Ethics in Human Subjects Research
Human research subjects are afforded certain rights and protection under the Nuremburg Code, the Declaration of Helsinki, the Belmont Report and the Common Rule, among others. With the exception of the Nuremburg Code, these guidelines for the protection of human subjects did not yet exist in the early 1950’s when a tissue sample was collected without informed consent from Henrietta Lacks, a young African American mother with cervical cancer. Lacks’ cells were given to medical researchers who still use the cells today. In 2010, a book entitled “The Immortal Life of Henrietta Lacks” was published, and it examined Lacks’ life, the collection and use of her cells, and the implications that the use of her cells had on her family, and the fields of medical ethics and research. We all have benefited from research conducted using Lacks’ cells. Some of us have even used HeLa cells in research–at my first job out of college we used HeLa cells to conduct research on insulin receptors. This website (http://www.wired.com/magazine/2010/01/st_henrietta/) gives a brief overview of the impact that Lacks’ cells have had on medical research. This link (http://www.npr.org/templates/story/story.php?storyId=123232331) takes you to an interview with the author of “The Immortal Life of Henrietta Lacks.” She talks about Henrietta Lacks and what stimulated her interest in the story of the HeLa cells.
Despite the protections that human subjects are offered, there are still questions regarding appropriate informed consent. Recently, the University of Arizona was sued by the Havasupi Indian tribe regarding the use of stored biologic specimens. Read about it here: Research Involving Stored Biologic Samples.pdf
Even more surprising and concerning to me is the fact that sponsors of human subjects research are not required to compensate research subjects who are injured as a result of a research. This is despite the fact that six different Commissions from 1978 to 2011 have recommended that subjects be compensated, and the fact that most other developed countries have programs to compensate injured research subjects. Did you know this? I have to admit that I didn’t until I read this article. I can’t imagine why anyone would ever participate in a research trial, knowing this is true. This article (Justice for Injured Research Subjects.pdf) discusses the topic and suggests some ideas to remedy this injustice.
Currently, government agencies are working to reform the rules concerning human subjects research. Read about the changes that are being considered here:Reforming regulations on human subject research.pdf
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