Informed Consent as an Ethical Component Professional Standards

Informed consent is one of the main concerns of ethical standards in treatment and therapy. The attention given to improving ethical standards and practices for informed consent is a recognition not only of its own legal and ethical value but more importantly, because of its critical role in initiating therapeutic relationships. Thus, ethical examination will likely lead to a review of current perspectives regarding informed consent and consequently, ethical standards as a whole. The study concludes that considering such extensive stakeholders and the extent of applications it has, there should be a concerted effort to improve the professional capacity and standards to maintain the quality of informed consent to ensure the ethical integrity of therapy as well as public welfare.

According to research developed by Granero-Molina, Fernandez-Sola and Aguilera-Manrique (2009) there is significant evidence that the lack of informed consent can have a severely negative impact on the effectiveness of therapy. They attribute this not to the lack of recognition of the importance of concern but rather to the need to review and update perspectives that consent can impact. Higgins and Daly (2002) consider informed consent as central to most ethical conflicts. Their study suggests that most of the contention lies in the degree and quality of disclosure, highlighting the need to improve professional aptitude and public knowledge regarding informed consent. Moreover, social developments such as growing diversity and globalization are increasing challenges for therapists in establishing and effective platform for communication critical to obtaining informed consent.

Though there has been significant effort form the government and professional organizations have made significant effort into maintaining the relevance and applicability of related standards or practice, there is still much debate on the definition and quality of informed consent. The objective of this paper is to determine prevailing issues regarding informed consent and its ethical implication psychiatric practice. In doing so, the research will be able to enhance insights into this ethical concerns and ultimately, improve professional practice.

Review of Related Literature
Conceptualization of Informed Consent
The establishment of standards for informed consent did not have auspicious origins the development of modern informed consent standards as a result of the human rights violations during World War II exposed at the Nuremberg trials (Simon, 2003). Informed consent developed from the legal and ethical need to ensure that patients or clients are given enough information to make decisions to ensure about ones own health care. Interactions are centered on the information exchange between service providers and clients which have been divided into three key phases the communication to the client of all the details of the therapy including its benefits, risks and alternatives. Since the client may not be fully knowledgeable in the issues regarding his treatment, the burden is on the service provider that he has access to sufficient information to mitigate such limitations.

The next issue that has to be dealt with by the therapist is the evaluation of the level of understanding of the client. One of the means by which this is done is by opening discussion with the patient of his thoughts regarding the treatment and the related information that has been provided. The consent then has to be fully documented, voluntary and not under any form of duress. Standard consent forms are provided by government and professional organizations but therapists and care providers are given authority to modify them in good faith to provide more coverage or protection. Much of these provisions were developed for application in research and medical procedures but were readily adapted into psychiatric practice with the recognition of the impact of treatment to the welfare of clients. Simon (2003) point out that, Psychiatrists commonly face ethical and legal issues such as informed consent, the right to treatment, the right to refuse treatment, substitute decision making, and advance directives when treating psychiatric patients. (p 349). This has profound impact on the assessment and management of patients which extends from the professional functions, requiring significant extrapolation of patients decision making competencies not only for treatment but also to his capacity to function productively in society and maintain quality of life and well-being. Since the 1970s the importance of consent has become widely recognized into medical and psychiatric practice (Gray, 1978).

Consent began as part of professional management practices and risk management. Consent-related documentation has primarily been developed in medical and surgical procedures but soon was adopted in other treatment and therapy services. Professional regulatory organization adopted its use into ethical practice in the 1990s as part of its efforts to establish professional standards of practice and to afford patients and clients protection (American Psychologists Association APA, 2010). As mentioned earlier, the most critical criteria in informed consent is based on the degree and quality of information a client is provided. According to and quoting from the standards provided by the U.S. Office for Human Research Protections (OHRP) (2010), informed consent needs to be documented by forms that include among other provisions such as descriptions of any reasonably foreseeable risks or discomforts to the subject description of any benefits to the subject or to others which may reasonably be expected disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject, statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained explanation as to whether there are any treatments or compensation if injury occurs and, if so, what they consist of, or where further information may be obtained as well as a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Implication to Standards of Practice and Public Policies
There are times when professional ethical standards are not equitable to civil and criminal standards but with regard to regulations regarding consent, provisions have generally been identical (Olumide, 2009). The main challenge in developing consent provisions is that social, cultural and perspectives can differ significantly, enough that they can impair treatment or generate risk for clients and providers. The need to acquire consent has also served to highlight the deficiency of social and welfare service to respond to the growing socio-cultural requirement of effective communication (Drake, 2001). Thus, informed consent is considered to be the foundation of therapeutic relationships and therefore dictates the quality of all subsequent care. Though informed consent has been designed to protect clients, it can also extend this protection to professional and service providers.

