AAMC's Comment Letter to
the ORI on the Expanded Requirement for Education in the Responsible
Conduct of Research
On July 21, 2000, the HHS Office of Research Integrity published
a proposal to expand the requirement for training in the responsible
conduct of research to all personnel on PHS grants.
The AAMC response is provided below.]
August 29, 2000
Chris B. Pascal, J.D.
Acting Director
Office of Research Integrity
Rockwall II, Suite 700
5515 Security Lane
Rockville, MD 20852
Dear Mr. Pascal:
On behalf of the nation’s 125 accredited medical schools,
over 400 teaching hospitals, and 91 academic and scientific
societies, the Association of American Medical Colleges (AAMC)
is pleased to comment on the proposed expansion of the requirement
for training in the responsible conduct of research, as announced
in the July 21 Federal Register [65 FR 45381]. Promoting
the responsible conduct of research (RCR) has been an Association
priority for over a decade, during which time we have been
intensively involved in the development of institutional guidelines,
resources, and meetings on a broad array of relevant topics.
In particular, the Association has long advocated RCR instruction,
which we have actively promoted through a series of four national
conferences cosponsored with PRIM&R that were targeted
at RCR program directors specifically. Several years
ago, we also developed with NIH support one of the first resource
books on this topic, Teaching the Responsible Conduct of Research
Through a Case-Study Approach, which has been much in demand.
We believe, as is consistent with the intent of this notice,
that it is not just trainees who can benefit from explicit
discussion of research ethics and practice, but also more
seasoned investigators. Even those with many years of
laboratory experience and stature in their field can benefit
from periodically revisiting not only regulatory requirements,
but also mentorship, data sharing, authorship, and other areas
of scientific practice where standards are not well established.
That said, the AAMC does hold a number of very significant
concerns about the manner in which the proposed expansion
of the current requirement is articulated in this notice.
First, the notice is poorly written. It includes much
contradictory language, making it hard to interpret.
In particular, many sections of the text are quite prescriptive
in spite of an apparent attempt to offer flexibility.
Second, the mandate as conveyed in the notice is an enormous
undertaking that will consume significant time and resources.
It must, therefore, be accompanied by funds to permit the
development of instructional tools and be implemented within
a reasonable timeframe. Third, given the infeasibility
of developing in such short order programs to train all grant
personnel at once, institutions should have a degree of latitude
in determining who would most benefit from this type of instruction
and, therefore, should be among the first participants.
Those most directly involved in the conduct and oversight
of research, and therefore most influential over its integrity,
should be the priority. We provide more detail on these
concerns below, drawing on examples from the text.
The Notice is Prescriptive in Tone and Lacks Clarity
On a passing glance, the intent of the notice seems rather
benign. One would initially surmise that its drafters
wanted to leave institutions free to educate for the responsible
conduct of research by developing whatever program content
and method of instruction seemed appropriate. But a
closer reading of the notice reveals language that is, to
the contrary, quite prescriptive and heavy-handed. It
states that “any” course “shall” address the core instructional
areas identified in the notice. It mandates that, within
six months of any revision to this requirement, institutions
“shall” revise their written programs of instruction accordingly,
thereby implying that the course plans will correspond closely
to the supposedly “suggested” topics. The entire notice
is peppered with additional language along these lines.
The list of course topics, while certainly addressing important
subject matter, does not include other salient issues that
institutions should address, such as general laboratory safety,
the regulations applying to recombinant DNA, special biosafety
requirements, and so forth. Given the manner in
which the list is presented, there is a risk that institutions
will construct programs around those exact topics, creating
an unbalanced educational experience in order to meet what
are perceived to be minimum standards.
Furthermore, many sections of the notice are unclear and
even contradictory. In the “Introduction,” the requirement
seems to apply to all individuals involved in research at
institutions receiving PHS grants. In the section on
“Scope,” it seems that only individuals actually being supported
on PHS grants must undergo this kind of educational experience.
Section V.B., on “Core Instructional Material,” suggests that
no formal evaluation is required in these courses (such as
a test to assess understanding of the material), but the second
section on “General Policy” states that these courses must
be “successfully” completed, which indeed implies some kind
of examination. The “Definition” section describes programs
of instruction as including many Internet and multimedia formats,
and yet section IX on “Phase-in Period and Implementation”
alludes to “written” programs of instruction. Finally,
while great latitude is implied in institutional methods,
the word “course” is used ubiquitously and is suggestive of
a certain educational approach (e.g., repeated interaction
with an instructor in a classroom setting) that might not
include self-paced methods that employ CD-ROM or Web-based
tools.
