Ethical Guidelines for
Managing Conflicts
of Interest in Health
Services Research
December 2004
Table of Contents
Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
AcademyHealth Ethical Guidelines Committee and Its Objectives . . . . . . . . . . . . . . . . . . . . . . 3
Conflicts of Interest. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
What is a Conflict of Interest?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Conducting Research versus Using Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Distinctive Characteristics of Health Services Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Guiding Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Ethical Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Initiation of Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Conducting Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .11
Reporting Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Analyzing a Potential Conflict of Interest. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Implementation and Enactment of the Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Appendix A – AcademyHealth Ethical Guidelines Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..15
Appendix B – Committee Actions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..17
Appendix C – Conflict of Interest Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Executive Summary
T
he primary interest of health services
researchers is to generate and disseminate
valid and reliable research that informs
policy and practice and to ensure integrity in
the process. A conflict of interest occurs when
secondary interests—such as teaching,
administration, political advocacy, or financial
or avocational pursuits—distort the integrity of
judgments regarding the primary interest.
AcademyHealth convened an Ethical Guidelines
Committee comprising individuals reflecting a
range of organizations and disciplines to provide
practical guidance to individuals and organizations
who struggle with the potential for conflicts of
interest in health services research and health
policy analysis.
The Committee identified five characteristics
that distinguish conflicts of interest confronted
by health services researchers from those faced
by other fields:
1. The predominant financial conflict is less
likely to be related to personal financial
interests (as in clinical research) than to
the financial viability of future research
possibilities.
2. Findings are frequently relevant to political,
legal, and regulatory proceedings—which
may make it difficult to distinguish between
research and advocacy roles.
3. Because of the limited feasibility of
randomized controlled trials in health
services research, such research often relies
on study designs and data sources that are
less straightforward than those in basic and
clinical research studies.
4. A substantial share of research funding
comes from corporate, foundation, or public
sponsors with direct financial, programmatic,
or institutional interests in the outcomes.
5. Researchers are employed by many types of
institutions (academic, private, government,
etc.), each of which has its own interests,
procedures, and perceptions of what
constitutes a conflict.
The Committee focused on three values to guide
development of the guidelines: preserving and
enhancing the integrity of health services research;
maintaining consistency with other ethical values of
health-related research; and adhering to ethical
guidelines of other intersecting fields.
Keeping these values in mind, the Committee
developed the guidelines summarized on page 2
of this report.
In developing these guidelines, it has been the
Committee’s intent to assist individuals and
organizations in managing conflicts of interest
and preserving the ethical values described
above. We hope this is a helpful first step in
creating a shared understanding of best practice
strategies in order to ensure that conflicts of
interest do not arise in the initiation, design,
conducting, or dissemination of health services
research. We look forward to receiving feedback
and to future discussions of this critical issue.
1
Ethical Guidelines for Health Services Research
Status of
Research
Initiation of
Research
Conducting
Research
Reporting
Research
2
◆
Pursue research maintaining openness to unanticipated results: do not pursue research
intended to reach a pre-determined conclusion. Many methods and techniques used in
research may be appropriately used to clarify or justify pre-determined positions, but that
is not research.
◆
Researchers and sponsors should come to a mutual agreement on the research objectives
and data sources at the outset.
◆
Make any sponsor-imposed limitations on the research explicit in the contract prospectively;
do not pursue research if the limitations are not acceptable to the researcher.
◆
Sponsors should assume responsibility to promote ethical research standards by setting reasonable
objectives and deliverables as well as giving the researcher freedom to analyze the data and report
conclusions as the researcher sees fit.
◆
There should be no fraud or fabrication in research, regardless of the purposes for which the
research will be used.
◆
Maintain objectivity in conducting research and analysis; whenever possible, use measures
and methods that are widely-accepted and reproducible.
◆
Record the methods and measures of research and analysis, making this information available
to legitimate requests, such as confirming or replicating the reported results.
◆
Authors should be free to report data and results within 2 months (but no longer than 6
months) after the research has concluded; any restrictions on this timing must be disclosed.
◆
Any sponsor-imposed changes in the reporting of results that distort or misrepresent the
research findings are unethical and should not be accepted by the researcher.
◆
Differences in opinion between the researcher and the sponsor about the interpretation of data
should be appropriately managed; if differences remain after the researcher and sponsor
endeavor to agree upon conclusions, differences should be disclosed whenever the data are
reported. Further disagreements should be resolved through a peer review-like mechanism
consisting of appointments by both parties of people with relevant expertise.
◆
Researchers should endeavor to make their methods transparent and available to peers for
replication or confirmation of results.
◆
All reporting of research results should specify who sponsored and financed the research, as
well as their role and involvement in the research at any point.
◆
Work originally intended for advocacy or similar purposes (rather than as research) should be
identifiable as such.
◆
Researchers must be explicit about their other roles and interests when reporting results and
must not conceal the possible limitations of the research.
Introduction
A
s in all professions, conflicts of interest
are inevitable in health services research
and health policy analysis. Conflicts can
arise when initiating projects, designing study
methods, analyzing data, and disseminating
research findings. Conflicts can involve
individuals or organizations. The purpose of this
report is to provide guidance to researchers,
sponsors, and others to help them anticipate and
manage the inevitable conflicts that will arise in
the conducting of health services research and
policy analysis.
AcademyHealth Ethical Guidelines
Committee and Its Objectives
At the request of its Board of Directors,
AcademyHealth convened the Ethical Guidelines
Committee (“Committee”) composed of
individuals from a variety of organizations and
reflecting a wide range of disciplines. The overall
objective of the Committee was to provide
practical guidance to individuals and
organizations who struggle with the potential for
conflicts of interest in the conducting of health
services research and health policy analysis.
Understanding that conflicts of interest vary
widely both across disciplines and with
circumstances, the Committee worked to develop
best practice strategies for navigating various
situations, including ones in which some parties
may not always act in an ethically appropriate
manner. According to the Institute of Medicine
and the Association for Health Services Research,
a predecessor to AcademyHealth, health services
research is:
a multidisciplinary field of inquiry using both
quantitative and qualitative methodologies that
examines the use, costs, quality, accessibility,
delivery, organization, financing, management,
and outcomes of health care services to increase
knowledge and understanding of the structure,
processes, and effects of health services for
individuals and populations.
Based on this understanding, health services
research encompasses activities ranging from
basic research intended to uncover knowledge
about health and health care, to applied research
assessing current policies, activities, and
organizations, to policy analysis intended to
inform new policies and decisions. Because of the
diverse aims and objectives of the health services
field, there are many manifestations of how this
work is carried out that fall along a broad
spectrum, encompassing activities ranging from
advocacy to research and policy analysis.
