Protocol Review - Lab Animal 30(8), 2001

Lab Animal 30(8), 2001

Did an Audiotape Squirrel Away the Minutes?

“Are you sure he said squirrels?” questioned Pat Woods, the IACUC Administrator at Great Eastern University. Al Russo, the Committee Chairman, nodded his head and assured Woods that a group of researchers from the Department of Zoology wanted to do field and laboratory research with ground squirrels. Woods smiled weakly because she knew there would be considerable IACUC discussion about this study.

At the IACUC meeting, it became apparent that Woods was right. The discussion meandered through almost every conceivable nuance of the protocol. In addition to many basic scientific questions, the IACUC discussed housing, dietary needs, and related topics. Woods was furiously writing as an audiotape recorded the discussion. After nearly 45 minutes, the IACUC voted to approve the protocol pending the Principal Investigator’s agreement to several modifications.
A few months later, with the ground squirrel study in full swing, the USDA Veterinary Medical Officer (VMO) came to Great Eastern for his annual inspection. Of course, he noticed the ground squirrels, and because of their uniqueness as a laboratory animal, asked to see the IACUC protocol and the minutes of the associated meeting. Woods had duly noted in the minutes that the IACUC discussed how the animals would be captured, whether appropriate permits were needed, how they would be housed, and whether there were biosafety concerns from enzootic diseases. There also were questions concerning blood sampling in the field and laboratory, euthanasia techniques, and so on. Nevertheless, the minutes did not give much detail. They were largely in single-sentence, outline format, just listing the questions raised by the IACUC. The VMO seemed perturbed, and asked if there was any other written information about the discussion that occurred at the meeting. Woods then told him about the audiotape. The VMO responded that he was looking for appended written information, otherwise it could not be considered part of the meeting’s minutes.

Great Eastern was cited for not keeping adequate minutes of a meeting. The VMO said that the sketchy statements in the existing minutes did not allow him to discern the essence of the IACUC’s deliberations. He pointed to other protocols discussed by the Committee, and noted that they went into much more detail than did the ground squirrel study. When Russo was called into the meeting with the VMO, he strongly objected to the VMO’s position, arguing that although the discussion on the ground squirrels had been long and complicated, the minutes accurately reflected the main areas of concern expressed by the IACUC. He said that just because there was more detail provided about other studies, it did not mean that the minutes reflecting the ground squirrel study were inadequate. He felt that any reasonable person could understand the concerns of the IACUC, and he knew of nothing that required the minutes to provide more detail than that.

Do you agree with Russo or the VMO? Were Woods’ minutes adequate, or is it necessary for IACUC minutes to provide more information?

Minute Detail

Stephen Curtis, DVM, DACLAM

Creating adequate minutes is a troublesome question for many institutions.
The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) recognizes that the topic of IACUC minutes is “one area in particular that continues to draw questions from AAALAC constituents1.” Unfortunately, the Animal Welfare regulations (AWR) lack specificity on this topic. AWR Sec. 2.35, Record Keeping Requirements, states that “the research facility shall maintain… minutes of the IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations [and] records of proposed activities involving animals, and whether IACUC approval was given or withheld…” (emphasis added). There is similar language in the Public Health Service Policy (Sec. IV.E). Lacking explicit guidance, it is not surprising that the facility has cause to disagree with the VMO citation.

Consistency may be the real problem in this case. It appears that minutes covering some protocols provided more details than others did. This drew undue attention to the squirrel protocol and gave the VMO the impression that there was something to hide or that something had been overlooked. Meeting recorders should be careful that fatigue or boredom does not result in a reduced effort when discussions are long or occur at the end of a long meeting. During lengthy discussions, it may be hard to keep up with vigorous exchanges, which may tempt the recorder to summarize without completely capturing the essence of the discussion. Recorders should not be timid in asking members to speak in turn, or in asking for a restatement or clarification of what was said. Recorders may also read back minutes to assure proper content.

In my opinion, and that of a standard dictionary, minutes are only a brief summary of the activities of a Committee. Therefore, the VMO may have failed to give proper attention to supporting documents. I believe the minutes can reference other important documents and documents that helped to bring the Committee to a particular decision. For instance, many Committees designate reviewers for all or selected protocols. These reviewers should be asked to provide written notes, which can be referenced in the minutes and added to the protocol file for future reference. The tape recording of the meeting could be referenced, but in doing so, the tape would have to be archived and saved in accordance with regulations.

Since the tape was still available, the VMO erred in not considering its content. The IACUC Chair might have avoided argument if he had offered to provide a transcribed copy of the squirrel-related section. In fact, if the specific citation is to be corrected, the University may need to submit a more detailed record based on the recording.

The Chair may also have overreacted. It is unclear who requested his involvement, the VMO or the University. Where regulations fail to provide clear guidance, it is sometime better to politely listen to the VMO, engage in civil discussion, and accept the outcome without undue stress or concern. It is unlikely that argument will change the mind of an inflexible VMO; quite the contrary, “a soft answer turneth away wrath, but grievous words stir up anger” (Proverbs 15:1). In many cases, “confession and repentance” will turn a citation into mere words of admonition.

1. Meeting the minute requirement, AAALAC International Connection; Summer 2000:1-4, 2000.

The opinions expressed are solely those of the author and not of the Veterans Administration or federal government. Curtis is Chief Veterinary Medical Officer, VA Greater Los Angeles Healthcare System, Veterinary Medical Unit, Sepulveda, CA.