The magnitude and complexity of the task cannot be overstated
The current requirement to develop a program of instruction
in the responsible conduct of research applies to institutions
with NIH training grants. The audience for these programs,
T-32 trainees, is both relatively small and fairly homogenous
with regard to educational level and scope of knowledge.
Thus, crafting a course to convey the numerous precepts of
responsible research conduct is a resource-demanding, but
generally manageable task.
Under the new requirement, all personnel on PHS grants would
have to undergo this sort of experience, from the most senior
investigator to the lab technician, and even support staff.
The audience would grow from perhaps 60 participants to 6,000,
depending on the size of the research and training programs
at an affected institution. Whereas small case-based
classroom discussion might otherwise be the educational mode
of choice, this very effective, yet labor and time-intensive
mode of instruction would no longer be feasible on such a
large scale, forcing institutions to use impersonal and mechanical
methods to reach the largest audiences possible.
In addition, experience, skills, and knowledge will vary
enormously among members of such a diverse audience.
Ideally, subject matter and content would be specific to the
needs of these audiences, but to do so would necessitate the
development of multiple educational tracks. Few, if
any, AAMC member institutions would have the resources to
do this at present.
Thus, any mandate to undertake such a demanding activity
on this kind of scale must be accompanied by the resources
necessary to ensure a quality educational experience, as well
as sufficient time to create curricula and to incorporate
these courses into institutional culture and practice.
Grants must be made available to institutions to develop educational
approaches locally, as well as to respected national organizations
and professional societies to develop resources and course
materials for both discipline-specific and general use.
A successful example of this is the AAMC handbook alluded
to above, which was funded through an NIH contract overseen
by the agency’s institutional liaison and research training
offices.
The target audience is poorly defined
The notice cites a long list of specific individuals who
must be subject to RCR training, to wit:
. . .principal investigators, co-principal investigators,
senior investigators, institutional officials who approve
PHS grants, contracts, or cooperative agreements, tenure-track
investigators, students, postdoctoral fellows, technicians,
staff scientists, data management staff, subcontractors, consultants,
clinicians, research nurses, research associates, research
assistants and anyone else involved in conducting the research.
The AAMC believes that this is the wrong way in which to
characterize the kind of individuals who should undergo such
training.
“Laundry lists” lead to errors of omission and encourage institutions
to adopt an accounting approach to compliance rather than exercising
sound judgment. Instead, HHS should take into account
the objective of ethics training, which is to ensure the integrity
of the research activity and the products of that research. Therefore,
it is simply sufficient to say that this requirement applies
to:
Individuals who have direct responsibility for development
of study design, the conduct of research activity, the analysis
and reporting of data, and the integrity of institutional
research programs.
Conclusion
In summary, the Association’s views are strongly in concert
with the principle underlying this announcement: all individuals
engaged in research have something to gain through the explicit
consideration and discussion of sound research practices.
At the same time, we do not believe that this notice enables
that objective in a coherent, feasible way. The
notice itself is over-reaching, prescriptive, difficult to
interpret, and whatever the requirement, would need to be
rewritten to articulate it in an interpretable manner.
Instead, the AAMC believes a different approach is in order.
A successful program to raise awareness of the responsible
conduct of research should be
developed and conducted by individuals enthusiastic
about the objective of such training; being forced to
develop programs will lead to resistance and cynicism;
supported with adequate resources, both for the creation
of instructional material, as well as to compensate for
the time of those who must develop curricula and carry
out instruction; and
tailored to the educational needs of participants, both
with respect to their levels of education and experience,
as well as disciplines.
With these criteria in mind, institutions should be permitted
to develop the specifics of their educational efforts as appropriate
to the characteristics of their research programs. In
addition, they must be accorded adequate time to formulate
curricula, identify resources, and phase-in programs starting
with those topics and audiences that are identified as a priority.
We therefore suggest that, by the two-year deadline cited
in the notice, institutions only be required to provide an
assurance that educational efforts are indeed underway for
key research personnel, defined in the way we propose above.
In fulfilling this assurance, institutions should be permitted
to determine the best manner in which to apply the educational
resources available to them. Furthermore, to promote
institutional compliance efforts, the government must concommitantly
provide mechanisms to fund the development of pedagogical
tools at local and national levels.
Thank you once again for this opportunity to comment.