Considering the possible legal and economic implications of the lack of informed consent into professional practice, there is a growing urgency in developing competencies to ensure that patients are provided with sufficient and adequate information to make their judgments. A review of current research and literature suggests that there are three major issues that have to be strengthened in current standards of practice and public policies improving insight regarding the communication process with clients creating the professional channels to enhance competency and finally, improving legal and industrial standards for more collaborative relationships. However, it is unlikely that any effort to change standards or other policies. Considering the length of time between the APAs two publication of its ethical standards, ten years in between, there may not be a ready response to the concerns that have been identified.

Ferguson (2001) believes that efforts in improving perspectives and practices related to consent should first focus on its professional dimensions. He points out that there is recognition of the importance of consent to their practice they do not have a full understanding of its implication to treatment or therapy. More alarmingly, many clients often encounter fraud or subterfuge when they are being asked for consent to diminish professional culpability in case of adverse results (Marzano, 2007). The study of how informed consent can be improved can also enhance insights on how to improve proactive and collaborative therapeutic relationships. For future research, it is essential to recognize the informed consent is not limited to the ability of service providers to get the signature of clients onto consent documents. Ferguson (2001) suggests that extensive audits be developed regarding professional opinions and recognized challenges related to informed consent issues. This highlights the need for quantitative data to serve as foundation for programs. This can also enhance relevance to other similarly concerned institutions which can improve the capacity to develop universal standards. Other researchers have emphasized the need to develop evidence as basis of organizational standards for informed consent which can then be used as foundation for larger organizations (Hoeyer, 2009). The view is that when these efforts are can be coalesced, there will greater capacity to institute and enforce changes in ethical standards.

Evaluation of Existing Provisions
The most specific provision for psychologists and psychiatrists from the APAs (2010) Ethical Principles of Psychologists and Code of Conduct can be found in Section 3.10, titled Informed Consent. Supporting provisions can also be found in Sections 8.02 Informed Consent to Research, 8.03 Informed Consent for Recording, 8.05 Dispensing with Informed Consent for Research, 9.03 Informed Consent in Assessments and 10.01 Informed Consent to Therapy.

According to 3.01,  when conducting research, provide assessment, therapy, counseling, or consulting services , informed consent is providing reasonably understandable  information to the client who has legal, mental and psychological capacity to evaluate the information to provide consent. Regardless if an individual can provide legal consent, psychologists need to (1) provide an appropriate explanation, (2) seek the individuals assent, (3) consider such persons preferences and best interests, and (4) obtain appropriate permission from a legally authorized person (APA, 2010, p 7). In cases were treatment is ordered or mandated, psychologists also need to inform their clients the anticipated nature of the treatment they are to receive, why it was ordered as well as the resulting impact to confidentiality before actually beginning. Finally, the standard also prescribes the need for thorough documentation.

8.02, 8.03 and 8.05 are standards that focus specifically for research applications. 8.02 gives the information that have to provided to research participants such as its purpose, duration and procedures right to decline or withdraw their participation possible consequences of declining or withdrawing potential risks, discomfort, or adverse effects condition related to confidentiality incentives and channels of communication available to access or clarify information. 8.03 deals with the digital documentation of the research which have to be naturalistic observations and do not constitute personal identification or harm to participants. If the research design includes the use of deception, then consent should be given by the client before the research actually starts. Section 8.05 gives the conditions where psychologists can dispense with informed consent. This is limited to instance when the researcher can ensure that the research will not create any distress or harm to the participant questionnaires and related research tools are anonymous, naturalistic and has no civil or criminal implications or negatively impact the personal circumstances of the participant personally or professionally and that it is not against any law or regulation.