Take a Minute to Update the Minutes

David L. Carlton, LATG, and Stacy Gillenwater, LAT

If the IACUC had the 45-minute discussion on tape, the tape obviously should have been reviewed, and the minutes updated with all the concerns brought up in the meeting. Everyone involved realized that the use of squirrels would bring up many concerns. Therefore, why should those concerns not have been addressed in the minutes? When keeping records, we must be careful about keeping sketchy, broad outline statements that don’t give specific details about procedures. A one-sentence outline format listing only the questions posed by the IACUC is not acceptable. Clearly, there was information on the tape that was not reported in the minutes. In this case, our vote is for the VMO.

NOTE: Tapes used to record meetings can also be considered a record. According to The Freedom of Information Act, 5 USC §552, as amended by Public Law No. 104-231, 110 Stat. 3048, “record” and any other term used in this section in reference to information includes any information that would be an agency record subject to the requirements of this section when maintained by an agency in any format, including an electronic format.

Carlton is Facilities Coordinator and Gillenwater is Lab Animal Technician in LARR, Texas A&M University, College Station, TX.

A Tape Is Not “Minutes”

Karen Anderson, LATG

One of the main purposes of the IACUC is to act as a mediator between the Institution and the USDA. During the annual inspections, the VMO acts a representative of the USDA. One of the many ways the VMO monitors the actions of the IACUC and assures the Institution’s compliance with the Animal Welfare Act is by reviewing the written minutes of IACUC meetings. As the VMO is not present at the meeting, the only way to effectively communicate the issues addressed at the IACUC meeting is to provide detailed written minutes for the VMO to review at the annual inspection.

In this case, the audiotape of the IACUC meeting was in a format that was not readily accessible to the VMO. As a result, the information cannot be considered an appropriate record of the minutes. Proper documentation of detailed minutes is the only way to assure that the IACUC approval was adequate and that all the concerns of the IACUC members were addressed. Russo’s comments, that the ground squirrel discussion was “long and complicated,” should raise a red flag to the VMO that something may be missing from the written minutes. There is particular concern here due to the complex nature of the ground squirrel protocol. Considering that this is a unique and complicated protocol, it is important for the written minutes of the meeting to provide extensive details of the discussion and comments from the IACUC members. The VMO is correct in thinking that the minutes were inadequate, particularly if his questions and concerns about this species were not addressed in the written minutes he reviewed. The Institution could have avoided the citation by providing a written transcript of the audiotape for the VMO to review.

Anderson is Laboratory Director at NeuroDetective, Inc., Quakertown, PA.


A Word From OLAW and USDA

In response to the question posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) and United States Department of Agriculture (USDA) offer the following clarification and guidance:

The wording related to IACUC minutes, as found in Section 2.35(a) of the Animal Welfare Act regulations and paragraph IV E of the Public Health Service Policy is identical; specifically, research facilities are required to maintain “minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations.” We have interpreted this requirement for a record of Committee deliberations to mean that minutes will include an explanation of the major issues discussed by the IACUC and the outcome of the discussions for each issue. A written transcript of the proceedings is clearly not required or even desirable from the perspective of the federal oversight authorities; rather, there should be enough information for an outsider to ascertain the nature of the discussion and the conclusions reached by the Committee.

The above scenario, as written, does not provide sufficient information to judge whether the degree of detail in the minutes is acceptable. In some cases, it may be obvious what the outcome of a particular deliberation was. For example, the protocol review form may reflect Committee acceptance of the investigator’s proposal to use a specific anesthesia as written. The results of deliberations may also be reflected in IACUC-required modifications to the protocol, which would also show up in the protocol review form and in correspondence with the investigator.

On the other hand, if the deliberations involved substantive issues not covered in the proposal or documented in Committee action, some indication of the Committee’s decisions or actions must be included in the minutes.

For the protocol in question at Great Eastern, it would appear that the minutes listed the questions or issues raised in the Committee deliberations. We are left to guess whether or not the outcome of the actual deliberations was obvious or documented in some other easily demonstrated way. While the audiotape was offered as a well-intended adjunct to the minutes, it is not an acceptable alternative to complete easily reviewable minutes.

Additional records (in this case, the audiotape) that are referenced in the IACUC minutes can be quite helpful when more detail is needed, but such records cannot substitute for the actual minutes that contain a record of the “Committee deliberations.” This ability to reference the discussion can be an important tool for Committees, administrators, investigators, and Institutional Officials. Issues that arise during the course of a study, semiannual inspection, or protocol review can often be easily resolved with a reference to the prior discussion.

From a practical standpoint, it is simply not feasible for an IACUC, an inspector, or a site visitor to search through (potentially) several hours of audiotape to glean the information that should be readily available in summary format in the minutes. Indeed, if audiotapes were acceptable, some institutions might choose to use them in lieu of adequate minutes, thus leaving inspectors and IACUCs with no choice but to listen to hours of tape in order to determine the adequacy or content of Committee deliberations and activities.

Nelson L. Garnett, DVM
Director, Office of Laboratory Animal Welfare
National Institutes of Health
W. Ron DeHaven, DVM
Deputy Administrator
USDA, APHIS, Animal Care
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