BIOST/STAT 578A •
Spring 2011
Ethical Issues
for Biostatisticians
Resources Page
- Resources:
Ethics-related topics by category
- Note
1:
This page is under development -- Expect
updates throughout the quarter
- Note
2: Copyright materials not available to users outside the UW;
consult the reference
list page for full citations (under development)
Authorship:
Communication:
- Goldstein & Goldstein have published How Much Risk?,
a
useful book about
understanding environmental health hazards. Chapter
8 discusses assessing
risks from exposure to a landfill. This book is a nice
example of effective risk communication to a lay audience.
Conflict of interest:
- University of Minnesota Ethics
Curriculum on Conflict of Interest
- NIH Links: General
conflict of interest information and Conflict
of Interest Resources
- IOM Report Brief: Conflict of Interest in Medical Research,
Education, and Practice. April 2009
- AAMC publication Protecting
Patients, Preserving Integrity, Advancing Health: Accelerating the
Implementation of COI Policies in Human Subjects Research,
February 2008
- JAMA 2006
Conflict of interest policy statement update with a
definition of COI
- Journal editorials:
- DeAngelis & Fontanarosa 2008
JAMA
editorial
on the adverse effects of industry influcence on research following up
on the apparent misrepresentation of Vioxx results and proposing 11
changes to the analysis and reporting of clinical trials.
- DeAngelis & Fontanarosa 2009 JAMA
editorial
on journals, undisclosed conflcts, and the press
- DeAngelis 2000 JAMA
editorial
on conflict of interest and the public trust with discussion of the
Kahn et al Remune study
- Korn 2000 JAMA
editorial on financial conflicts of interest in academic
medicine, also in the same issue as the Kahn et al Remune study
- Psaty 2009 JAMA
editorial on conflict of interest, disclosure, and trial
reports
- Research papers with a conflict of interest focus:
Ethics
books and other materials
- See
also the guidelines, strategies,
and policies topic and the human
subjects research -- ethics resources topic
- David
B. Resnik has several very readable books on ethics and science:
- The Responsible Conduct of
Research, published in 2003 with Adil E. Shamoo
- The Ethics of Science: An
Introduction, first published in 1998, covers basic
concepts and standards
- The Price of Truth:
How Money Affects the Norms of Science,
published in 2007
- Playing Politics with Science:
Balancing Scientific Independence and Government Oversight,
published in 2009
General
statistics
resources related to ethics:
Guidelines,
recommended
strategies, policies
- Abstracts: Writing informative abstracts and
interpreting
confidence intervals (Cummings
et al paper)
- Analysis planning: Sheppard
gives a template, oriented towards observational studies with a focus
on inference about health effects. A version of this analysis
plan was published in Chapter 7 of Environmental Epidemiology:
Study methods and application by Baker
& Nieuwenhuijsen
- Authorship: See authorship
above
- Clinical trials:
- Data management: Responsible data
management guidelines (HHS Office of Research Integrity)
- Peer review:
- Benos et al (2003) How to review a paper
gives principles of peer review and discusses elements of the process.
- Provenzale & Stanley's A systematic guide to reviewing
a manuscript (Note that this paper has been published
twice, once in 2005 and once in 2006
(with permission from the initial publisher))
- Academic
Medicine published a chapter on review criteria.
It is long and comprehensive with a different authorship list
for each section. Its length may be a deterrent, so here is a compilation of the
criteria most important for statistical reviews.
