How many regulations impact the conduct of research?

Navigating Issues in Research Compliance:what is all the fuss about???

Allison Griffin Ratterman, Ph.D. Director, Research Integrity

Research Integrity ProgramOffice of the Executive Vice President for Research

University of Louisville

The Average Researcher

How many regulations impact the conduct of research?

Research Compliance

Why do we care about conducting ethical research?

First and foremost, it is the right thing to do!

As an institution of higher learning, we strive daily to nurture and strengthen our relationship with the community. A headline or news item on TV or radio can shatter that trust in a matter of seconds

As funded researchers, we must be accountable stewards of those funds and conduct ourselves in an integrity driven manner

Institution Driven◦ Position◦ Role◦ Employment Location

Facility Driven◦ Hospitals◦ Center for Predictive Medicine◦ Private Practice

Compliance and Training Milestones

Activity Driven◦ Animals◦ Humans◦ Chemicals / Hazardous Materials / Equipment

Data Driven◦ Protected Health Information◦ Confidential / Sensitive Data

Sponsor Driven◦ Training◦ Reporting◦ Purchasing / Spending

Compliance and Training Milestones

Responsible Conduct

of Research

Human Subjects

HIPAA

Animal Subjects

Biological and Environmenta

l Safety

Conflicts of Interest

Fiscal Responsibility

Professional Standards

Social Responsibility

in Science

Research Misconduct

Responsible Conduct

of Research

Human Subjects

HIPAA

Animal Subjects

Biological and Environmenta

l Safety

Conflicts of Interest

Fiscal Responsibility

Professional Standards

Social Responsibility

in Science

Research Misconduct

Conflict of Interest is not a “four letter

word”…

but even in the best of times it can be

confusing to navigate

Why do we care????◦ It helps to assure the public that the research

community is acting in conformity with the spirit and guidelines of the University of Louisville Policy and with the public good in mind

◦ Newspaper Headlines

◦ Governmental Agency Reports

◦ Scientific Journals

◦ Funding Agencies

Conflicts of Interest

Conflicts of Interest:University Research Enterprise

University of Louisville supports technology transfer to patent and license, to participate in the establishment of industry

partnerships, to accept company-sponsored research funding,

and to consult.

Federal government has mandated that universities seek to commercialize the results of federally supported research for the public good

Conflicts of Interest:Types of Conflicts in Research

Conflict of Financial Interest◦ A researcher has a responsibility to respect the well being of the

University

Conflict of Research Integrity◦ Researchers should maintain the highest level of scientific integrity

in the conduct of research. The complete, objective, and timely distribution of new findings through publications and presentations, is essential for research integrity.

Conflict of Educational Mission◦ Students and post-doctoral fellows must be assured of an

educationally appropriate training program

Conflict of Commitment◦ The workforce owes its primary commitment and allegiance to the

University

Conflicts of Interest:University Process

The University has established policies that define potential conflicts and provide guidelines and procedures for limiting and managing them.

Annual disclosure requirement remains in effect Thresholds for disclosure have been lowered Training is required External Interests must be reviewed across the aggregate

relationship Relationships with non-profits are no longer exempt from disclosure Directly sponsored or directly reimbursed travel must be disclosed

Responsible Conduct

of Research

Human Subjects

HIPAA

Animal Subjects

Biological and Environmenta

l Safety

Conflicts of Interest

Fiscal Responsibility

Professional Standards

Social Responsibility

in Science

Research Misconduct

Financial Stewardship

Institutional and Sponsor Requirements

Training required

Fiscal Responsibility

Responsible Conduct

of Research

Human Subjects

HIPAA

Animal Subjects

Biological and Environmenta

l Safety

Conflicts of Interest

Fiscal Responsibility

Professional Standards

Social Responsibility

in Science

Research Misconduct

Authorship and Publication

Collaboration

Data Management and Stewardship

Mentor / Mentee Relationships

Peer Review

Professional Standards

Original work in which the author has made a new and significant intellectual contribution to others

Be Careful! ◦ Taking Credit=Responsibility for Accuracy

Avoid Dilution◦ Only include those who significantly contributed ◦ Laboratory, financial or technical assistance (i.e.) may be

acknowledged with consent Author Order

◦ Responsibility of Principals and determined early!◦ Become familiar with order of authorship in your discipline

Nativio, D.G. (Sep2000 ) Authorship. Journal of the American Academy of Nurse Practitioners. (V12, I 9, p351). Retrieved August 3, 2009 from http://web.ebscohost.com/ehost/pdf?vid=6&hid=9&sid=80c85c3f-550d-4411-af19-666faaec0dd1%40sessionmgr11

Authorship and Publication

All authors should review final before submission

Be prepared to produce original data

Be prepared to produce breakdown of contributions

Nativio, D.G. (Sep2000 ) Authorship. Journal of the American Academy of Nurse Practitioners. (V12, I 9, p351). Retrieved August 3, 2009 from http://web.ebscohost.com/ehost/pdf?vid=6&hid=9&sid=80c85c3f-550d-4411-af19-666faaec0dd1%40sessionmgr11

Authorship and Publication

Basis of collaborative arrangement is “contractual”

Look ahead, plan ahead, anticipate

Be direct and honest about possible problems, misunderstandings

Collaborative activity

In shared research all must adhere to ethical standards.

Confidentiality when promised or appropriate should be maintained.

Design and conduct research with honesty and integrity.

Original data must be recorded, preserved, made accessible to University.

