Problem Children
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Protocol Review
Jerald Silverman, DVM, Column Coordinator

Lab Animal 29(3), 2000

Problem Children

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 later.

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?
 

“Just Because”

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 protocol?

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 name.

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 numbers.

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.

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