Additional Readings and References

BRI Readings 2011

• Lecture #1 PEER REVIEW
  Pulverer, B. (2010) Transparency showcases strength of peer review.  Nature, 468(7320): 29-31.
• Lecture #2 PUBLICATION PRACTICES/AUTHORSHIP
  Schooler J (2011) Unpublished results hide the decline effect.  Nature, 470: 437.
  Optional Reading:
  Lehrer J (2010).  Annals of Science, The Truth Wears Off - Is there something wrong with the scientific method?  (Dec 13, 2010)  Read more  http://www.newyorker.com/reporting/2010/12/13/101213fa_fact_lehrer#ixzz1Qhq3YqFj 
• Lecture #3 DATA ACQUISITION, MANAGEMENT
  Couzin-Frankel (2011) What Would You Do?.  Science, 11 Feb 2011, Vol 331, 662-665.
  
• Lecture #4 CONFLICT OF INTEREST
  The PLoS Medicine Editors (2008)  Making sense of non-financial competing interests.  PLoS Medicine, 5(9): 1299-1301. (http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050199)
• Lecture #5 RESEARCH MISCONDUCT
  Koocher, GP & Keith-Spiegel P (2010).  Peers nip misconduct in the bud.  Nature, 22 July 2010, Vol 466: 438-440.

2010 Research Misconduct

• Bonetta L (2006).  Leading Edge Analysis: The Aftermath of Scientific Fraud.  Cell 124, 873-875.
• http://www.ethicsresearch.com/freeresources/rrwresearchwrongdoing.html

2010 Responsible Authorship

• Strange K (2008).  Authorship: why not just toss a coin?  Am J Physiol Cell Physiol 295: C567–C575, 2008; doi:10.1152/ajpcell.00208.2008.
• http://ori.dhhs.gov/education/products/niu_authorship/mistakes/index.htm#

2010 Conflict of Interest

• Psaty BM (2009).  Conflict of interest, disclosure, and trial reports.  JAMA, 301(14): 1477-1479.

2010 Data Acquisition, Management, Sharing & Ownership

• Connor JT (2009).  Statistical graphics in AJG: save the ink for the information.  Am J Gastroenterology, 104: 1624-1630.

2010 Peer Review

2009 Research Misconduct

• "Life after Fraud" http://www.the-scientist.com/article/display/55772/

2009 Peer Review

• Cummings P and Rivara FP (2002).  Reviewing Manuscripts for Archives of Pediatrics & Adolescent Medicine.  ARCH PEDIATR ADOLESC MED/VOL 156, JAN 2002.

2008 Conflict of Interest

• Psaty BM & Kronmal RA (2008).  Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation.  JAMA, 299(15): 1813-1817.
• AMSA COMMENDS PHRMA’S GIFT RESTRICTIONS; CALLS FOR FURTHER GOVERNMENT REGULATION
• Conflict of Interest Resources, US Department of Health and Human Services
  http://grants2.nih.gov/grants/policy/coi/resources.htm
• Significant Financial Interest Disclosure Policy, UW Grants Information Memo 10 http://www.washington.edu/research/osp/gim/gim10.html
• UW Policy for Addressing Allegations of Misconduct in Scientific and Scholarly Research http://www.washington.edu/faculty/facsenate/handbook/Volume4.html  [scroll to Part IX]
• Research Bioethics Consult Service, UW Institute of Translational Health Sciences http://www.iths.org/ResearchResources/RSB/Bioethics.aspx
• mpugning the Integrity of Medical Science - The Adverse Effects of Industry Influence
• When does a point of view become an intellectual conflict of interest?
• Nothing to see here.
• Conflicts of Interest in Clinical Practice and Research
• A Statement on Ethics From the HEART Group
• A Conflict of Interest Disclosure Policy for Science and Engineering Ethics
• Conflict of Interest? What conflict of interest?
• Trials and Tribulations
• A Bumper Crop of Conflicts
• Do Conflicts of Interest Really Matter or Does No One Read the Fine Print Anyway?
• Tar-nished reputations