9.03 and 10.01 are related to the therapy services. Based on 9.03, assessments, evaluations and diagnostics independently must have the consent of clients. The conditions of acquiring informed consent at this stage follow the provisions in Section 3.10 as well. The exceptions are also provided informed consent in assessment as in the case of mandated by law or governmental regulations. In turn, consent can be implied if testing is done as part of educational, institutional, or organizational activity or to determine capacity to make decisions. In cases where there are constraints ton how decision for informed consent can be made, special effort must be done for the benefit of the individual being assessed. When informed consent is given through the services of an interpreter, protections must extend to the information exposed to third parties by virtue of the interpretation services.  Subsequently in 10.01, informed consent for actual therapy requires that psychologists provide their clients the nature of their treatment, its terms and fees, options to develop effective therapeutic relationships.  Obtaining informed consent for treatment for new therapies required disclosure of the development of the therapy in addition to the ordinary requirements for consent. Even greater consideration is to be taken when the therapist is a trainee and to ensure professional responsibility, accountability is given to the supervising personnel.

Other sections of the standards also provide special conditions for consent in cases where services are acquired by or are participated in by third or multiple parties. In cases where the client is incapable of giving consent,  the APA also provides procedures how consent can be solicited there should be appropriate and adequate explanation of the circumstance, there must be at least an agreement from the client of the willingness to participate which includes acknowledgement of risks, benefits, implications and effects of the therapy acceptance of the terms of confidentiality and most importantly, solicit consent or permission from the legal authority the subject is under.

In a similar manner the Canadian Psychologists Association (CPA) (2000) provides for standards for informed consent. Sections I.16 to I.26 deal directly with the conditions necessary for informed consent. In turn, sections I.27 to I.30 deal with the freedom of consent which is considered to be a core quality of informed consent. Majority of the provisions made by the CPA are identical to that of the APA which can be seen as an indication of universal professional values regarding the need for quality informed consent. The provisions provided by Association of State and Provincial Psychology Boards (ASPPB) (2009) and the National Association of School Psychologists (NASP) (2000) support the professional standards of the APA and CPA.

Though the provisions of these parties are more general with regard to informed consent, they have significantly more policing provisions that can be used to pursue criminal and civil punitive measures in the event of violations. Beahrs and Gutheil (2001) point out that in addition to ensuring disclosure to clients, informed consent should also provide the means or reserve options by which the client can withdraw participation in the course of treatment and seek clarifications, resolution or possible damages in the event of fraud of malpractice. According to Felt, Bister, Strassnig and associates (2009), one of the biggest challenges for professional is determining the quality of the consent. At the same time, the lack of quality of consent is often afforded a great deal of levity because of difference in value systems in its valuation (Lynoe, Sandlund, Jacobsson et al, 2004 Cockcroft, Sandhu  Norris, 2009).

Application to Future Research and Standards of Practice
The first challenge in improving insight regarding the communication process with clients is creating a more positive perception regarding the acquisition on informed consent. There is a general perception that eliciting consent is for the protection or the service provider the tool is used to protect it, if not to limit liability to clients (Felt et al, 2009). Marzano (2007) also points out that though the law does not provide for absolute waivers of liability, limited knowledge of the public on what constitutes the process of providing informed consent creates opportunity for fraud and abuse. This in turn diminishes confidence in treatment and professional integrity. Increasing the challenge is the dependence of improving perceptions on the professionals who might also be the cause of clients apprehensions (Mueller, 2004). Early researches developed by Gray (1978) point out that though professional training provides for processing informed consent there are inadequate insights on the psychological dynamics affecting clients consent processing. Though this may be only a challenge in professions outside psychiatric practice, there should be a realization that there is no full recognition of the social and psychological communication systems that may impair the quality of informed consent.  Olufowote (2009) that there is a need for professional insights into social, cultural and political dynamics that can affect how their clients can provide informed consent that will benefit not only their treatment but also perceptions regarding the purpose and benefits of informed consent.

