|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Guidance for Reviewers|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
|Lab Animal 34(2), 2005|
The foibles of ‘electronic IACUCs' never seem to stop. Perhaps they result from the relative novelty of the concept or because there are no definitive guidelines on what is or is not acceptable. Consider what happened to the Great Eastern University IACUC during an evaluation of the procedures necessary to approve or request modifications to a protocol that was sent for Designated Member review. At Great Eastern, each Designated Reviewer (DR) received an electronic copy of the protocol along with a request to evaluate it. The DRs could communicate with each other, if they chose to, by any means they preferred. The reviewers emailed written comments to a previously selected ‘primary reviewer' (PR), who would ensure that all the other reviewers were speaking with unanimity to the Principal Investigator (PI). For example, if all reviewers agreed to approve the study, they would then email this information to the PR. In turn, the PR emailed the IACUC office and informed the IACUC administrator that all reviewers were in agreement to approve the protocol. If there was no agreement to approve the study, then the PR would synthesize the comments of the other reviewers and email the PI (via the IACUC office) with the requested modifications to help secure approval. The other reviewers received a copy of all emails. If, after two interactions with the PI, no agreement could be reached for approving the protocol, then it was automatically sent for Full-Committee review at the next scheduled meeting. Of course, any DR could request Full-Committee review at any point in the process.
The problem facing Great Eastern was not the general process but the specific means of indicating approval. The IACUC Administrator was cautious about any process in which the PR claimed that all DRs approved a protocol, yet there was no documentation from the other reviewers to prove that. After a discussion at an IACUC meeting, one member suggested that the easiest solution was to use the voting feature on the email program. Unfortunately, the school had more than one email program, not all reviewers had the voting feature, and, in any case, they could not agree on the details. Someone then suggested that the PR continue to copy all other DRs on the approval email that he or she sent to the IACUC office. With this approach, members reasoned, any reviewer who believed that he or she did not truly approve a protocol could immediately raise objections. The IACUC Administrator was not happy with that suggestion, because it was the same system they were currently using. Furthermore, because the approval would have already been recorded and any dissent would require that it be negated, it was a process that she did not want to incur. Her preference, under the circumstances, was to have each reviewer send her an email signifying approval. Nevertheless, the Committee voted to maintain the status quo. The rationale was that, not only was it easy to do, but there was also nothing to suggest that it was not in compliance with any existing federal regulation for approving an IACUC protocol by the Designated Member review process.
Do you agree with the actions and logic of the Great Eastern University IACUC?
Kelvin C. Buchanan, DVM, MPH, DACLAM
Though not stated in the scenario, we are to assume that the protocol going to the DRs has been previously sent to all members of the IACUC, any of whom have the right to call for a Full-Committee review. Given that no member calls for a Full-Committee review, it seems that the process that Great Eastern University's IACUC has been using to review protocols, by use of the DR method, complies with the Animal Welfare Act Regulation and is consistent with guidance provided by the Office of Laboratory Animal Welfare and the United States Department of Agriculture1. The Chair of the IACUC may appoint an individual to be the PR and grant him or her the authority to convey the final approval decision. DRs do not have the authority to disapprove a protocol. They can only “…approve, require modifications in (to secure approval), or request full Committee review…2.” Therefore, in effect, they do not vote. If, in the end, all DRs are not in agreement, then the protocol must go before the convened IACUC for a Full-Committee review. The suggested use of the voting feature on the email program would seem to give the erroneous impression that the DRs were voting.
If the Chair has appointed a PR and granted him or her the authority to convey the final approval decision, then there is no need for the IACUC Administrator to have on record documentation from all DRs indicating so. It is incumbent upon the PR to ensure that the process is complete before notifying the IACUC Administrator of a decision. All DRs must see the final product as changes are made and give agreement for approval before the PR conveys such approval. If the other reviewers are receiving email of all correspondence and interactions as indicated, then there should be sufficient communication to make an informed and appropriate decision.
1. Garnett, N. & Gipson, C. Suggestions to bring electronic protocol system into compliance. Contemp. Top. Lab. Anim. Sci. 40(6), 8 (2001).
2. 9 CFR, Subchapter A.
Buchanan is Chief, Veterinary Resources, Air Force Research Laboratory, Brooks City-Base, TX.