While all of the endeavors that fall along this
spectrum are integral and vital to the health services
field, this AcademyHealth report will maintain a
focus primarily on research and policy analysis and
will seek to establish ethical guidelines and
management policies for these central activities. In
fact, this report will focus on some vital differences
between research and advocacy in an attempt to
extricate the primary objectives and ethical conduct
related to health services research.
Because some important features of health services
research, such as methodology, funding, venue,
and oversight, often differ from those of clinical
and biomedical research, the types of conflicts that
confront health services researchers are also likely
to vary. For this reason, the Committee maintained
a focus on the situations and guidelines that are
particularly important in the context of health
services research, and supplemented such
guidelines with those that should be adhered to in
other fields relevant to the work being done.
Ethical guidelines cannot be mathematical
formulae or computer algorithms; rather they
require judgment in order to balance competing
values and to take into consideration the wide range
of possible facts and circumstances. The guidelines
proposed by the Committee should serve to
generate dialogue and as a resource for preventing
and resolving conflicts of interest in an ethical
manner while sustaining viable research programs
in diverse organizational environments ranging
from academic centers to commercial enterprises.
We urge that individual health services
researchers and their home organizations, as
well as journals that publish health services
research, adopt these guidelines and use them
as a starting point for developing their own
policies and practices to manage conflicts of
interest. Ultimately, we aim to ensure the
integrity of health services research findings
and the public’s trust in these findings.
3
Conflicts of Interest
A
cademyHealth members will confront and
need to resolve a wide variety of ethical
dilemmas in the course of their professional
lives. At this juncture, the Committee decided to limit
its focus by developing guidelines that address
financial and non-financial conflicts of interest, leaving
other important issues, such as authorship and
confidentiality, for attention at a later date.
What Is a Conflict of Interest?
AcademyHealth members take on many roles within
their professional lives. These roles may have
different public and professional expectations and
norms about what constitutes ethical behavior. For
example, in the role of an advocate, an individual may
promote certain health care reforms through political
campaigns, which naturally tolerate and even expect
zealous promotion.
In another role as a health services researcher, the
same individual may—perhaps should—restrain his
or her passionate commitments in order to conduct
the research with honest, reliable, and unbiased
methods; this includes an openness to discover and
disseminate findings, even if they prove counter to
his or her personal commitments.
When carrying out a specific activity, it is
imperative for an individual to recognize which
role he or she occupies and to abide by its ethical
norms. Frequently, identifying the appropriate
role will be obvious and straightforward; however,
in some circumstances it will require reflection,
discretion, and judgment.
Based on the nature of an individual’s principal
professional role, he or she has primary interests
that stem from that role. For teachers, it is
educating their students; for physicians, it is
promoting the well-being of their patients; for
judges, it is ensuring that justice be done. For all
researchers, including health services researchers
in their researcher role, the primary interest is to
generate and disseminate valid and reliable
research that informs policy and practice and to
ensure integrity in the process.
Individuals, however, are not typically limited
to a single role; in fact, they usually play multiple
4
roles. Thus, in addition to the primary interest,
individuals customarily have numerous
secondary interests that originate from their
other interests, personal commitments, and
roles. These secondary interests of researchers
include teaching, administration, financing
research, political advocacy, obligations to
employers, financial, as well as family and other
avocational interests.
The presence of secondary interests is not
necessarily unethical or otherwise nefarious. On
the contrary, such interests are frequently
praiseworthy activities in their own right; being
politically engaged, a devoted teacher, a dedicated
employee, or concerned with one’s family, for
example, is admirable. What makes these
interests potential conflicts is their ability to
unduly influence decisions that compromise the
health services research role. Thus, a conflict of
interest occurs when secondary interests distort
the integrity of judgments regarding the primary
interest.
A conflict of interest can occur when a secondary
interest of any type affects a judgment about a
primary interest. Researchers could have a
conflict between their research goals and
spending time with their families, advocating for
political beliefs, or volunteering in the
community. This report will concentrate on
financial conflicts of interest; that is, those
secondary interests related to the financial
interests. This focus is not to suggest that nonfinancial conflicts of interest are any less
dangerous; rather, we maintain a focus here on
financial conflicts of interest because they are
more objective and easier to regulate.
In the case of health services research, not only can
individual interests pose a conflict, but since much of
the research is conducted within organizations,
different actors in the same organization and even
on the same research team can have different
interests. This reality can easily lead to intraorganizational conflicts of interest.
Recent attention in clinical medicine has focused
on this issue. For example, the Association of
American Medical Colleges recently adopted
guidelines to address institutional conflicts of
interest, such as the conflicts that could arise
when an institution has licensed a patent or
obtained an equity interest in a company that
might be affected by research undertaken by
researchers at that institution, even if the
researchers themselves have no personal
financial interest in the company.
When referring to conflicts of interest, many
commentators distinguish between actual and
perceived conflicts of interest. An actual conflict
of interest occurs when these other, secondary
interests objectively distort judgment. It is
important to note that individual actors, as well
as outsiders observing them, will typically be
uncertain about the true motivations for specific
decisions and actions.
Observers—and even actors themselves—can be
unsure about which of myriad considerations and
interests ultimately influenced a person’s
judgments. The distance of observers, and the
inherent limitations on their access to knowledge
about decisions, means their perceptions about
the influence of interests may well differ from
those of the researchers. Uncertainty about what
interests a person has and how these interests
influence decision-making can cast suspicion on
the integrity of the judgments. Thus, a perceived
conflict of interest occurs when a reasonable
person could perceive that a secondary interest
might unduly affect the integrity of a judgment
regarding a primary interest.
Indeed, since it is impossible to know for sure
what considerations influence judgments, conflicts
of interest inherently entail how reasonable people
will perceive the influences on judgments.
Consequently, even perception of a conflict of
interest is ethically worrisome and requires
prevention, prohibition, or remediation. Health
services researchers should endeavor to avoid even
perceptions by others of conflicts of interest.
Health services researchers must take an active
role in ensuring ethical conduct regarding
conflicts of interest. It is imperative that not
only do researchers adhere to ethical guidelines
to manage such conflicts, but that they also
maintain a clear personal code of ethics that
might prevent such conflicts in the first place
and help to manage them when they arise.
Researchers should be responsible for acting in
an ethical manner while representing
professional organizations and conducting
health services research—not only because their
profession demands it, but also because we
would hope that individuals themselves would
abide by a personal code of ethics. Such
personal ethics will ultimately help to mitigate
conflicts of interest and will lead to a more
ethical mode of professional conduct in the
health services field.
