Office of Laboratory Animal Welfare
Jerald Silverman, DVM, Column Coordinator
As befalls many large institutions,
Great Eastern University had its share of “problem children,” and Dr. Dante
Blanchard was up there with the best of them.
The IACUC contacted Blanchard in writing two months, and
then one month before his IACUC-approved protocol was due to expire. Both times,
the IACUC informed him that he had to submit an entirely new IACUC protocol for
review if his research was to continue. When the expiration date finally
arrived, Blanchard received a curt letter from Dr. Dottie Wessin, the IACUC
Chair, informing him that he could no longer continue any research on his
protocol. True to form, Blanchard was very apologetic, extremely polite,
provided a weak excuse, and asked Wessin for a three-week extension on his
project. Wessin reminded him that the maximum period of approval for his
PHS-funded rat study was three years, and since that time had arrived, a new
protocol submission was required.
Blanchard became more demanding, arguing that either
Wessin or the full IACUC should grant him a small extension of time,
particularly since the project did not begin for some months after the IACUC
approved it. He said that rewriting an entire protocol for a project that would
be over in 21 days would waste everyone’s time. Further, he said he was unaware
of any policy or regulation that required him to submit a new protocol. He said
that since there were no changes to his procedures, the IACUC should review his
existing protocol and he would finish the study. Wessin told Blanchard to
continue his work until the next IACUC meeting, which was scheduled for two days
At the meeting, Wessin expressed her displeasure with
Blanchard, but asked the IACUC to consider a brief extension of his protocol.
This was agreed to by all but one person who said that he didn’t want to set any
precedent that the committee might later regret. Wessin said that she was
sympathetic, but if the IACUC did not extend the protocol, not only would there
be more work for the IACUC, but Blanchard or somebody else would have to
continue the treatments that the animals were getting, otherwise the entire
project would be lost and the lives of the animals would be wasted.
If Wessin asked you to be a consultant to this IACUC,
what advice would you give her?
Ellen J. Croxford, AA, RLATG
It is, indeed, most unfortunate that
we face this kind of dilemma more often than we should. There seems to be a very
small percentage of researchers who choose to think that their work should
receive special consideration “just because.” They count on the IACUC to allow
them to continue with their work, regardless of consequence, and their blatant
disregard for the rules sets them apart from the majority of scientists who
conscientiously follow the rules. The IACUC and Wessin have a multi-fold problem
with this particular researcher.
First, it is not the IACUC’s responsibility to see that
the project starts on time. The delay of several months had nothing to do with
the approval, as that had already been given. Blanchard bears full
responsibility for the project not starting on time.
Next, Blanchard was given ample opportunity to request an
extension of his protocol. He chose to ignore two written requests to submit a
new protocol, and did not respond until his research was suspended. That, too,
is his responsibility. Just because the project did not start on time, why would
Blanchard think it would be allowed to go beyond the expiration date of his
Blanchard’s argument that filling out a new protocol
would “waste everyone’s time” is distressing. To participate in the pursuit of
knowledge as it pertains to the scientific process in a responsible manner is
never a waste of time. Since Blanchard’s funding comes from PHS, he must
certainly have been aware of the requirements for a new protocol at the
expiration of his grant. If things are as he says and the protocol has not
changed, then it is a matter of copying the old protocol with a new date along
with any relevant changes of personnel and animal numbers. It could be as simple
as filling out a new cover sheet. I’m sure that Blanchard has the old protocol
saved on his computer or on a disc somewhere. If not, he could probably find a
research assistant to fill out the necessary paperwork (which is most likely
what he did originally), and then it is a matter of reading it and signing his
The real dilemma is what to do. My suggestion would be to
allow the study to be extended for the three weeks. Three years of work and the
lives of the animals involved cannot be ethically tossed aside. It is the
IACUC’s responsibility to see that research animals are used in an appropriate
manner and not wasted. I would, however, insist that Blanchard present to the
IACUC a new protocol and a letter explaning why the study did not finish on
time. I would also suggest that Blanchard be censured for his disregard of
proper procedures with respect to filing for an extension when it was clear that
he would not finish the study before his protocol expired. A copy of this should
be forwarded to the PHS as required by law when a protocol is suspended or
expired. This would set the precedent that there are definite consequences for
those who ignore the rules.
Croxford is the ASD Supervisor, St. Jude Children’s Research Hospital, Animal Research Center, Memphis, TN.
Adapt Their Methods
Marge Piel, MS, DVM
The Animal Welfare Act (AWA) requires
the IACUC to perform continuing reviews of all activities being conducted in the
facility at least annually. It does not require that these annual reviews be
based on written protocols (although most institutions use some sort of document
for review of ongoing projects, if only to facilitate documentation).
