56 · Representative Documents: Responsible Conduct of Research Overview
UNIVERSITY OF VIRGINIA
School of Medicine. Compliance and Training
http://www.medicine.virginia.edu/research/offices/research/home/compliance-training
Compliance and Training — School of Medicine at the University of Virginia
http://www.medicine.virginia.edu/research/offices/research/home/compliance-training[8/19/13 4:02:22 PM]
Responsible conduct of research (RCR). UVA expects the highest standards of teaching, research, and public
service from its faculty and staff. Biomedical research requires both personal integrity and public trust to continue
to flourish. UVA investigators should: openly exchange their findings via scientific publications provide unique
research materials to qualified academic investigators maintain detailed records of research procedures and results
fairly assign authorship or acknowledgment in research publications to the originators of ideas, methods, and
findings. These areas are of special concern for investigators:
Authorship. Refer to SOM, JAMA ("Authorship Criteria and Contributions") and International Committee of
Medical Journal Editors policies on authorship. Recommended best practices:
Initiate discussions concerning authorship when first planning a project: agree on authors and individuals
to be acknowledged, including the order of authors and each author’s responsibility on the project and in
preparing resulting manuscript(s).
Since authors assume responsibility for the integrity of the entire publication, each author should read and
approve the final manuscript and agree to take public or legal responsibility for its content.
SOM Authorship policy prohibits the use of ghost authors on scholarly publications and prohibits faculty
from serving as ghost authors on other authors' publications.
Conflict of Interest. Refer to the section below.
Financial sources/billing for clinical research activities. Costs of investigational procedures or subject visits on
clinical studies should not be borne by patients or third party payers, unless allowed by policy. Similarly, public
funds (e.g., external awards, University facilities/staff) may not be used to support industry-funded studies
without prior institutional approval. The Clinical Trials Office can help investigators and clinical study personnel
determine which charges to insurers are allowable.
Data integrity. Investigators should establish an analytic plan and agree on methodologies (e.g., laboratory
SOPs, exclusion of outlier data) at the start of their project. Once the data are collected, verified, and locked,
any changes in analytic methodology should be reported as post hoc and exploratory.
Plagiarism. Funding agencies and journals routinely compare submitted proposals and manuscripts to libraries
of prior proposals or publications. Submissions considered similar or identical to previously-published
documents are being rejected and their authors are at risk for corrective actions under applicable regulations.
For further guidance, consult "Guidelines for Avoiding Plagiarism, Self-Plagiarism, and Questionable Writing
Practices" (DHHS Office of Research Integrity).
Images. Steer clear of inappropriate computer manipulation of images when preparing them for publication or
presentations. See Rossner and Yamada, J. Cell Biol, 2004, 166:11-15. Consider developing a simple policy
for your research group along these lines (adapted from the Southwest Environmental Health Science Center):
Scientific content may not be knowingly altered in any image.
Limited enhancements are permitted for clarity, aesthetic reasons, or to eliminate physical artifacts.
Any manipulations must be described in resulting publications and presentations.
Training in RCR. Graduate students in the Biomedical Sciences Graduate Programs (BIMS) and individuals
supported by NIH training grants or career development awards are required to be trained in RCR, by
completing BIMS 7100, “Research Ethics.” Additional sources on RCR:
“On Being a Scientist: Responsible Conduct in Research” (National Academy Press free download)
DHHS Office of Research Integrity materials:
“ORI Introduction to the Responsible Conduct of Research” (Office of Research Integrity, DHHS)
Educational resources (select "RCR Resources")
"The Lab: Avoiding Research Misconduct" (video simulation allowing users to assume the role of a
graduate student, postdoc, research administrator, or PI and make decisions that affect the integrity
of research)
NIH "Update on the Requirement for Instruction in the Responsible Conduct of Research," providing
recommendations on RCR training required for NIH training, career development awards, research
education grants, and dissertation research grants.
Reporting misconduct. If you suspect misconduct in research, UVA policy requires that you report it to the Vice
President for Research. Informal discussions with the Research Integrity Officer (RIO, Dr. David Hudson 924-3606)
may help clarify whether the suspected behavior meets the definition of research misconduct. If it does, the RIO will
refer you to other officials with responsibility for resolving the problem. It is difficult to report misconduct by a
superior or supervisor however, the Research Misconduct Policy states that individuals who report allegations of
misconduct or of inadequate institutional response thereto must be protected in terms of the terms and conditions of
their employment or other status at the University of Virginia and requires that UVA protect the privacy of those who
report misconduct in good faith, to the maximum extent possible.
