| Course | HCR 574 Scientific and Research Review Boards |
|---|---|
| Module | Module 3 |
| Paper type | Regulatory comparison paper |
| Length | About 645 words, 5 pages |
| Format | APA 7 student paper |
| School | Arizona State University |
| Program | MS in Clinical Research Management |
| Updated | October 2026 |
Free sample paper for HCR 574 Module 3
Two Committees, Two Ethics: Comparing Federal Rules for Human Subjects and Animal Research
Student Name
MS in Clinical Research Management, Arizona State University
HCR 574: Scientific and Research Review Boards
Instructor Name
Month Day, Year
Two Committees, Two Ethics: Comparing Federal Rules for Human Subjects and Animal Research
Introduction
Research on people and research on animals are both reviewed by local committees under federal rules, but the rules rest on different ethical foundations. Human research protections center on respect for persons and informed consent; animal protections center on minimizing pain and distress for beings who cannot consent. This paper compares the two systems and explains their similarities and differences.
The Legal Frameworks
Human subjects research is governed by the Common Rule for federally funded research (45 C.F.R. § 46.101) and by FDA regulations for research on FDA-regulated products (21 C.F.R. pt. 50; 21 C.F.R. §§ 56.101-56.124). Animal research is governed by the Animal Welfare Act and its regulations, enforced by the U.S. Department of Agriculture, which cover warm-blooded animals but exclude purpose-bred rats, mice and birds (9 C.F.R. §§ 1.1-3.142), and by the Public Health Service Policy, which applies to all live vertebrates in research funded by PHS agencies such as NIH and relies on the Guide for the Care and Use of Laboratory Animals (National Research Council, 2011; Office of Laboratory Animal Welfare [OLAW], 2015).
Comparison
| Feature | Human research | Animal research |
|---|---|---|
| Committee | Institutional review board (IRB) | Institutional animal care and use committee (IACUC) |
| Minimum membership | Five, including a scientist, a nonscientist and an unaffiliated member (45 C.F.R. § 46.107) | Three under the Animal Welfare Act; five under PHS Policy, including a veterinarian, a scientist, a nonscientist and an unaffiliated member |
| Central ethical principle | Respect for persons, beneficence, justice | Replacement, reduction and refinement (the 3Rs) |
| Consent | Informed consent required, with few waivers | Not applicable; committee judges necessity and humane treatment |
| Key review questions | Risks minimized and reasonable, equitable selection, consent, privacy | Alternatives considered, numbers justified, pain minimized, humane endpoints, qualified personnel |
| Ongoing oversight | Continuing review for some studies; reporting of unanticipated problems | Semiannual program review and facility inspections; annual reports |
| Federal oversight body | OHRP and FDA | USDA Animal and Plant Health Inspection Service and NIH Office of Laboratory Animal Welfare |
| Enforcement | Suspension of assurance, FDA warning letters, disqualification | USDA citations and penalties; suspension of PHS assurance and funding |
Similarities
Both systems rely on local committees with mixed membership, including people outside the institution and outside science, to judge whether research is justified. Both require institutions to hold an assurance or registration with a federal office, and both can halt research. Both ask whether the scientific question is worth the burden imposed on research subjects.
Differences
The deepest difference is consent. Human research depends on a capable person's informed choice, and the committee's job is to make that choice meaningful. Animals cannot consent, so the committee itself must decide whether the use is necessary and humane, guided by the 3Rs first set out by Russell and Burch: replace animals where possible, reduce numbers to the minimum needed and refine methods to minimize pain. A second difference is coverage. The Animal Welfare Act excludes the rats and mice that make up most laboratory animals, so for privately funded research using those species, federal protection may be limited, while the Common Rule's gap is privately funded human research not involving FDA-regulated products. A third difference is inspection: animal facilities are inspected in person on a schedule, while human research oversight relies more on documents and reporting.