Because every person has numerous roles and
interests, conflicts of interest are inevitable. While
they may not always affect the decisions of the
research team, conflicts must be appropriately
managed. Left unchecked, these conflicts can
threaten the credibility of the research team or the
organization. More important, individual or
organizational conflicts that are not dealt with can
threaten the credibility of the entire field, raising
suspicions about research and the integrity of
researchers in general.
Ensuring the integrity of judgment of
individuals and the field requires that these
conflicts of interest be properly managed. To be
useful, any management strategy must be
sensitive both to legitimate competing interests
and to the manifold considerations of actual
practice, while simultaneously retaining
sufficient specificity to guide action in an
ethically acceptable manner.
5
Conducting Research versus
Using Research
There is a growing body of guidelines
concerning the ethical issues that arise in the
conducting of research—the actual “doing” of
the science—that are within the purview of the
researcher or analyst; these address issues such
as research integrity and independent control
over the conduct and publication of research.
Recently, this has been an area of special
concern in privately funded clinical research.
The same concerns, values, and level of control
should apply to health services research.
The relationship between research teams and
sponsors exists along a broad spectrum, from
grants in which researchers possess maximum
discretion in pursuing an objective to
solicitations and contractual relationships in
which the sponsor specifies the objectives and
outcome measures but leave the research team
discretion on the data sources and methods of
analysis, to even closer researcher-sponsor
partnerships in which the sponsor is involved in
each step from conception to analysis to
reporting of the results.
Nevertheless, the health services
researcher or
multidisciplinary
research team should
have primary control
over how studies are
developed and carried out
and how findings are
disseminated. In each of
these researcher-sponsor
relationships, it is
essential to recognize that
there is a crucial difference
between seeking research to
address certain questions, to
quantify trends, to identify or
assess the importance of causal
factors, and seeking support for
predetermined conclusions.
The difference inheres neither in the topics
being studied nor in the nature or sophistication
of the research methods, data, or findings.
Rather, the distinction exists in the intent in
conducting the research, the purposes for which
the research is being used, and how these
objectives affect the topics, methods, data, and
reporting of the findings.
Generating data merely to substantiate
predetermined conclusions is not research.
As such, it is vital that whenever the researcher
or research team works with the sponsor in a
collaborative partnership, all parties must work
together to reach decisions that maintain the
objectivity and credibility of the research. This is
not to say that researchers cannot engage in
work with sponsors under more restrictive
arrangements—just that such work should not
be construed or presented as research.
Health services researchers work within a vast
range of organizations, from those conducting
pure research to those engaged in policy
development and advocacy. The expectation of
independence assumed for a researcher in a
university or nonpartisan research organization
may or may not apply in an advocacy or policy
context, where such research may be applied.
Even within the university-based or independent
research setting, there are often legitimate
constraints and policies that may limit the
independence of an individual researcher.
For instance, how research is disseminated,
whether in a report to sponsors or peer-reviewed
publications, may not be decided by the
researcher. Similarly, while university-based
researchers may have more discretion to define
their research topics and agendas, other
researchers may appropriately have their topics
partially defined by the research organization
or policy group they work for. Clearly then,
when evaluating potential ethical dilemmas
and management strategies, it is crucial to
distinguish these roles and the context in
which the researchers are working.
Distinctive Characteristics of Health Services Research
T
here are similarities between the conflicts of
interest that arise in health services and other
social science research and those that arise in
clinical research. The essential values guiding conflict
of interest policies—integrity in research, public trust,
and ethical conduct of research—are shared among
health services research, the social sciences, and clinical
and basic science research. In addition, threats to the
integrity of researchers’ judgment occur predominantly
at similar junctures in the research process: research
design, data analysis, and reporting of results. What
distinguishes the conflicts of interest in health services
research from those in other fields are differences
more in degree than in kind.
In considering ethical issues in health services
research, there are at least five important
characteristics of the field that necessarily inform the
structure and emphasis of these conflict of interest
guidelines for health services research.
First, there can be significant conflicts of interest that
occur as a result of personal financial interests, such as
consulting arrangements with industry, speaking for
companies, licensing research instruments, and
royalties. In these cases there may be a conflict, or
perceived conflict, between financial interests and the
goals of research. Such conflicts of interest are
common in clinical and biomedical research.
While they can and do exist in health services research, it
appears that the predominant financial conflict in health
services research is less likely to be the result of the
personal financial interests of the researcher and more
likely to be related to the financial viability of future
research possibilities, both for the researcher and the
organization in which he or she works. Hints by a
company or government agency that future grant
funding or contract awards may be withheld if the
researcher is not compliant with funder requests (or
“suggestions”) can create conflicts between maintaining
research integrity and ensuring the future financial
security of the research initiative and organization.
In addition, there can be considerable financial
pressure in soft money organizations and academic
settings to secure grants for future research; these
pressures from within organizations can also present
similar conflicts between upholding the integrity of
the research and meeting the financial needs of the
organization.
Second, health services research findings are
frequently relevant to political, legal, and
regulatory proceedings. Researchers and sponsors
may themselves occupy the role of advocates in
such public arenas, making it important but
difficult to distinguish between research and
advocacy roles. Thus, even if the individual
scrupulously adheres to all the appropriate
guidelines in undertaking and publishing his or
her research, those guidelines, however desirable,
may not be mandatory when the individual is
involved in advocacy. Consequently, perceptions
about potential conflicts of interest may arise.
For example, a researcher who gains recognition
for advocating particular positions in the policy
arena could find the validity of his or her research
challenged even when it adheres to the scientific
standards of the field. Analogously, researchers
who constrain their advocacy may lessen their
ability to translate research to practice. One’s
balance of the various roles will be guided by
personal priorities.
Nevertheless, however they balance their various
roles, health services researchers must be attuned to
what role they are assuming at any particular time
and must avoid misleading others about being a
dispassionate researcher when, in fact, they are
assuming the role of an advocate.
Because perceptions by reasonable observers are the
essential ethical problem in conflicts of interest,
researchers must make clear to others about what
“hat” they are wearing in order to be explicit about
how the results of the research should be interpreted.
In addition to being attentive to the existence of these
various roles, identifying means to reduce the
influences created by these roles can help to diminish
the possibility of conflicts occurring in the first place.
Third, all research requires judgments about defining
the objectives of the study, designing the study, what
data sources to utilize, interpreting the data, and how
to disseminate it. Because of the limited feasibility of
double-blind, randomized controlled trials in health
services research, such research often relies on study
designs and data sources that are less straightforward
and more complex than basic and clinical research
studies with hard endpoints.
