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Compliance Office Resources
Office of the Vice Chancellor for Research & Graduate Education Compliance Office Resources Zoë Hammatt, J.D., M.Phil. Co-sponsored by RMATRIX Hawaii Award No. U54RR from the National Center for Research Resources, National Institutes of Health November 22, 2011
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Office of the Vice Chancellor for Research and Graduate Education
Ching Yuan Hu, Ph.D. Interim Assistant Vice Chancellor for Research and Graduate Education and Research Integrity Officer Renee Harada:
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Research Compliance Compliance with Federal, State, and University regulations Compliance Office oversees: 1. Animal Welfare Institutional Animal Care and Use Committee 2. Biological Safety Institutional Biosafety Committee 3. Committee on Human Studies Institutional Review Board 4. Research Integrity Responsible Conduct of Research Research and Scholarly Misconduct Conflicts of Interest
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Responsible Conduct of Research (RCR)
Section 7009 America Competes Act (42 U.S.C. 1862o-1) Each institution must have a plan to provide training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project (2010). Similar requirement (NOT-OD ) for RCR training, except PI is responsible (2010).
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UH RCR Training CITI - Collaborative Institutional Training Initiative
- on-line RCR modules - RCR Interactive Session - requirement to attend at least one session - offered at least 4x a year - case study discussion RCR training is valid for four years
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RCR Nine Core Areas Data management (acquisition, sharing, ownership)
Mentor/trainee responsibilities Responsible authorship/publication practices Peer review Collaborative science Human subjects research (CHS – IRB) Research involving animals (IACUC) Research misconduct Conflicts of interest and commitment
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Foundations of Responsible Conduct of Research
Ethical standards Laws and regulations Professional codes Institutional policies Departmental standards Individual researchers
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Research and Scholarly Misconduct
UH Executive Policy E5.211 Policy for Responding to Allegations of Misconduct in Research and Scholarly Activities (2008) Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
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Misconduct Definitions
Fabrication – making up data or results and recording or reporting them Falsification – manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented Plagiarism – the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit
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UH Ethics Committee Standing committee of faculty and staff members
Peer Review Process 5-member Review Panels Chairperson: Professor Chris Measures Vice Chair: Assoc. Professor Maureen Shannon
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Conflicts of Interest and Commitment
UH Executive Policy E5.214: Conflicts of Interest (undergoing revision) Applies to all UH and RCUH employees Provides oversight and management DHHS: NOT-OD , Final Rule
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Mentoring Case Whose Lab is it?
Prof. Baker’s lab developed unique protein purification method that provides the basis for the lab’s work and funding Alex has trouble with the method, does not yield enough purified protein and wants to try a detergent method Prof. Baker insists he persist with the lab’s method and offers suggestions
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Whose Lab is it? Alex has no success with lab method
He tries the detergent method and gets excellent results – 90% active protein purification Prof. B: “…I told you explicitly not to do that! Why did you go against me? I am in charge…!”
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Questions Did Alex make the right decision to test the detergent method? Is the uniqueness of the lab’s protocol relevant? Does Prof. B have authority and control over all research conducted in her lab?
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Ideal Mentors Invest time and resources
Establish ground rules, expectations, and “accepted” practices Provide supervision, support, advice, and review Ensure proper training in safety, SOPs, and RCR
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Ideal Trainees Understand mentor’s expectations
Perform assigned work conscientiously Respect mentor’s guidance Follow research regulations and protocols Ask for clarification
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Authorship
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Criteria for Authorship & Attribution Case
Bob Powell, a Biochemistry postdoctoral fellow, finished a manuscript following completion of a research study on how humans metabolize sulfite (fruit and wine preservative). During the study he received assistance from the following: A toxicologist at another university who shared with Bob his previous work on the in vivo activity of sulfites, advising Bob to choose the Abyssinian field mouse as the animal model. A wildlife specialist friend, who provided Bob with advice on rearing and maintaining Abyssinian field mice.
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Authorship & Attribution cont.
A experienced technician who helped modify the sulfite metabolites assay. This technician also assisted in writing the methods section of the paper. An undergraduate student collected most of the urine samples and conducted the assays yielding the data. A senior researcher in a neighboring lab helped outline the paper, added more experiments that strengthened the conclusions, and made editing changes in the penultimate draft.
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Questions 1. Who should be an author and who should receive an acknowledgment? 2. What criteria determines whether a) to list someone as an author? b) to note someone’s contributions in the acknowledgments? 3. When should decisions concerning authorship and acknowledgments be made? 4. Are decisions concerning attribution entirely Bob’s responsibility? Should he consult with others?
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Authorship guidelines
Authorship credit based on: 1) substantial contributions to conception and design, acquisition of data, OR analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3. For multi-authored publications, important to designate a lead author who is responsible for the integrity of the entire work.
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Thank you!! Research Integrity website:
Please complete evaluation forms Contact: UH Compliance Office Office of the Vice Chancellor for Research & Graduate Education East-West Road, Biomed T110 Honolulu, HI 96822 (808) or Research Integrity website:
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