| Course | HCR 579 Translational Research in Drug Discovery and Development |
|---|---|
| Module | Module 3 |
| Paper type | IACUC protocol analysis |
| Length | About 617 words, 5 pages |
| Format | APA 7 student paper |
| School | Arizona State University |
| Program | MS in Regulatory Science |
| Updated | October 2026 |
Free sample paper for HCR 579 Module 3
Reviewing a Xenograft Protocol: An Analysis of an IACUC Application for a PARP Inhibitor Study
Student Name
MS in Regulatory Science, Arizona State University
HCR 579: Translational Research in Drug Discovery and Development
Instructor Name
Month Day, Year
Reviewing a Xenograft Protocol: An Analysis of an IACUC Application for a PARP Inhibitor Study
The Application
The composite application proposes to test whether adding an oral PARP inhibitor to temozolomide slows the growth of human colorectal tumors implanted under the skin of immunodeficient mice. It requests 96 mice in four groups: vehicle, PARP inhibitor alone, temozolomide alone and the combination, with tumor measurement three times a week for up to 28 days. Because the study is funded by the National Institutes of Health, PHS Policy and the National Research Council's Guide set its standards (National Research Council, 2011; Office of Laboratory Animal Welfare [OLAW], 2015). Mice bred for research are excluded from the Animal Welfare Act, so PHS Policy is the governing standard here.
Section-by-Section Analysis
| Section | What the application says | Assessment | Recommended revision |
|---|---|---|---|
| Scientific rationale | Combination may overcome resistance in tumors with DNA repair defects | Adequate; links to published cell data | Cite the cell line's repair status |
| Alternatives | Cell culture studies already done; animals needed for drug exposure and tumor growth | Partly adequate; database search not documented | Document databases, dates and terms searched |
| Animal numbers | 24 per group | Not justified | Provide a power calculation from pilot variability |
| Pain category | No more than momentary pain | Understated; tumor growth and combination toxicity may cause distress | Reclassify and add analgesia plan |
| Humane endpoints | Euthanize at day 28 | Inadequate; no tumor size or weight-loss limits | Add tumor diameter, ulceration, body condition and weight-loss limits |
| Procedures | Oral gavage daily; injections; caliper measurements | Adequate with trained staff | Name training records and gavage limits |
| Euthanasia | Carbon dioxide | Acceptable method | State method per current veterinary guidelines and confirmation step |
The Most Important Problems
Animal Numbers
The application asks for 24 mice per group without a calculation. PHS Policy requires that the number of animals be appropriate, and committees expect a justification. A power calculation based on the variability of tumor growth in a pilot or published study may show that fewer mice are needed, or that more are needed to avoid an inconclusive result that would waste every animal used.
Humane Endpoints
Ending the study at day 28 regardless of the animals' condition is not acceptable. Welfare guidelines for cancer research recommend endpoints based on tumor size, ulceration, weight loss and body condition, and they advise that tumors be kept as small as the scientific question allows (Workman et al., 2010). The application should state, for example, that any mouse whose tumor exceeds a set diameter, whose tumor ulcerates or who loses more than 20% of starting body weight will be euthanized.
Pain Category
The combination of a PARP inhibitor and temozolomide can suppress bone marrow and cause weight loss. Listing the study as involving no more than momentary pain understates the expected burden. The study should be categorized as causing potential distress, with monitoring frequency and criteria for veterinary consultation spelled out.
The 3Rs in This Protocol
Replacement: the investigators have used cell culture and should explain why patient-derived organoids could not answer the question. Reduction: a power calculation and a shared vehicle group with other studies could reduce numbers. Refinement: humane endpoints, analgesia where appropriate, enrichment and trained handlers would reduce suffering.
Recommendation
The committee should require modifications before approval: a documented alternatives search, a power calculation, reclassification of pain category, explicit humane endpoints and a stated euthanasia confirmation method. With those changes, the study's scientific value would justify its use of animals.
Conclusion
An IACUC analysis tests whether a study's scientific value is real, whether animals are truly needed, whether their numbers are justified and whether their suffering is minimized. This application has a sound question but needs stronger answers on numbers, endpoints and pain before it can be approved.
