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

Hadley is a doctor herself she is aware of the clinical research, and the way a participant can enter into or offer herself as a participant, For the participant to enroll for clinical research informed consent is required is required. Informed consent gives an opportunity to the participant to decide whether to participate or not, The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study.

. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process so Hadley has indeed violated the regulation, being a doctor herself she is well aware the fact of clinical researches outcome and trial period., During clinical research the participants are even allowed to withdraw during the trial period, It is not time-bound.

In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it as she has not signed any consent letter she is wrong ethically

Yes, Cameron hs committed an ethical violation on her part by allowing, Hadley to participate in the clinical research for Huntington's disease

On Hadley's part, she wanted to hide her condition from the hospital's management so that she can pursue. she career as the head of the oncology department as she wanted to serve till her last moment, To try the new medicine she entered into a clinical research to get cured with a new medicine that might help improve her condition,

As Hadley has not signed any consent a legal issue can arise if something goes horribly wrong as the informed consent covers

• what will be done to them,

• how the protocol (plan of research) works,

• what risks or discomforts they may experience,

• participation being a voluntary decision on their part.

This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.

Genetic testing is done to find out about an inherited disorder in an individual patient or family. This type of testing can be harmful if the participant is allergic to the medicines used, as Genetic tests are performed on a sample of blood, hair, skin, amniotic fluid (the fluid that surrounds a fetus during pregnancy), or other tissue. For example, a procedure called a buccal smear uses a small brush or cotton swab to collect a sample of cells from the inside surface of the cheek as well as  interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition,It is useful if the remedy is cracked.