Informed consent

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Informed consent

Informed consent is the procedure of getting permission to take part in a research study or medical procedure founded on access to all vital and easily understandable information about the consequences of participation in terms of benefits and harms (Dolgoff et al, 2009). A healthcare provider may demand informed consent from a patient before providing care or a researcher may request it from a participant before enrolling the individual into a research trial. Informed consent is based on guidelines provided by research and medical ethics. To give informed consent, the person involved must have sufficient reasoning faculties and have all the relevant facts. However, not all individuals may have capacities for informed consent due to impairments to reasoning and judgment such as mental immaturity, severe intellectual disabilities, mental illnesses, high stress levels, being in a coma, Alzheimer’s disease, and severe sleep deprivation.

Medical and research actions may be carried out due to lack of informed consent. When a person is considered unable to give informed consent, another person can be authorized to give consent on behalf of that person (Manson & O'Neill, 2007). For instance, legal guardians or parents may give informed consent for young children and the mentally ill. In case a person is given insufficient information to make a reasoned decision, severe ethical issues may arise. In clinical trials, such cases are anticipated and avoided by Institutional Review Boards or ethics committees.

For a person to give informed consent, three elements must be present: capacity, disclosure, and voluntariness. Although the law and guidelines demand that the researcher or medical practitioner must provide the subject or patient with sufficient information needed to make an independent decision, they must ensure that the subject or patient has sufficient capacity to understand the information. This implies that the language used in the consent form must suit the comprehension skills of the patient or subject population. This also implies that the researcher or medical practitioner must evaluate the level of understanding of the subject during the meeting. Capacity means that the patient or subject must posses the ability to comprehend the information offered and construct a reasonable judgment based on the potential implications of the decision. Voluntariness is the patent of subject’s right to liberally make his/decision without being exposed to external pressure through manipulation, coercion, or undue influence (Manson & O'Neill, 2007).

Assessment of informed consent is intricate because neither expression of consent, nor expression of comprehension of consequences necessarily implies that adult consent was given, nor that complete understanding of vital issues is internally absorbed. It does not mean that consent must be expressed negotiated verbally or through writing, but it can be expressed though the subtleties if human communication. In some instances, consent is not legally possible even if the individual protests that he/she understand or wishes. Despite the accessibility of instruments for evaluating competence for informed consent, no perfect mechanisms are currently available in the market. Therefore, there is always a level to which informed consent is inferred or assumed based on knowledge, observation or legal dependence (Marshall & World Health Organization, 2007). This applies mainly to relational or sexual issues, in formal and medical contests, explicit expression of consent though signature is usually depended upon legally irrespective of actual consent. This applies to the case of “do not resuscitate,” which a directive given by a patient before their illness (Manson & O'Neill, 2007). Several examples illustrate the outlined circumstances. For example, an individual may verbally consent to a procedure due to fear, mental difficulty, and perceived social pressure in expressing genuine feelings. This individual may be honestly oblivious of this, believes that the expression of consent is true, and depend on it. This implies that consent is expressed and not internally given. Another example may involve a person claiming to comprehend the consequences of an action, but in reality, he/she is not fully capable of appreciating the likely implications and may deny the validity of the consent later. This means that the comprehension required for informed consent is present, but through ignorance is lacking. The last example is that of an individual signing a legal release for a certain procedure and later feeling that he/she did not consent to the procedure. Unclose such a person may prove real misinformation, the release is legally conclusive and the medical practitioner may legally depend on it for consent. Therefore, in legal contexts, a written consent overrides later denial of informed consent unless it was obtained through misinterpretation.

Waiver of consent is also possible in some instances. This is possible in circumstances where there is no foreseeable harm expected as an outcome of a research study or medical procedure. Additionally, waiver of informed consent is possible when it is allowed by federal regulations, or when institutional review boards have allowed the non-disclosure of specific information. Another scenario where waiver of consent is permitted is in military contexts. According to regulation governing the armed forces, limitations regarding the use of human subjects in experimental settings, waiver of consent are permitted by the secretary of defense if the research project meets certain conditions. These include direct benefits to the subjects, if it advances the creation of a medical product that is useful to the military, or if the research meets al the laws and regulations comprising food and drug administration regulations. Although informed consent is a basic right and should be implemented effectively, incapacitated patients must benefit from emergency experimentation. The departments of health and human services and the FDC have collaborated to develop guidelines that allow emergency research in the absence of informed consent. Nonetheless, such types of research can only proceed if an emergency exception from informed consent or waiver of informed consent is obtained.