2008 Responsible Authorship Additional Readings and References

• The green and gold roads to open access-the case for mixing and matching
• green and gold mixing and matching take 2
• access-impact problem and the green and gold roads to open access-an update
• author disincentives and open access
• when is open access not open access
• why faculty choose open access
• citation advantage of open access articles
• ethics of open access to biomedical research
• OA implications for scholarly publishing and medical libraries
• Open Access comparison of multiple countries
• open access to industry's clinically relevant data
• open access to peer-reviewed research through author-institution self-archiving
• open access-science publishing as science publishing should be
• the criteria for open access

2008 Data Ownership Additional Readings and References

• Authorship, Data Ownership Examined
• Dynamic Issues in Scientific Integrity Collaborative Research
• Guidelines for Responsible Data Management in Scientific Research
• Readiness and responsibility for managing research data-institutional perspectives
• Stewardship of digital research data-a framework of principles and guidelines
• What's in a picture-The Temptation of Image Manipulation
• 2008 Data Acquisition Additional Readings and References

Readings:

• The Belmont Report (Dept. of Health, Education, & Welfare) 
• Moral Reasoning in Scientific Research (M. Bebeau, et al) 
• Ghost Authorship Policy (University of Washington, School of Medicine)

top of page

UW & Partner Resources:

ETHICS IN MEDICINE - University of Washington School of Medicine

http://depts.washington.edu/bioethx/toc.html
A thorough clearinghouse of clinical ethics topics.  Wide range of topics addressed, organized by medical discipline, lists of key questions included, relevant links for legal info provided where appropriate, and useful case studies scattered throughout.  Section on research ethics (http://depts.washington.edu/bioethx/topics/resrch.html) includes discussion of human subjects, informed consent, honesty, and IRB issues.  Also has list of (and links to) other bioethics websites, but many links are faulty or outdated.

University of Washington Office of Postdoctoral Affairs (OPA)- Resources for Postdocs

http://depts.washington.edu/pdafrs
Provides services to postdoctoral scholars and to their faculty supervisors. The OPA works to enhance the learning and the productivity of UW postdocs...appointments, orientation, workshops, mediation and grievances, etc.

University of Washington Extension, Professional Development and Continuing Education Program

Certificate Program in Clinical Trials
http://www.outreach.washington.edu/ext/certificates/cli/cli_gen.asp
...introduces participants to the fundamental scientific, ethical, practical, regulatory and economic concepts underlying clinical trials.

University of Washington Office for Nursing Research

Research Seminar: RCT, Playing by the Rules
Monica Jarrett, PhD, RN,
http://www.son.washington.edu/research/seminars.asp?ViewSeminarID=15
Other seminars in this series may be of interest as well.

UW Human Subjects Division

http://www.washington.edu/research/hsd/index.php
Good resource for info on policy, IRBs, etc.  Includes links to ethics training, including one for CITI coursework.

UW Institutional Animal Care and Use Committee

http://depts.washington.edu/iacuc/

UW Animal Use Training Program

http://depts.washington.edu/auts/

UW Office of Research: ethics and policies page

http://www.washington.edu/research/4researchers/ethics.php
Info on tech transfer policies, open access policies, community-based research, disclosure policy, budget issues, more.

HealthLinks at UW: ethics page

http://healthlinks.washington.edu/clinical/ethics
Good library-associated resource for ethics links.  Includes everything from NIH, President's Council, AMA, to e-journal and book links on ethics, and links to relevant organizations and associations.

Institute for Translational Health Sciences
Research Bioethics Consult Service www.iths.org

Advice to ITHS members, research participants, families and communities,
and IRBs who have questions that could benefit from in-depth conversation and
analysis about ethical issues related to clinical research studies.
Consultant recommendations are advisory and are supplemental to the IRBs’
responsibility for research oversight. The consultations are confidential.

Fred Hutchinson Cancer Research Center, Research Ethics Education Program

http://www.fhcrc.org/science/education/courses/research_ethics/
Primarily for trainees at FHCRC, but the website contains links to their Ethics Events and Annual Bioethics Colloquium, as well as links to online ethics education.