Conflict of interest (COI). COI regulations govern situations in which financial considerations may compromise an
individual’s conduct or reporting of research, or his/her procurement decisions on behalf of the University. This
section specifically refers to conflicts of interest that relate to research activities. Federal regulations and UVA
UNIVERSITY OF VIRGINIA
School of Medicine. Compliance and Training
http://www.medicine.virginia.edu/research/offices/research/home/compliance-training
Compliance and Training — School of Medicine at the University of Virginia
http://www.medicine.virginia.edu/research/offices/research/home/compliance-training[8/19/13 4:02:22 PM]
Responsible conduct of research (RCR). UVA expects the highest standards of teaching, research, and public
service from its faculty and staff. Biomedical research requires both personal integrity and public trust to continue
to flourish. UVA investigators should: openly exchange their findings via scientific publications provide unique
research materials to qualified academic investigators maintain detailed records of research procedures and results
fairly assign authorship or acknowledgment in research publications to the originators of ideas, methods, and
findings. These areas are of special concern for investigators:
Authorship. Refer to SOM, JAMA ("Authorship Criteria and Contributions") and International Committee of
Medical Journal Editors policies on authorship. Recommended best practices:
Initiate discussions concerning authorship when first planning a project: agree on authors and individuals
to be acknowledged, including the order of authors and each author’s responsibility on the project and in
preparing resulting manuscript(s).
Since authors assume responsibility for the integrity of the entire publication, each author should read and
approve the final manuscript and agree to take public or legal responsibility for its content.
SOM Authorship policy prohibits the use of ghost authors on scholarly publications and prohibits faculty
from serving as ghost authors on other authors' publications.
Conflict of Interest. Refer to the section below.
Financial sources/billing for clinical research activities. Costs of investigational procedures or subject visits on
clinical studies should not be borne by patients or third party payers, unless allowed by policy. Similarly, public
funds (e.g., external awards, University facilities/staff) may not be used to support industry-funded studies
without prior institutional approval. The Clinical Trials Office can help investigators and clinical study personnel
determine which charges to insurers are allowable.
Data integrity. Investigators should establish an analytic plan and agree on methodologies (e.g., laboratory
SOPs, exclusion of outlier data) at the start of their project. Once the data are collected, verified, and locked,
any changes in analytic methodology should be reported as post hoc and exploratory.
Plagiarism. Funding agencies and journals routinely compare submitted proposals and manuscripts to libraries
of prior proposals or publications. Submissions considered similar or identical to previously-published
documents are being rejected and their authors are at risk for corrective actions under applicable regulations.
For further guidance, consult "Guidelines for Avoiding Plagiarism, Self-Plagiarism, and Questionable Writing
Practices" (DHHS Office of Research Integrity).
Images. Steer clear of inappropriate computer manipulation of images when preparing them for publication or
presentations. See Rossner and Yamada, J. Cell Biol, 2004, 166:11-15. Consider developing a simple policy
for your research group along these lines (adapted from the Southwest Environmental Health Science Center):
Scientific content may not be knowingly altered in any image.
Limited enhancements are permitted for clarity, aesthetic reasons, or to eliminate physical artifacts.
Any manipulations must be described in resulting publications and presentations.
Training in RCR. Graduate students in the Biomedical Sciences Graduate Programs (BIMS) and individuals
supported by NIH training grants or career development awards are required to be trained in RCR, by
completing BIMS 7100, “Research Ethics.” Additional sources on RCR:
“On Being a Scientist: Responsible Conduct in Research” (National Academy Press free download)
DHHS Office of Research Integrity materials:
“ORI Introduction to the Responsible Conduct of Research” (Office of Research Integrity, DHHS)
Educational resources (select "RCR Resources")
"The Lab: Avoiding Research Misconduct" (video simulation allowing users to assume the role of a
graduate student, postdoc, research administrator, or PI and make decisions that affect the integrity
of research)
NIH "Update on the Requirement for Instruction in the Responsible Conduct of Research," providing
recommendations on RCR training required for NIH training, career development awards, research
education grants, and dissertation research grants.
Reporting misconduct. If you suspect misconduct in research, UVA policy requires that you report it to the Vice
President for Research. Informal discussions with the Research Integrity Officer (RIO, Dr. David Hudson 924-3606)
may help clarify whether the suspected behavior meets the definition of research misconduct. If it does, the RIO will
refer you to other officials with responsibility for resolving the problem. It is difficult to report misconduct by a
superior or supervisor however, the Research Misconduct Policy states that individuals who report allegations of
misconduct or of inadequate institutional response thereto must be protected in terms of the terms and conditions of
their employment or other status at the University of Virginia and requires that UVA protect the privacy of those who
report misconduct in good faith, to the maximum extent possible.
Conflict of interest (COI). COI regulations govern situations in which financial considerations may compromise an
individual’s conduct or reporting of research, or his/her procurement decisions on behalf of the University. This
section specifically refers to conflicts of interest that relate to research activities. Federal regulations and UVA
