Informed consent: Is it always necessary?
Introduction
Currently there are over 27,000 clinical studies underway in the United States.11 While the noble goal of all these investigations is to further scientific knowledge for the betterment of our society, the safety of the human subjects involved in these studies and means of garnering this knowledge can not be overlooked.
When a clinical research project is being developed, it is necessary to assess the ethical aspects surrounding it and its impact on the subjects. However, informed consent is not the only ethical criteria to take into account; it also constitutes the legal and ethical cornerstone for all research involving human subjects. Informed consent serves as a valuable tool in asserting proper regulations in clinical trials, as well as providing assurance of safety for the patient.
While most clinical studies can only be performed under an informed consent, there are exceptions to this rule. In situations such as emergency research or research with minimal risk to the subject, informed consent is not absolutely necessary. Nevertheless, efforts to protect the subject's rights and safety should be a principal concern in every clinical study.
Informed consent is the process of obtaining the permission of a subject to participation in studies and have an opportunity to decide about his or her healthcare. This notion originates from the legal and ethical right of the patient/subject to retain autonomy and from the ethical duty of the physician/researcher to involve the patient in healthcare decisions. Informed consent also implies that a dialog has taken place about the nature of the decision, reasonable alternatives, relevant risks, benefits and uncertainties of the decision, and the comprehension and acceptance of the healthcare decision by the patient/subject.10, 4
We need not look any further than recent history to highlight the importance of informed consent. There have been some paramount circumstances which have necessitated greater regulation of human subject medical research. The inception of informed consent has its roots in the Nuremberg Code of 1945. This code was formulated in response to the shocking discoveries during the Nuremberg trials. Nazi doctors were found to have committed horrific medical experimentation abuses against the inmates in concentration camps, who were exploited as research subjects. These experiments ranged from inflicting burns and gunshot wounds onto the subjects to test anti-infective agents, to immersing detainees in tubs of ice water for hours to assess the body's reaction to cold temperatures. The code attempted to set a standard for ethical behaviour when conducting human experimentation. It reflected the need for informed consent, condemned physical and mental suffering in experiments, stated that death and disability were not expected outcomes of experiments and affirmed that human subjects were to be protected from the slightest possibility of harm. The Nuremberg Code was a first legal attempt to grapple with ethical issues involved in human research.4
Soon thereafter in 1953, the Declaration of Helsinki was drafted by the World Medical Association. It reaffirmed the Nuremberg Code's stance on informed consent as well as allowed legal guardians to grant permission to enrol patients in therapeutic and non-therapeutic research. The Declaration of Helsinki also recommended written consent, a proposal not mentioned in the Nuremberg Code.4
While significant strides were occurring in the informed consent field, human subject safety in clinical trails was far from being guaranteed. The efforts to improve the ethical standards in clinical research took a significant step backwards when the details of Tuskegee Study came to light in 1972. Overseen by the Center for Disease Control and Prevention, this study, which began in 1932, exploited the lives of more than 400 African American sharecroppers suffering from syphilis by withholding medical treatment. These findings resulted in a considerable damage to the reputation of the medical research community and helped harbour irreconcilable mistrust from the public.4
In 1974, Congress passed the National Research Act in an effort to better protect human subjects. This act mandated that Institutional Review Boards (IRBs) be responsible for peer reviewing any research involving human subjects by requiring informed consents and reviewing the protocols of the experiments. This move was unprecedented since investigators never before had to seek approval of their own experiments.4
An IRB may be created by independent firms or run by hospitals or universities. IRB is legally bound to be comprised of a wide variety of members ranging from scientists to lawyers to clergymen. Their responsibility lay in assessing the risks and benefits to ensure that the risks do not outweigh the potential benefits. They must also agree with the ethical standards met by the proposed study and ensure that the rights of vulnerable populations such as children, prisoners, pregnant women and mentally disabled persons are not compromised. The IRB also must be convinced that it is clinically appropriate to conduct the study. However, the IRB's responsibilities do not end there, since it is constantly updated on the study's progress and is notified of any changes in protocol during the course of the investigation.4
Section snippets
Reason for informed consent
In many ways, informed consent serves as a patient's bill of rights. It is the patient's right to be completely informed about the study, to be presented with information that is understandable, and to agree to participate willingly without coercion. Therefore, it is imperative that guidelines exist which ensure safety and eliminate false pretences for human subjects. Protection of research participants is based on three principles: Beneficence, which implies that the goal of the study is to
Vulnerable populations
There are populations of research subjects that are for various reasons not considered to be fully autonomous and are thus designated by the FDA as “vulnerable population.” There are many variables that would affect the level of autonomy, such as ethnicity, education level, age (children), mental capacity, pregnant women and incarcerated prisoners.
Ethnicity and cultural beliefs play a critical role in patient recruitment. In many cultural circles, the idea of primary intervention or prevention
When informed consent is not necessary
While federal regulations have required informed consent on almost all clinical research, there are instances where it is not necessary. Informed consent is not required for research involving no more than minimal risk. Minimal risk is defined as risk that is comparable to those encountered in daily life. Informed consent is also not required in studies where the consent process may adversely impact the findings by disclosing too much information and creating a bias.8, 9
As in the case of Final
Conclusion
The recent history of human medical research necessitated proper protection of subjects’ rights and safety. Through it all, informed consent emerged as a means to uphold ethical behaviour towards patients and to protect them in clinical studies. While it has served its purpose well, it is not without its shortcomings. There are still many challenges encountered in acquiring informed consent. Difficulties faced with vulnerable populations, especially with cultural biases and discrepancies in
Acknowledgement
Dr. Javad Parvizi receives funding for orthopaedic research from Stryker Howmedica.
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Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not?
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