The Role of Intuition in Risk/Benefit Decision-Making in
Human Subjects Research
David B. Resnik, J.D., Ph.D.
National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle
Park, North Carolina, USA
ABSTRACT
One of the key principles of ethical research involving human
subjects is that the risks of research to should be acceptable in
relation to expected benefits. Institutional review board (IRB)
members often rely on intuition to make risk/benefit decisions
concerning proposed human studies. Some have objected to
using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine
the role of intuition in IRB risk/benefit decision-making and argue
that there are practical and philosophical limits to our ability to
reduce our reliance on intuition in this process. The fact that IRB
risk/benefit decision-making involves intuition need not imply
that it is hopelessly subjective or biased, however, since there
are strategies that IRBs can employ to improve their decisions,
such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to
guide the evaluation of harms and benefits, and engaging in
moral reasoning concerning the acceptability of risks.
Pesticides, Neurodevelopmental Disagreement, and
Bradford Hill’ s Guidelines
Kristin Shrader-Frechette, Ph.D.a and Christopher ChoGlueck B.S., B.A.b
aDepartments of Biological Sciences and Philosophy, University of Notre Dame, Notre Dame, Indiana,
USA; bDepartment of History and Philosophy of Science & Medicine, Indiana University, Bloomington,
Indiana, USA
ABSTRACT
Neurodevelopmental disorders such as autism affect oneeighth of all U.S. newborns. Yet scientists, accessing the
same data and using Bradford-Hill guidelines, draw different
conclusions about the causes of these disorders. They disagree about the pesticide-harm hypothesis, that typical
United States prenatal pesticide exposure can cause neurodevelopmental damage. This article aims to discover
whether apparent scientific disagreement about this hypothesis might be partly attributable to questionable interpretations of the Bradford-Hill causal guidelines. Key scientists,
who claim to employ Bradford-Hill causal guidelines, yet
fail to accept the pesticide-harm hypothesis, fall into errors
of trimming the guidelines, requiring statistically-significant
data, and ignoring semi-experimental evidence. However,
the main scientists who accept the hypothesis appear to
commit none of these errors. Although settling disagreement over the pesticide-harm hypothesis requires extensive
analysis, this article suggests that at least some conflicts
may arise because of questionable interpretations of the
guidelines.
KEYWORDS
Bradford-Hill; cause;
neurodevelopment;
pesticide; statistical
significance; trimming the
data
The Ghost Collaborator
David Shaw, Ph.D., M.A., M.Sc., M.M.L.a and Bernice Elger, M.D., Ph.D.a,b
aInstitute for Biomedical Ethics, University of Basel, Basel, Switzerland; bCenter for Legal Medicine,
University of Geneva, Geneva, Switzerland
ABSTRACT
Collaboration is increasingly important for researchers in all
disciplines. Universities and funding bodies tend to prefer
projects that involve interdisciplinarity, collaboration between
different institutions, and international consortiums. Such projects can yield great benefits, but they also pose particular
challenges for certain aspects of research integrity, and particularly for awarding credit and authorship. In this article, we
describe and analyze the phenomenon of the ghost collaborator, who is initially fully involved and makes a full contribution
to a project’s design, but then finds him- or herself excluded
from meetings and publications.
KEYWORDS
Authorship; conflict of
interest; justice in research;
misconduct in research;
research integrity; science
funding