Fred Hutchinson Cancer Research Center, Good Clinical Practice (GCP) Training

FHCRC/UW Cancer Consortium is offering web-based training or a 2-day training course on GCP for all investigators and research staff “involved in the design, conduct, or reporting of therapeutic clinical studies an prevention studies that involve drugs, biologics or devices.”
http://extranet.fhcrc.org/EN/sections/iro/irb/training/GCP/index.html

Community-Campus Partnerships for Health

This organization seeks to address the research-related interests of communities (in contrast with the established IRB protection of individual interests).  Through training, education, awareness, and partnerships, they hope to establish and address the need for improved community health and protection of community interests.  There are links for conference proceedings, training programs, information on projects and partnerships.
http://depts.washington.edu/ccph/irbhome.html

Virginia Mason/Benaroya researchers use the CITI modules for training.

top of page

Federal resources and guidelines

Office of Research Integrity (ORI) at DHHS

The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.

Organizationally, ORI is located within the Office of Public Health and Science (OPHS) within Office of the Secretary of Health and Human Services (OS) in the Department of Health and Human Services (HHS).

The PHS is composed of the following offices and agencies:

Office of Public Health and Science
National Institutes of Health.
The Centers for Disease Control and Prevention
The Food and Drug Administration
The Substance Abuse and Mental Health Services Administration
The Health Resources and Services Administration
The Agency for Healthcare Research and Quality.
The Agency for Toxic Substances and Disease Registry
The Indian Health Service
Office of Regional Health Administrators

top of page

Publications:

On Being A Scientist: Responsible Conduct In Research by the COMMITTEE ON SCIENCE, ENGINEERING, AND PUBLIC POLICY at The National Academies, 1994
http://www.nap.edu/html/obas/
from preface: To reflect the developments of the last six years, the National Academy complex is issuing this new version of "On Being a Scientist." This version incorporates new material from Responsible Science and other recent reports. It reflects suggestions from readers of the original booklet, from instructors who used the original booklet in their classes and seminars, and from graduate students and professors who critiqued drafts of the revision. This version of "On Being a Scientist" also includes a number of hypothetical scenarios, which have proved in recent years to provide an effective means of presenting research ethics. An appendix at the end of the booklet offers guidance in thinking about and discussing these scenarios, but the scenarios remain essentially open-ended.

Introduction to the Responsible Conduct of Research by Nicholas H. Steneck and ORI
http://www.admin.mtu.edu/research/vpr/documents/rcrintro.pdf

 RCR Education Resource Bibliography by Nicholas H. Steneck and ORI
http://ori.dhhs.gov/documents/bibliography_rcr_2004.pdf
Compiled 2004, clearinghouse, includes web addresses for online RCR courses, textbooks, and other publications on relevant topics.

top of page

Online courses, tutorials:

Inventory of RCR materials is now available online at:   http://twiki.library.ucsf.edu/do/view/ResearchEthics/WebHome

Collaborative Institutional Training Initiative (CITI)

http://www.citiprogram.org/
The Collaborative Institutional Training Initiative (CITI) was founded in March 2000 as a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a web based training program in human research subjects protections.

This program requires subscription (except RCR). It includes coursework in:

    * Basic Courses in the Protection of Human Research Subjects.
          o Biomedical Focus
          o Social and Behavioral Focus.
          o Refresher Courses
    * Good Clinical Practice Course.
    * Health Information Privacy and Security Course (HIPS)
    * Laboratory Animal Welfare Courses for investigators and IACUC Members
    * Responsible Conduct of Research (RCR).

The RCR course is available free of charge at https://www.citiprogram.org/rcrpage.asp

Contemporary Science, Values and Animal Subjects in Research

http://ori.dhhs.gov/education/products/ncstate/index.htm
This site, developed at North Carolina State University, is an Office of Research Integrity (ORI) sponsored project. It is intended to be both a learning tutorial and a clearing house. Ethics and the use of animals in research is an enormous topic: this site is an introduction both to the central issues and the information resources available.

Columbia University’s online RCR courses

http://ccnmtl.columbia.edu/projects/rcr/index.html
COURSE 1: Conflicts of Interest
COURSE 2: Mentoring
COURSE 3: Responsible Authorship and Peer Review
COURSE 4: Research Misconduct
COURSE 5: Collaborative Science
COURSE 6: Data Acquisition and Management

Duke University School of Medicine's Research Ethics Education & Resources

https://researchethics.duhs.duke.edu/
This site includes basic  education and resources  in research ethics. Continuing education modules are intended for investigators at Duke institutional and non-institutional research sites; and for Duke physicians, staff and faculty involved with human subjects in research. Regardless of your involvement with human subjects, the materials offered here provide an opportunity for further education on the protection human subjects.