Verda A. Davis, BS, RLAT
PHS Policy outlines the procedure for Designated Member review of IACUC protocols, stating that the IACUC Chair may select one or more members qualified to review the protocol. The Designated Members act on behalf of the entire IACUC to approve the protocol, request additional information from the PI, or to refer it for a Full-Committee review. There are, however, no specific guidelines for the emailing of Designated Member approval. Each IACUC must devise a comprehensive system to satisfy all possible contingencies and comply with federal regulations. I agree not with the IACUC's decision to have a PR email approval to the IACUC office, but rather with the IACUC Administrator's request that each DR email his or her approval to the IACUC office. I feel that the IACUC office must have some documentation from each reviewer that they do indeed approve the protocol. The IACUC Administrator has a valid fear that a case could arise in which an approval is recorded while one of the DRs did not truly believe they had approved it. We are all familiar with downed servers and the failure of some emails ever to arrive. What if the PR sends the approval email to the IACUC office with copies to each Designated Member, but the one member who did not truly feel he or she approved the protocol is not in the office that day, or does not receive the email right away? It is much easier to catch the dissent before approval is recorded, than to have to rescind a protocol approval. Is it that difficult and time consuming for each DR to email the IACUC office rather than the PR?
Davis is Research Analyst, University of Kentucky, Anatomy and Neurobiology, Lexington, KY.
Susan R. Blumenthal, PhD
The problems facing Great Eastern's IACUC are not unique to their institution or the use of electronic communications. Although the use of electronic communications in IACUC processes and procedures is relatively new, they do not fundamentally change regulatory requirements for these processes and procedures. Under PHS Policy and AWA/USDA Regulations, there are two acceptable methods of protocol review—Full-Committee review and DR review—both of which are specifically described. It is not clear whether the protocols are being handled properly by allowing for any member of the Committee to call for Full-Committee review before assignment of the protocol to the DR process. However, for the purposes of this discussion, we will assume that the Committee has properly assigned the protocols.
Although the primary concern of the Committee was about the details of expression of agreement among the DRs and the PR for protocol approval when communications were conducted electronically, this is a minor issue that is amplified by the awkward system currently in use. The authenticity of the electronic communications is not in question in this situation, as they are in most problems using electronic communication as part of the review process; instead, it is the lack of documentation being provided to the Committee, a concern about the absence of the usual full and open communication among all of the DRs, the PR, and the Administrator, and the use of an overly complex, quasi-legitimate process that is creating the problem.
Regulations do not require full and open communication among the DRs, nor do they require a PR. Regulations do require that one or more DRs be appointed by the Committee to review a protocol. The DRs can then either approve the protocol or refer the protocol for Full-Committee review; they cannot reject a protocol or withhold approval. In addition, not only must all DRs approve or require the same modifications, but all DRs must also review each revision of the protocol. The Great Eastern system is not fully satisfying these requirements.
DRs do not function as true DRs, but act as a subcommittee performing a prereview of the protocol, which is forwarded to a PR, who then functions as a facilitator of the prereview and/or as a true DR. The DRs do not seem to have final authority on approval or referral to Full-Committee review of a protocol (that seems to be indirectly under the authority of the PR), and it does not seem that all of the DRs are reviewing each revision of a protocol. However, the Regulations do not give this authority to a PR. A DR system of this design is not only awkward and unwieldy with its multiple layers of authority and input, but it is also within the gray area of legitimacy in complying with the Regulations.
In this particular situation, the Committee is attempting to improve the function of a system that has gone awry. Although this is a commendable and much-needed goal, they are attempting to correct a problem with the system's design by adding further responsibility onto a dissenting DR (who may already be unlikely to interject dissent at this late stage in the process), or by adding yet another layer of authority to the system. Wisely, the Committee chose not to increase the responsibility on a dissenting DR, or to add another layer of authority to the system. Unfortunately, they also did nothing to repair the system.
A wiser course of action would have been to follow the old acronym KISS (Keep It Short and Simple) and redesign their DR system. A true system of Designated Review could eliminate the PR. The DRs could communicate directly with the IACUC office, which could then consolidate the DRs' initial response to the PI and then facilitate communication back and forth between the PI and all of the DRs. The limit on interactions between the PI and the DRs is an appropriate mechanism for eliminating a prolonged review process on a difficult protocol and should remain in place.
Thus, the IACUC Administrator would have the documentation of the review process that she rightly desires, the DRs would fulfill their responsibilities in a legitimate manner, there would be fulfillment of the letter and intent of the Regulations for a DR review, and no changes would need to be made in the use of electronic communications.
Blumenthal is Director, Comparative Medicine, Carolinas Medical Center, Charlotte, NC.
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:
IACUC communications can be complex. USDA regulations and PHS Policy allow the IACUC Chair to designate (if Full-Committee review has not been requested by any IACUC member) at least one qualified IACUC member to review research projects involving the care and use of animals. The phrase “primary reviewer” does not exist in regulation or policy. Each Designated Reviewer has the authority to approve, require modifications in (to secure approval), or request Full-Committee review. If any Designated Reviewer calls for Full-Committee review, then the protocol must go to Full-Committee review. If modification of the protocol occurs at any stage of the review, all Designated Reviewers must see and approve the changes. If each Designated Reviewer approves the protocol they must all reference the same version of the protocol. All Designated Reviewers' approvals, requests for modifications, or calls for Full-Committee review must be documented.
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