I think that using human subjects is a good thing, but post animal testing. Drug testing may not be as effective in humans because they may develop symptoms either mild or life threatening and possibly die. A person's dignity, health consideration should be at the forefront when using humans in clinal trials. There are always risks, even the drug hit the market.

As previously stated by others, the best time to expose human subjects even if harm is unavoidable is when the patient agrees and gives consent, along with the clinical trial being something that could potentially cure a disease that has had either no cures or methods to reduce the disease. Extreme diseases that are currently incurable, which could either be cured or even just have a therapy to reduce the rate of the disease, would obviously have side effects because the drug or method used would have some sort of potency to the body, but it would be necessary science, and these clinical trials have the potential to be dangerous.

I think if the patients/subjects willing to undergo the clinical trial is informed of what they are participating in, and given the free choice to vacate the study whenever if they feel uncomfortable would not be an attack on their freedom and rights. Additionally, many people who undergo these extreme trials typically are very ill so they are more willing to undergo a clinical trial because they know their current state, hence why It wouldn’t be an attack on their freedom because many of them understand the severity of their disease (especially if they have a small percentage chance of living due to no cures/their current diseases state) and they are more willing to contribute beat the disease or help create something that could prevent others from dying.

Health is not up to the interest of the sick, it’s based on regulations that the government places to uphold the public order. The ethics of human tests in my opinion should only be allowed if the drug passes the first phase of the FDA and had a positive outcome from the subjects they were used on. Clinical trials are the source of ethical procedures because they care about human use from the place the trial is conducted to the treatment of the patients, everything goes through various phases by the ethics boards and committees. It doesn’t matter if the test subjects want to be in the trial, if the law says no, and if it does not pass the regulations then you cannot do it. These laws are not placed to limit the citizen's free will or the freedom of choice, it’s about keeping the public in order. These regulations are strict and detailed for the sole purpose of safety and limitation. The social contract binds people to the belief that we give up some rights to live in safety and happiness. This I would say is a part of those rights we give up in order to create a balanced community.

Thanks!

If the research involves elements of potential harm, as long as patients are made aware, then it is ethical. I do think that in this scenario, pre-operative clinical screenings are critical. As long as subjects are appropriately informed, these studies display ethical principles.

No, I do not think that it imposes on patient autonomy. Subjects must be adequately informed about the study before enrollment. In other words, all information regarding all potential benefits and risks. As long as researchers provide this information and the study has been deemed safe by regulatory entities, it should be a successful study (in the approval process). However, though I understand patient autonomy may extend to studies that fail to obtain approval, if there is appropriate reasoning to disapprove, I think it is in the best interest of the subjects.

I like the questions you posed. This is a very thought-provoking post. I for one, don’t have any issues with clinical trials, as long as it is the participant’s choice. A lot of times people choose to be a part of studies because the doctors don’t have a solution and will do nothing more for them. I know someone who has stage 4 liver cancer, and without the clinical trial therapy that he receives a few times a month, he would not be here. It’s costly, but thankfully he can afford it.

I don’t think it’s right to infringe on someone’s freedom of choice, but if you think about it, they already do. We can’t do certain drugs without risk of getting arrested. To me, this falls under that category. It should be a person’s right to do whatever they want as long as it’s not harming anyone else, but in reality, that’s not always true. I don’t know why they won’t approve certain trials, I’ll have to do more research. But I do think it’s necessary to have someone posing regulations, because things can get out of hand. You can’t trust everyone, and not everyone is in it for the right reasons. Making sure you don’t make it to easy to start a clinical trial, means only the serious ones will make it through.

I'm not sure there is a time where it's ethical or permissible for humans to be a subject for clinic trials. Although humans tend to become the subject when this is offered as a last option which may or may not help the patient but will definitely help patients later on down the line. I believe if possible animals should be used as the first option.

What is ethical and what is not can be somewhat of a grey area. Peoples opinions will always differ greatly when it comes to this topic. I think if the patient is well informed on the risks they are taking on when they enter the clinical trial, then ethically the company has done right. I am assuming at this point that animal trials have already been conducted, and substantial data has been collected to warrant them moving forward to human trials. On that note, patients are free to leave the trial at any moment without any repercussion as well.

