So I agree with your comments regarding that medicine involves situations where values come into conflict. I also think that the regulators such as the FDA have put in place regulations to temper the potential expectations have with clinical studies. The general population as well as healthcare providers assume that pre-clinical work will answer most questions so when clinical studies happen, no difficult issues will arise and one would have only positive outcomes with clinical studies. Clinical studies are on a path that continues even after regulatory approval with post market surveillance. We continually learn about the medical device or drug and need to constantly evaluate what we are doing and does it make sense. Our predictive capabilities are still not mature enough and therefore, situations will come about including ethical issues during clinical studies. I certainly do not have all the answers but I do know, it takes various sources of input to evaluate whether the clinical work is being conducted properly but also the potential to re-evaluate the whether to move forward or change direction.
I believe it is acceptable to expose a few human subjects to risk of harm for the benefit of future patients, since those few human subjects are told of all the risks and benefits of the clinical trial and make a voluntary choice to join or not. It would not be ethical to force these patients into the clinical trials, or misinform them. However, the IRB makes sure that the human volunteers are well-informed and risk is minimized before the administration of the clinical trial. However, one ethical issue that arises is whether or not the patient really has a voluntary choice to join or not, given the current lack of successful treatments on the market for them. Do they really have a choice in joining the clinical trial, or has society pushed them toward this last resort?
Although one may view an unapproved clinical trial for a patient as an attack on their freedom of choice, I believe it is more ethical to disapprove of the clinical trial in cases where the patient is clearly going to have more risks than benefits. Although the patient wants to take part in the unapproved clinical trial, there have been multiple steps taken to assess whether or not it is safe for the patient to do so. If after all the information, the patient decides to take part in the unapproved trial, and something goes terribly wrong, then they may be deterring others from participating in future clinical trials. Overall, it is imperative that the clinical trials are given in a way to minimize risk and misinformation.
This is an interesting topic and it is also interesting to see that some people chose the Utilitarianism approach, where the "justified" scarifies of life is thought to be okay, as long as it served a higher purpose of benefiting the majority. This is opposed to Kantianism, which would argue the fact that that single person's life is not outweighed by the majority. Well, that is enough ethical philosophy spiel. I think that it depends on the typed of patients we are speaking off. There are patients that (how other mentioned) are on the verge of death and are willing to enroll in any clinical trial that promises more time with their loved ones. However, I can not agree that it should be any trial. These trials should be well investigated and thoroughly studies for efficacy, toxicity, and other effects that could harm the patient and if approved to be "safe"; meaning that the drug has minimal side effects, than the trial should be ran. I also believe that the although the patient is motivated to enroll, investigators have the right to exclude them based on clinical evidence that shows how the device or drug could be harmful to the patient. I don't think that this is arguable or unethical, if the trial has a higher percentage of harming or killing the patient and a small chance to cure the disease, then he or she should not be included in the trial.
The ethical concerns related to the use of clinical trials that require human subjects are complicated. Primarily, these issues are hard to deal with because sometimes animal models and normal in vitro testing doesn't give the most accurate picture of how a certain drug will affect the body. This is why drugs must be tested for safety by using human subjects. However, I feel that ethically a person must be informed of all risks and the severity of them before participating in a study. Hopefully one day there will be more technology that allows us to study the drug pathways for development that will help us create safer drugs for the people who need them the most.
From an ethical standpoint, it is acceptable to expose humans with their informed consent and knowledge of test trials. Th first group is usually healthy humans who give their informed consent. I believe that those who enter study and test groups understand how their participation is helping advance science. A few other ethical issues include possible and unknown side effects and bribery with monetary compensation. When subject willingly consent, I do not think of the situation as being an attack on their freedom of choice. When there is a clear understanding on both the side of the subject and scientist, and the subject makes an informed consent, it negates any possible cases of attack because both parties are willing and understanding.
