Question

Hadley, a thirty-five-year-old physician, has worked at Princeton Plainsboro Hospital for six years. She recently received a promotion to the head of oncology and is looking forward to spending the remainder of her medical career at the hospital.

Unfortunately, Hadley has a family history of Huntington’s disease, a condition that causes movement, cognitive and psychiatric disorders. Hadley’s mother suffered and eventually passed away from the disease, as there is no cure. Huntington’s is an autosomal dominant condition, meaning that Hadley has a fifty-percent chance of inheriting the condition from her mother.

For years, she has put the thought of inheriting the condition out of her mind, but she is quickly approaching her thirty-sixth birthday, and that is when her mother began to show symptoms of the disease. Hadley decides that now is the time to go ahead and have the genetic testing done to see if she will inherit the disease from her mother.

Hadley has the testing done at Princeton Plainsboro, and two weeks later receives her results – she is positive for Huntington’s. Hadley is devastated, but decides that she will continue with her oncology practice until she is mentally and physically unable to perform her duties.

Additionally, she speaks to her friend, Cameron about a clinical trial for a new medication to treat Huntington’s that has recently begun at the hospital. Because she is too late to enter the study and does not want anyone to know she has the condition, Cameron agrees to allow her to take the experimental medication and participate in the trial without signing any documents.

Three weeks later, a lab tech speaks to Hadley’s superior regarding her unfortunate diagnosis. Because hospital management knows that Hadley likely only has a few more years to work in oncology, they terminate her employment to hire a new head of oncology that can run the unit for the foreseeable future.

Please read the scenario carefully, and discuss the following:

• What, if any regulations were violated when Hadley entered into the clinical trial in this manner?
• Did she commit any ethical violations by entering into the clinical trial this way?
• Did Cameron commit any ethical or legal violations by allowing Hadley into the clinical trial?
• What ethical and legal issues arise with the type of genetic testing that Hadley underwent? Do you think this type of testing is beneficial or harmful to the individual being tested?

Answer 1

Harley being doctor, she is aware of the responsibilities regarding clinical trial. For a person to enter into a clinical trial, first they should search for the clinical trial in the hospital, then they have to look for the eligibility criteria, along with this contact study organises and review study description, and then learn about the informed consent.

1) Food and Drug Administration(FDA), lays out regulations towards the conduct of clinical trials which includes informed consent.

In this scenario, both Cameron and Hadley clearly violated the informed consent that were clearly required.

2) Before entering into clinical trial at the patient has certain responsibilities. These responsibilities were clearly ignored by Hadley. She should have provide complete current and past medical conditions, any hospitalizations, allergies, any surgeries, any medications and other medical related conditions. She also didn't sign any agreements. She also hasn't designated a family member to make decisions in an event if she becomes unable to speak. She even didn't have a good communication with questions leaving behind an unclear understanding of clinical trial.

All these things gives a clear understanding about ethical violations.

3) Cameron also committed ethical or legal violations by allowing Hadley to enter into clinical trial in this way. At least Cameron should have said Hadley about the legal issues and not supported her in doing so by violating the ethical issues. Hadley told Cameron about clinical trial and maybe Cameron as her friend she wants to satisfy Hadley's need ,that's why maybe she allowed her committing ethical violations.

4) ethical and legal issues arise with genetic testing are -respect for privacy, autonomy, personal best interest, responsibility for the genetic health of future children, maximizing social best interest, minimising social harm, genetic justice, cost effectiveness, the reproductive liberty of individuals and respect for difference.