Informed Consent In Research

In our day today lives we make complex decisions, continually weighing up the risks and benefits of our actions. However in the hospital environment, the Doctor knows best attitude has prevailed for many years, patients deemed unable to be involved in decisions regarding treatment. Development in law relating to consent has been slow, based on paternalistic approach and therapeutic privilege to decide treatment choice for patients. Whilst health care practice moved towards informed consent, the law lagged behind. In 2015 informed consent has finally been recognised in Law. The author will describe the changing attitude in the law of consent from 1950’s to present day and how these changes affected nurses duty to obtain consent from patients

This paper is a representation of two separate healthcare professions; a paramedic (Roscoe) and a registered nurse’s (Gale) perspective of the ethics of informed consent. Informed consent is a familiar and ethically important component of healthcare, grounded by principles and values that provide and maintain professional standards. The following will discuss and analyse the similarities and differences between the two professionals from the AV resource. Present international and national frameworks that influence decision making as well as the individual impact that the Code of Ethics provides in moral dilemmas will be examined. Contrasts of legalities versus ethics will also be explored in regards to vulnerable patients. Furthermore the

According to According to (Gerald, Corey, Schneider, & Callanan, 2015) “Informed consent involves the right of clients to be informed about their therapy and to make autonomous decisions pertaining to it” (p.154). Section B of the ASCA National standards for School Counselors states “Recognize that providing services to minors in a school setting requires school counselors to collaborate with students’ parents/ guardians as appropriate” (pg.6). Since I will be working in the school system. I have to be aware that parents and guardians are heavily involved with the student’s school counseling experience.

In an elective, non-emergency procedure, an informed consent is a physician’s obligation to provide their patient with information to help them in making the best possible decision for their care. Likewise, the patient acknowledges that they have reviewed and understand the information provided. There are three things that an informed consent addresses including, information about the recommended procedure, any available alternatives, and the risks associated with the procedure, and alternatives (Mazur, 2013). Furthermore, it provides an opportunity for the patient to ask the doctor additional questions they may have (Mazur, 2013). In an emergency situation, an informed consent is not required and is considered “implied,” as long as the [conscious and competent] patient or their authorized representative have not refused treatment (Showalter, 2015, p. 367).

Currently, there are nearly as many human biological samples stored in the United States as there are people in the United States, and many of the sources of the samples remain unknown because informed consent was not previously required.   The main dilemma between informed consent and scientists lies within the ethics and practicality of research on tissue removed from a patient’s body for surgical purposes.   Meanwhile, the tissues are studied in labs across the country.  In recent years, the HeLa cell line and the cells backstory have precipitated outrage towards how the tissue was obtained, managed, and the inadequacy of informed consent from Henrietta Lacks and her family.  Since then, other cases have become public regarding the lack

“Following ethical informed consent procedures requires nurses to advocate for participants' best interests, ensures participants' understanding of the informed consent process and the research study, and upholds the ethical principles of autonomy, beneficence, and justice” (Judkin-Cohn et al., 2014, p. 36). The two main objectives that must be met within the informed consent are to promote participant autonomy and protect the participants from potential harm (Judkin-Cohn et al., 2014). In order to meet these objects for my Capstone Project Proposal, the participants will need to provide voluntary, informed consent prior to enrolling. Respect for the participants is gained through the informed consent process involving the following: full disclosure of the nature of the research, the process, and the possibility of withdrawal from the study (Judkin-Cohn et al., 2014). The privacy of the participants must be maintained, as well. I plan to maintain privacy by locking all of my research participant data in a locked filing cabinet, within my mentor’s clinical lead office. The research will demonstrate principles of beneficence and nonmaleficence by distinguishing the possibility of direct benefit versus lack of direct benefit, but potential for improving future patient care (Judkin-Cohn et al.,

Informed consent is the authorization that gives the patient to the doctor and the institution to receive the services they need for their recovery. The patient can give consent orally or in writing may be total, partial or for a specific procedure. Also the patient has the right to submit advance directives of which stipulates the refusal of a treatment such as blood transfusions or intubation. Guide the hospitalization process, the patient may reject some study or treatment for which he is taking a leave of refusal of treatment, although their lives may be in danger, what matters is that the guidance provided by both the physician and the nurse are documented.

The standard of medical practice involves the practitioner to, disclose the medical facts to the patient/responsible party with recommendations for health management in accordance with the facts (1).

The article further elaborated that even though there are a set of principles to follow this does not curb all the problems. Issues still arise in action research. Informed consent is an issue which the article expounded on. It is stated by Kowalczyk (2015), stated that informed consent is essential because it provides participants with information so that they will know whether to make the decision to participate in the research. As an educator, I strongly believe that is an

Is informed consent always necessary for randomized, controlled trials? The following sentences are different scenarios that answer the question. Informed consent should not be waived unless the treatment is offered inside and outside the trial. Treatment should not involve more than minimal risk compared to alternatives. Genuine clinic must value the treatments the same. No reasonable person should have a preference for one treatment or another (Truog et al. 1999).

Informed consent is the current guiding principle for the ethical conduct in medical research and originated after the 1947 Nuremberg Code and the 1964 Declaration of Helsinki (Nguyen et al., 2015). The purpose of the informed consent process is to provide potential research subjects information about the nature of the clinical trial, the risks, benefits, underlying procedures, and alternative treatments (Bloswick & Skowron, 2015). The research team must provide the patient with sufficient information so the participant can fully make an informed, uncoerced choice about whether to begin or continue participation in a clinical trial. This process is an ongoing exchange between the subject and the research team throughout the research study.

I agree that this family is vulnerable and that their vulnerability should not exclude them from participating in a research study. Schrems (2014) discussed the importance of allowing vulnerable individuals the freedom to choose and I agree that in this case Fatima and her husband should be allowed the decision to participate in the study or not. However, I don’t agree that they should be encouraged. According to the Council for International Organizations of Medical Sciences (2002), “Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation” (p. 22). This definition of informed consent explicitly states that the participant not be subjected to coercion and therefore encouragement would be in violation of the patient’s rights. So while I believe the family is capable of decision making, I do not believe they should be encouraged to participate.

Informed consent is required for the principle of autonomy for all treatments, including exams, injections, surgery, medication and radiation, to name a few. It is found in the Health Care (consent) and Care Facility (Admission) Act part 2. Informed consent may be expressed or implied and is based on a reasonableness standard. The elements of informed consent are that the consent must be voluntary (ie. not coerced, forced, or made unconsciously), it must be made by a patient who is mentally capable of consent (adult or mature minor, not suffering from inebriation or mental incapacity), and it must be informed. A patient is mentally capable to consent and can understand the nature of the treatment, understand its intended effects and alternatives,

Informed consent is an important ethical principle which is applicable to medicine and research. By definition it should be given freely, without coercion (1). All the relevant information which might influence or inform the participant’s decision such as the nature of the study, the risks and benefits must be provided by the researcher (1). Participants should be informed that they can withdraw their consent at any time and withdraw from the study.

The principle of a well formed conscience: This is the commitment to our creator through His son Jesus Christ is the source of well-formed conscience, and this is the origin of all morality. This could be achieving by listening to His teaching, obeying his commandment and following Jesus Christ steps. In some cases, ideals and principle of others that have displayed good character might be following