7
Well-executed health services research often
involves numerous decisions that rely on
judgments that cannot be specified in advance
and for which objective criteria may be difficult
to define. The measurement of endpoints,
as well as the endpoints themselves, may be
controversial, as this often depends on
judgments (e.g., cost per year of life or patient
measures of acceptability rather than just
mortality). Much of the data used by health
services researchers have been collected
primarily for other purposes and are being
adapted for the research.
Finally, the interest in moving from the results
of a particular study to implications for generic
policy issues requires assessments of
generalizabilty. The need for complex judgments
about design, data quality, particular analyses, and
applicability of findings in health services research
is more pervasive and harder to prospectively
delineate in a formal protocol. Thus, there is an
even greater necessity to rely on the integrity of
the researcher and on his or her organization.
Fourth, the balance of funding for health services
research between sponsors focused purely on
supporting the research enterprise and those
concerned with the particular programmatic
implications of the research findings is likely to
differ between health services research and clinical
and basic science research. Basic science research is
primarily financed through publicly funded
investigator-initiated (often know as R-01) funding in
which the research objectives are typically specified
by the researcher and where the sponsor does not
have a direct interest in outcomes.
Much clinical research is supported in a similar
manner, by investigator-initiated grants for public or
foundation funding in which the sponsor
has a direct interest in the completion of the project
but not in the findings themselves. Nevertheless, a
substantial proportion of clinical research funding
comes from corporate sponsors, who typically have a
financial interest in specific outcomes—for example,
in the positive outcome of a drug trial that would
promote the use of the drug they manufacture.
8
In health services research, on the other hand, a
substantial share of research funding comes from
corporate, foundation, or public sponsors with direct
financial, programmatic, or institutional interests in
the research outcomes. Frequently, funding support
is explicitly directed toward evaluation of the
sponsor’s programs or to further a preferred policy.
In these contexts, it is not uncommon for particular
research findings to be viewed as objectionable by a
sponsor; perhaps the findings run counter to a
preferred policy or the research results speak to the
ineffectiveness of highly visible programs. This type
of objection may create a conflict over the reporting
of those results no less problematic than unfavorable
results of a drug trial.
Finally, health services researchers are employed by
many types of institutions—academic, nonacademic, consulting, advocacy, government, and
private/commercial. Each entity has distinct
characteristics, interests, standard operating
procedures, and perceptions of what constitutes a
conflict of interest both within the organization and
with outside sponsors. Each research and working
environment has its own set of expected behaviors,
and this is likely to influence both the researcher and
how his or her work is perceived by others.
In determining how to apply these general guiding
values of research to the health services research
field, the particular characteristics of health services
research need to be considered. While the guiding
values may be the same for all types of research,
the particular attributes of health services research
necessitate management strategies specific to
health services research; in other words,
management of conflicts of interest in the health
services research field is best determined by
tailoring such strategies to the issues and settings in
which conflicts are most likely to arise.
Indeed, when the Committee reviewed conflict of
interest guidelines that focused predominantly on
clinical research, these guiding principles tended
to emphasize the personal financial interests of
researchers, and thus did not seem to address the
most pressing conflicts confronting health
services researchers.
Guiding Values
I
n developing a set of guidelines for the field, the
Committee focused on three underlying values.
We began with a belief that health services
research can lead to improved clinical and public
policies, but only if such research and analyses are
conducted to yield valid and reliable results and are
considered credible by the public. Therefore, the first
and most crucial value is preserving and enhancing
integrity in health services research by identifying and
minimizing potential bias—and appearances of such
bias—and by providing effective oversight for
individual and institutional decisions.
Such a commitment to integrity includes not only
professional integrity as a health services
researcher, but also personal integrity to act in an
ethically responsible way, especially when faced
with difficult or complicated decisions and
situations. At the very least, integrity in research
requires not knowingly making false, inaccurate,
or misleading statements or withholding relevant
information.
Furthermore, while researchers can have—and
probably need—conjectures and passionate
commitments, integrity requires fairness and
openness to finding the truth. Integrity in research
requires not pursuing a pre-determined
conclusion, but pursuing a hypothesis and
accepting whatever conclusions are revealed
through the research, particularly if they contradict
one’s initial preconceptions. Integrity requires
thoroughness and transparency in regard to the
multitude of decisions made, conclusions drawn,
and the consequent limitations in the analysis.
Fundamental to the notion of integrity, then, is the
realization that perceptions of conflicts of interest,
particularly those that are perceived as concealed,
can be damaging not only to the organization or
individual researchers, but to the entire discipline.
In this sense, health services researchers must
recognize that their actions are both individual
and communal—they not only ensure personal
integrity, but also the integrity of the field.
The second value is maintaining consistency with
other ethical values of health-related research.
Conflicts of interest are not the sole relevant ethical
consideration in health services research; these
guidelines must be consistent with other ethical
principles—such as respect for research subjects
and confidentiality of information—that guide
health services researchers in their related fields.
Basic ethical principles apply across all arenas; thus,
it is important for health services researchers to be
clear and transparent about the role they have
assumed and to maintain their ethical principles at
all times.
A third guiding value is adhering to the ethical
guidelines of other intersecting fields. As noted by
the IOM, health services research is inherently a
“multidisciplinary field of inquiry” and health
services researchers frequently associate with
other disciplines. For instance, health services
researchers’ findings may be used to improve
service delivery, shape policies in the political
arena, or researchers may be called as expert
witnesses in a court of law or regulatory hearing.
In each of these cases, health services researchers
must not only recognize the ethical expectations
of these other fields, but also recognize how
these expectations may conflict with the ethical
imperatives related to their research role.
For example, health services research should be
open, transparent, and available to the public
when possible. However, if health services
research is introduced into a legal proceeding,
such research may be required to adhere to the
special norms of the law, such as having testimony
sealed and therefore not available to the public.
Health services researchers should adhere to the
ethical guidelines related to health services research
and, when ethical expectations and guidelines
differ from those in health services research, there
must be compelling reasons to deviate, such as
the requirements of law or national defense.
Lacking such compelling reasons, they should
choose not to undertake activities because of the
possibility of such conflicts.
9
Guiding Values of Health Services Research
Guiding Issues
Principals
Actions
Preserving and enhancing
integrity in health services
research
Integrity
◆
Ensure the personal integrity of individual
researchers.
◆
Ensure the credibility of the health services
research field.
◆
Minimize possible bias in conduct and reporting
of results.
◆
Be fair and open to pursing the truth rather than
predetermined conclusions.
◆
Maintain transparency in research judgments.
