Practice of Informed Consent in Clinical Research Essay

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Practice of Informed Consent in Clinical Research Essay

Research Ethics

 Overview

Research ethics is a relatively new area of bioethics. In fact, it was not until the 1970’s. After conducting hearings on unethical research involving human subjects, including the Tuskegee study, Congress passed the National Research Act in 1973, which President Nixon signs in 1974. The Act authorizes federal agencies (e.g. the NIH and FDA) to develop human research regulations. In reviewing some highly publicized cases this week, seek to identify which ethical principle(s) was/were violated.Practice of Informed Consent in Clinical Research Essay

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Trigger warning: This week you will be reviewing some disturbing cases where research ethics were not considered. Each of these cases violated the rights of human subjects and exemplifies why this legislation was necessary. For many, reparations never occurred. However, in the case of Henrietta Lacks, a settlement was finally reached (August 2023) with Thermo Fisher Scientific who was one of the companies that have finically benefitted from the use of her cells. Additionally, there has been passage of the Henrietta Lacks Enhancing Cancer Research Act.

At the academic level, implementation of an Institutional Review Board (IRB) and the use of the Collaborative Institutional Training Initiative (CITI) program ensure protections for human subjects and facilitates the training needs of faculty, researchers, students and staff, respectively.

Readings & Resources

  • Read the Belmont Report  (link provided below)

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html Practice of Informed Consent in Clinical Research Essay

 

  • Read the attached article

Assignment instruction

you will present your assigned case (the assigned case is the attached article) using a narrated PowerPoint presentation. The narrated presentation should be 5-8 minutes in length and include the following 7 sides:

  1. Overview of the study: Location(s), years the study was active, study participants
  2. What did you find particularly troubling about this case?
  3. What responsibilities to the participants was omitted? Were the participants considered a vulnerable population? Socio-economically disadvantaged? Members of a culturally distinct group (some with their own governing bodies and laws)?
  4. Were the results of the study ever published? Do you believe there was value added to society as a result of the study?
  5. In many instances, these studies have resulted in long-standing distrust in medicine and research. How might this be overcome?
  6. Reflection on the case and research ethics—what did you learn that was unknown prior to the assignment? How did this assignment influence your thoughts on research ethics? Any other comments.
  7. References

Please have a note at the bottom of each slide that will be used to narrate the PowerPoint  Practice of Informed Consent in Clinical Research Essay