Module 2 Discussion
docx
keyboard_arrow_up
School
Ohio State University *
*We aren’t endorsed by this school
Course
7781
Subject
Medicine
Date
Dec 6, 2023
Type
docx
Pages
1
Uploaded by dankescone
Case Study #5
There are major issues regarding informed consent, communication between patient and
physician, and medical record privacy. The Common Rule wasn’t established until 1991, and so
receiving informed consent from the patient rarely, if ever, happened. Additionally, there were no
standards in regards to using cells taken from a patient for research, nor was there anything
prohibiting hospitals from releasing patient information to the public, especially in regards to
research findings. Thus, Henrietta Lacks and the case of Moore vs Regents of the University of
California were typical of the time since there were no regulations regarding bioethics and no
institutions to enforce these regulations. However, the German researchers who released the
genome of the HeLa cell line should have obtained explicit consent from the family of Henrietta
Lacks, especially since they have been vocal about their dislike of researchers using Henrietta’s
cell line and commercializing it.
Case Study #6
There is a disconnect between what the Havasupai tribe and the researchers had discussed
versus what actually happened. The researchers could have given members of the Havasupai
tribe additional choices in how their blood is to be used and who it would be shared with. These
additional options could have more accurately reflected what members of the tribe wanted,
especially since their blood has spiritual significance. A study that gave the tribe more options as
to what could be researched could have opened an additional dialogue in which they could have
asked the researchers questions about the consent process and the trials to follow.
Case Study #7
Explicit consent must be obtained before any patient specimen can be used for research. Even
if these samples are explicitly de-identified, there is still an inherent ability to identify someone
based on their genetic makeup and not by sample identification alone. If patients are generally
willing to have their tissue samples used for archival research, they should still be asked for
clear consent when anything new is to be done on their tissue samples.
All of these case studies have something in common, and that is lack of informed and explicit
consent throughout the entire process. Sometimes researchers get carried away in their trials,
get an idea, and research that idea before sending out an additional consent form while using
patient samples. Even with the best intentions in mind, this is still bioethical malpractice and is
subject to review by an IRB.
The difference between these case studies lies in how much informed consent is invalidated or
whether it was obtained in the first place. It is essential for consent to be obtained to continue
with or even begin research. In Case Study #5, what had transpired was the norm because the
Common Rule wasn’t established yet, until 2013 when the Lacks’ genome was sequenced and
published.
Discover more documents: Sign up today!
Unlock a world of knowledge! Explore tailored content for a richer learning experience. Here's what you'll get:
- Access to all documents
- Unlimited textbook solutions
- 24/7 expert homework help