Implications for Review Boards
Institutions often run both committees. Sharing training on conflict of interest, record keeping and reporting can strengthen both, but members should not import one system's logic into the other: an IACUC cannot substitute a consent-like judgment for the 3Rs, and an IRB cannot treat participant welfare as a matter of committee approval alone.
Conclusion
Human and animal research oversight share a structure, local committees under federal assurance, but not a foundation. One protects people who can choose; the other protects animals who cannot. Understanding both makes each committee clearer about its own task.
References
Animal welfare, 9 C.F.R. §§ 1.1-3.142 (2025).
Institutional review boards, 21 C.F.R. §§ 56.101-56.124 (2025).
IRB membership, 45 C.F.R. § 46.107 (2025).
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
To what does this policy apply? 45 C.F.R. § 46.101 (2025).
Reading the HCR 574 Module 3 assignment instructions
Paper 3 completes HCR 574's three-part Week 4 exercise and asks you to compare and contrast federal regulations for human and animal research. The comparison works best when it is organized around features both systems share, such as the committee, its membership, its review criteria, ongoing oversight and enforcement, so that differences stand out against a common frame. Name the specific laws and policies on each side: for human research, the Common Rule and FDA's human subjects regulations; for animal research, the Animal Welfare Act and its regulations and the Public Health Service Policy, with the Guide for the Care and Use of Laboratory Animals. Then go beyond the table to explain why the systems differ, which is where the ethical analysis belongs. The three papers together carry 200 points.
Inside the HCR 574 Module 3 example
The sample opens with the shared structure and different ethical foundations of the two systems. A framework section names the laws and policies on each side and notes their coverage limits. An eight-row comparison table sets IRBs beside IACUCs on committee, membership, principles, consent, review questions, ongoing oversight, federal oversight body and enforcement. A similarities section and a differences section follow, the second built around consent, coverage gaps and inspection. A short section on implications for institutions that run both committees adds an applied point, and the conclusion states the paper's contrast in two sentences. Its margin note defends putting the table ahead of the discussion.
Where the marks sit in the HCR 574 Module 3 rubric
Paper 3 shares the exercise's 200 points with the first two parts. Readers credit accurate identification of the laws and policies for each type of research, a structured comparison on features both systems share, correct details such as committee membership and which species the Animal Welfare Act covers, an explanation of why the systems differ grounded in their ethical principles and clear writing with citations. Points are lost when the paper describes each system separately without comparing them, when details are wrong, such as stating that the Animal Welfare Act covers laboratory mice, and when the ethical basis of the differences is never discussed. Readers value attention to coverage gaps on both sides, since that is where regulatory understanding shows.
HCR 574 Module 3 help: mistakes that cost marks
Build your comparison table before you write prose; it shows what to discuss. Use the regulations and policies themselves for membership and review criteria. Check which species each animal rule covers. Organize the prose around similarities and differences rather than describing one system and then the other. Explain the 3Rs and contrast them with informed consent. Note a gap in each system. If you are unsure how PHS Policy and the Animal Welfare Act overlap, the desk can help you sort out which applies when. Keep the conclusion short and focused on the single contrast your paper has shown, since a long summary of both systems repeats the table.
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 574 Module 3 questions, answered
Where can I find a free HCR 574 Module 3 sample paper?
The full Paper 3 comparing federal rules for human and animal research is on this page.
What is the difference between an IRB and an IACUC?
An IRB reviews human subjects research around consent and risk; an IACUC reviews animal research around necessity and minimizing pain under the 3Rs.
What are the 3Rs in animal research?
Replacement, reduction and refinement: use alternatives, minimize numbers and reduce pain and distress.
Does the Animal Welfare Act cover laboratory mice?
No. It excludes purpose-bred rats, mice and birds, which are covered by PHS Policy when research is PHS-funded.
How many members must an IRB and an IACUC have?
An IRB at least five; an IACUC at least three under the Animal Welfare Act and five under PHS Policy.