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.

As Dave mentioned above, one essential aspect of allowing risky clinical trials is letting patients who are using them as a last resort go through with them. A patient should be free to engage in a trial where a research estimates even a 90% chance of death if the alternative is (for example) a type of cancer with a 1% survival rate. Consent and education are both essential in cases like these, to ensure that patients are making well-informed decisions without coercion.

In general cases, however, research committees do well to ensure that patients are facing reasonably safe and ethical clinical trials, and should continue to do so. There are some patients that are adamant to try to get into trials that are not good decisions for them (Charlie Gard's case comes to mind) but there is little to be done in those situations.

I agree with the points the above students have stated. Clinical trials are done because doctors are trying to improve science and medication. There are many ways to test if a medication or a procedure will work but in certain cases, the only way to know if it works is through clinical trials. Doctors will have myriads of research about the procedure and know what they are doing. So with that trust and the trust that they will inform us about all the risks and complications of the procedure, we can decide ourselves if we would like to participate in the trial.
Although some trials might not be approved, when presented with all the information, I don't think clinical trials are unethical. Trials might have a very low chance of survival like 1% as Ibraheem has stated but it is a 1% chance of surviving and being cured from a cancer or disease. When all the information is shared with the patient, there should be no ethical issues involved.

There are a lot of ethical issues that arise in clinical trials. One approach that is taken to address these issues is to do a risk-benefit analysis to see if the outcome is worth the input. Medical research often requires patients or subjects to endure pain, discomfort, or even injury during procedures. Such things can lead to momentary or permanent effects, but most of the time the effects are temporary. However, there is always risk that is involved when it comes to treating patients. virtually every medication/drug has side-effects, which can vary based on the individual. Some of the medical procedures that are followed in trials are designed to carefully monitor a patient's response to a drug treatment over a period of time. This is essential because data is required to support the argument that the treatment can be effective or can work on patients. Patients who undergo a procedure may suffer from mental stress such as anxiety, depression, or even confusion as the setting is controlled, not natural. Given these possibilities, I think that it's permissible for patients to undergo clinical trials after they have given written consent to participate. Consent should be given after the patient is fully aware of what he/she faces during the procedure. I don't believe that it is an attack on an individual's freedom if he/she chooses to participate in a research project that doesn't get approved. There are always risks and dangers when it comes to clinical trials but without participation, there's no way to know for sure if a drug treatment is effective and should be introduced to the market. We cannot experiment on animals since their genomes are much different from humans. I think that the individual should be assessed to see if he/she is capable of making personal decisions and that a full explanation should be given beforehand to avoid legal risks and ethical issues.

Whether it be about freedom of choice or some other ethical issue, I can understand when conducting clinical trial on a medical device. From what I know of the engineers trend of thought, the idea is always to bring about improvement to the health of the human being; it is always to determine the efficacy of the device when used on the human being; i.e., its ability to generate the desired results without causing any harm to the individual it is being tested on.

But when the clinical trial has to do with a pharmaceutical drug, the whole idea behind conducting the test comes into serious questioning.

We are fully aware that the most a pharmaceutical drug will do for someone is, may be, give them some relief; i.e., if that is acceptable. The whole idea behind going to visit a medical doctor - if they may be called that - is to obtain some cure of a disease after seeing the physician. But if relief is all they can get while the physicians makes lots of money by billing the patient's insurance company for a visit while the pharmaceutical industry makes more money out the sale of drugs to the patient who only received relief, then the moral behind the clinical testing of pharmaceutical drugs comes under questioning. Remember, the patient has to see the 'so-called' my doctor for more of the pharmaceutical drugs and then the vicious cycle - of billing the insurance company while the pharmacy makes more money out of drug sales without the patient deriving some cure from the drugs - repeats itself.

It is a mystery that such a process is even allowed to exist in a society; and we the engineers seem to allow its existence.

Question is: Should clinical testing be carried out on pharmaceutical drugs as well if all they will give is relief, if at all? What is clinical trials on pharmaceutical drugs all about? That should be the larger question and that is the ethical issue that should be looked into.

The ethics behind this sort of decisions are quite hard. If subjects are interested in research that has not been approved I think consent should be given only after they have been educated, informed, and fully capacitated of what the studies will involve and aware of what they will go through. I don't see it as an attack on their freedom of choice. Even clinical trials that have been approved will include risks that the patient needs to be aware of. Some risk might be greater than others, yes, but if this doesn't happen we could not make medical advancements. The individual who is interested should be in a good state of mind when making the decision of undergoing these type of trials and should be fully educated on the topic. If a patient is fully educated/assessed on the risks, dangers, etc. and willing to go under an unapproved clinical trial, is it ethical to deny consent?

I feel that are a lot of ethical issues if a patient wishes to undergo an unapproved clinical trial. Firstly, there may be a big reason behind why the committee is not approving this trial. Is the device or product in question have more harmful effects than beneficial or is there such a low chance of successfully relieving the patient's symptoms? Clinical trials are definitely important but there should be no reason to expose a patient to such a risky trial.

