Informed Consent

After termination of the study, the government implemented and has regulated several changes that impact nursing and public policy today. After ethical concerns had been publically raised and the study was terminated, the National Research Act was signed into law in 1974. This policy was used in the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which proved helpful in identifying policy issues such as the lack of identified basic principles of research conduct and lack of informed consent. Regulations were passed according to this panel’s recommendations that required voluntary consent from all persons involved in studies which are funded or conducted by the Department of Health, Education and Welfare (DHEW) (CDC, 2013). For nurses, this involves a responsibility to ensure that research participants are advocated for and the consent being obtained is used as an educational, informative

So again, is there a way to know whether the patient or their representative even understand the treatment being offered so that they can truly give informed consent. Doctors go to school for many

The research ethics, especially with the human subjects, is a very complex topic, and the completion of the certification opened my eyes on many aspects of research process. I learned how important it is to fully understand the research purpose and the methodology especially when selecting participants. I learned which populations are considered vulnerable, how to balance risk and potential benefits of research, and the importance of obtaining an informed, voluntary consent. I learned how important it is for researchers to ensure subjects confidentiality and privacy. Hardicre (2014) said that the research would be impossible without volunteers, and that the researchers “must act as patient advocates to ensure that every stage of the research

Informed consent is an integral part of the medical process, but what is it? How can the principles of Informed Consent conflict with each other or with patient care? It is important to examine Informed Consent very carefully and explore how the principles of Beneficence and Patient Autonomy work with each other for the best interests of the patients, even if the patient is refusing some treatment that is important in the standard of care. However, it may be possible that Informed consent and these elements work against one another, and conflict with the best interests of the patient.

In the world of medicine, consent is an ethical and a legal agreement between patient and their health care provider; to participate in but not limited to research trials or to obtain medical or surgical interventions. Consent generally is expressed or implied. Express consent can be an oral declaration or it can be provided by printed document. (informed consent). Nevertheless, consent is not an independent entity. It does not function on its own. It works in conjunction with capacity. Spike 2017, stated informed consent is the single most important concept for understanding decision-making capacity. This is measured by a patient’s ability to understand, retain, process and re-communicate the information provided by the medical professionals.

Informed consent is commonly obtained from patients for medical treatment procedures and protocols. While it may serves as a litigated protection and assurance for healthcare professions to confidently perform their duties as healthcare providers, informed consent also ensures patient’s understanding and acknowledgement of their involvement in multiple medical interventions pertaining to their health. As the patient sign these consent documents, they might be unaware of the existence of uncertainty in medical practice. Medicine is the evident of probability because we are not physiologically created equal. Therefore, medical uncertainty is inevitable and physicians have to face tough choices to make a decision they believe to be in patient’s

Review Ethics boards should be considerate of the patient’s they are using to conduct their research by first having them fill out an agreement to participate in the research. This idea is reinforced by a field researcher who had to get the patients to sign permission slips before interviewing them and the research wouldn’t reveal their identity. The field researcher found this was an effective way to make the patients whom the experiment is being conducted on comfortable and willing to participate. It allows the patients to have a say on whether they are willing to have specific research done on them whether related to psychological reasons such as asking questions or to have biological research

The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research, hence, IRB approval must be obtained prior to conducting a research project. To accomplish this purpose, IRBs’ use a group process to review research protocols and related materials like informed consent

The study selected by this author centers around ethical and oversight issues concerning standard of care interventions received by participants in research studies. So as to address recently arisen concerns regarding key aspects of regulation and oversight of standard of care interventions executed during trials, the office for human research protections (OHRP) solicited comments from experts on what has been termed as “Draft Guidance” (Institute of Medicine [IOM], 2015, pp. 1-3).

The informed consent should indicate the participant has read, and understands the details of the study. A statement regarding the maintenance of privacy, confidentiality, and right to decline to participate is included on the consent form, and discussed with each participant prior to the beginning of any interviews. One copy of the consent form is provided to the participant for their records, with the original signed copy is maintained by the researcher in safe

Demographic information as well as information about the research process was collected through consent forms obtained from patients. Patient education regarding the treatment, interventions, procedures as well as potential risks associated with these procedures clearly disclosed and patients can participate voluntarily as evidenced by signature on an informed consent form.

Informed consent was obtained by nursing staff when subsequent interviews were undertaken after notice of failure to comply with the guidelines and they did so voluntarily (Knoll, Lautenschlaeger, & Borneff-Lipp, 2010). Benefits of participation were not addressed by the researchers.

This, in my opinion makes perfect sense. It makes sense for they’re to have consent in not only voluntary medical studies, but with other decisions in everyday life. As humans, living where we do, we have the right to our own bodies therefore, before anything, there needs to be consent. The remaining codes also provide insight on what regulates voluntary consent, such as the following principle stating that the results if the research must be for the good of society and inaccessible to any other means. Also, the study must be based on the information provided by the results of animal experimentation, natural history if the disease or any other circumstances to be studied.

The informed consent should be clear, describe in detail, and be written in lay terms so that participants in the study can make an informed decision whether or not to participate in the study. It should be constructed in a way to protect all human rights. Research participants are sometimes threatened by abuse or exploitation and the possibility of harm through research. To protect these participates the informed consent was developed (Schrems, 2014). It is extremely imperative to protect the human subjects in any research study. All researches need to complete the NIH “Protecting Human Research Participants” course in order to learn just how important it is to protect human

Note: No consent was necessary because we reviewed only the patients' records and no patient personal data was taken. This study approved in accord with IRB standards.