Findings of liability on the part of universities have become more frequent in recent years

5. Successful Qui Tam Lawsuits

Federal Sentencing Guidelines reduce penalties if a fully-functioning corporate compliance program is in place. Corporate Integrity Agreements are onerous.

7. NIH Proactive Compliance Visits have helped set standards

Critical Components !!!

1 . Instill a Culture of Compliance

Communication

Policy development

2 . Develop an Organizational Structure

RCR Committee

Compliance/Integrity/Ethics Officer

3 . Develop Comprehensive Education and Training

RCR and Integrity/Ethics

1. Culture: How to Promote Research Integrity, or Finding Your Voice, Ensuring Research Protections

Match Your Approach to Your Culture What Will Be Successful in Your Institution?

It’s all about the shared values in promoting outstanding science or research!

Use language that appeals to the faculty

Promote institutional core values first and foremost

e.g. excellence in research, research protections, code of conduct, stewardship, research responsibilities

Then find a balance between promoting research integrity and providing appropriate programs for compliance and accountability

Requirements are increasingly complex

Faculty increasingly rely on internal expertise and guidance

Research compliance programs are now an essential element of institutional research infrastructure

every bit as important as research facilities and instrumentation

Unfortunately, the institution and the research community need safeguards against fraud and abuse

Recovery from damage to the reputation or good name of the institution is a long term process!

Communication from the President or Provost

Letter or Message to Faculty

Be proactive, exert leadership

Obviously a currency not be squandered or overused

Time with announcement of a research integrity program, office, role, or an education program for faculty and/or administrators

Reference to some other institutional case or event

One Example from Vanderbilt University Division of Sponsored Research Office of Compliance

A Sample of One Institution’s Messages

The Principal Investigator (PI) role at Stanford University brings significant rewards and responsibilities. PIs are responsible for the intellectual direction of research and scholarship and for the education and training of students. In carrying out these critical tasks, PIs are also responsible for compliance with laws and regulations that touch on all aspects of the research enterprise.

John Hennessey, President, Stanford in a letter to the faculty 2000

http://www.stanford.edu/dept/DoR/PIship/

Cite Respected Sources or Distinguished Scientists

“ The scientific research enterprise, like other human activities, is built on a foundation of trust. Scientists trust that the results reported by others are valid. Society trusts that the results of research reflect an honest attempt by scientists to describe the world accurately and without bias. The level of trust that has characterized science and its relationship with society has contributed to a period of unparalleled scientific productivity. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct . ” [1]

[1] On Being a Scientist: Responsible Conduct in Research, Second Edition (1995) ,

National Academy of Sciences

2. Consensus on Structure and Function

Who is responsible?

What is our Structure?

What RCR areas are critical?

How To Begin?

Draft Outline of plan

Review of policies (COI, etc.)

Extensive Survey of Education & Training

Strategic Planning Session

Engage a Compliance Officer

Set up a committee

Write Plan

Design curriculum

Teach and Train

Commit Money!

Conduct an Institutional Risk Assessment

Convene group of key faculty and administrators from departments and central offices

Run consensus process by:

Appropriate Dean or academic official?

Associate VP for Research?

Compliance Officer?

Internal Audit?

Research Compliance Program Goals

Promote high standards of research integrity

Effectively manage public funds to maximize research outcomes

Protect research subjects

Assure coordination of compliance programs

Avoid serious cases of fraud or mismanagement of federal funds through self-monitoring

Assure coordination of compliance programs

Compliance Program Elements

Written standards, policies and procedures

Education, training and communication

Monitoring

Audits

Appointment of a High Level Official

Mechanism to report violations (e.g. hotline)

Record Retention policy

Defined roles and responsibilities

Compliance Program Models

Institutional Compliance Program

Single Compliance Office/Program with a clearly identified Compliance Officer

Research Compliance Program

Separately established from other compliance programs

Focused on oversight for research compliance

Compliance Program Models

Functional Compliance Model

Traditional organizational models building on existing compliance structures

Increased clarity of roles and responsibilities

Increased focus on education

Oversight and/or coordination

Hybrid Models

No Model

No Program

Washington University Compliance Program

Roles and Responsibilities of Research Compliance

University Compliance Research Compliance Functional Areas Research Compliance

Support, assist and verify effectiveness of compliance activities

Develop, revise & maintain the Code of Conduct

Perform audits

Receive & Respond to Allegations of Wrongdoing

Communicate with the Board

Develop and maintain Expertise on laws and regs

Develop and implement Policies and Procedures

Develop and Provide Edcuational Programs

Develop and implement methods to monitor compliance

Respond to allegations of wrongdoing

Develop & Promote Principles

Develop & Coordinate Educational Programs

Facilitate Monitoring

Respond to allegations of wrongdoing

Provide Necessary Infrastructure to facilitate compliance activities

Washington University Research Compliance Program

Research Compliance Accomplishments

Defined roles and responsibility of offices accountable for Research Compliance

Began project to document roles and responsibilities of other key offices and individuals involved in research

Completed Inventory of Research Compliance functional areas

Policies

Educational Programs

Information Systems

Monitoring/Auditing Programs

Communication Tools

Developed, updated and revised polices based on inventory results

Enhancing Educational Program

Research Administrators Forum

Implemented Research News – a web-based communication tool targeted at specialized audience with associated library

Hired Director of Research Education

Departmental Educational Retreats

Compliance Audit follow-ups

Developing Administrators Financial Program

University of Utah

Began development in 2000

NIH Proactive Compliance Visit, August 2002

Increased concern on the part of administration

Increased concern expressed by faculty and other researchers

Concerted Effort in re-engineering clinical studies including financial and regulatory

How Did Utah Begin?

Draft Outline of plan begun in 2001

Revision of numerous policies (COI, etc.)

Extensive Survey of Educ. & Training

Strategic Planning Session

35 participants (compliance admin & faculty)

1 day

Strategic plan for structure and function of compliance program

Plan for NIH visit incorporated

Compliance Mission

“The University of of Utah’s research compliance program is committed to the achievement of high ethical and legal standards of conduct through a culture of compliance and conscience that reflect our core values”.

Organization Chart

Sample: Stanford Roles and Responsibilities

Sample: Common Elements of an Institution-wide Compliance Program

UC Davis Gap Analysis Worksheet

3. Education and Training

NIH Training Grant Requirements

NSF Training Grant Requirements

America Competes Act Requirements:

RCR training for ALL students and fellows

It is Right Thing to Do!!!

Establish Program Parameters

Comprehensive Programs?

Select RCR Modules?

Resources:

Office of Research Integrity

Responsible Conduct of Research Education Consortium (http:/rcrec.org)

PRIM&R (Public Responsibility in Medicine and Research

It is not permitted to the most equitable of men to be a judge in his own cause. Blaise Pascal (1670)

References and Resources

Grant, Geoffrey, Guyton, Odell, Forrester, Robert, Creating Effective Research Compliance Programs in Academic Institutions, Academic Medicine, vol. 74, No., September 1999.