The expression Informed Consent came into utilization when healthcare providers needed to convey more information to patients so the word ‘informed’ was combined with the word ‘consent’ so appropriate consent could be given by the participants (Beauchamp, 2011). In this paper, I will focus on theory of informed consent, history of the informed consents, types of consents and the legal and ethical challenges related to informed consents. I will address the current issues, as well as alternate solution that can be applied to improve the informed consent process. Theory of Informed Consents
The theory of informed consent is that patients have to be informed about the “potential risks, benefits and alternatives of proposed procedure” and have a right to evaluate the medical or surgical procedure being proposed to the patient (Pozgar, 2010, p. 404). The patient has to understand what procedure or treatment he or she is consenting to, to be performed on them. Majority of the time this should be done by the treating physician as he or she “has education, expertise, skill and training necessary to treat the patient” (Pozgar, 2010, p. 404). Additionally it needs determination whether the person giving consent are capable of giving consent. If the determination is made and documented in the patient’s medical record by the attending physician, that the patient is unable to give consent, clearly noting the reason, the extent and kind of incapability and the duration of this incapability, a Legally Authorized Representative (LAR) like a spouse in case of incapable patient, or a parent in the case of a child can provide consent. History of Informed Consents
The history of informed consent includes number of studies that were conducted without appropriate consent. For example the well-known Tuskegee study of Syphilis where the participants were not informed about the cure just because the researchers wanted to investigate the progression of syphilis however the participants were under the impression they were being cared for but this deceptive case brought issues of racism, and harm to subjects as unethical (Littleton 2010). Then the crimes against humanity by the German physicians that resulted in establishment of the Nuremberg Code followed by the International Code of Medical Ethics when the exploitation of Nazis in the concentration camps was discovered. All these and similar unethical behavior and other experiments led to numerous regulations that include the Declaration of Helsinki, the Belmont Report and the Nuremberg Code for good clinical practices or for research experiments (Pozgar, 2010). Introduction of institutional review boards to provide approval before research experiments can be implemented and reviewed at least annually thereafter; as well as the state and federal regulations that the institutional review boards have to follow were enacted. The federal regulators include the Office of Human Research Protections (OHRP), Food and Drug Administration (FDA) as well as the Code of Federal Regulations. Types of Consents
The consents can also be implied as Pozgar notes that there may be situations where implied consent would be “presumed when immediate action is required to prevent death or permanent impairment of a patient’s health” (2010, p.413). Therefore it would be implied if a unconscious patient that arrived at the emergency center after an accident, that the patient would have wanted to be treated and this assumption would mean an implied consent. In such situations of emergency, if the physician did not do anything, it would cause injury to the patient so it is accepted that an emergency consent is acquired, as a good medical practice to treat the patient to preserve life or to prevent harm. An example of an implied consent is when a patient is in the hospital and the nurses have to give medications or take their blood pressure, the patient either opens their mouth or gives their open palm or rolls up the sleeve to allow the nurse to take the blood pressure (Cole, 2012). Another example of consent is express consent where the patient gives verbal consent to the treating physician or the healthcare professionals but with verbal consent, there is no evidence as there was a signed informed consent document.
The other forms of consents that are not given by the patient themselves are Spousal Consent where the spouse of a patient may be able to give consent for a patient in case of severe disability of the patient and the spouse knows the wish of the patient that he would want to be treated for that disability. Guardianship is another instance when an individual is given the authority to protect the incapable patient. This kind of management is allowed when the guardian has been granted guardianship, sometimes temporary, for the wellbeing of another individual (Pozgar 2010). Similarly the parents often are required to provide consent for their children but if the parents are not available, the treatment should not be delayed and sometimes the consent of a minor is effective or considered valid in situations where obtaining parent’s consent is not feasible. For example a child was injured during school and the 911 was called, the child is taken to the emergency room and at that time treatment is necessary, the child could sign the consent so the treatment, to save his life, can be initiated because waiting may be detrimental to the child. The statutory consent refers to emergency treatment that is given to the patient when they are unable to give consent to a lifesaving emergency treatment which has been approved by legislation (Pozgar, 2010). The best way to manage all these consenting is to ensure all the circumstances are documented in the patient’s medical records which will avoid litigation for the healthcare professionals. Challenges of Informed Consents
The Informed Consent – is it a process or is it a document with a signature? This is the first dilemma because the information about the treatment or research is provided, and additional time given for the patient to ask questions but the bottom line is to obtain the signature of the patient on the informed consent document, without which the treatment or research cannot be conducted. Erlen states it well “the emphasis is often more on the product rather than the actual process of informed consent” where the signature confirms that the patient and the physician had some conversation (2010, p. 276). Often times the patients want their disease to go away so they may just think, if I sign now and the treatment will begin and it will all be over soon. The contents of the informed consent may be a little
overwhelming to a patient who has been diagnosed with a debilitating disease.
