Alternate IACUC Members: What Are the Rules?
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Jerald Silverman, DVM, Column Coordinator

Lab Animal 34(1), 2005

Alternate IACUC Members: What Are the Rules?

Once again summer vacations and professional meetings took their toll on the number of members present for a Great Eastern University IACUC meeting. However, unlike past years, the Committee believed it was now prepared to deal with the situation. As soon as Helen Trotta, the IACUC secretary, discovered that two of the three scientists on the IACUC would not be present at the upcoming meeting, she called Dr. Tommy Hendricks. The Chief Executive Officer (CEO) had appointed Hendricks, also a scientist, as the alternate for any of the scientific members of the Committee. He was available for the meeting, and all went smoothly.

The evening after the meeting, Trotta casually mentioned the day's events to her husband, George. To her surprise, George, an IACUC administrator at another university, questioned the legitimacy of what had transpired. He was of the opinion that an alternate member could only serve on behalf of one specifically named regular IACUC member, and also had to have the same designation as the regular member. He said that Hendricks, as a scientist, could only serve as an alternate for one specifically named scientist. “I don't think so,” said Helen. “As far as I know, a person can be appointed as an alternate for one, two, three, or any other number of people, as long as that alternate has the same designation as the absent member. We named Hendricks, who's a scientist, as an alternate for any scientist on the committee. He didn't vote twice, George, he only voted once, so as far as I'm concerned, there's no problem.” “Well, there's no problem until you get caught” said her husband. “If I were you I'd think twice about this.”

What is the correct answer to the disagreement between Helen and George Trotta?


Call the Florist, George
David Burbank, PhD

George, George, George, “until you get caught … think twice.” Call the florist, George. Then, practice saying, “Helen, I'm sorry; you're right.”

OLAW, with USDA's concurrence, issued guidance regarding alternate IACUC members1. The provisions listed therein include the following:

“There must be a specific one-to-one designation of IACUC members and alternates. This is necessary to ensure that a committee is properly constituted, even when alternates are serving. For example, an alternate for a non-affiliated IACUC member would need to also meet the non-affiliated member requirements. Use of a pool of alternates would not be consistent with this requirement.”

This provision neither prevents an individual from being appointed as an alternate for more than one regular member, nor does it preclude a regular member from having more than one alternate. Each alternate member must have adequate training and must meet the applicable membership requirements for the regular member(s) for whom he or she is appointed as an alternate. Obviously, it can get confusing. This is another reason there must be a specific one-to-one designation of regular IACUC members and alternate members (i.e., for each regular member–alternate member relationship or appointment).

For example, let us give the two absent scientists in this scenario names, Smith and Jones. Both serve on the Committee in the scientist capacity or role. If Hendricks is a practicing scientist and is experienced in research involving animals, then the CEO can appoint him as an alternate member for Smith and as an alternate member for Jones. These are two separate specific one-to-one designations. Hendricks can, however, only actively serve in the alternate capacity for one member at a time.

The meeting minutes should reflect that Hendricks was present at the meeting and was actively serving, in an alternate capacity, for Smith or for Jones—but not both. Because Hendricks voted only once (I assume this to mean that he had only one vote—either as Smith's alternate or as Jones' alternate), it would seem that there is “no problem,” George.

In George's defense, he was of the opinion that an alternate member can only serve on behalf of one specifically named regular IACUC member. At a single point in time, this is true. At any given time, an alternate can only actively serve as an alternate for a single member. However, as described earlier, it is permissible for an individual to be appointed as an alternate for more than one regular member.

References

1. National Institutes of Health. Office of Extramural Research guidance regarding administrative IACUC issues and efforts to reduce regulatory burden. NOTICE: NOT-OD-01-017 (12 February 2001).

Burbank is an Investigator at Great Eastern University.


By George, He's Got It!
Joseph D. Thulin, DVM, MS, DACLAM

Helen should listen to George. The use of alternate IACUC members can be a very effective way to spread the Committee's workload and to have a contingency for absences. However, the practice comes with some risks, and its implementation should include some thoughtful planning. An alternate member may be called at a moment's notice to fulfill the responsibilities of a regular IACUC member. As such, it should be obvious that the alternate member must meet certain requirements to function adequately; for example, he or she should be an appointee of the CEO or Institutional Official and have training consistent with that provided for the regular IACUC members. The manner in which they are ‘activated' is important as well.