References
National Research Council. (2011). Guide for the care and use of laboratory animals (8th ed.). National Academies Press. https://doi.org/10.17226/12910
Office of Laboratory Animal Welfare. (2015). Public Health Service policy on humane care and use of laboratory animals. National Institutes of Health. https://olaw.nih.gov/policies-laws/phs-policy.htm
Workman, P., Aboagye, E. O., Balkwill, F., Balmain, A., Bruder, G., Chaplin, D. J., Double, J. A., Everitt, J., Farningham, D. A. H., Glennie, M. J., Kelland, L. R., Robinson, V., Stratford, I. J., Tozer, G. M., Watson, S., Wedge, S. R., & Eccles, S. A. (2010). Guidelines for the welfare and use of animals in cancer research. British Journal of Cancer, 102(11), 1555-1577. https://doi.org/10.1038/sj.bjc.6605642
What the HCR 579 Module 3 instructions ask for
Written Assignment 2 is due in Module 3 of HCR 579, the module on regulatory processes for animal and human research, and it is worth 75 points. The syllabus lists the analysis of an IACUC application among the course's papers, and Canvas supplies the instructions and any sample application. An IACUC analysis reads like a committee member's review: for each section of the application, it asks whether the investigator has met federal policy and accepted welfare standards and what must change. For PHS-funded work the rules come from PHS Policy and the Guide; for species the Animal Welfare Act covers, its regulations apply too. Organize your analysis around the sections committees always examine: rationale, alternatives, numbers, pain category, humane endpoints, procedures and euthanasia, and finish with a recommendation.
How the HCR 579 Module 3 example is put together
The sample summarizes the application in one paragraph and identifies the governing policy. A table then reviews each section of the application with what it says, an assessment and a recommended revision. Three problems receive deeper discussion under their own headings: unjustified animal numbers, missing humane endpoints and an understated pain category, each supported by policy or published guidelines. A short section applies the 3Rs to this protocol specifically. The recommendation states the committee's decision and the required modifications, and the conclusion restates what an IACUC analysis tests. Each recommended revision is specific enough that an investigator could rewrite that section of the application from it.
HCR 579 Module 3 rubric: what earns full marks
Canvas awards up to 75 points for the IACUC analysis. A strong analysis identifies the governing regulations correctly for the species and funding, reviews every major section of the application, applies the 3Rs, judges numbers, pain category and humane endpoints with reference to policy or guidelines and ends with a clear recommendation and specific revisions. Points are lost when the paper describes the application without judging it, when the Animal Welfare Act is applied to purpose-bred mice, when humane endpoints are not addressed and when recommendations are vague. Readers value analyses that treat scientific value and animal welfare together, since an underpowered study wastes the animals it uses.
HCR 579 Module 3 help with common mistakes
Identify the species and funding first; they decide which rules apply. Review each section in the order the application presents it. Check whether numbers are justified with a power calculation. Look hardest at pain category and humane endpoints. Apply the 3Rs to the specific study. Write revisions an investigator could act on. End with approve, modify or withhold. Pain categories confusing? The desk can go through them with your protocol in hand. Write as a committee member would, firmly but constructively, since the goal is an approvable protocol. Check species coverage before citing a rule. Keep your recommendation to approve, modify or withhold clear in the last paragraph.
Write yours, or have the desk draft it
This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.
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HCR 579 Module 3 questions, answered
Where can I find a free HCR 579 Module 3 sample paper?
Above on this page is a full Written Assignment 2 analysis of an IACUC application for a mouse cancer study.
What does an IACUC review?
Whether animal use is justified, alternatives were considered, numbers are appropriate and pain and distress are minimized.
What are humane endpoints in animal research?
Predefined signs, such as tumor size or weight loss, at which an animal is removed from the study or euthanized to limit suffering.
Does the Animal Welfare Act cover laboratory mice?
No. Purpose-bred mice and rats are excluded, but PHS Policy covers them in PHS-funded research.
What are the 3Rs?
Replacement, reduction and refinement of animal use in research.