Informed Consent and Consent Term Paper

consent a "yes or no" response? Enhancing the shared decision-making process for persons with aphasia

Informed consent constitutes a legal and moral requisite for any research works that involve fellow human beings. Study subjects are provided information regarding every element of a study trial deemed to be vital for subjects' decision-making, including study significance with respect to societal welfare and for advancing the medical field. After an examination of every trial related facet, subjects ought to be able to voluntarily confirm their readiness to be a part of the given clinical trial. This 'informed consent' principle has been imbedded in the Helsinki Declaration, Belmont Report and Nuremberg Code. It is compulsory before commencing any study that entails humans as research subjects (Jayes & Palmer, 2014). This provision essentially suggests if the subject's mental or physical state allows for informed, well- thought-out decisionmaking. But aphasics aren't always able to satisfy the aforementioned informed consent requisites, thus giving rise to moral and ethical challenges such as communication problems, wrong decisions, surrogate consent usage, conflicting doctor-researcher interests and respondent recruitment timing related challenges. A thorough analysis of the following two bioethical concepts -- the need for a detailed conversation on the advantages and risks of the study and respect for subject independence -- reveal their significance in the matter of informed participant consent.

What is the ethical dilemma? How does the dilemma affect nursing?

Ethical problems surface for aphasics, especially severe aphasics, resulting in their being typically excluded from study participation. Even researches that expressly aim at examining stroke survivors' experience do not include this patient population. Consequently, there is not much scope for generalizing study findings for aphasic stroke patients. Moreover, this type of research practice serves to deny aphasics the right of research participation. Even in case of researches intending to include aphasics, issues linked to obtaining their informed consent suggest their vulnerability in recruitment (Jayes& Palmer, 2014).

Diminished communication abilities can screen people's capacity of engaging in informed decision-making. It impacts the field of nursing as research scholars having a limited grasp of the condition (i.e., aphasia) may mistakenly reach the conclusion that individuals having impaired speech or language expression ability may not have adequate capability to offer informed consent. By contrast, mistaken judgment of people's comprehension abilities may cause research scholars to hold the wrong assumption that they can offer well- thought-out consent. Consequently, aphasics may be enrolled in research works without comprehensive understanding of the major implications of taking part. This may expose unwitting subjects to possibly upsetting, negative experiences (Jayes& Palmer, 2014).

Ethical aspects represent a key consideration in designing and performing clinical studies. Numerous completed stroke therapy trials give rise to typical challenging ethical dilemmas. Issues may surface when the treating doctor him/herself is the researcher as well or a research team member. In such scenarios, the severely ailing individuals or their family members will not be able to always differentiate between customary therapies, toxicity researches and therapeutic trials. They generally follow the advice of their doctor. The treating doctor's responsibility, of course, is promotion and safeguarding of their patients' welfare. However, considering their dual doctor-researcher role, their aforementioned responsibility may conflict with research goals. The possibility of such conflicts arising has led a number of commentators to recommend a separation of treatment team/doctor and research scholar roles (Slyter, 1998).

What are the main moral issues raised in the situation?

Communication Problems

The ability of using language for oral or written communication with other individuals necessitates the abilities of understanding facts and conveying them to other people in an understandable way. A large number of rehabilitation patients might be suffering from diverse kinds and levels of aphasia. If their language deficiencies involve understanding, acquiring their informed consent for researches will undoubtedly be tricky and researchers might be forced to exclude them from their research or seek proxy consent. Patients suffering from expressive deficiencies can offer non-verbal consent. However, taking part in the study protocol may prove hard for them if researchers don't incorporate specific mechanisms for accommodating their deficiencies (Blackmer, 2003).

Hence, under circumstances where prospective study participants are believed to be aphasics, an exhaustive examination ought to be conducted for ensuring the patient can provide participation consent as well as for ensuring they possess adequate communication skills for facilitating their actual study participation. Further, the services of language and speech pathologists may facilitate participation of individuals suffering from particular communication problems that otherwise prevent their participation (Blackmer, 2003).

Timing of Participant Recruitment

Several hospitalized rehabilitative medicine patients are individuals who have experienced critical and, at times, life-changing and shattering medical conditions or injuries. Given sufficient time to adapt themselves to their changed circumstances, a number of these individuals may eventually adopt a different perspective of things and end up willingly volunteering for studies following their mental and physical healing. But numerous researches' goals necessitate participant analyses throughout the course of their hospitalization for rehabilitation, with some even continuing after patient de-hospitalization. Thus, recruitment of individuals for any given research might be vital at the initial stage or at some point prior to the completion of comprehensive behavioral and cognitive evaluations. Hence, patient recruitment might be necessary before researchers clarify their ability of properly consenting to participate (Blackmer, 2003).

Surrogate Consent Requests

The informed consent provision essentially suggests the subject's mental or physical state allows for informed, well-thought- out decision making. But aphasics aren't always able to satisfy the aforementioned informed consent requisites, thus prompting researchers to seek surrogate third-party consent. As one would expect, healthcare team members will be pressed to seek surrogate consent in case of aphasics, or individuals with sensorimotor deficits or altered consciousness which hampers their writing ability. But this is a relatively indirect procedure in other scenarios like anosognosia, neglect, visual field loss and moderate comprehension issues wherein consent isn't totally "informed" (Mendyk et al. 2015).

Discuss two bioethical principals as they relate to the ethical dilemma.

Balancing Risks and Advantages

One main requisite for codes of ethics is that study goal significance is proportionate to innate research subject risks. Clinical trial can potentially prove directly advantageous to certain subjects (e.g., the chance of being administered a freshly developed, highly efficient drug yet to receive…