In the absence of official guidance, some institutions in the past had developed rather creative ways to employ alternate members. One extreme practice placed the alternate IACUC members in a pool of extras from which individuals could be called to substitute freely for any absent regular member to achieve a quorum at a convened meeting or as a member of the team conducting semi-annual inspections of facilities. Of course, this raised questions about whether a nonscientist alternate could substitute for a scientist regular member and similar questions about the ‘equivalency' based on the expertise of the alternate relative to the regular member. In addition, the pooled-alternate practice could be construed as a means for an institution to achieve a quorum with, say, 25% plus one of the total IACUC appointees (assuming an equal number of regular and alternate members).

Even though the scenario at Great Eastern is not as extreme as this example, it does present some of the same difficulties. Can the alternate scientist member adequately represent any of the regular scientist members? Perhaps. Is the University bolstering the total number of IACUC appointees in a manner that achieves a false quorum? Perhaps. To avoid such questions, I think it's best for the University to do what George has suggested—that is, appoint one alternate for one specifically named regular member.

However, even if Helen holds the view that these aren't problems for the policies at Great Eastern, she ought to be aware of NIH guidance published on this topic1. The NIH notice states, in part, “There must be a specific one-to-one designation of IACUC members and alternates.” If Great Eastern is receiving PHS funding or uses USDA-regulated species, the University should follow the NIH guidance on this.

Reference

1. National Institutes of Health. Office of Extramural Research guidance regarding administrative IACUC issues and efforts to reduce regulatory burden. NOTICE: NOT-OD-01-017 (12 February 2001).

Thulin is Attending Veterinarian and Manager, Veterinary Services Department, 3M Health Care Business R&D, 3M Company, St. Paul, MN.

A Word from OLAW and USDA

In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:

The intent of the NIH Notice issued 12 February 2001 (ref. 1) is to provide guidance concerning the use of alternate IACUC members. It outlines a number of provisions that must be met in order to properly use such a system. One of these provisions is that there must be a specific one-to-one designation of IACUC members and alternates. This is necessary to ensure that a Committee is properly constituted, in accordance with PHS Policy and Animal Welfare regulations.

This does not preclude one alternate being designated for more than one regular member, provided the alternate for a member who fulfills a particular membership requirement 2,3 also fulfills that requirement.

The scenario states that “Hendricks, also a scientist, had been appointed by the CEO as the alternate for any of the scientific members of the Committee.” This is not a one-to-one designation. If the CEO had appointed Hendricks as the alternate for Smith, and Hendricks as the alternate for Jones, and Hendricks as the alternate for Brown, each appointment would be a specific one-to-one designation. However, if multiple scientific members (Smith and Brown) were absent for a Committee meeting, Hendricks would serve as an alternate for only one of them. This could result in the IACUC not achieving a quorum for the meeting.

Conversely, the CEO might appoint more than one alternate to represent a particular member (assuming the provision in the second paragraph is met) as long as each designate is specific one-to-one (e.g., Hendrick is appointed as the alternate for Smith, and Taylor is appointed as the alternate for Smith). The use of a generic “pool of alternates” for IACUC members is prohibited in order to ensure proper IACUC constitution.

Regardless of the system used by the research institution, the alternate designations should be listed on the IACUC rosters for review by both OLAW and USDA.

References

1. National Institutes of Health. Office of Extramural Research guidance regarding administrative IACUC issues and efforts to reduce regulatory burden. NOTICE: NOT-OD-01-017 (12 February 2001).
2. Public Health Service. PHS Policy on Humane Care and Use of Laboratory Animals IV. A.3.b.(1)-(4) (US Department of Health and Human Services, Washington, DC. revised 2002).
3. 9 CFR 1, Chapter 1, Part 2, 2.31. (b)

Carol Wigglesworth
Acting Director
Office of Laboratory Animal Welfare
OER, OD, NIH, HHS

Chester Gipson, DVM
Deputy Administrator
USDA, APHIS, AC

The original article is listed on the Lab Animal Web site, www.labanimal.com, and the citation is Lab Animal. 2005; 34(1): 11-12.

This paper can be downloaded for personal study use and cannot be copied for commercial purposes without the permission of the publisher.

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