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The Responsible Conduct of Research (RCR)

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1 The Responsible Conduct of Research (RCR)
Adapted with permission from the RCR programs at Carnegie Mellon University, Christopher Newport University and NAVY MEDICINE EAST, PORTSMOUTH, VA

2 “[T]he responsible conduct of research is not distinct from research; on the contrary, competency in research encompasses the responsible conduct of that research and the capacity for ethical decision making." ( Public Health Service Policies on Research Misconduct, 42 CFR Parts 50 and 93 (quoting Institute of Medicine (IOM) Report “Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct,” 2002) The basic principle in the conduct of scholarly activity rests on objective inquiry and the pursuit of truth. Integrity in the conduct of scholarly activity is essential and must be maintained. (Butler University, 2010)

3 The building blocks of responsible conduct of research include:
Integrity – Doing the right thing when no one else is watching •Honesty - conveying information truthfully and honoring commitments, •Accuracy- reporting findings precisely and taking care to avoid errors, •Efficiency- using resources wisely and avoiding waste, and •Objectivity- letting the facts speak for themselves and avoiding improper bias

4 Why me? NSF and NIH Requirements for RCR Education
On August 20, 2009, the National Science Foundation (NSF) published (74 FR 42126) a new requirement for RCR education. For proposals submitted on or after January 4, 2010 and subsequently awarded, institutions are responsible for verifying that undergraduate students, graduate students and postdoctoral researchers supported by NSF to conduct research have received (RCR) training. At this time Auburn is using the CITI RCR online program to meet the NSF requirement. The National Institutes of Health (NIH) also require RCR education for certain types of awards. NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in the responsible conduct of research. The CITI RCR modules are also used to partially satisfy the NIH requirements.

5 Typically RCR education addresses the following topics:
•Data Acquisition and Management - collection, accuracy, security, access •Authorship and Publication •Peer Review •Mentor / Trainee Responsibilities •Collaboration •Conflict of Interest •Research Misconduct •Human Subject Research •Use of Animals in Research

6 Data Management ensure data accuracy protect confidential data
collection, storage, analysis share data for societal benefit

7 Peer Review, Authorship, and Publication
peer review – impartial review, determine true merit, protect confidentiality authorship – give credit where due, describe research accurately publication – no repetitive publication, authorship per guidelines, corrections/retractions

8 Examples of Irresponsible Authorship/Publication

9 Mentoring/Training good mentor traits good student/trainee traits
mentor/trainee relationship

10 What is Bad Mentoring/Training?

11 Collaborative Research
strives toward common goals takes different forms sets ground rules

12 Why Not Collaborate?

13 The Cooper/Kripke Inversion

14 Roles and relationships
Before beginning a collaboration make sure that all parties have an understanding of: The goals and anticipated outcomes of the project The role of each partner How data will be collected, stored, and shared How changes in research design will be made Who will be responsible for drafting publications Criteria that will be used to identify and rank contributing authors Who will be responsible for submitting reports and meeting other requirements Who will be responsible for or have the authority to speak publicly for the collaboration How intellectual property rights and ownership issues will be resolved How collaboration can be changed and when it will come to an end

15 Conflict of Interest or Commitment
The term “conflict of interest” in research refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising a researcher's professional judgment in conducting or reporting research. must be disclosed must be mitigated avoid appearance of impropriety agency thresholds

16 Examples of Conflict

17 At Auburn, applicable University personnel are required to recognize and disclose significant financial interests that might give rise to conflicts of interest or the perception of conflicts and to ensure that such conflicts are seen to be properly managed or avoided, with the goal of ensuring, to the extent possible, institutional responsibilities are free from bias and inappropriate influence. Conflict of Interest Guide (training (CITI)) and FCOI Disclosure (COISmart)

18 Conflicts of commitment arise from situations that place competing demands on researchers’ time and loyalties, such as: Working on one or more funded projects Preparing to submit a request for a new project Teaching and advising students Clinical responsibilities Attending professional meetings and giving lectures Serving as a peer reviewer Sitting on advisory boards Working as a paid consultant, officer, or employee in a private company Care needs to be taken to assure that these commitments do not inappropriately interfere with one another.

19 Research Misconduct Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

20 •Fabrication is making up data or results and recording or reporting them.
•Falsification is manipulating research materials, equipment, or processes, or changing, omitting, changing or omitting data or results such that the research is not accurately represented in the research record. •Plagiarism is appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion.

21 The Electric Can Opener Fluctuation

22 Examples of Misconduct

23 Years Before Heading Offshore, Herpes Researcher Experimented On People In U.S.

24 Case Summary: Baughman, Brandi M.
Brandi M. Baughman, Ph.D., University of North Carolina at Chapel Hill: Based on an assessment conducted by UNC, Respondent’s admission, and analysis conducted by ORI in its oversight review, ORI found that Dr. Baughman, postdoctoral fellow in the Center for Integrative Chemical Biology and Drug Discovery, Division of Chemical Biology and Medicinal Chemistry, UNC, engaged in research misconduct in research supported by NIGMS, NIH, grant R01 GM (Data manipulation; data falsification) Penalties : She agreed to exclude herself voluntarily from any contracting or subcontracting with any agency of the United States Government and from eligibility; and  Dr. Baughman agreed to exclude herself voluntarily from serving in any advisory capacity to the U.S. Public Health Service (PHS) including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. Additional Case Summaries:

25 •The allegation be proven by a preponderance of evidence
A finding of research misconduct requires that: •There be a significant departure from accepted of the scientific practices of the relevant research community; and •The misconduct be committed intentionally, or knowingly, or recklessly of accepted practices; and •The allegation be proven by a preponderance of evidence

26 Human Subjects Research
definition Institutional Review Board (IRB) cost/benefit analysis of research

27 The Comic Book Store Regeneration

28 What’s Going on Here? There are three questions utilized to determine if an activity is human subjects research: Is it research? Is it generalizable knowledge? Does the research involve human subjects? The rules contained in 45 CFR § (Protection of Human Subjects) are enforced by The Office for Human Research Protections (OHRP) The responsibilities of OHRP include education, compliance oversight, and administration of assurances

29 Animal Research & Welfare
definition Institutional Animal Care of Use Committee (IACUC) reduction, refinement, replacement

30 Institutions using live vertebrate animals must establish an Institutional Animal Care and Use Committee to oversee and evaluate all aspects of the institution's animal care and use program The IACUC is a self-regulating entity with authority that is derived from two sources: Animal Welfare Act, which is administered through USDA Animal Plant Health Inspection Service Health Research Extension Act, which is administered through the Office of Laboratory Animal Welfare (NIH)

31 Additional Information :
Office of Research Compliance ( RCR- (


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