Secondly, why is the patient so willing to consent to an unapproved trial? They may be in desperate straits or maybe they want to be able to help future patients with the same conditions. Either way, as mem42 states, it is important to educate them before the are allowed to give consent. They need to understand what will be done, and all risks involved.

I believe that it is okay to allow them to consent to an unapproved clinical trial if they have no chance at living, understand what this trial will do, and there are no other less risky options. I feel that at that point, denying them consent becomes unethical.

The paradox seen here is people want a cure but they do not want to risk their lives for it. You ask the person given the clinical trials If they would risk their own life to save those for the future. They may say yes or they may say no. The ethical dilemma we face is if we do proceed with clinical trials then drugs will not be made because the FDA would not allow it. If we do proceed with clinical trials the ethical dilemma is how much do we value human life to the extent of risking another’s life.
I agree with the points of view of a terminally ill individual as long as the terminally ill individual agrees and agrees only to be tested upon.

I believe that it is in fact an attack on our freedom of choice when a government entity decides what clinical trials are permitted and what are not. By doing so, governments tend to create a bureaucratic delay in advancing medical research that might result in discovering or inventing new treatments. I think that an easy argument can be made for the freedom of voluntarily participating in clinical tests that could cause some harm to us; by using the same reasons usually mentioned when recruiting individuals to join any country’s army. People, generally speaking, would say that there’s nothing more noble in life than one’s selfless sacrifice in defending one’s state or land. The same life, and the same health, that an individual would willingly sacrifice for a cause that he or she thinks legitimate, is the same life or health that could be sacrificed (partially or fully) if the participants in questionable clinical trials decide to go through. Our morals are different and our concerns in life are also different. Governments cannot, on one hand, be recruiting young, strong, and healthy individuals to join their armed forces, in many cases because of financial circumstances, and be sent to war zones fighting unnecessary fights, while on the other hand, those same governments would be banning elderly, weak and dying individuals who feel strongly that they have lived their life to the fullest, and at some point want to risk their life or health for a greater cause; which might be the next big medical treatment.

It is hard to say if it is ethical or not when I thought about these questions. One side of it that these been tried on animals before the clinical trials so we sort of know how it works but not fully especially on the human body and how it will react. I Think people agree to go through these trial because they are suffering from a disease and they hope to find a medical treatment along the way with the doctoral studies. Also, unless the doctor is clear and explain the pros and cons in details and educate the patient on everything, Then it is the patient well to choose either to participate or not. So at this point, I think it is ethical. However, I believe that from a business perspective, sometime everything goes around how to generate money and at this point, it is in the gray area if whether it is ethical or not. One example came to my mind that it is like soldiers in the army, they sacrifice their lives to save our nation and families with there own well.

I do agree there is a partly ethical issue in clinical trials because people can endure harsh side effects from the product they are testing. However, in clinical trials scientist do not force people to test the product it is the tester decision if they want to risk their life in testing product. In order for future generation to prosper we have to want make sacrifices for them to achieve a better life. There is a lot that can happen during the trial but there is a document that is signed by the tester that they must understand all the warning side effects and give consent before starting the trial. People can die but they give consent and should have understand what they committed to.

Clinical trials are definitely important but there should be no reason to expose a person to such a risky trial. But in most scenarios,  subjects agree to go through these trials willingly because they are suffering from a disease and they hope to find a medical treatment along the way with the research. If subjects are interested in the clinical trials,  I think consent should be taken only after they have been educated, informed, and fully capacitated of what the studies will involve and aware of what they will go through. The individual who is interested should be in a good state of mind when making the decision of undergoing these types of trials and should be fully educated on the topic. If a patient is fully educated/assessed on the risks, dangers, etc. and willing to go under an unapproved clinical trial, I do think it becomes unethical to deny consent. 

Generally, clinical research is planned and designed to be as low-risk as possible for patients. Any human testing requires IRB approval and oversight at multiple steps of development. 

This is necessary since new medical products or drugs can be extremely risky without proper safety precautions and pre-clinical research. In that, I don't think it would be even remotely ethical to allow patients to choose whether or not they want to participate in clinical studies that have not been approved. Even if a patient is able to understand exactly how an unapproved treatment works (which is unlikely since it often requires years of study to understand how treatments work) it's not entirely possible to gauge if they completely understand the risks associated. Add in the fact that patients might be misled or manipulated into agreeing to a treatment that is unnaproved and risky and you enter an entire zone of ethical violations and issues. Even if you go by a, "freedom of choice" perspective, without the proper guidelines or approvals in place the patient would be accepting to be a part of a trail that lacks proper oversight and thus cannot be entirely informed of the potential issues that may arise from participating in such. 

It also sets a bad precedent for clinical trails that may follow. 

The practice of medicine sometimes involves situations where important values come into conflict. The refusal of life-saving treatment, the concern that telling the truth could have problematic consequences, acceptable ways of facing a request to die all are examples of dilemmas that can arise in the practice of medicine. The absence of clear-cut 'right answers' to questions raised by these situations have led to the development of support services, such as ethics consultations, to help in decision-making concerning ethical problems that arise in clinical settings.