Both clinical (involving humans) and basic science (often involving animals or cells) research are critical in the development of new treatments for various disorders or for understanding normal physiological or pathophysiological (disease) processes. Therefore, the purpose of your final paper is to explore ethical issues surrounding clinical and basic science research.
Before beginning your paper, be sure to complete the required reading to help you learn more about these issues:
Required Reading: Clinical Research:
- A historical overview of ethical violations and the creation of policies and laws:
http://www.niehs.nih.gov/research/resources/bioethics/timeline/index.cfm (Links to an external site.) and http://www.cgu.edu/pages/1722.asp (Links to an external site.) - Visit ASU’s website on the use of human subjects in research: http://researchintegrity.asu.edu/humans (Links to an external site.)- be sure to visit the sections on “Ethical codes” (Note: Once you access the ASU Research and Assurance website, on the far right-hand side of the page under Protecting Human Rights, there you will find the Ethical Codes).
- What makes clinical research ethical: http://jama.jamanetwork.com/article.aspx?articleid=192740 (Links to an external site.). (An alternative for students is to search for the article using the library link in Canvas, which will bring you to the search box, or you can access the library directly by going to https://lib.asu.edu/ (Links to an external site.). I did find the article in the ASU library resource).
Required Reading/Viewing: Animal (Basic Science) Research - Overview: Be sure to review the various links for overviews of current policies and laws governing the use of animals in research.
Why do we use animals in research? (Links to an external site.)
Animal Research Laboratory (Links to an external site.)
Dispelling myths around animal research (Links to an external site.)
http://www.understandinganimalresearch.org.uk/ (Links to an external site.) - How to become familiar with the misconceptions as well as to explore medical breakthroughs through animal research: http://www. understandinganimalresearch. org.uk/?gclid= CKDJiPbOlMECFQOSfgodvJgAwg (Links to an external site.)
- Visit ASU’s website on the use of animals in research at the university: http://researchintegrity.asu.edu/animals (Links to an external site.)
- Find examples of discoveries that have helped humans and animals that resulted from animal research: http://www.understandinganimalresearch.org.uk/resources/animal-research-news-feed/ (Links to an external site.) and http://www.animalresearch.info/en/ (Links to an external site.)
- View information on numbers of animals and types of animals used; example here is the UK)- contrary to popular belief we actually consume more animals as food in the United States annually than are used for research…think about how many chickens it takes to make a 12-piece family chicken bucket meal. Also, the vast majority of research is conducted using rodents, not monkeys, contrary to some claims. It is important to keep in mind that the health and well-being of the animals is extremely important in medical research as any stress or illness would negatively affect the outcome of the research. http://www.understandinganimalresearch.org.uk/the-animals/ (Links to an external site.)
- You might also find this NIH website on the timeline of laws regulating human and animal research useful in your writing: http://history.nih.gov/about/timelines.html (Links to an external site.)
- Click here to view the Ethics Research Paper Grading Rubric (Links to an external site.)
How to write your paper
You will be responsible for preparing a 5-page (minimum, NOT including references or title pages) final paper (maximums: 1” margins, 12-point Arial or Times New Roman fonts, can be double-spaced). Proper grammar, organization and spelling will be scored (10 total points), so be sure to proofread your paper prior to submission. A full grading rubric is available by clicking “Section 7” above.
Your paper should be divided into 5 main sections and include well-developed discussions for each subsection. Be sure to use the following subtitles and discuss each of the points outlined below: (NOTE: Do not copy/paste the content under the subtitles into your paper). - From bench to bedside (~1 page; 10 pts)
o Explain the process of developing new treatments or studying physiological/pathophysiological processes from the bench to the bedside. In other words, when would animal studies be necessary (bench studies) as compared to clinical trials involving humans (“bedside” studies)? - Clinical Research Ethics (~2 pages; 15 pts)
o Provide a brief history of some of the main ethical violations in clinical research based on your readings (and in your own words). Include a brief discussion on some of the major historical events which prompted laws to be created to protect humans in research.
o What specific laws protect clinical research subjects or participants as a result of these violations?
o What is informed consent and why it is important to obtain prior to starting a clinical research project involving humans? What are the essential components of informed consent? When can informed consent be invalid?
o If you were reading a scientific article, how could you tell that the research was approved by an oversight committee? What is the name of the committee that approves and oversees research involving humans at universities? - Use of Animals in Research (~2 pages; 15 pts)
o Give examples of ethical violations involving the use of animals in research. What was the outcome of these violations?
o What laws are in existence to protect laboratory animals? What committee is responsible for the approval and oversight of research involving any animal at universities? What federal organization oversees the university committee and performs annual inspections of all facilities involved in animal research? Can research be legally conducted using animals without having approval?
o Discuss some of the common misconceptions regarding the use of animals in research?
o Discuss why is animal research important in scientific discovery?
o Using PubMed to find relevant research articles, give at least 2 examples of scientific discoveries that have been made in animals. This could be something discovered in laboratory rodents, like improved vision for blind mice using a new chemical (this did just happen). Or it could be something that an animal was discovered to naturally have or be adapted to (ex: Gila monster saliva contains a chemical that lowers blood sugar and is now used to treat diabetes (drug: Byetta)). DO NOT re-use these examples! - Conclusion
o What are your final thoughts on the topics? - References
o List all references used to write your paper in APA format and be sure to cite your references properly within the text of the paper.
Sample Solution