◆
Ensure conflicts of interest are balanced
within all basic ethical principles relevant to health
services research:
Maintaining consistency
with other ethical values
of health-related research
Adhering to the ethical
guidelines of other
intersecting fields
10
Consistency of
Research Ethics
Inter-Disciplinary
Ethics
–
Respecting research subjects;
–
Maintaining confidentiality of personal
information;
–
Endeavoring to pursue meaningful research;
–
Minimizing risks or negative effects of research;
–
Maintaining justice and equality in research; and
–
Avoiding coercion or undue inducement.
◆
Recognize the ethical expectations of other arenas
engaged with health services research, such as
legal procedures.
◆
Be aware of conflicts between the ethical
expectations of the health services research field
and other related fields.
◆
Avoid conflicts by not undertaking research that
could pose such inconsistencies in ethical
expectations.
Ethical Guidelines
T
will be involved or have constrained the
specification of outcome measures, data sources,
methods of analysis, or the timing of the release of
results.
Initiation of Research
When sponsors seek to impose restriction
and constraints that are likely or intended to
affect the major elements of study design,
methods, and analysis in ways that may
produce biased results, researchers should
avoid conducting such research.
o be practical, these values must be
specified in ethical guidelines delineated
according to the temporal sequence of
initiating, conducting, and reporting research.
As all of these stages are tightly interconnected,
safeguards introduced at earlier stages can
influence and frequently pre-empt potential
ethical dilemmas at subsequent stages in the
sequence.
◆
◆
◆
◆
It is unethical to label an activity or project as
research if it is designed to reach a predetermined result. Research requires the real
possibility of finding potentially unanticipated
results. When a contract either explicitly or
implicitly (by specification of the research
process) is intended to reach a pre-determined
or biased conclusion, it should be rejected as
unethical if it is to be presented as “research.”
Just because a research question is specified
does not mean that the activity is not research;
rather, it is the preset definition of an endpoint
or conclusion that should be viewed as
unethical.
Researchers and sponsors should mutually
agree upon the objectives of the research and
the data sources at the outset. From the
perspective of research, the ideal is to leave the
researchers free to analyze the data, draw their
own conclusions, and report the results
consistent with their professional training and
judgment.
While this is the ideal, we also acknowledge that
sometimes limitations and constraints on
contracts cannot be avoided; such restrictions, if
reasonable, can be ethical as long as they are
properly disclosed. Researchers should also be
vigilant about disclosing any alterations to such
contracts.
Because much valuable health services research is
sponsored under contract or through
organizational-financed research that entails
restrictions or constraints on the nature of the
research, it is important that such limitations be
made explicit in the contract prospectively. This
includes, for example, any ways in which sponsors
◆
Sponsors themselves should assume
responsibility toward adhering to ethical
standards and conducting of research when
entering into professional relationships in the
health services field. Sponsors should seek to
implement fair and ethical contracts and
agreements with health services researchers.
This entails setting reasonable objectives and,
if necessary, specifying any constraints on
outcome measures or data sources at the
outset and allowing researchers the freedom to
analyze the data and draw conclusions based
on the researcher’s professional judgment.
Conducting Research
◆
There should be no fraud or fabrication
in research, whether carried out for
publication, legal proceedings, public
advocacy, or another form of dissemination.
◆
Research and analysis should be conducted
with a fair and objective assessment using,
whenever possible, measures and methods
that are widely accepted and could be
reproduced by peers.
◆
The use of data sources, variables, coding,
outcome measures, and methods of analysis
should be recorded and made available in
response to legitimate requests. Details that
would enable independent researchers to
reproduce and evaluate the research should
be kept and made available for the purpose
of confirmation and/or replication of
reported results. The various disciplines
involved in health services research, however,
vary in the degree to which they expect
detailed “lab notes” to be kept.
11
Reporting Research
◆
All data and research results should be
available for reporting by the authors after a
short time, preferably within two months but
no longer than six months. Any restrictions
on the researchers’ ability to publish any and
all findings they feel worthy of submission
should be specified in the contract.
Contract—or even verbal and/or implicit—
restrictions on the reporting of results should
be disclosed to journals and other publication
sources, with the expectations that such
restrictions will be disclosed to readers,
included in final reports whenever the data
are reported, and made publicly accessible if
the findings are not reported.
◆
Changes sought to be imposed by the
sponsor in the reporting of the research
findings or implications that threaten the
integrity of the research, the research results,
or the research report are unethical and
unacceptable.
◆
Differences in opinion between sponsors and
researchers in interpreting data and findings
are not unusual; many differences are
resolved in discussions of the relative merits
of alternative conclusions. When differences
of opinion remain, they are most effectively
addressed by publicly presenting both sides.
Differences should be disclosed to journals
and other publication sources, which should
endeavor to publicly provide coverage of both
sides of the argument. More complicated
disagreements over the quality of research
and the interpretation of results between
researchers and sponsors should be resolved
through a peer review-like mechanism that
draws upon people with the relevant
expertise who might be named by each party.
◆
12
Researchers, analysts, and their funders
should strive to make the reporting of
methods transparent. Researchers should
make the study databases, variables,
computer programs, and related materials
available to peers in order that others can
replicate the study if desired. To the extent
that there are legitimate limitations on this
peer accessibility to databases and related
material, such as confidentiality of patient
records, researchers should attempt to create
transparency through other vehicles. The
purpose of peer accessibility, however, is to
ensure the integrity and validity of research,
not to facilitate the undertaking of new
research where conflicts may exist among
competing researchers for access to unique
data sets.
◆
All reporting of research results should specify
who sponsored and financed the research, the
role—including no role—of the sponsor, any
involvement of the sponsor in defining the
study objectives, measures, endpoints, data
sources, and other methodological
considerations, and any restrictions imposed in
these areas whether specified in the contract or
done verbally. All journals and other
publications should contain a table, note, or
other mechanism that clearly and explicitly
specifies this sponsorship information.
◆
When publishing research in journals or other
publications, researchers cannot disclose
relevant information unless the journals
themselves have disclosure procedures in place.
To this end, journals and other publications
should work to implement policies that ensure
appropriate and sufficient disclosure.
◆
Researchers and policy advocates should
always be sensitive to and aware of the
various roles in which they may be acting, or
perceived to be acting, especially with respect
to the distinction between research and
advocacy. In reporting research results, it is
unethical not to clearly and explicitly
distinguish research from advocacy roles, and
it is the responsibility of the researchers and
policy analysts to properly specify the role in
which they are acting. There cannot be any
deliberate concealment or dissemblance of
the limitations of the research and there
must be explicit disclosures of: political,
legal, or other interests; payments for research
or advocacy work; or advocacy role as distinct
from researcher role.