Presumably, Great Eastern’s IACUC conducted its annual project review of
Blanchard’s work, and was satisfied that he had met the AWA requirements for a
proposal. The fact that his project is taking a few additional weeks to complete
should not preclude his being allowed to complete this project, nor require that
he submit another protocol for approval. The IACUC should grant a three-week
extension, but make clear to Blanchard that his work must be completed within
that time frame.
With a history of his being a “problem child,” the IACUC
should not have relied solely on written notification to Blanchard two months
(and then one month) prior to their deadline. Wessin waited until the deadline
arrived to contact Blanchard, and then responded with a “curt” letter. Thus, she
further set the tone of the situation as an antagonistic one, which could have
led to Blanchard’s eventual defensive stance. Verbal communicationæa short five-
or ten-minute phone call during which the IACUC chairperson or representative
could have elaborated on the requestæwould not have taken any more time than
Wessin used to compose her “curt” letter and could have elicited a prompt
response from Blanchard well in advance of the deadline.
Many investigators may seem flippant towards IACUC
communiqués because they do not understand the IACUC’s mission and goals or the
role that they, as investigators, play in both animal care and use and
regulatory compliance. Just as skilled teachers adapt their teaching methods to
their pupils’ different methods of learning, a skillful IACUC may need to employ
a variety of communication methods, adapted to their individual investigators,
to foster cooperation. To assist the IACUC in this task, a question could be
added to the institution’s protocol form that asks the investigator to indicate
her or his preferred method of communication (e.g., email, phone call
with or without voice mail message, letter, or memo) regarding renewal
reminders. This may facilitate prompt responses to IACUC notices and, as an
added benefit, may advance a positive image for the IACUC to their
investigators—that the IACUC is interested in facilitating quality research and
in communicating with investigators as individuals rather than as protocol
Piel is a Clinical Veterinarian at Searle, Skokie, IL.
To Help or Hinder
Brad Williams, DVM
The IACUC is in the difficult position of simultaneously
advocating for animal well-being, managing regulatory compliance, and supporting
the research process. The arbitrary regulatory requirement of complete protocol
review every three years (Section IV.C.5, PHS Policy) often seems a
nuisance, particularly with many grants lasting five years. However, the mandate
is not without purpose. As our knowledge base changes, there are times when
improvements in animal care or study design should occur.
Whether Blanchard must submit a new protocol for IACUC
review depends on the funding agency, the animal species used, and institutional
policy. Since PHS funds Blanchard’s project, the PHS Policy applies. The
IACUC, however, can develop their own unique method to accomplish this goal. The
original protocol could be duplicated, assigned a new protocol number/ID, and
easily qualify for expedited review. This would minimize the effort by all
parties and satisfy regulatory requirements.
Blanchard had adequate opportunity for protocol review
before the existing protocol expired, but chose to ignore the IACUC
correspondence. If animals could be maintained without further treatment and the
project would not be jeopardized as a result, a temporary extension until
appropriate IACUC review occurred would not be warranted—all activities would
need to cease until IACUC review was possible. If animals require ongoing
treatments that started before the expiration of the protocol, a temporary
extension until the expedited review was complete would be justified. This
provides an excellent time to review IACUC procedures and re-emphasize the
importance of the IACUC review process. An appropriate condition for the
protocol approval would be a refresher course on the functions of the IACUC and
institutional policies and procedures.
Williams is the Campus Veterinarian, University Research Office, University of Idaho, Moscow, ID.
A Word from OPRR
For PHS purposes, the maximum interval between
IACUC approvals for an ongoing activity is three years (PHS Policy at
IV.C.5). There is no provision for IACUCs to grant administrative
extensions of that time interval. Accordingly, a formal continuing review
process using one of the two described procedures in the PHS Policy at
IV.C.2 is required in this case. Continuation of animal activities beyond
the maximum approval period without such review would be a violation of
PHS Policy and the terms and conditions of the NIH grant.
The PHS Policy does not specify a format for
protocol resubmission, but assumes that the information available to the
IACUC for continuing review is complete and current. Great Eastern
University appears to have adopted an institutional policy requiring the
submission of completely new protocol forms as part of its renewal
process. If Great Eastern has incorporated this policy into its approved
Assurance, OPRR would expect adherence to it. See
http://grants.nih.gov/grants/oprr/contop96.htm for further discussion of
the continuing review issue.
Nelson L. Garnett, DVM, Director, Division of Animal Welfare, Office for Protection from Research Risks, National Institutes of Health.