|
|
|
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.
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. 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 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.
- 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.
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 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.
___________________________________________
Continue
to:
|