Analyzing a Potential Conflict of Interest
I
n discussing conflicts of interest, it is
important to specify what types of conflicts of
interest are impermissible and what types
may be permissible with proper management.
There are some conflicts that are always
impermissible and should be prohibited. For
example, a conflict could arise when a sponsor
makes it clear that an agreed upon endpoint not
be used because it is potentially detrimental to
the position of that sponsor. The contract
language may preclude the sponsor from
prohibiting the use of the endpoint, but if the
sponsor pressures the researcher to “voluntarily”
decide to change his or her mind, perhaps
because of the fear of losing future work, such
influence can be unethical and constitutes a
serious conflict of interest.
Similarly, if a sponsor insists on not being
disclosed as the source of financial support or
if the sponsor specifies certain data sources,
outcome measures, or methods of analysis and
refuses to include that specification in the
contract and disclose it to the appropriate
reporting sources, this would remove the work
from the realm of research and it would be
unethical for the researcher to lead others to
believe that it was research.
13
Other types of conflicts require careful
discussion and may be permissible with
appropriate management, such as disclosure and
oversight. For example:
◆
A dispute arises over contract parameters.
Disputes may arise for any number of
reasons, the vast majority of which do not
necessarily imply ethical problems.
◆
A sponsor threatens to withhold future
funding unless project design is revised.
However, the nature of health services
research often makes difficult or inappropriate
the a priori specification of a rigid study
design and may require discretion in
implementing a protocol. Thus, rigid
adherence to an initial design when new
data suggest a change is neither good
science nor ethical.
◆
A researcher also serves in an advocacy role
on the subject of his or her research.
Constitutional rights to freedom of speech
protect a wide variety of advocacy roles that are
not necessarily in conflict with good,
dispassionate research. Deciding just how to
present one’s activities in each realm, however,
may require careful thought and negotiation.
It is the responsibility of the researcher or
advocate to ensure the reasonable observer is
informed about the actual role of the
presenter.
13
Implementation and Enactment of the Guidelines
A
cademyHealth is a professional
organization lacking formal
enforcement authority. At best, it can
use its suasion to identify ethical practices that
act as moral standards for others. Nevertheless,
AcademyHealth’s guidelines can serve as a
backdrop against which individuals and
institutions can evaluate their own behavior
and educate their trainees, as well as a resource
when managing difficult ethical situations.
The Committee believes that a set of ethical
guidelines outlining accepted behavior will
serve health services researchers well.
◆
Journals that publish health services research
should adopt policies that require disclosure
of sponsors’ involvement in the research,
especially in identifying the objectives,
measures, data sources, methods of analysis,
and interpretation. These disclosures should
accompany the reporting of the research
results.
◆
AcademyHealth and other supporters of
research should increase awareness of these
guidelines in the field and among research
sponsors, taking whatever actions are feasible
collectively to encourage research sponsors to
employ practices consistent with these
guidelines.
◆
Researchers and policy analysts should
adhere to these guidelines in the conducting
of their research and whenever they are
engaged in advocacy. They should clearly and
consistently distinguish their researcher and
advocacy roles when they might be confused
by observers, disclose the sponsorship of
their work, any personnel payments for
research and advocacy work their have
received, and any political, legal, or other
interests in their research.
◆
Institutions that train or sponsor training of
health services researchers should include
instruction in conflict of interest and these
guidelines as part of that training.
To implement the spirit of this policy,
AcademyHealth urges the following substantive
changes.
◆
Organizations entering into grant and contract
agreements for research and analysis with
sponsors should require that the agreement
contains explicit statements allowing
researchers to be free to analyze the data, draw
their own conclusions, and disseminate the
results. The agreement should specify the
outcome measures, data sources, methods of
analysis, and mode/timing of the release of
results required by the sponsor and agreed to by
the researcher; if not specified, these items
must be at the sole discretion of the researcher.
Contracts should also specify that all
restrictive requirements necessitated by the
sponsor may be publicly disclosed by the
researcher. In addition, contracts should
contain information regarding the amount of
time that the sponsor has for review of the
results prior to reporting; this time is
preferably two months, but should not exceed
six months, except in extraordinary
circumstances.
14
Appendix A – AcademyHealth Ethical Guidelines Committee
Robert A. Berenson, M.D.
Senior Fellow
The Urban Institute
2100 M Street, NW
Washington, DC 20037
202.261.5886 (tel)
202.223.1149 (fax)
rberenson@ui.urban.org
M. Gregg Bloche, M.D., J.D.
Professor of Law
Georgetown University Law Center
600 Jersey Avenue, NW
Washington, DC 20001
202.662.9123 (tel)
202.662.9408 (fax)
bloche@law.georgetown.edu
Norman Daniels, Ph.D.
Professor of Ethics and Population Health
Dept. of Population and International Health
Harvard School of Public Health
665 Huntington Avenue
Building 1, Room 1104C
Boston, MA 02115
617.432.2360 (tel)
617.566.0365 (fax)
ndaniels@hsph.harvard.edu
Ezekiel J. Emanuel, M.D., Ph.D.
Director, Dept. of Clinical Bioethics
National Institutes of Health
Warren G. Magnuson Clinical Center
Building 10, Room 1C118
Bethesda, MD 20892
301.435.8706 (tel)
301.496.0760 (fax)
eemanuel@nih.gov
Marsha R. Gold, Sc.D.
Senior Fellow
Department of Research
Mathematica Policy Research, Inc.
600 Maryland Avenue, SW
Suite 550
Washington, DC 20024-2512
202.484.9220 (tel)
202.863.1763 (fax)
mgold@mathematica-mpr.com
W. David Helms, Ph.D.
President and CEO
AcademyHealth
1801 K Street, NW
Suite 701-L
Washington, DC 20006
202.292.6700 (tel)
202.292.6800 (fax)
david.helms@academyhealth.org
Harold S. Luft, Ph.D.
Caldwell B. Esselstyn Professor
of Health Policy & Economics
Director, Institute for Health Policy Studies
University of California, San Francisco
3333 California Street, Suite 265
San Francisco, CA 94118
415.476.5147 (tel)
415.476.0705 (fax)
hluft@itsa.ucsf.edu
Nicole Lurie, M.D.
Senior Scientist and Paul O’Neill Alcoa
Professor
RAND Corporation
1200 South Hayes Street
Arlington, VA 22202-5050
703.413.1100 x 5127 (tel)
703.413.8111 (fax)
lurie@rand.org
William D. Marder, Ph.D.