Creating the professional channels to enhance competency requires the cooperation of government and professional services. Majority of the conflict comes from lack of universally accepted and practiced standards (Ferguson, 2001). In the US, the APA, the OHRP, the Association of State and Provincial Psychology Boards (ASPPB), the Food and Drug Administration as well as state governments have all made efforts to improve professional training and standards regarding informed consent but there is still no existing standards to determine quality of informed consent (Holmes-Rovner  Wills, 2002 ASPPB, 2009). Worse, there have been some conflicts regarding regulatory and professional groups on the definitions and requirements of informed consent the former has been criticized for standards that are prohibitive to professional practice. This has results in the persistence of non-collaboration which creates further challenges in developing necessary skills and competencies to improve the quality of informed consent from clients. At the same time, this limits professional competence to deal with developing professional and moral issues that may challenge informed consent protocols (Drake, 2001). Ultimately, without providing psychiatric professionals and service providers the means by which to improve the capacity to communicate with clients to solicit informed consent, then the issues that continue to impair the quality of informed consent will not be addressed in a professional manner that can lead to enhancement of treatment prognosis.

The final challenge, improving legal and industrial standards for more collaborative relationships will require long-term collaboration of state, federal and international institutions.  This is not only to recognize the professional consequence of obtaining informed consent but also the sociological and cultural issues that are affecting consent to psychiatric treatments. Growing globalization and cultural integration is challenging therapists to provided services to accommodate for greater diversity, increasing further the communication and professional challenges (Granero-Molina et al, 2009). The first task to accomplish this challenge is to be able to integrate the independent standards that they have developed regarding maintaining the quality of informed consent. As the institutions progress from being local to international ones, the difficulty of the tasks becomes even greater and thus, will require a significant investment of time and effort. The main objective of the efforts should the development of standards to define the quality of consent which have been so far remained to be not sufficiently defined to improve actual practice.

Current research also shows the need to update research perspectives particularly regarding social contexts and mechanisms. Consent always has an underlying ethical issue and thus, securing informed consent in the absence of sufficient standards and compliance suggests a limited understanding of the social constructs affecting consent conceptualization. In the research developed by Sin (2005) he suggests that securing consent involves external agencies serving as intermediaries. At the same time, he points out that providing or getting consent is not a singular event but has several phases that do not have a standard response. However, this should not be construed that standards for quality informed consent cannot be established but rather that there is a need to recognize the negotiation and fluidity of consent demands which requires a reflexive approach. In a similar manner, Spath (2007) also encourages the need to recognize the information and communication requirements for continued participation. In doing so, consent will continue to be relevant to treatment and mitigate changes in the mental capacity or competency of clients. Moreover, this can also extend to therapists the ability to continue therapy without intermittent interruptions that may be due to clients regression or other deterring circumstance in the interest of the client or the public given that the quality of the consent given earlier.

Marzano (2007), Felt and associates (2009) as well as Olufowote (2009) believe that the ultimate impact of these insights will have an overall change in ethical perspective not only those that directly deal with informed consent. This is said to be particularly apparent as perspective recognize the impact of culture and even development in information technology into the issue of ethics and informed consent. One of the opinions given is that, by examining problems, such as the influence of the cultural context on the ethnographers moral choices, or the value of informed consent and ethical committees, in the light of the empirical materials previously presented (p 417). The implication is that ethical examination will likely lead to a review of current perspectives regarding informed consent and consequently, therapy perspectives as a whole. The attention given to improving ethical standards and practices for informed consent is a recognition not only of its own legal and ethical value but more importantly, because of its critical role in initiating therapeutic relationships. Subsequent research should make and effort in developing universal ethical standards concerning informed consent. Considering social and cultural diversity, it is not likely to be able to develop uniform ethical standards for the whole therapy programs but if the focusing on informed consent alone, can significantly be more feasible.

As the term informed consent implies, there should be full and quality disclosure to the clients regarding the treatment or therapy they are receiving, the alternatives available and even more important, and its impact to their long-term welfare. Informed concern standards may differ across societies and professions but they all have a common goal of improving safety, professionalism and quality of service which in turn is critical in professional as well social growth and development.  Informed consent clearly is not just means to get permission but should also been seen as the tangible manifestation of the social and professional contract between clients and their therapists. As such, they also are indicative of the quality of therapy as a whole. The concern for informed therapy is also not limited to the parties directly involved in the therapy or regulatory and legal institutions, they also have an impact on general public since standards and principle are easily carried over into other public services. Considering such extensive stakeholders and the extent of applications it has, there should be a concerted effort to improve the professional capacity and standards to maintain the quality of informed consent to ensure the ethical integrity therapy as well as public welfare.


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