Download - Jo Ellen Sherow Office of Research Compliance Introduction to Responsible Conduct of Research (RCR)
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?