Informed consent is a continuous process, which implies that researchers and medical practitioners must ensure that subjects continue to comprehend what the research or medical procedure is about and the consequences of participation (Dolgoff et al, 2009). Additional new information that can affect the decision to continue participating in the research or medical procedure should also be provided. In research settings, revisiting informed consent is carried out informally, but it is appropriate to occasionally reconsent research subjects formally. For instance, during longitudinal research it is prudent to ask the subjects of they are satisfied to continue with the research before implementing research procedures. Reconsenting is al applicable when there is a significant change to a research projects or there is new information that may change the subject’s willingness to continue with the research (Marshall & World Health Organization, 2007). In such a scenario, revisiting informed consent in a formal manner is appropriate.

Legal and ethical frameworks govern informed consent and the process of getting it must be independently evaluated and approved. Obtaining informed consent for research or medical procedures that involve invasive procedures is considered as a legal condition. If a medical procedure of research activity proceeds in the absence of informed consent, the subject may take legal action. In most jurisdictions, the three requirements to be satisfied in order for informed consent to be given are the mental ability to give consent, having sufficient information take an informed decision, and consenting without external pressure. The absence of these three requires invalidates informed consent. It is imperative the researchers and medical practitioners consider the law when obtaining informed consent.

The main ethical principle concerning informed consent is the belief that every individual must be treated with respect. Freely obtained informed consent is the foundation of ethical research and medical procedures (Dolgoff et al, 2009). National and international governance frameworks comprising the declaration of Helsinki also provide for it. Researchers and medical practitioners must consider several factors when obtaining informed consent (Marshall & World Health Organization, 2007). These include culture, disability, ethnicity, religious beliefs, gender, language, and level of comprehension. Since researchers and medical practitioners cannot anticipate how these factors may affects subject, they must be sensitive to them when obtaining informed consent.

The case of HCA Inc v. Miller illustrates the complex issue if informed consent. In this case, Karla miller was admitted to HCA’s Women’s Hospital in Texas when she was 23 weeks pregnant. Dr. Jacobs, the obstetrician and Dr. Kelly the neonatologist informed the parents that if the baby survived the birth she would suffer from severe impairments. Consequently, the millers verbally requested that no extreme measures should be carried out on the baby after birth. This request was documented in the medical record and the neonatologist was released. Nonetheless, Dr. Jacobs later concluded that if the baby was born alive and weighed more than 500 gram, the medical practitioners would have the legal obligation of administering life-saving procedures even if the parents had not consented to it. The dr. claimed that this caveat was conveyed to the parents and the subsequent neonatologist Dr. Otero determined that the baby was viable and administered resuscitative procedures. However, the baby was born, but suffered from severe mental and physical impairments (HCA. Inc. v. Miller). The parents later failed a suit against the hospital and Dr. Otero for vicarious liability for its actions in treating the bay in the absence of parental consent, implementing a policy of treating infants weighing 500 grams and above without parental consent, and for lacking policies that prevent such treatment without consent. A jury determined that the hospital was liable for vicarious injury and awarded the parents $29,400, 000 for previous and future medical costs and an additional $13,500,000 for punitive damages and $17,503,066 for prejudgment interest (HCA. Inc. v. Miller).

Subsequently, the hospital appealed arguing that it could not be liable for treating the infant without informed consent of the parents and against their instructions because the hospital and the doctor are legally required to undertake such actions and the parents had no right to withhold life0saving medical procedures. In its analysis, the court determined that there were three important but competing legal interests. The first is that parents have the legal duty to offer needed medical care to children and failure to do so constitutes a criminal offense. The second issue tat while parents have to offer medical care to their children, they cannot determine the level of care or how much care. According to Texan law, parents have the express right to give informed consent to the care of their children. Additionally, parents may withdraw or deny life-saving treatment if the child were certified terminally ill and providing medical care would just postpone death. The only exception to parental consent is during emergencies. The last interest is that of the state acting as the guardian of children’s welfare even if t means limiting the right of parents over the children. A court may grant temporary conservatorship of child with right to consent to medical treatment denied by parents. However, the intervention of the court requires a notification by a government agency pursuant to a state’s interest in safeguarding the welfare of the child. The key issue is the parent’s right to deny urgently needed life-saving treatment to a child. In this case, the baby was not certified as terminally ill; therefore, the parents had no right to refuse life-sustaining treatments (HCA. Inc. v. Miller). The court rules that in case a child is not certified terminally ill a healthcare provider has no duty to consent to parental instructions to deny live-saving treatment to a minor. The court determined that hospital and physicians involved acted reasonably and withdrew the vicarious liability against the hospital.

