Jo Ellen SherowOffice of Research Compliance

Introduction to Responsible Conduct of Research (RCR)

RCR Responsibility

"Research mentors, laboratory directors, department heads, and senior faculty are responsible for defining, explaining, exemplifying, and requiring adherence to the value systems of their institutions." Responsible Science: Ensuring the Integrity of the Research Process. Vol. 1:7, NAS, 1992.

Federal RCR Content AreasConflict of Interest and CommitmentHuman SubjectsAnimal SubjectsPublication Practices and Responsible

AuthorshipData Acquisition, management, Sharing

and OwnershipMentor/Trainee ResponsibilitiesPeer ReviewCollaborative ScienceResearch Misconduct

Responsible conduct of research needs to be integrated in the entire research effort – it is not a single point in time effort

PlanningConductingReportingReviewing

RCR in Practice

Ohio Revised Code 102.01

Honorarium

Means any payment made in consideration for any speech given, article published, or attendance at any public or private conference, convention, meeting, social event, meal, or similar gathering. “Honorarium” does not include ceremonial gifts or awards that have insignificant monetary value; unsolicited gifts of nominal value or trivial items of informational value.

The Legislative Framework of RCRFederal RegulationsAnimal Welfare ActNational Research ActHealth Research Extension Act

State Ethics Law

Other RCR Criteria

Institutional PolicyProfessional Standards

Personal Ethics

How does RCR apply prior to beginning

research?

The Planning Phase

Determine what regulations and guidelines apply to your research:

Do you use humans?Consult with the IRB office.

Do you use animals?Consult with the IACUC office and Laboratory Animal Resources

Do you have a potential conflict of interest?Consult with the Director of Research Compliance

Other considerations

What are the professional standards that apply to my work?

What are the Ohio University policies and procedures that my work will intersect?Think broadly – (e.g. export controls, space utilization,

procurement, etc.)

Know your RequirementsDo you know what a human

subject is? An animal subject?What is the IRB and the IACUC? Understanding your

responsibilities:Regulatory requirementsTrainingFollowing the rulesAccepting responsibility

Area 1: Protection of Human SubjectsFounded on three principles

BeneficenceRespect for personsJustice

Important take away messages:The researcher is not

permitted to determine if the research is exempt – it must be submitted and that determination made by the compliance office.

Not all interactions with humans are research.

Area 2: Welfare of Laboratory AnimalsFounded on three principles

ReductionRefinementReplacement

Important take away messages:Animal use includes teaching,

testing and researchAnimal use sites are inspected

twice per yearAnimal use includes observation

“bird watching”Animal use includes use outside of

Ohio University

Area 3: Conflicts of Interest

There are different types of conflictsFinancial conflictsConflicts of commitmentConflicts of interest

Important take away messages:Conflicts are not inherently “bad”There are reporting thresholds that require

disclosureDisclosure is required for funded projectsDisclosure is your friend.

Specialized Training Available

Navigating the IACUCNavigating the IRBNavigating Conflict of Interest

These have detailed regulatory requirements and a more comprehensive overview is offered at special training sessions each quarter.

What needs considered with respect to RCR as you

and your colleagues conduct the research?

The Conduct Phase

Data Management

What are the requirements?Funding agency, Ohio University, Legislative

Ownership of the DataIs this clear to all involved?Do you own the data or does Ohio

University? What are the sponsor requirements?What about graduate students and postdocs?

Mentor/Trainee ConsiderationsWho has responsibility for what

part of the research?Does everyone understand their

responsibilities?Have you thought out the

supervision of trainees?Recognize that trainees have

desired outcomes and need to be able to work toward those

Remain aware of what is occurring

Collaborative Research ConsiderationsWho is in charge of project

management?Who is writing up the results?Who will be listed as authors, who

as acknowledgements?Recognize that different

collaborators have different interests

Recognize any cultural differences that could impact the project

Data Management

Who manages the data?Establish at the start of the project

Assure that there is agreement among the team

Special consideration for graduate students:

Publishing rights

Ownership of DataRecognize that external funds are

not the property of the PI – they are provided to Ohio UniversityOhio University generally owns

research conducted at Ohio University

Some funding agencies have restrictions on the right to use data, these are generally different between public and private entities

Collection of DataThe reliability of your methods impacts

the reliability of your resultsData is the foundation of future research

Sloppy work not only wastes resources, it can resemble misconduct

If you fail to gain the appropriate permissions, you may not be allowed to use the data you have collected!

Protection of DataStorage Methods

Consider disaster planningBack up

AccessIf your permissions to collect

has authorization or confidentiality requirements they must be followed!

RetentionNIH requires 3 years, but some

agencies require up to 7 yearsKnow what the agency AND

institutional requirements are

Grant or Contract?

Grants usually require research to be done and reports filed, but the data remains under control of the institution

Contracts generally require the researcher to deliver a service or product.

Know which you are working under since the rights to publish and use results later can be very different.

Sharing DataRelease of preliminary data is not generally

requiredException: If public health is endangered

Data can be held until researchers publish their work, unless there was an agreement to release it in some other time frame at the start of the work

Once published general practice is that all data is available to other researchers.

Other ConsiderationsLarge projects, such as a multi-center

clinical trial, have special data management issues.Do individual PI’s get to retain some control

over their data?