Though intended for Duke employees, it may be possible to request access.  Educational modules include: subject protection (including modules on children, adolescents, and prisoners), community-engaged research, conflicts of interest, drug development ethics, informed consent, privacy, research in emergencies, and database ethics.

top of page

Other:

Illuminata, Inc.

http://www.illuminata-inc.com/index.html
Illuminata is a Seattle-based education and information services company, providing services and resources in the areas of human subjects research, ethics, and genetics.  We support IRB professionals, research teams and others through identifying their information and education requirements and developing tailored products and services to meet their needs.

This site includes a nice page of links for human subjects review, a list of upcoming (national) courses and presentations on human subjects research, and links to online coursework and tutorials.

Boston College RCR Program

http://www.bc.edu/research/rcip/rcr.html
Good clearinghouse for links on RCR topics, including data management, IP, mentoring, publication issues, peer review, collaboration, animal and human subjects, safety, responsibility to society, misconduct, financial issues, more.

Responsible Conduct of Research Education Committee

http://rcrec.org/
The mission of the RCREC is to provide leadership to the research community in identifying, developing, and promoting programs of education in the responsible conduct of research.  This is accomplished by collaborations among institutions, organizations, and federal agencies that have roles and interests in the responsible conduct of research.
The RCREC is a non-profit, non-governmental consortium of institutions and organizations.  Merged with APPE.

The Association for Practical and Professional Ethics

http://www.indiana.edu/~appe/
The Association for Practical and Professional Ethics was founded in 1991 with support from Indiana University and the Lilly Endowment to encourage interdisciplinary scholarship and teaching of high quality in practical and professional ethics by educators and practitioners who appreciate the practical-theoretical aspects of their subjects. The Association facilitates communication and joint ventures among centers, schools, colleges, business and nonprofit organizations and individuals concerned with the interdisciplinary study and teaching of practical and professional ethics.

LINKS:

• PHS policy : http://ori.dhhs.gov/policies/RCR_Policy.shtml
• ORI Model Policy and Procedures for Responding to Allegations of Scientific Misconduct. http://ori.hhs.gov/policies/model_policy.shtml
• NIH Office of Extramural Research Peer Review Policy: http://grants1.nih.gov/grants/peer/peer.htm
• NIH Center for Scientific Review. Policy, Procedure, and Review Guidelines.  http://www.csr.nih.gov/review/policy.asp
• ORI Model Policy and Procedures for Responding to Allegations of Scientific Misconduct. http://ori.hhs.gov/policies/model_policy.shtml
• Office of Research Integrity. Silence is not Golden: Making Collaborations
  Work. http://ori.hhs.gov/education/science_not_golden.shtml
• A Guide to Training and Mentoring in the Intramural Research Program at
  NIH. http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/mentor-guide.htm
• National Academy of Sciences.  Advisor, Teacher, Role Model, Friend:
  On Being a Mentor to Students in Science and Engineering.
  http://www.nap.edu/readingroom/books/mentor/
  
• NIH Office of Extramural Research Peer Review Policy: http://grants1.nih.gov/grants/peer/peer.htm
• NIH Center for Scientific Review. Policy, Procedure, and Review Guidelines.  http://www.csr.nih.gov/review/policy.asp
• Barker K. Accountability and Authorship. Science Careers:
  http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2030/accountability_and_authorship/
• International Committee of Medical Journal Editors (ICMJE):
  Uniform Requirements for Manuscripts Submitted to Biomedical Journals
  http://www.icmje.org/
• University of Washington Copyright Connection
  https://depts.washington.edu/uwcopy/creat/ownershipfactors/1.shtml

2007 Powerpoint Presentations:

• Conflict of Interest – Opportunities Abound, June 28th, 2007, John Slattery
• Data Sharing Between Academia and Industry: Drug Companies have a Conscience Too, July 25th, 2007, Wes Van Voorhis

For more information, contact uwbri@u.washington.edu or call (206) 221-6548.

top of page