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Epi Wit & Wisdom Articles
SER Committee Supports Sharing
of Research Data With Interested Outside Parties
Contentious Issue Raises Many
Concerns
After considering the issue for
three years, an SER committee has produced a report which comes down
squarely in favor of sharing data. The principal reason cited for this
“open book” recommendation is because “...the spirit underlying
epidemiologic research activities should in general favor the sharing
of research data with colleagues and with appropriate agencies.”
Although the committee states
that sharing data should remain “a voluntary activity,” and that there
might be circumstances when sharing data is not desirable, it seems
clear from the report that epidemiologists will no longer be seen as
having “exclusive rights” over their data and that they will have to
have good reasons for refusing to share data. According to the
recommendations, epidemiologists will not be allowed to delay sharing
indefinitely, particularly when the data are at issue in government
decision-making.
Key Points
Among the key points made in the
report are the following:
1) The presumed motivation of
the person requesting the data should not be a factor in the decision
whether or not to release the data. However, the requester is expected
to demonstrate competence in data analysis prior to receiving the
data.
2) The requester should
compensate the investigator for the time, materials and expenses
involved.
3) The requester should discuss
the findings from the secondary analysis with the primary investigator
and give an opportunity to refute the results, if appropriate, before
they are publicized.
4) Outside parties must respect
the privacy and confidentiality of the original study subjects.
Investigators should design their study protocols under the assumption
that study data may at some time be used by others.
5) Informed consent statements
should reasonably disclose the true risk involved in release of data
to other investigators. When release of personal identifiers appears
warranted, it should be done only with prior approval of the
Institutional Review Board.
6) Journals should increase the
publication of secondary analyses and give full credit to the original
data collections.
7) Investigators should be
allowed to delay granting access to their data until they are
satisfied they have completed their efforts to have the data
published.
Data Ownership
The committee sidestepped the
thorny issue of who actually owns the data generated during a research
project. While it seems clear the committee believes that
investigators have exclusive rights to data up to the time of
publication, the associated tough questions such as who is responsible
for storing the data and for how long are not addressed in the
committee report.
An example of how thorny this
issue can become when scientists stop to think about it is provided by
the results of a recent workshop on Data Management (including access,
sharing and archiving) held in late April under the sponsorship of the
Public Health Service (Science, May 4, 1990). According to a former
PHS attorney present at the workshop, the law does not give federal
grantees exclusive rights to the data they produce. According to this
view, “No one has an absolute ownership interest, as you have with a
piece of land.” Rather, federal data rights are like water rights;
they may restrict access, but they require sharing and forbid
pollution.
The overall goal of the SER
report is to balance the competing interests of investigators who may
wish to restrict access to data with those of outside individuals who
wish to gain access for whatever reason. The committee endorsed the
public’s right to know and did not differentiate between data sets
collected with public or private funds. For example, whether or not
the committee’s recommendations apply to data collected by private
companies is not made clear in the report. The SER report is slated
for discussion at the upcoming annual meeting in June at Snowbird.
Members of the SER committee on
data sharing included Queta Bond (Institute of Medicine), Philip
Enterline (University of Pittsburgh), Leni Field (Proctor and Gamble),
Leon Gordis (Johns Hopkins), Mary Guinan (CDC), Carol J. R. Hoque
(CDC), and L. Lynn Hoque (Private attorney).
Published May 1990 v
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