Research funded by the Department of Defense may have data security and sharing issues.Restrictions are usually heightened

Research where national security issues may be identifiedChanging policies and regulations

Area 5: MentoringThe key to mentor-trainee relationships is

to set the ground rules at the beginning of the relationship.Clearly state responsibilitiesProvide adequate supervision and guidanceRecognize that trainees have agendas of

their own

Mentors must understand their responsibility to their trainees, and trainees must be aware of their responsibility to their mentor. Review these on a regular basis during the

research project

Mentoring Issues for the MentorExpectations with respect

to time commitments of the trainee

What will be the criteria for evaluation of the trainee?

What are the specific responsibilities of the trainee?

Determine ownership and authorship expectations BEFORE you begin

Mentoring

Mentoring IssuesResearch environment

Is it collaborative or competitive?

Assure that everyone understand their responsibilities

Understand RCR and hold yourself to those standards, especially if things seem wrong

Collaborative Research

Special Issues with PostdocsMentors must be willing to allow postdocs

to become independent researchers

Recognize that postdocs do not have the protections of either students or faculty

First authorship may be appropriate, but should be agreed upon at the beginning.

Collaborative Research

Requires diligence in management of relationships and duties

GoalsRolesData managementAuthorship issuesReporting PresentationsIntellectual propertyMethods to alter agreement

Managing Collaborative VenturesWho is in charge?

ScientificFinancialTrainingCompliance

Reconcile interdisciplinary differences

The Reporting PhaseThe purpose of research is to create results.

When the work is publicly funded there is a responsibility to share results for the public benefit.Those results are of no public value if they

are not shared.

Shared results form the structure on which future research is built.

Reporting ResearchFoundation blocks for reporting research

HonestyAccuracyEfficiencyObjectivity

Authorship

Considerations

Authorship requires significant contribution to the projectConcept and design of the researchResponsibility for data collection and interpretation

Drafting the publicationApproving the final version of the publication

Other contributors can be listed in the acknowledgements

Authorship OrderOrder of authorship should be an

agreement among the research participants

Single most common authorship complaint in my office

Authors are generally listed in order of importance BUT some publications and/or disciplines use alpha order

Discuss this BEFORE you begin the work!

Publication IssuesGenerally, “honorary authorship” is not an

accepted practiceNot an author because they are chair, add

“weight”, etc.

Duplicate publicationsRewriting the information for a different

publication is not ethical without referencing the initial publication.Distorts the research record, e.g. clinical trial resultsSelf-plagiarism

Publishing in smaller “bites” of information for the purpose of increasing the number of publications.

Area 8: Peer ReviewPeer review is a critical part of the research

chain

There can be public as well as professional consequences to peer evaluations

Peer review can influenceWhich projects are fundedWhich findings are publishedInvestigator status

Peer Review

Know the RequirementsMeet deadlines if you agree to do the

review

Be diligent in assessing the quality

Use an open mind to assess the importance

Recognize and adhere to the confidentiality factor

What is the difference between “research” misconduct and “academic” misconduct?

Research Misconduct

Survey suggests research misconduct is commonThu Jun 19, 2008 12:34am EDT WASHINGTON (Reuters)

“Research misconduct at U.S. institutions may be more common than previously suspected, with 9 percent of scientists saying in a new survey that they personally had seen fabrication, falsification or plagiarism. The survey of 2,212 mainly biomedical scientists at 605 universities and other research institutions, published in the journal Nature on Wednesday, also showed that researchers are very reluctant to report bad conduct.”

http://www.reuters.com/article/scienceNews/idUSN1846626420080619

What is Research Misconduct?Know the research misconduct policies and

standardsResearch misconduct under federal

guidelines focuses on:FabricationFalsificationPlagiarism

Includes the proposing, performing, or reviewing phases.

Includes actions that:Are a significant departure from accepted

practicesAre committed intentionally, knowingly or

recklesslyAre proven by a preponderance of the

evidence

Universities Look for Lessons as Professor Awaits Sentencing Over Export-Law Violations

The Chronicle of Higher Education Tuesday, April 21, 2009By PAUL BASKEN

On May 13, John Reece Roth, a retired University of Tennessee professor, is expected to walk into a Knoxville courthouse and be sentenced to at least five years in prison for allowing unauthorized foreign citizens access to classified technology.

Mr. Roth, 71, who taught electrical and computer engineering at the university's Knoxville campus, was convicted on charges involving his use of a Chinese graduate student on a Pentagon research contract.

http://chronicle.com/daily/2009/04/16330n.htm

“Research Misconduct” vs. “Ethical Research”

Not all ethically questionable circumstances are prosecuted under the research misconduct policy Academic misconductCriminal behaviorViolation of other institutional policies and procedures

Other Research MisconductThe definition of research misconduct

under Ohio University policy 19.048 also includes:

“…or other practices that seriously deviate from those that are commonly accepted within the academic community for proposing, conducting, or reporting research”Violation of other state, federal or

institutional policies

Ethical allegations that are not defined within the scope of 19.048 or federal research regulations may still be academic misconduct and/or criminally liable

MisconductHas career ending consequences in some cases

Wastes resources and public funds

Taints the research recordCan impact public health and safety

Undermines the public trust

Questions?