Hints on Preparing on Animal Study Proposal (ASP)
The review of ASPs has not always gone as smoothly as one would like. While there are sometimes major issues involved with some proposals, it frequently happens that ASPs are held up due to more easily preventable deficiencies. This guide is an attempt to avoid some of these problems.
Make certain that you are using the most recent version of the NICHD Animal Study Proposal (ASP) form. ASPs submitted on outdated forms will not be reviewed by the ACUC. Contact the ACUC Coordinator if you need additional information, forms, or assistance.
Personnel - section A (Administrative Data)
Don't forget to include the terminal degree (M.D., Ph.D., D.V.M., etc.) and affiliation (Laboratory/Branch) of all personnel.
All investigators coming into contact with mammals need to be enrolled in the (Animal Exposure Surveillance Program). For work with aquatic species (frogs, fish), enrollment is currently optional. To arrange AESP enrollment, call Annette Drazin at 496-9278 and set up an appointment (her office is in Building 13). She will issue a "Proof of AESP enrollment" slip that must be attached to the ASP.
All personnel using animals must have taken or be registered to take the NIH course Using Animals in Intramural Research: Guidelines for Animal Users. The course can be taken on-line; go to the NIH Office of Animal Care and Use web site and follow the links to the training course. The Principal Investigator must take the NIH course Using Animals in Intramural Research: Guidelines for Principal Investigators; this course is not available on-line. Call the NIH Office of Animal Care and Use (301-496-5424) to register for these courses.
Proposed animal numbers - sections B (Animal Requirements), E (Rationale for Animal Use), and H (Pain or Distress Category)
This is important for two reasons. First, the ACUC needs to know how much holding space your project will need, and second, we need to know how many animals you will receive, buy, or breed during each year. The number proposed for years two and three should include any animals you keep from previous years. Therefore, the total number proposed for the three-year approval period may not always be the sum of the animals listed for each year.
Offspring from breeding animals or timed-pregnant animals should be included. If you have to make an estimate (e.g., mouse litter sizes vary considerably), then do so, but explain how you arrive at the number.
Make sure that the numbers add up, and that they agree with the other sections of the form (i.e., sections E-3, F, and H). Please note that the ACUC is supposed to encourage investigators to use as few animals as possible. If the committee feels that the numbers you request are excessive, it is obligated to ask for further justification.
If you will be rearing animals from embryos, for example as part of zebrafish genetic screens, the definition of "animal" becomes problematic. Until a ruling has been handed down on this issue, you can estimate the number based on how many are in the tanks used to house adults (i.e., not including fry or tadpoles).
Study objectives - section D.1 (Non-technical Description of Study Objectives)
It is very important to write this in non-technical and positive manner, since it is intended for readers who are educated but non-scientists. Bear in mind that this includes individuals who do not necessarily believe all animal research is automatically justified. Avoid obscure jargon, unfamiliar abbreviations or anatomical terms, etc. Most importantly, you must make it clear why the study is valuable. If the work has clinical applications, it is useful to mention them here.
Background - section D.2 (Background, Hypothesis, References)
The NICHD Scientific Director has instructed the NICHD ACUC to evaluate each ASP for "Scientific Merit". While this is not intended to be a full-blown peer review process, the committee does look closely this section to see if the proposed research makes scientific sense. You should state the hypothesis(es) being tested by the research and explain the reasoning behind the proposed experiments. Many investigators excerpt from their publications, annual reports, etc. for this narrative. This is perfectly acceptable as long as the final product is coherent.
Renewals - section D.3 (Renewal Animal Study Proposals)
When renewing an ASP, be sure to complete this section summarizing the progress made during the previous life of the ASP. Justify in meaningful terms why the research project should continue. In particular, do not attempt to justify renewal by asserting that "a major investment has already been made", or words to that effect.
Section F (Description of Experimental Design and Animal Procedures)
Provide a complete description of experimental design and animal procedures in narrative form. The items appearing under this section of the ASP form are intended to provide an incomplete list of topics to be addressed in the narrative, not as a list of specific questions to be answered. All proposed procedures must included, including breeding and injections (identify substance, dosage, and route of administration). No animal procedures may be conducted on animals under the ASP if they are not specifically described on the form.
Pain and distress categories - section H (Pain or Distress Category)
This is the most sensitive topic dealt with in the ASP. Once again, remember this document may be seen by non-scientists, some of whom may be hostile to animal research in general. The Animal Welfare Act stipulates that pain or distress caused by research procedures must be either relieved by some satisfactory method, such as analgesia, anesthesia, or tranquilization (USDA Column D), or there must be extensive and convincing justification why the relief of pain or distress is contraindicated (USDA Column E). The IACUC looks closely at how you categorize animals in this section, and very closely at any Column E animals, which can only be approved under highly restrictive circumstances. An Explanation for USDA Column E Listing form must be completed for these studies. Note that this Column E form must accompany the NIH annual report to the USDA. This Column E form and any attachments (e.g., the entire ASP) are subject to release under the Freedom of Information Act.
The USDA requires specific details of how you have searched the literature to document your claim that there is not alternative to causing unrelieved pain or distress. You must describe your consideration of alternatives to procedures listed for Column D and E that may cause more than momentary or slight pain and distress to the animals, and your determination that alternatives were not available. Delineate the methods and sources used in the search. Data base references must include databases searched, the date of the search, period covered, and keywords used.
Hazardous agents - section K (Hazardous Agents)
Biological agents are potentially infectious bacteria or viruses, human blood, body fluids, or toxins that will be fed to, injected into, or otherwise introduced into or onto animals. These must be registered and approved prior to the initiation of the ASP. Also, if you will be inserting recombinant DNA into animals (e.g., transgenic/knockout mice) then it must be registered with the Institutional Biosafety Committee and the appropriate documents attached to the ASP. Contact Gail Katz, the NIH safety representative, to find out how to do this (496-2346). Hazardous agents not actually used in or on animals do not need to be included (e.g., phenol, ethidium bromide, etc).
Signatures - section O (Concurrences)
You are responsible for collecting all of the required signatures except those of the NICHD Animal Program Director and the ACUC Chair, who sign when the proposal is approved. Do not forget to sign your name at the bottom of page 4 under section N (Principal Investigator Certifications). Have your Laboratory/Branch chief sign at the top of page 5 (the Scientific Director signs for Laboratory/Branch Chiefs). You also need the signature of the Safety Representative (Gail Katz if you are in NICHD) if there are hazardous agents or recombinant DNA involved. Signatures must be obtained from both the Facility Veterinarian and the Facility Manager for each animal facility where the study will be conducted. It is best to obtain these signatures before the ASP is submitted to the ACUC to avoid delay in final approval of the ASP.
Time frame
The ACUC usually meets on the third Wednesday of each month. In order to allow sufficient time to copy and distribute ASPs to committee members, we ask that you deliver the finished version to the ACUC Coordinator by the first Friday of the month. Since it is illegal to work on vertebrate animals without a valid ASP, and extensive revisions are sometimes necessary, it is not a good idea to wait until an ASP is about to expire before working on the renewal.
Modifications
Any change in the personnel, experimental design, animal procedures, or animals needed for an ASP must also be approved by the ACUC. Use a Modification to Animal Study Proposal form. Once again, please allow sufficient time for these modifications to be copied and distributed to the committee prior to the monthly meeting. If an emergency arises, expedited review is possible on a case-by-case basis for personnel changes or other relatively minor modifications. Contact the NICHD Animal Program Director or the NICHD ACUC Chair to discuss this.