Furthermore, this case illustrates the waiver if informed consent under certain circumstances and this case it involves parental consent in denying life-sustaining interventions. Although the law expressly gives parent the right to determine treatment for their children, the state also has an interest in safeguarding the welfare of children (HCA. Inc. v. Miller). However, the right of the parent to deny treatment is only restricted to when a physician through writing has certified the child terminally ill. In the above case, the baby was not certified terminally ill, but was preterm and could suffer from severe mental and physical disabilities.

In reaching their decision to administer resuscitative procedures on the baby, the doctors involved followed the seven-step path to ethical decision making. The case presented the doctors with a major decision to make, and following the seven-step process was effective in reaching a decision that did not contravene the law and ensure that the welfare of the infant is safeguarded.

The first step of the guide is to stop and think. Stopping and thinking is important in that it prevents the likelihood of making rash decisions. It also facilitates the thoughtful discernment before making important decisions (Dolgoff et al, 2009). If Dr. Jacobs had not stopped and thought, he could have followed the directions of the parents and denied life-saving treatment to the baby. The second step is to clarify the goals and separate short-term from long-term goals. Decisions that aim at achieving as short-term need prevent the realization of important life goals. Dr. Jacobs was able to clarify the goals and determine that saving the baby was the most important objective. If he had not clarified his objective, he could have fallen into the danger of denying treatment to the baby to meet the instructions of the parents.

The third step is to determine the facts. It entails having sufficient information to support intelligent decisions. It is impossible to make intelligent decisions in the absence of facts. This step begins with resolving known facts and then what it needs to be known. Other important things to consider when determining the facts are to verify assumptions and uncertain information. It is clear that Dr. Jacobs and Dr. Otero determined the facts because they were able to conclude that a baby weighing more than 500 grams was viable and they the legal responsibility to administer life-saving treatments contrary to the instructions of the parent. Part of making ethical decisions involves determining what we believe in and this is impossible without determining the facts.

The fourth step is developing options. It involves broadening perspectives and developing new choices. At first, Dr. Jacobs had dismissed the neonatologist, but after considering that the law mandated medical practitioners to administer resuscitative measures if the baby is born alive and weighing more than 500 grams. He also explained this situation to the parents.

The fifth step in ethical decision-making is considering the consequences of decisions. This is achieved by filtering choices using the six pillars of character: trustworthiness, fairness, responsibility, respect, citizenship, and caring (Dolgoff et al, 2009). Doing so allows one to determine if a decision breaks the law, is disrespectful, uncaring, breaks a promise, and is irresponsible. It eliminates the possibility of making unethical decisions. This step also entails identifying stakeholders involved and the impact of the decision on them. Dr. Jacobs was able to consider the consequences of administering life-saving procedures and its impact on the baby and the parents. By doing so he was able to avoid breaking the law and. It also ensured that he made the decision that favored the main stakeholder, who in this case was the infant. The sixth step is to make the choice. Lastly, monitoring and modifying is the seventh step. In the above case, there was no need to monitor or modify the decisions because it was a life-saving decision. In conclusion, informed consent is a key pillar of ethical decision-making ad the above case illustrates the complex nature of obtaining informed consent especially for populations lacking the capacity to make their own independent choices.

References

Dolgoff, R., Loewenberg, F. M., & Harrington, D. (2009). Ethical decisions for social work practice. Belmont, CA: Thomson Brooks/Cole.

Manson, N.C & O'Neill,O. (2007). Rethinking Informed Consent in Bioethics. Cambridge: Cambridge University Press.

Marshall, P. L., & World Health Organization. (2007). Ethical challenges in study design and informed consent for health research in resource-poor settings. Geneva, Switzerland: World Health Organization.

No liability for providing life-saving care to an infant over the parents' refusal - HCA. Inc. v. Miller, 36 S.W.3d 187 (2000). Retrieved from http://biotech.law.lsu.edu/cases/consent/hca_v_miller_brief.htm