- Publication ethics: Committee on Publication
Ethics (COPE) home
page
- Reanalysis and reinterpretation of others' work:
Peer-reviewed paper (Neutra)
and guidelines
- Reporting observational studies: STROBE statement
checklists
- Reporting statistics:
- Statistical societies: Ethical guidelines
- UW policies:
- Writing:
Human
subjects research
-- ethics resources:
Human
subjects research
-- famous examples of ethical misconduct or practices currently
questioned:
- Overviews of many famous examples:
- Behavioral research examples
- Vidich & Besman's study of a small rural
community (1958): Small
town in mass society: Class, power and religion in a rural
community
- Stanley Milgram's studies of obedience (1966; wikipedia; Milgram's
paper in Harper' Magazine on The Perils of Obedience
and excerpts
from his book Obedience
to Authority)
- Zimbardo's Stanford prison experiment (1971) (website;
Stanford University News article)
- Humphrey's Tearoom
trade: Impersonal sex in public places (1970)
- Foulks' work on alcoholism in Barrow Alaska (1979)
- Biomedical research examples:
- Recent examples
- Indian tribehs successfully restrict research on their DNA
- Fake TB game show for a French documentary
Industry
influences on
science:
- The Remune story (a
therapeutic AIDS vaccine)
- The lung CT story (needs expansion and further explanation)
- The Vioxx
(Rofecoxib) story
- Peer-reviewed papers or other reports of trial results:
- VIGOR study (Bombardier et al 2000) of
gastrointestinal effects for rheumatoid arthritis patients
- Alzheimer's Disease studies:
- APPROVe study results (Bresalier et al 2005) showing increased cardiovascular risk with Rofecoxib
- Expressions of concern and evidence of problems:
- David Madigan fall 2007 UW biostatistics department
seminar slides
- The Actimmune (subcutaneous interferon gamma-1b) story for
treatment of idiopathinc pulmonary fibrosis (IPF)
- October 2002 registration
of the GIPF-001 study of Actimmune for IPF on ClinicalTrials.gov
- August 2002 press release
by InterMune announcing survival benefit from Actimmune for IPF brom
GIPF-001
- April 2003 New
York Times article
about off-label use of Actimmune for IPF
- 2004 New
England Journal of Medicine paper
giving the primary study results that don't support the survival benefit
- January 2004 registration
of the INSPIRE trial on ClinicalTrials.gov for Actimmune treatment of
IPF in patients with mild to moderate impairment
- 2005 paper
by Johnson & Raghu in European Respiratory Journal cautioning
about
choice of outcome measures in IPF trials and citing statistical papers
on surrogate endpoints
- December 2006 Deferred
Prosecution Agreement for Actimmune promotion
- March 2007 press
release and FDA
public health advisory about early stopping of the INSPIRE
trial to confirm benefit of Actimmune for IPF
- March 2007 Business
Week story
about InterMune stock plunging after it halted the Phase III INSPIRE
trial of Actimmune for IPF
- January 2008 article
in The Recorder
giving a succinct summary of the issue with links to the indictment
- March 2008 news
story of the indictment of former Intermune CEO for false and
misleading advertisement of Actimmune and another
in the San Francisco
Chronicle
- February 2009 New
York Times news
story
that InterMune stock soars thanks to new results from two trials of a
different drug (pirfenidone) to treat IPF. These trials
showed
mixed results.
- Corporate influences on epidemiology:
- Bodenheimer
lecture on managing industry-academia relationships noting
that
management of financial conflict of interest is not the only concern
- Journal editorials:
Plagarism
- Resources:
- Wikipedia
- Ethical
writing guidelines section on plagarism;
Michale Roig, St. John's University
- Is
self-plagarism OK?
- Self-plagarism
defined (the Wikipedia article on plagarism
has a section on self-plagarism)
- A
debate in the Scientist
by Jef Akst, September 2010
- Guidelines
from Michael
Roig, of St. John's University including dealing with the
thorny issue of text
recycling
Precautionary
Principle
Public and environmental health: Ethical considerations
Selective
reporting
- In a 2008 NEJM paper, Selective Publication of
Antidepressant Trials and Its Influence on Apparent Efficacy,
Turner
and colleagues discuss the impact selective reporting has on
risk-benefit ratios and estimates of drug effectiveness.
Additional
opinions in several letters
to the editor.
Specific
scientific
topics or controversies
- Autism and vaccination against measles
- Epidemiology
- Nortin M. Hadler, "Worried Sick," Univ. of North
Carolina Press, 2008. The author is Prof.
of Medicine
at UNC Medical Center. The theme of the book is an
attack on
contemporary low-risk well-patient epidemiology. An
eighty-page
"supplement" is a guide to a great range of technical
literature
here. Hadler is one of those who believes that the
use of
published research findings in clinical medicine often kills
people, and rarely helps them. He also notes that SES is an
unmeasured, probably unmeasureable confound in nearly every
prospective study of low-risk events.
- Lead
- Kaufman's 2001 review of the lead and IQ loss literature, arguing for greater caution in interpretation of the lead-IQ data.
Statistical topics
Subgroup
analyses
Uncertainty
- Understanding
uncertainty -- a website "that
tries to make sense of chance, risk, luck, uncertainty and probability"
- Tannert et al 2007 article
on the ethics of uncertainty
- Manufactured uncertainty: In the context of environmental regulations, it is
important to understand the concept of
"manufactured
uncertainty" or the use of uncertainty to delay regulations
to protect the public
- New developments and guidelines in communicating
uncertainty
- Uncertainty and policy for environmental exposures
- Knol et al (2009) Dealing with uncertainties in environmental burden of disease assessment, Environmental Health 8:21
- van der Sluijs et al (2008) Exploring the quality of evidence for complex and contested policy decisions, Env. Res. Letter 3, 024008
- NUSAP.net
educational website dedicated to coping with uncertainty and quality in
science for policy
References:
See the
Reference list page