Data Acquisition, Management, Sharing and Ownership

What the Mentor can do!◦ Serve as a Positive Role Model◦ Be Available◦ Continually Evaluate Progress and Performance◦ Serve as Career Coach◦ Engage Beyond Current Projects◦ Encourage Relationships

◦ University of Louisville Graduate School Graduate Council. (1998-1999) Mentor and Graduate Student Strategies for Success. Retrieved August 3, 2009 from https://graduate.louisville.edu/pubs/mentor-and-graduate-student-strategies-for-success.html

Mentor / Mentee Relationships

What the Mentee can do!◦Keep in Touch

Problems◦Contribute Knowledge

Good mentors know mentees will surpass them◦Seek Advice from Others

From best prepared◦Change the relationship if necessary

Not all are successful

◦ University of Louisville Graduate School Graduate Council. (1998-1999) Mentor and Graduate Student Strategies for Success. Retrieved August 3, 2009 from https://graduate.louisville.edu/pubs/mentor-and-graduate-student-strategies-for-success.html

Mentor / Mentee Relationships

Reviewers shall provide reviews that are thorough

Reviewers shall provide reviews that are unbiased

Reviews should be done in a timely fashion

Expert reviews and the materials being evaluated shall remain confidential

Peer Review

Responsible Conduct of Research

Human Subjects

HIPAA

Animal Subjects

Biological and

Environmental Safety

Conflicts of

Interest

Fiscal Responsi

bility

Professional

Standards

Social Responsibility in Science

Research Miscondu

ct

Why do we care about conducting socially responsible (ethical)

research?

Ethical questions arise because of social responsibilities to others in the community and because behavior is capable of influencing the welfare of others

Research with Vulnerable Populations International Research Research on Controversial Issues Dual Use Technologies Genetic manipulation of plants,

organisms, people

Social Responsibility in Research

Keys to Socially Responsible Research Valid research design

Competent research personnel

Consequences / Impacts have been identified and addressed as needed

Design, Performance and reporting of the research is free from bias

Responsible Conduct of Research

Human Subjects

HIPAA

Animal Subjects

Biological and

Environmental Safety

Conflicts of

Interest

Fiscal Responsi

bility

Professional

Standards

Social Responsibility in Science

Research Miscondu

ct

Research Misconduct means fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting research results

Research Misconduct

Making up data or results and recording or reporting them

Fabrication

It would have taken me forever to actually perform all of those tests.

Altering raw data for reporting purposes

Falsification

22% 98% 12% 100%Sample size: 16 Sample size: 900

Reporting others’ data, ideas, processes, results, or words without giving credit by acknowledging the source

Plagiarism

Copier

Research Misconduct Proceedings Allegations of Research Misconduct

◦ Consult with Research Integrity Ombudsperson Barbara Speck (Nursing) Richard Stremel (Physiology) Eleanor Lederer (Renal Medicine) Douglas Darling (Dentistry)

◦ Consult with Research Integrity Allison Ratterman – 852-2453

While not meeting the federal definition of research misconduct, the following behaviors are examples of unethical research practices:

◦ Forging a practitioner's signature on medical orders; ◦ Breaching human subject confidentiality; ◦ Failing to obtain IRB and/or FDA approval for changes implemented in an

approved protocol.◦ Serious deviation from accepted practices in proposing or carrying out

research, improper manipulation of experiments to obtain biased results, deceptive statistical or analytical manipulations, or improper reporting of results.

◦ Improper use of information gained by privileged access, such as information obtained through service on peer review panels and editorial boards.

◦ Deliberately sabotaging or physically damaging the laboratory research set up, equipment, or records.

Unacceptable Research Practices

Research Misconduct Proceedings Allegations of Research Misconduct

Process◦ Allegation Referral Form

Dr. Ratterman will work with you to complete the form

◦ Research Integrity Ombudsperson performs Preliminary Assessment

◦ Depending on outcome of assessment, inquiry may be opened

Research Misconduct Proceedings Allegations of Research Misconduct

Process◦ Inquiry determines whether alleged actions meet

regulatory criteria of research misconduct or unacceptable research practices If yes, investigation opened If no, recommendation made for resolution of any identified

issues

◦ Investigation determines if misconduct occurred, by whom and to what extent

◦ Deciding Official determines institutional action required

Plan, then act When in doubt, ask Make use of available

resources both inside your unit, your institution and beyond…

Getting all the pieces…

Faculty and Administrators

Research Integrity Program

Professional Societies

Colleagues

Available Resources

Questions????

If you have questions about anything included in this presentation, please feel free to contact:

Allison Griffin Ratterman, Ph.D.Research Integrity ProgramOffice of the Executive Vice President for Research

[email protected]@louisville.edu502-852-2454research.louisville.edu/researchintegrity

Sources used for this presentation include:

http://louisville.edu/research/humansubjects/investigator-research-team-information

www.asiaplanet.net http://web.missouri.edu/~bondesonw/Laud.html

www.kwintessential.co.uk/resources/global-etiquette

“Culture and Global Business Research” road.uww.edu/.../Marketing%20Research%20Spring

“Responsible Conduct of Research” presentation by Allison Griffin Ratterman PhD

“The Research Integrity Program” presentation by Laura Engel

Screen Beans Art : © A Bit Better Corporation, used under licensed permission

Clip art provided by Microsoft “Clip art on Office Online” at : http://office.microsoft.com/en-us/clipart/download.aspx

“Ethical Concerns in Research: What is all the fuss about?” The Research Integrity Program, University of Louisville, Presentation by Allison Griffin Ratterman Ph. D.

http://louisville.edu/research/humansubjects/investigator-research-team-information