Protocol Review - Lab Animal 25(5), 1996

Lab Animal 25(5), 1996

Majority Rules?

Once again, the Great Eastern University IACUC found itself facing a dilemma with no resolution in sight. A drug trial protocol in sheep spurred a debate. The protocol’s purpose was to determine if a new antihelminth was effective in eradicating certain intestinal parasites that are poorly controlled by current means. The details of the proposed study led to significant disagreements among the committee members, not the least of which was whether the IACUC should even review this protocol. Finally, after a committee member seconded a motion, a vote was taken. Six members voted for approval of the study, three members voted against approval, and six members abstained from voting. The chair stated that the committee approved the protocol.

John Stanza, one of the negative voters, objected to the approval. He noted that of the IACUC’s 20 voting members, only 15 had attended that day. Therefore, he said, as required by both Public Health Service (PHS) policy and Animal Welfare Act (AWA) regulations, a vote for approval, a majority of the quorum present, required at least eight favorable votes. Because only six members voted favorably, he argued that the vote was against approval, not for approval. The chair politely corrected him, noting that abstentions are not counted. He said that without the abstentions, there were nine votes, six in favor, and three opposed. Therefore, the chair said, the vote was for approval, and the motion to approve was passed.

Stanza took a minute to think about the situation. He then said to the chairman, “You cannot have only nine members voting, since nine members do not constitute a quorum of the full committee.” The full IACUC had 20 members and that required 11 voting members to make a quorum. “I’m sorry,” said Stanza, “but no matter how you look at it, this protocol is either disapproved or we have to postpone action until we can get a quorum.”

In terms of the actual vote, was this protocol approved, disapproved, or in need of postponement? If you chaired this IACUC, what actions would you take to resolve the problems surrounding this protocol in a timely manner?


What’s a Quorum?

Ronald M. McLaughlin, DVM

The algorithm surrounding this protocol is, “Should the IACUC review the protocol?” If so, “What constitutes a quorum of the IACUC?” Given a quorum, “What number of yes votes is required to approve the protocol?” And finally, “Is the protocol, as described, actually approved?”

Should the IACUC review the protocol? If the study is agricultural (which it seems to be), the AWA regulations exclude it from mandatory consideration. If it is biomedical, the same regulations require its review. Under the PHS policy, a review is mandatory only if the PHS funds the work. However, if an institution, via its Assurance statement to the PHS, states that it will include activities funded by sources other than PHS, it is obligated to comply with that Assurance until it is changed. An institution could, on the other hand, exclude non-PHS-funded or agricultural animal activities from its Assurance statement, yet still require the IACUC to review protocols using those animals. Whether the IACUC is actually required to review the protocol in question depends on all of the above, and the IACUC chair must be aware of these issues. In the final analysis, there is virtually no risk in reviewing a protocol for which review is not mandatory, but there is significant risk in not reviewing one for which review is necessary.

What constitutes a quorum of the IACUC? A quorum is the number of members of a body required to legally conduct its business. Generally, a quorum is taken to mean a majority of the members. As a rule, organizations may provide for fewer, or selected members to constitute a quorum. For IACUCs, however, the AWA regulations and PHS policy define a quorum as a majority of the members. Both AWA regulations and the PHS policy state that a member who has a conflict of interest may not contribute to the constitution of a quorum. My interpretation is that a member with a conflict of interest does not count as either present or absent in determining a quorum, which seems logical and fair. If, in the case under consideration, the six abstentions are due to conflict of interest, the total countable number of IACUC members is 14 (the actual number of 20 minus the six with a conflict of interest). Eight or more constitute a quorum, and five votes carry a motion. So, the motion is approved.

If the abstentions occur for reasons other than conflict of interest, one must ask, “How many yes votes are required to approve the protocol?” Both the AWA regulations and PHS policy specify an “approval vote of a majority of the quorum present.” Robert’s Rules of Order, Article VI Vote, Section 38, define a majority vote: “a majority of the votes cast, ignoring blanks, is sufficient for the adoption of any motion that is in order.” In other words, what matters in determining a majority vote of a quorum is the number of votes cast in favor versus those cast opposed, not the number of votes in favor versus the number of members present. So, either way, the protocol is approved. Abstentions for reasons other than conflict of interest may represent problems beyond procedural issues in the IACUC.

If I chaired the IACUC, I would strike my gavel smartly on the table, declare the protocol approved, and advise John Stanza that further discussion after the vote is not in order. I would direct him to the Institutional Official if he asked for further clarification or appeal.

Dr. McLaughlin is Director, Office of Laboratory Animal Medicine, University of Missouri, Columbia, MO.


Try Diplomacy

H. Hugh Harroff, Jr., DVM, ACLAM

If I chaired the Great Eastern University IACUC, I would seek a vote to postpone action on this protocol in order to have the time to talk individually with the members of the committee. While I believe that a quorum was present and the members had a fair opportunity to vote for or against approval, I think that “hanging one’s hat” on the votes of only six out of 20 members is certainly contrary to the intent of having an IACUC. Of particular concern is the large number of abstentions.

In my opinion, there are very few valid reasons for abstaining from voting, and they all have to do with an individual member’s involvement in the study. If, however, the abstaining members did so because they believed that the IACUC should not even consider the protocol, I would suggest they vote on whether or not to review the protocol at the next meeting. Then, if the IACUC decides to review the protocol, all members not directly associated with the study must vote. During the time afforded by the postponement, I would hope to gain an understanding among all members that everyone’s vote is important in accepting or rejecting the study.

This case seems a good example of a situation in which the chairman must very carefully conduct business in a manner that is fair to all members. Even though by strict “book” interpretation, the supporters of the study probably carried the vote, allowing so few members to decide on the question appears as though the committee was manipulated to achieve a desired outcome. If the protocol is good and the study worthwhile, the committee as a whole will come to the same conclusion when everyone votes. In addition, a more cohesive action will reinforce feelings of fairness, teamwork, and value for the opinions of others. As the IACUC chairman, I would remain mindful of the fact that I would not want to gain approval of one study (i.e., win a skirmish) at the expense of losing the war by disrupting the vital harmonious interactions of my committee members.

Dr. Harroff is Chief, Laboratory Animal Resources Division, Wilford Hall Medical Center/RD CID, San Antonio, TX.


A Note From the NIH and USDA

Stanza is partially correct in his interpretation of the PHS policy on Humane Care and Use of Laboratory Animals and the regulations of the AWA. Both documents are explicit that approval of a research project requires an approval vote of a majority of the quorum present. In this case, the quorum present was 15, more than the minimum number of members needed to constitute a quorum. The minimum number of votes needed to approve the protocol is a majority of the 15 members present (i.e., eight approval votes). Although the abstentions do not contribute anything to the number of votes cast for or against the motion, neither do they alter the “quorum present.” Therefore, the number of approval votes needed (eight) remains the same. It does not follow that the protocol was disapproved. Approval was simply withheld.
Without the specific instructions in the PHS Policy and AWA regulations governing the “majority of the quorum present,” and in the absence of any institutional policies to the contrary, the chair may have correctly interpreted ordinary parliamentary procedure. Based on a layman’s understanding of Robert’s Rules of Order, and in the absence of specific modifications in an organization’s bylaws, abstentions are treated in the way described by the chair, and a simple majority of the votes cast would mean an approval vote. Obviously, federal policy and regulation take precedence in this case.
Nelson L. Garnett, DVM, Director, Division of Animal Welfare OPRR, NIH, Bethesda, MD and Dale Schwindaman, DVM, Deputy Administrator, USDA, APHIS, REAC 21763A3F45F4, Washington, DC.
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