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 ProvostUniversity of WashingtonDenver, 2008

Conduct of ResearchPrinciple:

Ensures validity of results/Maximizes return on public investment

Conflict of InterestsResearch Integrity

Conflict of CommitmentData, Resource Sharing, Cyber Security (new)

Public Access to Publications (new)

Public Policy RequirementsPrinciple:

Meets National Social, Economic, Security InterestsSEVIS/Visas (new)

Export controls (new)Title IX

Lobbying DebarmentDrug Use

Protections/SafeguardsPrinciple:

Provides safety/welfare of subjects and environmentHuman SubjectsAnimal WelfareHIPAA (new)

Environmental Health & Safety Select Agents (new)

Cost Policy/Financial ManagementPrinciple:

Ensures fair and reasonable costs to the GovernmentReasonable Allocation of CostsSalary Charges/Effort Reporting

Indirect CostsCost Sharing

Geoff Grant, May, 2005

Ensuring Research Protections Principles and Ensuring Research Protections Principles and ResponsibilitiesResponsibilities

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

Research Compliance – Why? Why is there so much emphasis on this topic

now?

1. 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

2. Recent, significant compliance failures at large, research institutions

Research Compliance – Why?

Why is there so much emphasis on this topic now?

3. 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

Research Compliance – Why? Why is there so much emphasis on this topic

now?

5. Successful Qui Tam Lawsuits

6. 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 CultureWhat 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 UniversityDivision of Sponsored ResearchOffice 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 2000http://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

C o m p lian c e O ff ice r

S en io r V ice P re side n tH e a lth S c ien c es

C o m p lia nce C o m m ittee

A ss oc ia te V PR e se arch In te g r i ty

a ndC h a ir o f C om p lia nce C o m m ittee

R e s ea rchC o m p lian c e O ff ice r

V ice P res ide n tR e s ea rch

P res ide n t

Sample:Stanford Roles and Responsibilities

COGNIZANT POLICY OFFICE

OFFICER

FUNCTIONALLY RESPONSIBLE OFFICE

OFFICER

PRIMARY LOCUS OF RESPONSIBILITY

EH&S Dean of Research & Graduate Policy

EH&S PI’s

Medicare Billing VP for Medical Affairs SHC Compliance Office Medical Faculty SHC Compliance Office

Research/ Administration

Dean of Research & Graduate Policy, Assoc. VP for Research Admin.

Office of the Dean of Research

Office of Research Admin

PI’s/Departments

Scientific Misconduct

Dean of Research & Graduate Policy

Office of the Dean of Research

Schools

Human/Animal Subjects

Dean of Research & Graduate Policy

Administrative Panels, Compliance Office

PI’s

HR/EEOC VP for Business Affiars Human Resources Departments, Central HR

NCAA Provost DAPER Coaches

Fire and Bldg Safety VP for Land & Buildings EH&S/Fire Marshal EH&S/Schools/ Departments

IRS & CA Tax VP for Business Affiars Controller FAIR Group

Donor Gift Restrictions

President Office of Development SMC Schools/Departments/

Faculty Conflicts of Interest Provost Dean of Research &

Graduate Policy Business Affairs

Schools/Faculty, Controller,

Director of Procurement Immigration VP for Business Affairs Human Resources Departments,

Central HR Technology Licens’g/ Intellectual Property

Dean of Research & Graudate Policy

Office of Technology Licensing

OTL, Faculty

Land Use VP for Land & Buildings SMC/CP&M SMC/CP&M

Sample:Common Elements of an Institution-wide Compliance Program

Components of Compliance Program EH&SMedicare

Billing ResearchHR/

EEOC NCAA

Fire &Bldg

SafetyIRS &

CA TaxDonor Gift

Restrictions

Written code of business ethics and conduct

Expliciitly stated ethical and compliance policies and standards

Training for all employees on ethical and compliance policies and standards

Training for affected employees on laws and regulations related to their jobs

Designation of a compliance officer with appropriate powers and expertise

Adoption/provision of adequate procedures, resources, and systems to permit compliance

Maintenance of a process to allow anonymous reporting of alledged noncompliance

Protection for employees who lodge reports

Regular monitoring and auditing processes to test compliance

Mechanisms to enforce rules and discipline rule violators

Management commitment to take corrective actions and follow up

System to communicate corrective actions and follow up undertaken

Adequate Board-level oversight of compliance function

Mechanism to communicate the impact of rules to the creators and enforcers of the rules

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

1. Comprehensive Programs?

2. 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.

Walsh, Barbara E., Moran, James, McDougall, Gerald, The Compliance Umbrella, Business Officer, January 2000,

American Association of Academic Medical Colleges website @ www.aamc.org/research/dbr/compliance/models.htm

Office of Research Integrity www.ori.dhhs.gov/

Kulakowski, Elliott, Chronister, Lynne, Research Administration and Management, Jones and Bartlett, 2007.

OMB Compliance Supplement, March 2008 www.whitehouse.gov/

Contact

Lynne ChronisterAssociate Vice Provost for Research

University of Washington,

[email protected]

206-543-4043