Informed Consent and Consent

¶ … 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 license for being marketed for general public consumption). However, without clinical equipoises, clinical trials wouldn't be ethically right (that is, if scholars definitely knew the given medication was better as compared to the remaining interventions, their withholding it from a particular participant cluster would be unwarranted). Respondents are requested to share in a given study's uncertainties (they may enjoy certain benefits; however, they may end up in the control group or the experimented drug may exhibit damaging side-effects or be less efficient compared to already available medications). To sum up, researchers can seldom give participants promises of direct advantages. But they ought to prove either directly beneficial to research subjects or the broader community, and study advantages ought to appreciably outweigh the likely harm to study subjects (Slowther, Boynton & Shaw, 2006).

Respect for Informed Consent and Subject Autonomy

Regard for participant independence and integrity lies at the core of the informed consent principle. A major function of ethical evaluations is to make sure study participation consent is correctly acquired and recorded. The consent acquisition process should bear in mind prospective subjects' cultural values to ensure researchers have true regard for their autonomy. Legitimate consent for all medical (clinical or research) procedures necessitates: (a) Informing the individual of the process's nature, which includes its potential advantages and risks; (b) Individual ability to engage in decision making; and (c) Autonomous unforced decisionmaking. Each of the above consent related aspects must be taken into account in the proposed study's precise context, and will be informed by 'regard for autonomy' principle (Slowther, Boynton & Shaw, 2006).

Study subjects will be incapable of making autonomous decisions regarding whether or not to take part in a given research if they lack relevant information. Just like actual clinical practice, clinical research also entails a couple of key factors that help ensure truly informed consent:(1) Information content, its preciseness, detail and clearness and (2) the information transmission process and mode of presentation, its context, time given to reflect and discuss with others, and the power balance between researchers and respondents. Furthermore, voluntary valid consent should be provided. Research ethics teams and scholars must take into consideration the aspect of whether the informed consent acquisition process includes direct or indirect participant coercion (Slowther, Boynton & Shaw, 2006).

Based on personal, group and societal moralities, identify a value of your own personal morality.

Moral integrity represents a highly salient personal value which I prize and uphold even in my career. I feel I am ethically correct at the workplace if my behavior and action correspond to my personal moral values. We all possess some idea, within our minds, of a respectable and good life. I believe integrity forms the basis to adopting values and acting in a manner that corresponds to the ideals that make up a good, respectable person. Comprehending how I can retain a clear idea of the way I must act by being guided by my own personal morals is simple. My reward when I do so is: I am able to maintain unified direction, purpose, and action under diverse circumstances (Purtilo & Doherty, 2016).

Describe that value's relationship with the morality of a group or society you are currently living.

I realize the fact that large aspects of integrity arise from the morality shared with fellow societal members. Social morality encompasses the notions of character or duty and values stemming from deep-seated cultural views regarding humanity and its association with the Almighty (or a number of gods as some cultures believe), with nature and with one another. Social morality gets codified as policies, laws, and norms. The Founders of America who undertook the risk of crossing oceans, giving up nearly every security they enjoyed in their native lands, attempted to encapsulate the common social morality denominator in their declaration that God has created everybody equal and hence everybody ought to enjoy equal opportunities in terms of life, happiness and freedom (Purtilo& Doherty, 2016).