The informed consent must include the required elements listed in the Health and Human Services (HHS) regulations which also must be relayed to the patient or participant. The list of elements are shown in Table 1. Although all the elements are of importance the major element is autonomy which involves the individual’s right “to make his or her own decisions about what is best for him-or herself” Pozgar (2010). Table 1: Elements of informed consent (adapted from HHS web page) •The purpose of the research with a statement that it is research •Depiction of benefits and probable risks and discomforts •List of available alternative treatment options
•Information about entities that may have access to confidential data •Contact information in case of emergency or injury
•Statement about voluntary participation and ability to withdraw consent
Any supplementary elements that may assist the patient to make a determination can be added to the informed consent. For example consequences of withdrawing consent, the costs to the patient for participating, the possibility of ending the research early in case of efficacy or the futility analysis and expected number of study participants, etc. By the time all this information is added to the consent document, it becomes a lengthy one which has become an issue of discussion lately. The length of informed consent has increased by 40% between 2005 and 2011 which resulted in 17 pages from 12 pages (O’Donnell, 2012). As Erlen states, “too much information can raise a person’s anxiety such that the person does not hear what is being said and automatically refuses to participate” (2010, p.278). In cases where the length of informed consent form has not been increased, additional information sheets have been added to it “with more administrative and legal information than scientific content” (O’Donnell, 2012). So it is important that the informed consents are informative but short enough to not overwhelm the patients. The next dilemma refers to what Beachamp calls the “Broad Consent” which involves situations where obtaining informed consent is difficult and the institutional review board may waive the requirement of informed consent for conducting research on banked biological samples (2011). The investigator comes up with an idea of doing research on samples previously collected, but not the same purpose that was originally discussed with the patient or the participant. This is an example where the protection of human subject may be violated if the patient or participant did not consent to this new research. For example the experiment with Havasupai tribe and the Arizona University where the researcher conducted genetic studies for schizophrenia, migration and genealogy using the blood samples that were originally collected for diabetic study (Caplan & Moreno, 2010).
When the Havasupai tribe found this information accidently and was devastated at what the researchers at Arizona University had done, they filed a law suit against the researchers, the institutional review board and the University Regents of Arizona University; the Board, finally settled the case and returned the blood samples and provided scholarships for their young members and build a new health clinic for their tribe members (Caplan & Moreno, 2010). Although the participants from the Havasupai tribe had been consented, the possibility of them comprehending the consent process was diminished or there was also a possibility that the translation of the consent was not adequate. This leads into the next dilemma related to informed consents about how information is presented to the participants. The way information is presented greatly influences what a patient may understand or remember and the information may not be retained well or they may forget the important information Therefore, all patients are given a copy of the consent and they also are required to sign consent before a treatment or procedures is carried out. But will reading this consent be understandable to the patient. As Leclercq, et al states that elements of the consent forms are not always well written and only half are “at 12-year-old reading level” which is best practice (2010 p. 1411). So comprehension of the written consents is not always possible nor is a proof of comprehension required but patients do sign them. The legal aspect of not obtaining appropriate consent always ends up in litigation. Although there are “legal mandates, which establish necessary minimums of healthcare services, ethical codes seek to hold providers to a higher moral obligation in serving the public or at least serve as a guide for ethical actions” (Littleton 2010, p33). So obtaining consent from a competent person before procedures or treatments are considered is necessary or as Pozgar states, “failure to respect this right can result in a legal action for assault and battery” (2010, p. 415). So it is important to explain the importance of the treatment or the research to the potential patient or participant without coercion or intimidation. If the patient still refuses treatment, than their decision should be upheld, even if it means the patient may die. Further, it would be necessary to document the refusal by the patient and release the patient from the medical facility. Possible Solution of Informed Consents
As Rowbotham, et al suggests an interactive approach may be helpful, if the patients had a choice of hearing, or viewing instead of only reading to comprehend and provide feedback (2013). They conducted a randomized study with two groups, one group was consented with a regular printed consent and the other group utilized an iPad, which has features to include video and audio summaries of the consent and option to read the consent online or in the printed form and in addition the participants utilizing the iPad consent also had to complete a consent related quiz (Rowbotham, 2013). The iPad involved questions that related to the elements of the informed consents shown below in Table 2. Each question had 4 multiple choices and if the participant picked incorrect answer, they were directed to the part of the consent that provided information related to that question so the participant could re-review that part of the consent for correct understanding. Table 2: iPad questions related to the elements of the consents 1.What is the main reason for the study?
2. What is the role of the study doctor?
3. What happens if you agree to participate?
4. What are the risks involved in the study?
5. What reimbursement would you get for participation?
6. What happens if you are injured accidentally?
7. What is the total duration of the study?
(Adapted from Rowbotham, 2013).
The next day the participant had to go on the web and take a on-line survey
of similar questions to verify the comprehension and recollection of the information read the previous day. The final conclusion of their study was that the participants with the iPad interactive consent “demonstrated that combining an introductory video, standard consent language and an interactive quiz on a tablet-based system improves comprehension of procedures and risks” (Rowbotham, 2013, p. 6). The only drawback to the interactive consenting would be the cost of purchasing the iPads in addition to allowing the participant to print the consent (Rowbotham, 2013). With this interactive process, the voluntariness of the participant can be verified. As Nelson concludes that “two actions must be satisfied for an action to be voluntary” action in this case being the consent has to be voluntarily given, the first action being “intentional and other free of controlling influences” (2011, p. 4). When the person is left with an iPad, there isn’t any influence of any healthcare professional and the person willingly gives consent. In conclusion informed consents are an important part of participants’ healthcare, where the patients have a right to have autonomy to decide whether to have the treatment or to participate in research without any coercion. The patient or participant is able to view the consent at his/her own pace in the interactive informed consent process and the responses to the quiz and survey questions from the patients provide the evidence of comprehension of the informed consent. This interactive process would essentially help with the consenting process and allow the healthcare providers to protect the patients or the participants.