Senior Vice President and
General Manager
Medstat
125 Cambridge Park Drive
Cambridge, MA 02140
617.492.9329 (tel)
617.492.9365 (fax)
bill.marder@thomson.com
David Mechanic, Ph.D.
Director
Institute for Health Care Policy
Rutgers University
30 College Avenue
New Brunswick, NJ 08903
732.932.8415 (tel)
732.932.1253 (fax)
mechanic@rci.rutgers.edu
15
Deborah Prothrow-Stith, M.D.
Associate Dean for Faculty Development
Director, Division of Public Health Practice
Harvard School of Public Health
1552 Tremont Street
Boston, MA 02120
617.496.0713 (tel)
617.384.8081 (fax)
dprothro@hsph.harvard.edu
Elliot M. Stone
Executive Director & CEO
Massachusetts Health Data
Consortium, Inc.
460 Totten Pond Road, Suite 385
Waltham, MA 02451
781.890.6040 (tel)
781.768.2510 (fax)
estone@mahealthdata.org
Dennis F. Thompson, Ph.D.
Alfred North Whitehead Professor of
Political Philosophy
Director, The Center for Ethics
and the Professions
Harvard University
79 John F. Kennedy Street
Taubman Building
Cambridge, MA 02138
617.495.1336 (tel)
617.496.6104 (fax)
dennis_thompson@harvard.edu
AcademyHealth Staff
Anne K. Gauthier
Vice President
AcademyHealth
1801 K Street, NW
Suite 701-L
Washington, DC 20006
202.292.6700 (tel)
202.292.6800 (fax)
anne.gauthier@academyhealth.org
Bonnie J. Austin, J.D.
Senior Manager
AcademyHealth
1801 K Street, NW
Suite 701-L
Washington, DC 20006
202.292.6700 (tel)
202.292.6800 (fax)
bonnie.austin@academyhealth.org
Research Fellows
Lindsay A. Hampson
Department of Clinical Bioethics
National Institutes of Health
10 Center Drive, MSC 1156
Bethesda, MD 20892-1156
301.435.8707 (tel)
301.496.0760 (fax)
lhampson@cc.nih.gov
Naomi K. Seiler, J.D.
Greenwall Fellow in Bioethics and Health Policy
Johns Hopkins School of Public Health
1865 California Street, NW, #4
Washington, DC 20009
203.675.2987 (tel)
naomi_seiler@post.harvard.edu
16
Appendix B – Committee Actions
Background
In 2002, AcademyHealth’s Board of Directors
approved the formation of an advisory
committee to assess how we might assist our
members as they confront ethical issues in the
conducting of health services research and
health policy analysis. The Ethical Guidelines
Committee’s charge was to explore/affirm the
need for AcademyHealth to develop a set of
ethical guidelines, make recommendations on
the scope of such guidelines, and prepare a draft
report for the full Board approval and broad
dissemination.
November 2002: The Committee agreed on the
scope of the project—financial and non-financial
conflicts of interest, rather than a broader range
of ethical issues. They identified dimensions that
influence potential conflicts of interest and
discussed examples of conflicts of interest that
could be used to help inform the guidelines.
February 2003: The Committee refined the
sources and character of conflict in health
services research, which are influenced by types
of research organizations, types of research
sponsors, types of research financing, and types
of dissemination strategies.
May 2003: The Committee reviewed an outline
of the report and refined the guiding values and
examples of conflicts.
June 2003: Members of the Committee conducted a
special session at AcademyHealth’s Annual Research
Meeting. They sought input from the membership
on how best to respond to specific ethical dilemmas
and examples of real-world cases that individuals or
institutions have confronted. Committee Members
made presentations at AcademyHealth’s Center
Directors’ Meeting and Meeting of AcademyHealth
Members on progress to date.
July 2003: A call for information was sent out to
AcademyHealth’s Center Directors for insights
into the ethical dilemmas that they face or about
which they may be aware.
September 2003: Drawing on suggestions by
Committee members and insights from
AcademyHealth’s members, Chairman Zeke
Emanuel prepared an initial draft report. The
report was distributed to Committee members
for critical review.
October 2003: The Committee reviewed the
draft report, with emphasis on a list of ethical
guidelines.
November 2003: The report drafting and review
process continued among Committee members.
December 2003: Chairman Zeke Emanuel
presented the draft report to AcademyHealth’s
Board of Directors for its review.
Winter 2003: Board members offered substantive
comments on the draft report for consideration
by the Committee.
April 2004: Draft report was distributed to
AcademyHealth members for comment.
The Committee reviewed comments and
provided final edits on the draft report.
June 2004: At a June 7 meeting of
AcademyHealth members during the Annual
Research Meeting in San Diego, a summary of
comments to date was provided and additional
comments invited. A final report was presented
to the Board for its approval at its June 8
meeting. In addition to the Board’s review and
approval of the final report, they provided
guidance on a dissemination strategy for the
ethical guidelines.
