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  • ETH7: Is there a need for any specific IGGs or supportive actions concerning information in order to respect patient autonomy when IGG is used?
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Is there a need for any specific IGGs or supportive actions concerning information in order to respect patient autonomy when IGG is used?

Authors: Plamen Dimitrov, Anelia Koteva

Internal reviewers: Pseudo99 Pseudo99

Intravenous immunoglobulin therapy is associated with invasive procedures that should be explained in detail to the patients – potential participants in a research. The partially compromised decision-making capacity of MCI persons makes the situation even more complicated as far as it may result in inadequately estimated (belittled) risks. In the context of bioethics, this conflict between the right to autonomy and the limits of competence of the subject needs to be envisaged, with the informed consent process involving a detailed description and clarification of all stages of the therapeutic procedure/experiment/study, including the provision of information on painful interventions, tests and manipulations, data on the effectiveness of the methodology, expected outcome, price, alternative treatments, etc. The information should be presented in an accessible form and in a way that does not hinder patients with a slight cognitive decline to understand the treatment options and make appropriate decisions regarding their quality of life accordingly. With the new experimental strategies, such as the blood product concerned, there is a risk of producing subtle side effects, which can hardly be caught/seen in patients with communication disorders. The potential risk of other unforeseen but serious complications and the harm to persons in the event of being placed into the placebo group in placebo-controlled trials, depriving them of treatment during the experiment, should also be discussed before the patient is asked to give final informed consent.

 

Involved medical personnel needs to be responsible for balancing benefits and risks. In bioethics literature, this is known as a “risk-benefit analysis” where the researcher must weigh and balance the probable benefits and damages occurring in the course of research. One of the main tasks of the medical staff is to ensure that the principle of nonmaleficence has been observed or refrain from causing harm to the subjects in the study by assuring that potential benefits exceed unknown risks. Other negative consequences, such as in the case of patients with compromised decision-making capacity must also be provided for, for example a decisionally impaired person, who has significantly recovered due to the treatment, might realize his/her deteriorating physical and mental state and as a result become distressed, feel anxiety, hopelessness and despair, thus causing increased suicidal risk among these patients and compromised quality of life. Physicians should be prepared for timely response to prevent this side effect.

 

These and other issues arising in the course of each experimental therapy and the common belief in the medical community that individuals with compromised capacity belong, by default, to a special class of subjects and should therefore be treated with utmost caution necessitate the provision and development of special protective measures when giving consent so as to properly balance the benefits and risks:

 

  1. Maximum involvement of the persons with mild cognitive impairment in the risk assessment process – a risk that they are willing to take;
  2. Providing an inventory of potential risks and burdens for each case study;
  3. In light of the vague benefits of experimental drugs and therapies, volunteers must be fully acquainted in advance with the potential risks and burdens of the treatment by providing the individuals with relevant detailed information in the most accessible and understandable manner;
  4. Guaranteed opportunity for patients to abstain from participation or reject further participation in the experimental study at any time;
  5. Providing indemnity insurance by researchers. The latter are required to insure themselves against potential damage by making best efforts to identify possible adverse effects and determine the likelihood for participants to encounter similar events;
  6. Ensuring that patients are aware of the purpose of the randomized controlled trial, whose subject they are, namely, hypothesis testing and providing general knowledge of a medication or therapeutic procedure;
  7. Ensuring by researchers that potential participants understand that they may be allocated in the control/placebo group to be randomly determined, with each of them likely to fall into that group;
  8. Control over the balancing of study benefits and risks should be carried out by an ethics commission/committee or similar body (it is commonly accepted that such committees approve and coordinate each experimental or epidemiological study with a focus on the population or groups of it).

 

In order to protect human dignity of dementia patients, in some European and international legal documents, i.e. the Charter of Fundamental Rights of the European Union and the Convention for the Protection of Human Rights and Biomedicine have been stipulated a number of key principles and requirements that must be observed during the intervention, whereas in the field of bioethics they can be summed up into several points as follows[1]:

 

  1. Respect for the dignity of both the persons with dementia and their caregivers and the need for polite and respectful behavior towards them, observing their personality and cultural traditions (ensuring that they are treated tactfully, considerately, carefully and in a good manner);
  2. Use by researchers of an appropriate language in the process of communication with dementia patients. Avoiding terms, such as “mad” and “dementia patient”, etc.;
  3. Researchers through their own behavior and attitude should ensure the promotion and protection of the dignity of people with dementia;
  4. Introducing standardized feedback forms enabling the participants in the experiment to anonymously share opinion, especially in cases when they have some critical remarks on the procedure or wish to express their dissatisfaction or disapproval;
  5. Development and implementation of a customized procedure for each individual based on the principle of personal uniqueness and avoiding standardized programmes, except in the cases requiring such standardization;
  6. Ensuring the principle of confidentiality when processing the personal data of AD patients by securing the privacy of their personal lives through transparent and legitimate procedures (personal data that have become known to researchers during the experiment);
  7. Strict adherence to the principle of voluntariness through the avoidance of deception, fraud, manipulation, coercion and abstaining from unethical behavior on the part of researchers;
  8. Viewing informed consent not as a single act but as an ongoing process during which each patient may withdraw whenever he/she wishes to. The informed consent procedure needs to be periodically revised, especially in cases of new information made ​​known to the research team regarding treatment methods;
  9. Questioning the need to conduct repeated, painful, stressful or invasive procedures for the patients in the context of missing prevention or efficient etiopathogenetic therapy, i.e. in the event of increased suffering for the patient;
  10. Preliminary risk assessment by researchers and allowing only minimum risks in cases where the research does not contribute to the benefit of the subjects;
  11. When recruiting volunteers for participation in scientific experiments with unknown risks should be favored the involvement of patients with less severe mental disorders, who are deemed to have basically preserved their competence;
  12. Application of methods and techniques simplifying the process of decision-making by reducing the number of possible options and decomposing more complex decisions into a series of simple instructions and step-by-step guidance through the process (compliant with the ethical guidelines of the Alzheimer Society of Canada);
  13. Critical use of the legal instrument “advance treatment directive” for expressing consent in advance when the individual is still cognitively intact (typical of early diagnosed patients) due to the possible discrepancy between the present and future “self” of the person;
  14. Respect for the patient’s right to autonomy and control over his/her own body and soul, and addressing his/her legal representative only in the event of missing or severely impaired capacity without favoring the second option;
  15. Safeguards against stereotyping and infantilizing adults through the practice of restrictive procedures for consent (the so-called “double consent”).

 

[1]Ethics”, Alzheimer Europe, available at: http://www.alzheimer-europe.org/Ethics ; Guide to Consent for Examination or Treatment”, second edition, Department of Health, United Kingdom, July 2009, available at:  https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/138296/dh_103653__1_.pdf ; “Dementia – Caring, Ethics, Ethnical and Economical Aspects: A Systematic Review”, Chapter 36 “Ethical and Societal Issues in Dementia”, volume 3, June 2008, SBU Statens beredning för medicinsk utvärdering (The Swedish Council on Technology Assessment in Health Care), available at: http://www.sbu.se/upload/Publikationer/Content1/1/Dementia_vol3.pdf ; Agich, G., “Alzheimer Disease: Therapeutic Strategies”, edited by E. Giacobini and R. Becker, Boston, 1994, available at: http://personal.bgsu.edu/~agichg/Articles/AutAD.pdf .

Dimitrov P, Koteva A Result Card ETH7 In: Dimitrov P, Koteva A Ethical analysis In: Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 24 October 2020]. Available from: http://corehta.info/ViewCover.aspx?id=267