It is instructive to examine how the US has attempted (after the Enron fraud) to
prevent future deceptive accounting practices through increased regulation as
specified by the Sarbanes–Oxley Act (SOX) (Rezaee 2007). This approach of
regulation for accounting reports differs from the approach of self-regulation for
scientific research ethics. There is no systematic regulatory oversight of research
ethics by either the National Institutes of Health (NIH) or the National Science
Foundation (NSF). Only Food and Drug Administration audits have specific
evaluation standards. The only research integrity requirement for research facilities
is to document the existence of a Responsible Conduct of Research (RCR) program.
We propose that research ethics, like corporate ethics, would be enhanced by
increased oversight. We propose a departure from self-regulation, unquestioned
reassurances and self-reports. Others have also proposed using outside evaluators to
enhance research integrity (Titus and Bosch 2010). Researchers should adopt the
financial accounting approach in establishing trust through an external validation
process, in addition to the reporting entities and the regulatory agencies.
Additional regulations are unlikely to be welcomed by either the researchers or
their institutions. However, there are no viable alternatives. The approach of
increasing oversight and regulation has been consistently pursued for strengthening
the integrity of accounting reports (Brenkert 2004). Alternative approaches have not
been perceived as realistic or effective. In the current environment of increasing
transparency and accountability to taxpayers and funding agencies, the increased
regulation of research ethics is not an option. Just as increased federal regulations
were used to strengthen accounting reporting ethics with SOX, a similar approach
would be appropriate for research ethics. Any regulation of research ethics would
depend upon the requirements of the primary funding agencies, NIH and NSF. The
concentration of research funding among a small number of research institutions,
makes it feasible to review major portions of the total research budget with focused
efforts.
The general conceptual framework for reviewing financial reports, utilizes
external auditors who are certified and objective in using established standards to
provide an opinion on the financial reports. These financial reporting standards, over
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the course of time, have resulted in increasing disclosure both through the increased
scope and increased specificity as to what information is reported and the
methodologies to be employed.
The general trend of increased scope and specificity in financial reporting
standards is a response to changes in the general business environment and business
fraud, and failures in past reporting practices. The Sarbanes–Oxley Act (SOX) is the
most recent American federal legislation affecting financial reporting that has
transformed a range of business behaviors that were previously nebulously defined
and classified as ethically desirable, into specific legal requirements. These
regulatory changes were implemented in recognition of perceived deficiencies in
reporting and potential conflicts of interest among the auditors. The purpose of SOX
was to prevent the failures (deception) in financial reporting that occurred in the
cases of Enron and Worldcom.
Financial reports must be audited for all publicly traded companies. This is an
extensive external review process that occurs regardless of any documented or
suspected deficiencies. This is in addition to reviews by the reporting company and
the regulatory agencies.
There is no equivalent regulatory oversight process for research integrity at either
the institutional or research project level. There are few regulations, no systematized
evaluations and no integrated assessments of research integrity. The major
requirement is to establish a Responsible Conduct of Research program. These
deficiencies in regulation and oversight limit the detection and correction of
research integrity problems.
Others have proposed additional oversight through special institutional inspections
which would allow access to additional funding (Titus and Bosch 2010).
Educational (Steneck 2007) and judicial approaches (Downie 2006) have been
proposed to enhance research integrity. In this paper we propose an accounting
approach based on the Sarbanes–Oxley Act (Brenkert 2004).
Trust is a fundamental requirement in both the research and financial
communities (Titus et al. 2008; Rezaee 2007). In the research community, a
number of high-profile incidents have raised serious concerns about research
integrity over the past few years (Errami and Garner 2008). Research misconduct
wastes resources, misleads colleagues and destroys trust in science and support for
public funding.
Proposals to establish trust in science and engineering research have been
fragmented, with no overriding systematic conceptual framework. Financial
reporting has a long history of dealing with crises of confidence (Clikeman
2008). We propose that science and engineering research consider the integrated
systems developed to establish trust in financial reporting.
Our proposals draw on the latest US legislative response to the financial crisis of
2002, the Sarbanes–Oxley Act (SOX) (Wikipedia 2010). The accounting framework
is the result of a long history of reacting to lack of trust in the financial markets. The
Sarbanes–Oxley Act of 2002 enhanced standards for boards of directors, management
and public accounting firms.
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Sarbanes–Oxley Act: Internal Controls
First, SOX requires corporations to have and document a complete set of internal
controls, to ensure the validity of their financial reports. For similar reasons, the
bigger research organizations should document and retain the processes, analytic
procedures and methodologies for each research project and maintain internal
depositories for all relevant data. In scientific and engineering research projects, it is
not rare for basic data results and analyses to be scattered or inaccessible. We are
proposing the establishment of a formalized process to collect and retain project
data and results in a centralized location. The complexities and costs of long-term of
storage of research materials has already been recognized (John 2009; Lynch 2008).
These materials could be sampled by internal and external oversight bodies. Similar
specific rules are needed for lab procedures, analytic methods and the internal
review process. This is a critical component in the process of enhancing trust.
Currently, institutions do not generally monitor research projects, particularly the
non-financial aspects, on an ongoing basis.
Relevant information must be reported in a timely manner. In the case of
scientific and engineering research, most projects disclose information at three
points of time, application for funding, submission for publication and publication.
We propose that research organizations publish research oversight reports for
individual projects at a point after the application for funding, but before submission
for publication.
We are proposing not only the collection of data and documentation by project,
but the ongoing audit of those project reports. So, just as only a statistical sampling
of the transactions affecting the important or vulnerable components of the financial
statements are audited, only a sample of the research project documents would be
reviewed.
The institution of record is primarily responsible for the enforcement of ethical
standards (Editorial 2010). Other entities, such as the academic journals, professional
associations and funding agencies have limited power to penalize
misconduct.
For clinical trials of new medications on human subjects the sponsoring drug
company and the Food and Drug Agency conduct audits of clinical trials
(Mihajlovic-Madzarevic 2010). We are proposing that the institution where the
research project physically occurs, should also conduct ongoing internal reviews.
A short example, of what the reviews for clinical trials currently include, follows.
First, the files for a selection of recently recruited subjects are audited for
consistency with the specified recruitment criteria. Second, the randomization of
treatments are reviewed. Third, the informed consent forms are verified for
accuracy, compliance with the Institutional Review Board (IRB) approval and
completeness. Fourth, the documentation of medical care provided is checked for
completeness and consistency with treatment protocols. Fifth, the reasons for, and
characteristics of, patient withdrawals are reviewed. The data collected are
compared with the original protocol. The analyses of data are similarly compared
to those specified in the application. Finally, the storage of patient records is verified
(Mihajlovic-Madzarevic 2010).
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In addition there should be documentation specifying the co-authors’ roles in the
research project and manuscript creation, and where reports of the research were
submitted and published. This ongoing process of monitoring the non-financial and
ethical aspects of research projects internally should result in fewer instances of
institutions learning of inappropriate activities through third parties.
Sarbanes–Oxley Act: Certification by Chief Financial Officer
Second, SOX specified that the Chief Financial Officer personally certifies that s/he
understands the methods used to create the financial reports. Although s/he does not
personally check the accuracy of financial statement numbers, s/he affirm that there
are systems in place to detect reporting improprieties. In a similar way, we propose
that the bigger research organizations should have their Vice-President of Research
(or equivalent) certify their responsibility for research integrity.
Currently, inst