17
Appendix C – Conflict of Interest Resources
Federal
Associations/Societies
NIH Guide – Objectivity in Research
http://grants2.nih.gov/grants/guide/noticefiles/not95-179.html
AAMC Guidelines for Dealing with Faculty
Conflicts of Commitment and Conflicts of
Interest in Research
www.aamc.org/research/dbr/coi.htm
Miscellaneous CoI Information from the NIH
Office of Extramural Research
http://grants1.nih.gov/grants/policy/coi
Frequently Asked Questions Concerning the
Department of Health and Human Services
Objectivity in Research Regulations and the
National Science Foundation Investigator
Financial Disclosure Policy
http://grants1.nih.gov/grants/policy/coifaq.htm
NIH Site Visit Mock Interview Questions
www.ncura.edu/resources/Annualslides/AdminNIHSITEVISITMOCKINTERVQUESTIONS.doc
NIH Guide – Financial Conflicts of Interest and
Research Objectivity: Issues for Investigators
and Institutional Review Boards, June 5, 2000
http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-00-040.html
NSF COI Policy
www.nsf.gov/od/ogc/coipolicy.html
FDA “Guidance: Financial Disclosure by Clinical
Investigators” (March 20, 2001)
www.fda.gov/oc/guidance/financialdis.html
GAO “Biomedical Research: HHS Direction
Needed to Address Financial Conflicts of
Interest” (November 2001)
www.aau.edu/research/gao.pdf
Department of Veterans Affairs – Conflict of
Interest in Research Handbook
www.vard.org/forms/coi.htm
OHRP Draft Interim Guidance – Financial
Relationships in Clinical Research: Issues
for Institutions, Clinical Investigators, and
IRBs to Consider When Dealing with Issues of
Financial Interests and Human Subject Protection
www.dhhs.gov/ohrp/nhrpac/mtg12-00/finguid.htm
AAMC Task Force on Financial Conflicts of
Interest in Clinical Research – Individual and
Institutional Guidance
www.aamc.org/members/coitf/
Washington Fax Article: AAMC conflict of
interest proposal puts rebuttal burden on
“financially interested researchers” (12/20/01)
www.washingtonfax.com/samples/2001/
20011220a.html
Association of American Universities –
Conflict of Interest Resources
www.aau.edu/research/conflict.cfm
International Society for Pharmacoeconomics
and Outcomes Research – Code of Ethics for
Researchers
www.ispor.org/workpaper/healthscience/
TFCodeEthics.pdf
American Society of Clinical Oncology –
Oversight of Research and Conflict of
Interest Policies
www.asco.org/ac/1,1003,_12-002144-00_180027455-00_19-0027456-00_20-001,00.asp
American Anthropological Association – Ethics
www.aaanet.org/committees/ethics/ethics.htm
American Political Science Association – A
Guide to Professional Ethics in Political Science
www.apsanet.org/pubs/ethics.cfm
American Sociological Association Code of Ethics
www.asanet.org/members/ecoderev.html
Ethical issues in CME, Clinical Research –
From the May 2001 ACP-ASIM Observer, 2001
www.acponline.org/journals/news/may01/
ethicalprobs.htm
Medical Professionalism Project
www.annals.org/cgi/reprint/136/3/243.pdf
Universities
NCURA: Conflict of Interest: What’s An
Institution to Do? Article by Beth H. Israel,
Executive Director, Office of Projects and
Grants for Columbia University
www.ncura.edu/data/newsroom/newsletters/
pdf/newsdec.pdf
Summary of Federal Laws Governing
Independent Colleges and Universities
from the Catholic University of America
Office of General Counsel
http://counsel.cua.edu/FEDLAW/index.htm
Stanford University – Conflicts of Interest Resource
www.stanford.edu/dept/DoR/Resources/coi.html
Harvard University – Conflicts of Interest Resource
www.hms.harvard.edu/integrity/conf.html#2s
University of New Hampshire Policy on Financial
Conflict of Interest in Research
http://usnholpm.unh.edu/UNH/II.Acad/D.htm
University of Michigan Conflict-of-Interest Policy
www.research.umich.edu/policies/um/
conflict_procedures.html
Other
Uniform Requirements for Manuscripts
Submitted to Biomedical Journals
www.icmje.org/index.html#ethic
Canadian Medical Association Journal – Bioethics
for clinicians: 17. Conflict of interest in research,
education and patient care (CMAJ 1998; 159:960-5)
www.cma.ca
Activism and Medicine. “An Incomplete Bibliography
of Online Readings Related to Conflicts of Interest”
(articles from 1999 to 2002)
http://home.cwru.edu/activism/pubs.html
Responsible Research: A Systems Approach to
Protecting Research Participants, Institute of
Medicine, October 2002
www.nap.edu
Sounding Board, “Nonfinancial Conflicts of
Interest in Research,” New England Journal
of Medicine, September 2002, Vol. 347, No. 10,
pp. 759-61.
http://content.nejm.org
Drazen, J.M. and G.D. Curfman, “Financial
Associations of Authors,” New England Journal of
Medicine, June 2002, Vol. 346, No. 24, pp. 1901-02.
http://content.nejm.org/cgi/content/full/346/24/1901
Sounding Board, “Maintaining the Public Trust in
Clinical Research,” New England Journal of Medicine,
January 2002, Vol. 346, No. 4, pp. 285-7.
Lo, B. et al. “Conflict-of-Interest Policies for
Investigators in Clinical Trials,” New England
Journal of Medicine, Vol. 343, No. 22, pp. 1616-20,
November 2000
http://content.nejm.org/cgi/content/short/
343/22/1616
Emanuel, E., and D. Steiner. “Institutional Conflict of
Interest,” New England Journal of Medicine, January
1995, Vol. 332, No. 4: pp. 262-7.
www.med.utah.edu/ethics/RCREthics/
emanuel.html
Speech on Conflict of Interest in Biomedical
Research by David Korn, MD
http://ohrp.osophs.dhhs.gov/coi/korn.htm
Southwest Oncology Group Conflict
of Interest Policy
http://swog.org/Visitors/Policies.asp
Fred Hutchinson Cancer Research Center
Conflict of Interest
www.fhcrc.org/admin/hr/pppm/p0911.htm
19
Ethical Guidelines of Health Services Research
State of
Research
Initiation of
Research
Conducting
Research
Reporting
Research
20
◆
Pursue research maintaining openness to unanticipated results; do not pursue research
intended to reach a pre-determined conclusion. Many methods and techniques used in
research may be appropriately used to clarify or justify pre-determined positions, but that is
not research.
◆
Researchers and sponsors should come to a mutual agreement on the research objectives
and data sources at the outset.
◆
Make any sponsor-imposed limitations on the research explicit in the contract prospectively;
do not pursue research if the limitations are not acceptable to the researcher.
◆
Sponsors should assume responsibility to promote ethical research standards by setting
reasonable objectives and deliverables as well as giving the researcher freedom to analyze the
data and report conclusions as the researcher sees fit.
◆
There should be no fraud or fabrication in research, regardless of the purposes for which
the research will be used.
◆
Maintain objectivity in conducting research and analysis; whenever possible, use measures and
methods that are widely-accepted and reproducible.
◆
Record the methods and measures of research and analysis, making this information available to
legitimate requests, such as confirming or replicating the reported results.
◆
Authors should be free to report data and results within two months (but no longer than six
months) after the research has concluded; any restrictions on this timing must be disclosed.
◆
Any sponsor-imposed changes in the reporting of results that distort or misrepresent the research
findings are unethical and should not be accepted by the researcher.
◆
Differences in opinion between the researcher and the sponsor about the interpretation of data
should be appropriately managed; if differences remain after the researcher and sponsor endeavor
to agree upon conclusions, differences should be disclosed whenever the data are reported.
Further disagreements should be resolved through a peer review-like mechanism consisting of
appointments by both parties of people with relevant expertise.
◆
Researchers should endeavor to make their methods transparent and available to peers for
replication or confirmation of results.
◆
All reporting of research results should specify who sponsored and financed the research, as well
as their role and involvement in the research at any point.
◆
Work originally intended for advocacy or similar purposes (rather than as research) should be
identifiable as such.
◆
Researchers must be explicit about their other roles and interests when reporting results and
must not conceal the possible limitations of the research.
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