Clinical research is a is the study of health , it is important for the progress of modern medicine. It determine the safety and efficacy of medications, devices, and treatment regimens intended for human use. During a clinical research if a human got an experimental drug intended to improve his health , and the result coming wrong causing the death of the human. Who is responsible doctors or scientists ??
It is important to find the root cause of death before making any initial assessments on what to blame. The responsibility will depend on the language in the informed consent regarding risks and adverse events. I have not been involved in any studies where there was a risk of death, but for serious injury as a result from the study, some consent forms may ask the patient to rely on their own insurance for any medical costs resulting from any hospital visits and therapy sessions. Some clinical trials, like the protocol example provided by Prof. Simon, may reimburse patients for medical expenses not paid by insurance, but that depends on the CRO or sponsor overseeing the clinical trial.
As mentioned above, responsibility (or blame) may depend on the wording used in the informed consent form and in the ethical practices of the sponsors and investigators running the clinical trial. For example, if the risk of death was mentioned in the informed consent form, then the patient had accepted that risk when he or she joined they study. However, there have been instances where the investigators have personal stakes in the drug being developed and compromise their ability to provide unbiased information to the patients. This is exactly what happened in the case of Jesse Gelsinger, who died after participating in a 1999 gene therapy clinical trial at UPenn. It was discovered that the investigator running the trial would make millions if the therapy was successful. It was also discovered that there were several failures in the informed consent process regarding the side effects of previous participants and that the scientists had not reported side effects to the FDA. The patient's family sued the university and the case was settled for an undisclosed sum.
https://www.sciencehistory.org/distillations/the-death-of-jesse-gelsinger-20-years-later
Clinical research is a is the study of health , it is important for the progress of modern medicine. It determine the safety and efficacy of medications, devices, and treatment regimens intended for human use. During a clinical research if a human got an experimental drug intended to improve his health , and the result coming wrong causing the death of the human. Who is responsible doctors or scientists ??
It could be both and again could be no one. There are 3 possible options that it can happen.
1) Scientists made a mistake. However, that doesn't make a scientist the one at fault. Sure, if the scientist did some of its steps wrong while developing the drug with or without noticing it, completely jumped steps without necessary procedure, or everything was correct. Still, the produced drug was not the drug that it was intended. Of course, everything could be according to the book, and there is still a possibility that this can happen. At that point, the scientist maybe could be the one to blame ethically but not legally.
2) Doctor did not use the drug according to the instructions and/or the candidate was not a good candidate to use it. In that case, it is a doctor error, and the doctor is completely to blame. Of course, doctors can mistake things, and/or the patient can hide his/her medical history intentionally or unintentionally.
3) In the case both the doctor and the scientist did his/her job to the letter, there is always a chance that patients could show unexpected reactions or he/she is not a good candidate in the first place that cannot be identified previously because of misleading medical history.
This is indeed a sensitive topic since are dealing with the death of a person, however, before accusing someone, an investigation must take place to evaluate the root cause of death. Also, the question itself is very vague; are we dealing with stage 4 cancer patients or healthy people using a drug to boost metabolism. Regardless of the case, as some of you mentioned, the informed consent form will weigh heavy on determining if this was wrongful death, or just a fatal side effect of the drug. When I was working from my precious lab, a part of my job was managing the delivery of a dug called Zofigo, now this was an already approved drug by Bayer, but it will de delivered to stage 3-4 patients and in some cases the patient will die before the treatment would be complete. Now, there was no fault placed on the drug, nor the doctor, it was simply that the patient's body will just not tolerate the drug, or the drug will have no effect and the prostate cancer will ultimately kill the patient. I think this same scenario could apply in clinical trials, and as harsh as it sounds; the Informed consent form and protocol will turn this death into just a fatal side effect of the drug or random circumstance that can occur. As long it is disclosed in the form and protocol, this will be determined to be non-fault death.
Now I will have to agree with other students that if the doctor deviates from protocol or a root cause of death is linked to the misuse of the product of drug, then it is ultimately the doctor's or center's fault for the death.
In this situation, it would be essential to find the underline cause of the death. For example, if the doctor did not follow protocols correctly or the patient did not meet all of the requirements for the medication, the doctor should be held responsible. However, if the drug itself was defective, the scientist should be held accountable. The doctor should not personally be held responsible for a drug they did not create. Especially if they have been informed that treatment is effective based on results or research received (assuming the doctor has thoroughly reviewed all of this information before prescribing or treating a patient).
I think in this case it would be important to do an autopsy and see the exact cause of death. I also think it is necessary to analyze the patient's medical history and current conditions. Also, all medications have possible side effects and it is uncertain whether or not this medication along with the patient's other prescribed medication could have collectively had adverse effects on the patient. I think an in depth analysis into the patient's history and the autopsy reports will be vital in possibly determining who if anyone is to blame for this patient's life. Also, patients are to be informed in clinical trials on the adverse effects and the possible risks associated with participating in the trial.
Adverse events including death are a reality, but not a routine occurrence in the field of research studies and clinical trials. As many have stated, patients signed informed consent forms that should outline the potential risks associated with participating in a clinical research trial. Prior to human trials, novel drugs are tested on animal models and the effects may not always translate the same way in human subjects. Nevertheless, death must be reported and the cause ascertained. Death during a clinical trial may not always be attributed to the test drug as some patients receive placebos, death may occur due to other circumstances, or the death may be due to negligence. There are different protocols in depending on the circumstances surrounding the death. Clinical research is an ethical and justice gray area and unless there is evidence of gross negligence by the personnel, I don't think blame should or can be easily assigned in the event of a death.
