TERA
Procedures for Panel Selection and Conflict of Interest and Bias
(Adopted
April 2005)
Background
Toxicology Excellence for Risk Assessment (
TERA
) is an independent non-profit organization with a mission to
protect public health through the best use of toxicity and
exposure information in the development of human health risk
assessments.
TERA
’s
peer review and peer consultation program is a cornerstone of
the organization. This
program provides independent peer review and peer consultation
services to a variety of sponsors.
TERA
conducts these scientific peer reviews and consultations in
accordance with the U.S.
Office
of Management and Budget (OMB) "Final Information Quality
Bulletin for Peer Review".
TERA
’s program also follows the procedures used by the
National Academy of Sciences (NAS),
and the U.S. EPA.
These organizations emphasize careful planning,
independent selection of appropriate expertise, balanced panels,
transparency in process and results, and public participation.
TERA
’s independent peer review program has embraced
these concepts since its inception in 1996.
TERA
organizes and conducts each peer review or consultation at the
request of a sponsor, which may be a government agency, a private
company, or another organization.
The sponsor pays for the direct costs of conducting the
peer review meeting and for
TERA
’s labor costs to organize and convene the meeting.
Although the sponsor provides funding, the sponsor has no
influence over the conduct of the peer review or the content of
the report.
TERA
has sole responsibility for selecting panel members and acts
independently to organize the review and to prepare the charge to
reviewers.
Selection of the Panel and Evaluation of Potential Conflict of
Interest and Biases
TERA’s
peer review panels are selected to be free of conflicts of
interest and also to be free of any biases that would prevent
panel members from giving their best independent scientific
opinions on the subject. TERA
follows the OMB Bulletin and NAS guidance in selection of panel
member by applying the three principles of expertise, balance, and
independence as discussed in the OMB Bulletin.
The most important criterion
TERA
uses to consider panel members for its peer reviews is
high-quality, relevant scientific expertise.
Following a careful evaluation of the draft work product
and discussion with the sponsors, authors, and other interested
parties, TERA determines the areas of technical expertise
or scientific disciplines that must be represented to insure that
the panel can conduct a comprehensive review.
Selected panel members have recognized technical expertise
in one or more of the identified areas relevant to the subject
matter under discussion.
Following
NAS guidance,
TERA
creates panels that have a balance of respected scientific
viewpoints on the issues to be discussed.
As a result,
TERA
’s panels have a broad and diverse range of knowledge,
experience, and perspective, including diversity of scientific
expertise and opinion. In addition, TERA creates panels
with multiple organizational perspectives (e.g., academic,
consulting, environmental, government, and industrial/commercial). However,
panel members serve as individuals,
representing their own personal scientific opinions.
They do not serve as representatives of their companies,
agencies, funding organizations, or other entities with which they
are associated. Their
opinions should not be construed to represent the opinions of
their employers or those with whom they are affiliated.
Another
issue essential to the credibility of the peer review process is
the independence of each panel member.
To insure independence,
TERA
evaluates conflicts of interest for each candidate, following
procedures described by NAS. NAS
defines a conflict of interest as “any financial or other
interest which conflicts with the service of the individual
because it (1) could significantly impair the individual’s
objectivity or (2) could create an unfair competitive advantage
for any person or organization.…The term ‘conflict of
interest’ means something more than individual bias.
There must be an interest, ordinarily financial, that could
be directly affected by the work of the committee.
…no individual can be appointed to serve (or continue to
serve) on a committee of the institution used in the development
of reports if the individual has a conflict of interest that is
relevant to the functions to be performed.”
NAS notes that conflicts apply “only to current
interests” and that conflict of interest “applies not only to
the personal financial interests of the individual but also to the
interests of others
(original emphasis) with whom the individual has substantial
common financial interest if these interests are relevant to the
functions to be performed.”
Others interests may include spouse or minor children, and
individual’s employer, business partners, or others with whom
one has a substantial common financial interest.
TERA
also recognizes that it is important that panels not be
compromised by issues of bias or lack of objectivity.
Therefore, TERA
evaluates bias as well as conflict of interest. NAS
notes that “questions of lack of objectivity and bias ordinarily
relate to views stated or positions taken that are largely
intellectually motivated or that arise from the close
identification or association of an individual with a particular
point of view or the positions or perspectives of a particular
group.”
As NAS notes, potential sources of bias are not necessarily
disqualifying but a balance of potentially biasing backgrounds or
professional or organization perspectives is needed.
However, some potential sources of bias may be so
substantial that they would prevent an individual from considering
others perspectives or relevant evidence contrary to their
strongly held position.
TERA
utilizes a multi-step process to identify conflicts of interest or
biases. Each
prospective panel member is required to disclose to
TERA
all information related
to their association with the work product, subject matter,
authors, or sponsor(s) of the review.
Each candidate is required to complete a questionnaire and
sign a statement concerning conflict of interest and bias.
In conversations with each candidate,
TERA
discusses the nature of the review, key issues, the sponsor, and
other interested parties and stakeholders.
Using questions similar to NAS and the
Office
of Government Ethics,
TERA
asks the candidates questions regarding their work and
relationships with the sponsor and other affected parties, sources
of employment, funding, public testimony, investments,
liabilities, and other situations and matters that may create
conflicts of interest or biases.
TERA
staff carefully review the information provided to determine
whether conflicts of interest or unacceptable biases exist.
