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 Executive
Summary
The 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.
Ethical
Guidelines for Health Services Research
| Status
of Research |
Initiation
of
Research |
-
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.
|
Conducting
Research |
- 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.
|
Reporting
Research |
- 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.
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