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The risks of legalization
Published in Govert den Hartogh, What Kind of Death, 2023
But perhaps undue influence will be exerted on patients from vulnerable groups in more subtle ways. The doctor may sincerely or half-sincerely believe that euthanasia is the best option for her patient, even though she wouldn't have thought that in the case of a better-educated middle-class patient in the same condition, and that opinion may colour the way in which she informs the patient, even though that information is accurate as regards the facts. And the consultant may not be able to identify that kind of bias, or even share the underlying discriminatory attitude. The doctor may in that case even recommend a choice for death, and many patients are still in the habit of doing what the doctor recommends.20 It will be hard to determine in particular cases whether influence of that kind really undermines the voluntary character of the request, but it is to be deplored anyway.21
Obtaining Informed Consent for Research Studies
Published in Lynne M. Bianchi, Research during Medical Residency, 2022
Whenever you or a member of your research team present an informed consent document or answer participant questions, it is essential that the conversations be free of coercion and undue influence. Coercion refers to intimidation or a threat of harm. Undue influence means a person is swayed to do something, often without considering the consequences.
Law and dementia
Published in Beverley Clough, Jonathan Herring, Disability, Care and Family Law, 2021
The special nature of the older parent-adult child relationship has been recognised by equity in relation to the doctrine of undue influence. Undue influence applies where a “donor” confers a benefit on another because of the “undue” influence of that person on the donor's decision-making process. A decision that is the product of undue influence is not genuine; it is not the person's “own,” and the decision will not be recognised as valid (even where the person was mentally capable of making the decision in question). Undue influence may be proven by acts of coercion and manipulation, but it is also presumed to arise in relationships where the potential for domination is inherent in the nature of the relationship itself (Geffen v Goodman Estate, 1991 2 SCR 353). This presumption will always arise in certain classes of relationship (as where a minor child confers a benefit on her parent e.g.); in others, a “meticulous examination of [the] facts” will be required (National Westminster plc v Morgan, 1985 17 HLR 360). Once the presumption has been raised, it may be displaced by evidence establishing that the decision was truly the person's own (generally by showing that she or he received independent legal advice). In this way, undue influence may constitute a form of exploitation under circumstances of actual undue influence but is distinct in nature (although exploitation adjacent) where undue influence arises through a relationship giving rise to the presumption.
When Professional Meets Personal: How Should Research Staff Advertise on Social Media for Research Opportunities?
Published in The American Journal of Bioethics, 2021
Liza-Marie Johnson, Devan M. Duenas, Benjamin S. Wilfond
As part of the regulatory review process, both the Food and Drug Administration (U.S. FDA 1998) and Office for Human Research Protections (OHRP) (U.S. Department of Health and Human Services [HHS] 2013) have issued guidance stating that institutional review boards (IRBs) should review and approve direct advertising to study participants. Research opportunities advertised online, and specifically through social media, would be included in this requirement. The FDA considers recruitment via direct advertising for study participants to be the start of the informed consent and subject selection process. Advertisements should be included in the IRB review to assure that they are not unduly influential and do not promise any expectation of cure beyond what is described in the consent materials and the protocol. This is especially critical when a study may involve participants who are likely to be vulnerable to undue influence. The previously published directives from federal agencies predate the widespread use of social media platforms as a method of health communication and participant recruitment and are largely silent on the potential blurring of personal and professional boundaries when study staff members advertise through their personal social media platforms. For example, should there be any concern if a team member simply shares an IRB-approved advertisement from an institutional account to their personal twitter or Facebook news feeds? What if they attach a comment to the retweet or share?
Consent in the Acute Setting: A Necessary Evolution
Published in The American Journal of Bioethics, 2020
Patients who present with acute clinical conditions represent a specific type of at-risk population. In the cases of myocardial infarction and stroke, for example, individuals may be facing imminent death or severe disability, which introduces emotional stresses that undoubtedly can and often do impair judgment. In such situations, it seems unlikely that patients will be able to provide valid informed consent to participate in research, and it is equally unrealistic to expect a single discussion or consent form to adequately educate subjects or their surrogate decision makers. When faced with a life-threatening disease, patients or their surrogates may be willing to sign any form or agree to any procedure that will expedite care or offer any purported benefit. Consequently patients suffering from acute, life-threatening illness and their families may be particularly vulnerable, so using current methods and documents to obtain consent could be interpreted to fall under the definition of undue influence, and therefore could be considered invalid (Subpart A of 45 CFR Part 46, §46.111). Even if an Institutional Review Board approves such a consent process, it may still be morally suspect.
A Proposal for Fair Compensation for Research Participants
Published in The American Journal of Bioethics, 2019
Given the power differential between the pharmaceutical industry and medical researchers on one hand and patients desperate for cures or individuals in need of quick cash on the other, concerns about undue influence, coercion, and exploitation are warranted. But, the reality is that evidence-based medical treatment requires research with human participants, which will in turn require those participants to bear some risk. No matter what future developments in cellular, animal, and computer models take place, because the end of all research is treatment of human patients, systematic data collection in humans, healthy and affected, will be required. Financial incentives are a primary reason for participation, and particularly for healthy volunteers—who are critically needed yet derive no direct personal benefit from participation. There is likely nothing that can be done to change this motivation, which may or may not lead to increased risk of harm (e.g., if individuals lie to meet study inclusion criteria). However, human research protections exist to safeguard the health and well-being of participants. Therefore, it is time to extend our current protections and implement new, systematic measures to better protect human research participants and ensure that offers of payment are optimally ethical.