I feel that it is acceptable to take the risk of a clinical trial when the results of the trial are expected to either benefit or not affect those involved. This would be in the case of testing an intervention that can be supported by pre-clinical trials to have the ability to positively impact the patient. It is not ethical to deny an established treatment in order to test a new one. Often times, those that sign up for risky clinical trials are those who choose to do so after exhausting their other treatment options. Because we need the trials to provide for the health needs of the community, so long as there is consent and transparency, I feel that it is ethical to conduct the trials.
I feel that this is not an attack on their basic freedoms because it is only a blockade on companies/groups that wish to maintain their certifications and clearances. It is the duty of the regulating bodies to protect the general public from possible harm, and this includes harm that can come about from making a decision that is misinformed. Of course, if someone is adamant about seeking a risky treatment option, there are avenues to avoid regulating bodies. However, it is important to make sure that the regulating bodies do all that they can to preserve the health of the public.
I agree with your viewpoint on affirming a patient's right to participate in a trial at his/ her own risk. Consent and transparency are paramount. If someone is given all of the facts and understands the risk involved and still wants to participate, perhaps they should, especially if it is their last treatment option. At the same time, I do believe that if the trial has been denied for certain, detrimental reasons it might be best not to allow people to participate. Even if they are aware are the risks, it may be possible that they do not have their own interest in mind and might want something bad to happen. Should an unapproved trial be the vehicle for such a potential agenda?
I believe that human subjects should be exposed to life threatening clinical trials when there is a life alternating, or dying disease available. I believe that this is a sacrifice of the small for the many. Thousands of people could die if there is not a few to sacrifice. I believe the individuals that should be tested should be individuals who are convicted felons that have life in prison. This should be there punishment and since they have chose to commit a life of crime, I believe the system should make it to where they should be used for clinical research to help discover cures for others. Other ethical issues that occur include obtaining consent. Some clinical trials that have been conducted did not include consent from the participate stating that they give permission to use there body for clinical trials.
Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount of laboratory and pre-clinical trails conducted prior to the clinical testing. The idea of improving the greater health of a whole by subjecting a few subjects to a certain risk is a huge ethical dilemma. From an ethical standpoint, when is it acceptable and permissible to expose human subjects to risk of harm for the benefit of future patients? Also, what other ethical issues are out there pertaining to clinical trails?
From what I have read and noticed, no one is arguing that sponsors and investigators shouldn't conduct research if they can get the appropriate informed consent of the subjects they enroll and test. However, currently, regulations place restrictions on types of research that can be conducted and committees may approve. For research that doesn't get approved, what if test subjects are interested in enrolling in this type of research. This research that doesn't get approved, that test subjects would be open to enrolling in, would that be a basic attack on their freedom of choice? Thoughts?
I tend to take a utilitarianism approach when it comes to conducting clinical trials of any kind. Even though the situation may not be ideal, if the potential good strongly outweighs the potential bad, some risk is necessary, and I think it is still ethical. With that being said, a lot of the times that the situation mentioned above is present, the people involved in the clinical trials are using it as a last resort. I don't think that it makes the clinical trials ideal but I think it does justify the risk.
Your question has a lot of depth. As accepting clinical trials “as is” is easy because they have always been done a certain way. It is easy to also conclude that it must be okay because patients provide consent. The process is also insulated by the fact that patients receiving the placebo are entitled to immediately receive the treatment, if it is determined that the treatment has success. This is certainly the detail that has helped me accept clinical trials “as is”. Therefore, the most ethical use of clinical trials is when a patient consent is secured.
There are many ethical issues behind initial clinical studies in small groups of volunteers for the study. Initial study groups are small in order to test initial impacts on the human body. It is important that these volunteer clinical trial participants are made fully aware of all aspects of a clinical trial before proceeding to sign the informed consent form. Ethically having a small group of initial participants will minimize the long-term negative impact of large groups of people. These small human clinical trials are needed to understand the long-term impacts of the product on the human body. This limited clinical trial can have negative impacts on the volunteer test group. Clinical trial approval for stage one is essential for establishing safety. If it is not approved, the volunteer test subjects should be able to wait on approval before testing the safety within their bodies.
