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Ethical
Guidelines
To 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.
A.
Initiation of Research
- It is
unethical to label an activity or project as research if it is designed
to reach a pre-determined 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.
- 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 will be involved or have constrained
the specification of outcome measures, data sources, methods of analysis,
or the timing of the release of results. 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.
However, in all cases, restrictions and constraints that affect the
major elements of study design, methods, and analysis should be disclosed
to journals and other publication sources with the expectations that
these will be disclosed to readers and included in final reports whenever
the data are reported.
- Sponsors
themselves should assume responsibility towards adhering to ethical
standards and conduct 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.
B.
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 to legitimate requests.
The various disciplines involved in health services research vary in
the degree to which they expect detailed “lab notes” to
be kept. 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.
C.
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.
- Researchers,
analysts, and their funders should strive to make their 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
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.
- 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:
ETHICAL
GUIDELINES
OF HEALTH SERVICES RESEARCH
| STAGE
OF RESEARCH |
ETHICAL GUIDELINES |
| Initiation
of Research |
- Pursue
research maintaining openness to unanticipated results: do not
pursue research intended to reach a pre-determined conclusion
- Researchers
and sponsors should come to a mutual agreement upon 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 towards ethical research standards
by setting reasonable objectives and data points 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 |
- Data
and results should be reported by the authors 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
- Researchers
must be explicit about their other roles and interests when reporting
results so as not to conceal the possible limitations of the research
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