Michael Mann, Ph.D., executive chairman of UNMC’s Institutional Animal Care and Use Committee (IACUC), shares the following message with all investigators using animals in research.
Use only current forms
The IACUC periodically revises the application forms to clarify information it requests or to request additional information. The forms on the IACUC Web site http://www.unmc.edu/iacuc/forms.html are the latest, up-to-date versions. Please use the current form from the Web site for all submissions. Effective May 1, submissions made on old forms will be returned.
Justifying animal numbers
As you know, the IACUC requests a justification for the number of animals requested in an application. The most acceptable justification is the result of a power analysis, which is essentially a statistical test run backward to obtain the value of n. To do such a test, you supply what you think will be the difference resulting from your treatment (effect size), the variances that you expect, the p value that you will use, and the power that you want to have in finding significant differences. When those are plugged into the statistical formulae, the unknowns are the values of n. On the IACUC Web site are a number of links to Web sites at which you can supply these values for various kinds of statistical tests; the Web site will then return the value of n. A number of commonly used statistical packages, e.g., SigmaStat, also include the ability to make power analyses. What the IACUC wants are the parameters that you plugged in along with the n that was returned.
Besides the advantage of supplying the information that the IACUC requires, the use of a power analysis has the advantage of helping to ensure that you have enough animals in your study. Even if the treatment used in the study does have an effect, you will not be able to detect it if you use too few animals. In that case, you would be wasting your time and the animals. The IACUC is required to certify that you are using the proper number of animals — that’s why the information is requested.
There are some kinds of experiments for which a power analysis is inappropriate. For example, studies in which animals are used primarily to collect tissues for use in various assays (whether or not the animals are pre-treated somehow) may not lend themselves to power analysis. In these studies the justification should be presented in terms of the amount of tissue required for the assays and the amount of tissue that can be acquired from a single animal.
IACUC certification of approval of animal use in grants/contracts
As you know, many granting agencies require the IACUC to certify that it has reviewed and approved the animal use aspects of a grant proposal before the grant is funded. The Sponsored Programs Administration (SPA) Office at UNMC requires this certification whether or not the granting agency requires it. When you submit a grant proposal or develop a contract, SPA requests from you the number of the IACUC protocol that goes with that grant proposal or contract. When the NIH or other granting agency requests IACUC certification, SPA gives the grant proposal and the protocol number to the IACUC, which then does a comparison of the grant/contract proposal with the IACUC protocol. If they are different, the IACUC will ask the investigator to alter the IACUC protocol or the grant/contract proposal to bring them into correspondence. Most commonly, this results from differences in procedures or in procedures that are missing from the IACUC protocol. Changing the IACUC protocol is a fairly easy process; changing the grant/contract proposal could result in funding delays.
Often, the granting agency does not give us very long to complete the comparison, never long enough for the investigator to submit a new IACUC protocol and have it approved. Therefore, investigators should not wait until a request for certification is made to start the IACUC review process. Also well in advance of possible funding, investigators should examine the IACUC protocol to be sure that it actually does match with the grant proposal. That can speed up the process and avoid needless anxiety. Our experience is that about one-third of the grant/contract proposals do not have a matching IACUC protocol.
The review process
When you submit an application, it is assigned to the designated-review process or the full-committee review process based on the type of animal use and the number of animals requested. In both processes the application is sent to all members of the IACUC for their review. In the full-committee review process, two members of the committee are assigned as reviewers. They present their reviews at a regular meeting of the committee, the application is discussed and the committee votes. Applications may be approved, approved if modifications are made or tabled, or the committee can decline to review based on insufficient information or disapprove. Because the committee only meets once each month, it can take a month or so to receive approval even if no changes are required. The deadline for submission of materials requiring full-committee review is the last business day of the month for review the third Wednesday of the following month.
Under designated review, two members of the committee are assigned to review the application but all members are required to review it. If any member of the committee refers the application to the full committee, then we are required by law to send it for full-committee review at the next possible meeting. If no member refers the application to the full committee, then the two reviewers decision is communicated to the investigator. These reviewers may approve the application or approve it if modifications are made or refer it to the full committee. The deadline for submission of materials qualifying for designated review is Monday of each week.
When the investigator submits modifications to an application after it has been reviewed, a subcommittee of two members typically reviews them; occasionally it must be a convened subcommittee. They do not go back to the full committee unless the full committee has requested to see them again, i.e., tabled protocol. Therefore, the turn-around time on modifications can be short if all of the requested information is supplied providing your protocol was approved subject to modifications. If you have questions about what is being requested, call the IACUC office and ask for clarifications.
Special considerations
Any time you are in need of special considerations, contact the IACUC office to discuss your situation and alternative measures that might be taken to meet your needs. Whereas we must have deadlines and follow regulations, adjustments can sometimes be made to meet your deadlines without compromising regulatory requirements. To achieve this balance, we must communicate and work together on a case-by-case basis exploring all possible avenues. Through this communication, the IACUC hopes to better serve your research deadlines and still provide protection for you, the animal and the institution