Is Informed Consent Always Necessary for Randomized, Controlled Trials?

This temptation happens when the research question, such as a cure for cancer, is extremely important and the answer could save lives. If the investigators cared more about the scientific or medical advancement than the well-being of their participants, they would cross a line that prohibits treating human subjects as a means to an end. When this line is crossed, there is little left to protect patients from a callous disregard of their welfare for the sake of research goals. Informed consent would not matter because of the unbalanced relationship between the knowledge and authority among the researcher and the subject. Approval by an institutional board, although it is important, can be subject to change in its responsiveness to patients’ interests when they conflict with the welfares of the researchers. Going back to Paul’s case, he agrees to enter a clinical trial which was suggested by his oncologist. The study, that Paul has agreed to enter, has claimed that this research team has created a new drug that may be on its way to cure cancer. Obviously to a father and husband, this trial looks very appealing. However, the researchers knowingly form two groups that will compare two treatments. What Paul doesn’t know, is that one of the treatments is better than the other. One group will receive this new drug and the other group will receive a placebo. Comparing this new treatment

Another issue with the implementation of Informed consent arises when the patient waives the right to Informed consent and leaves the right to make the decision on the physician. Though legally correct, this can cause psychological stress for the physician especially when the decision is about a life threatening medical condition. Moreover, this also makes the patient vulnerable to abuse. (Manthous, DeGirolamo, 2003)

I made an informed consent form. In the informed consent form, I explained the purpose of the study, the methodology of the study and that I will ensure confidentiality by having no identifying information on the questionnaire. None of the participants raised concerns about their rights as a participant. One participant did ask about the purpose of the informed consent.

Informed consent is the process by which a patient is fully informed about all aspects of their healthcare and has the ability to participate in choices and make an apprise decision regarding their care. It is the legal right of the patient to direct what happens to them and the ethical duty of the doctor to involve the patient in their care. My final paper analyzes informed consent and its perilous deception. I shall present three main points against informed consent by arguing the complexity of the information given to the patient, the decision-making process and lastly patient competency.

In 21 CFR 50.24, federal regulations allow for emergency research to be conducted without an informed consent. The Consent is designed to exempt the subject’s normally required signature due to the following reasons below: (1) The patient is in a life threating condition, requiring treatment outside of the standard of care. The study treatment may be unproven and require data on safety and effectiveness. (2) The patient’s mental and/or physical state does not permit them to give their consent. (3) The treatment in question will need to be administered before a family member or a Legally Authorized Representative (LAR) is able to provide consent. (4) There is no way to determine prospectively if patients would be eligible and provide their consent to participate in the trial. (5) The benefits associated with the investigational product

Participation is voluntary. Informed consent is given in writing and signed with a personal signature. Participants can withdraw from informed consent at any time, without any consequences for their treatment. Randomization took place after informed consent was obtained. Subjects that met all of the inclusion criteria were randomized to tow modalities of treatments or to the wait list. A patient in the wait list was give pharmacological treatment and took a part in monthly supportive consultations. Offering crisis intervention if needed. The patients that had given consent could not receive treatment for another clinic while waiting for day-treatment care. Also after the waiting period patients were randomized into two intervention group.

In 21 CFR 50.24, federal regulations allow for emergency research to be conducted without an informed consent. The Consent is designed to exempt the subject’s normally required signature due to the following reasons below: (1) The patient is in a life threating condition, requiring treatment outside of the standard of care. The study treatment may be unproven and require data on safety and effectiveness. (2) The patient’s mental and/or physical state does not permit them to give their consent. (3) The treatment in question will need to be administered before a family member or a Legally Authorized Representative (LAR) is able to provide consent. (4) There is no way to determine prospectively if patients would be eligible and provide their consent to participate in the trial. (5) The benefits associated with the investigational product

6. Informed consent is one of the primary ethical considerations in research involving human participants. Since it’s voluntary, the potential study participant must be given enough time to consider whether or not to participate in the research, and the possibility of coercion or undue influence should be minimized. They should understand everything that’s going on and have a waiver of Rights Prohibited. The consent may not include language through which the participant or their representative is made to waive the participant's legal rights or releases the investigator, the sponsor, the institution or its agents from liability for negligence.

Before addressing the topic of drug trials, we first need to discuss concept of patient consent. Patient consent plays a major role in how medical professionals can treat their patients in today’s medical field. For a doctor or other medical professional to legally treat a patient they must first gain consent from the patient, this concept also applies to drug trials. There are two main forms

The role of trust in successfully communicating informed consent is very important. Informed consent is necessary to make sure that the patient/subject is properly aware of all factors involved in his or her choice to proceed with any medical decision. All risks, side effects, steps or methods, and even intention should be disclosed at this time. If a patient does not receive full disclosure, it can lead to the perception of dishonesty on the doctor’s/researcher’s part. No one wants to feel lied to or misled by someone that was trusted to perform a specific task.

People are not clear what is expected of them when they agree to participate in the study. The situation presented directly violates general principles of ethical research. The situation states that people is not clear what is expected from them, meaning they do not have a complete understanding of the study. This shows how the study is not adhering to one of main principles of ethical research, informed consent. Informed consent in the context of research means that participants must have a complete understanding of possible risks involved in the study. This study does not tell what participants what is expected from them and thus could be leaving out information about the risks of the study. An issue that makes the research completed by this

In the 21st century Doctors and Researchers take informed consent very seriously. What is informed consent? Informed consent is the patient rights of awareness of treatment the doctor intends to give. Four guidelines/ rules are followed to confirm the patient has informed consent. Knowing the information about the study and telling patient specific details that will help them understand what will be occur during treatment/ research. The role the patient will have about the study. The contact information of the researcher/ doctor so patients can choose to back out of treatment anytime. The patient should know the risks and Benefits of the research. Patients should be aware of any possible adverse side effects and if there is no personal benefit, then the benefit of the research/ treatment for the overall population because of the study. Doctors and Researchers today initiate these guidelines when giving treatment or asking patient to participate in experiments/ studies. However it hasn’t always hasn’t been the case.

We will need to have informed consent if we happen to ask human subjects questions about their treatment outcomes and the success of those outcomes. That means that the subjects will need to give us permission to ask questions and that even if consent is given they have the choice to opt out at any time.

Ridley DT. Informed consent, informed refusal, informed choice—What is it that makes a patient’s medical treatment decisions informed? Med Law.

Consent vs blinding the subject of studies can be a touchy subject but if you know that the people who are involved in the study are not harmed or may results in death, you should still be informed the people involved in the study. Consent or blind people still need to know what they are asked to do and take. According to GCU HTL 540 Lecture 8 (2010), “The purpose of an IRB is to ensure effective, well-designed research that protects subjects from harm. The IRB reviews and must approve study designs, consents to be signed by subjects, and the processes and treatment in which subjects will participate and receive as part of the study. This must happen prior to initiation of the study.” (para 6, sentence 3). So, yes people should be informed