I agree that once patient consent is given, they should be able to proceed with the test treatment that is being offered. There are other issues that could arise as a result of this decision. The negative impacts of the product on the body may leave the patient in a worse condition than when they began the clinical test. Patient safety is of the utmost importance when considering testing a new product. As long as the patient is fully aware, they should be allowed to proceed. The risks may outweigh the benefits if the product is not found to be safe and secure within the human body.
If a patient chooses to participate in an unauthorized clinical experiment, I believe there are several ethical concerns. To begin with, there may be a major cause for the committee's refusal to approve this trial. Is the equipment or product in issue causing more harm than good, or does it have such a slim possibility of effectively treating the patient's symptoms? Clinical studies are essential, but there should be no justification to subject a patient to one that is so dangerous.
Second, why is the patient so eager to participate in an unauthorized study? They may be in severe difficulties, or they may wish to aid future patients suffering from the same ailments. In any case, as mem42 points out, it's critical to educate them before allowing them to agree. They must be aware of what will be done as well as the hazards involved.
Allowing someone to consent to an unauthorized clinical experiment if they have no other alternatives and have little prospect of survival is acceptable to me. Denying them consent becomes immoral, in my opinion, at that point.
Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount of laboratory and pre-clinical trails conducted prior to the clinical testing. The idea of improving the greater health of a whole by subjecting a few subjects to a certain risk is a huge ethical dilemma. From an ethical standpoint, when is it acceptable and permissible to expose human subjects to risk of harm for the benefit of future patients? Also, what other ethical issues are out there pertaining to clinical trails?
From what I have read and noticed, no one is arguing that sponsors and investigators shouldn't conduct research if they can get the appropriate informed consent of the subjects they enroll and test. However, currently, regulations place restrictions on types of research that can be conducted and committees may approve. For research that doesn't get approved, what if test subjects are interested in enrolling in this type of research. This research that doesn't get approved, that test subjects would be open to enrolling in, would that be a basic attack on their freedom of choice? Thoughts?
When it comes to experimenting, morals and ethics play an extremely heavy role. In my opinion to answer the question, I feel that it is acceptable to expose human subjects to risk of harm to benefit future patients only if it voluntarily. I believe the average is not willing to volunteer mainly because the average human experimental test will most likely have toxic side effects. I appreciate the growth of science and how the anatomy of zebrafish was discovered to be closely related to humans. Although it still may not be morally correct to experiment on a species that still have a life, their life span is simply a few weeks and they spawn hundreds of eggs in one sitting. I think the sacrifice is much lesser than a human. Other ethical issues that pertain to clinical trials would include privacy. Even when individuals sign paperwork giving consent to have their information protected, it is not necessarily guaranteed. Invading a person's right is extremely unethical even for research purposes.
Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount of laboratory and pre-clinical trails conducted prior to the clinical testing. The idea of improving the greater health of a whole by subjecting a few subjects to a certain risk is a huge ethical dilemma. From an ethical standpoint, when is it acceptable and permissible to expose human subjects to risk of harm for the benefit of future patients? Also, what other ethical issues are out there pertaining to clinical trails?
From what I have read and noticed, no one is arguing that sponsors and investigators shouldn't conduct research if they can get the appropriate informed consent of the subjects they enroll and test. However, currently, regulations place restrictions on types of research that can be conducted and committees may approve. For research that doesn't get approved, what if test subjects are interested in enrolling in this type of research. This research that doesn't get approved, that test subjects would be open to enrolling in, would that be a basic attack on their freedom of choice? Thoughts?
Based on research there are 3 main things that should be considered for human test subjects. The 3 main things include respect for persons, justice, and beneficence. I think if it is to create ways to help out science and create room for future growth it is always best. Clinical trials will always be a test of a hypothesis, so in order to create or redefine treatment, I would do it. If testing is not done how will we know the risk before using it on others? when testing you want to get the best results and should do everything to get them.