With clinical trials, there is always a risk that the patients are willing to take as long as it is explained to them. Within my current job, the clinical trial patients are those with cancer. With their consent, we are able to use their blood to create the treatment for the specific cancer they have and re-inject that altered blood. The patients know that there is a risk that either the treatment might not work or that the treatment process could not get completed depending on how sick they are, but they are willing to take the risk because it gives them some hope. I think that if the patients are willing to take that risk, they should be allowed to have the freedom to choose to continue with the study if it isn't approved. Yet the issue with it not being approved could cause an issue with the data if proceeded with. If its not approved, the study would really just be for personal research or it could possibly be used to prove that the treatment would be useful. I think the issue is that there might not be as many regulations and considerations taken into account if it isn't an approved study, especially because you would have to make sure there are no unnecessary risks when it comes to the safety of the patients as well as the staff conducting the research. 

I think it is important to note first that any kind of clinical trial does not force any of the patients to take part in it and does not force the patients to stay in the study for the entire time. The researchers will provide all the information having to do with the study and will answer any questions that the patient has pertaining to the topics of the study. There are multiple consent forms that also need to be signed in order for the patient to participate in the study. After all this framework and setup, I think it is acceptable to expose human subjects to a potential risk of harm. Not only will this benefit future patients, but this is also how humanity will be able to push forward the boundaries of medicine and science and apply it to future issues. Other ethical issues that might arise from this can have to do with the initial process not being done correctly, whether that means hiding information or forcing certain people to take part in a study. If everything is done correctly and legally, I think it is acceptable since the patients know what they are getting themselves involved in and always have the option to opt-out. 

There may be moral but not ethical issues with human trials. Before trial the patient signs INFORMED CONSENT, so it is by choice someone goes for trials. Secondly when drugs or devices are tried on human subjects, they are safe and have less possibility of having life threatening adverse reaction. It is never like lab rats which are injected with something novel to study effects on different organs. The aspect of 'Greater Good' plays into picture. It is worth to risk a handful of people if you want to save millions, this is core to medical research and what most pharma companies did while rolling out covid 19 vaccines.

Whether or not a clinical trial proceeds is not just based on if the sponsors and investigators can get the informed consent of individuals enrolled in their study but the study must be reviewed, approved, and monitored by the Institutional Review Board (IRB). The purpose of the IRB , as per the Belmont Report, is to ensure the right of persons, beneficence, and justice for human subjects, which may include vulnerable populations, participating in a study. Therefore, to answer the first question - it is acceptable and permissible to expose human subjects to risk factors as long as there is no undue influence and the study ensures beneficence which involves balancing the concept of “do no harm” while maximizing benefits for the research project (and minimizing risks to the research subjects and securing their well-being). In the event that a trial has not been approved yet the subjects who enrolled are still interested, then the sponsors and investigators should make the effort to revise the clinical protocol, address all ethical concerns, and amend any discrepancies in the consent forms (i.e. description of risks) based on the feedback by the IRB. If that cannot be done then it is in the subjects and the coordinators best interests to not go through with the study.

I believe clinical trials are useful for research and how to benefit the majority. But if clinical trials are to be used, they should not cause unnecessary harm to the person being tested. There should be necessary precautions taken and anything done to the subjects should have scientific groundwork to back up the reasoning. By doing this it can create the safest environment for clinical trials and leaves little to no room to injure the patient unintentionally. 

As for the unapproved research question, if a research does not get approved then it shouldn’t have the option to continue with test subjects. I don’t believe it is an attack on the freedom of choice but rather companies protecting the majority from harm.

Ethics in clinical research are emphasized for many reasons. Not only do ethical strategies ensure the integrity of the research results, but they also protect the safety of patients who volunteer to participate in the trials. And ethical parameters help prevent participants from being exploited or treated unfairly by the research group. Many government regulations require that all proposed clinical trials be approved by an institutional review board to ensure that the trials are ethical and that the rights of participants will be protected. Good Clinical Practice is international guideline to ensure hat clinical trials are designed, conducted, implemented, monitored, audited, recorded, analyzed, and reported scientifically and ethically.