scholarly journals Therapeutic appropriation: a new concept in the ethics of clinical research

2016 ◽  
Vol 42 (12) ◽  
pp. 805-808 ◽  
Author(s):  
Rosalind McDougall ◽  
Dominique Martin ◽  
Lynn Gillam ◽  
Nina Hallowell ◽  
Alison Brookes ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Research ◽  
Clinical Care ◽  
Research Participation ◽  
Therapeutic Benefit ◽  
Therapeutic Misconception ◽  
Ethical Problems ◽  
Ethical Concerns ◽  
Research Participants ◽  
Therapeutic Needs

Ethical concerns about therapeutic misconception have been raised since the early 1980s. This concept was originally described as research participants' assumptions that decisions relating to research interventions are made on the basis of their individual therapeutic needs. The term has since been used to refer to a range of ‘misunderstandings’ that research participants may have. In this paper, we describe a new concept—therapeutic appropriation. Therapeutic appropriation occurs when patients, or clinicians, actively reframe research participation as an opportunity to enhance patients' clinical care, while simultaneously acknowledging the generalised research aims. To illustrate the concept of therapeutic appropriation, we draw on data from an interview study which we conducted to investigate the experiences of patients and general practitioners involved in clinical trials in primary care. We argue that therapeutic appropriation has two key elements: comprehension that the research project is not necessarily aiming to benefit participants and the deliberate use of incidental features of the research for personal therapeutic benefit of various kinds. We conclude that therapeutic appropriation is a useful concept that refines understanding of potential ethical problems in clinical research, and points to strategies to address them.

Research Ethics and Misguided Moral Intuition

2004 ◽  
Vol 32 (1) ◽  
pp. 111-116 ◽  
Author(s):  
Franklin G. Miller
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Clinical Care ◽  
Research Participation ◽  
Ethical Standards ◽  
Therapeutic Misconception ◽  
Physician Patient Relationship ◽  
Research Designs ◽  
Ethical Thinking ◽  
Physician Patient

The term therapeutic misconception was coined by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs.

scholarly journals 2530

2017 ◽  
Vol 1 (S1) ◽  
pp. 54-54
Author(s):  
Bernadette McKinney
Keyword(s):  
Clinical Research ◽  
Policy Analysis ◽  
Research Participation ◽  
Equal Access ◽  
Policy Issues ◽  
Research Participants ◽  
Science Discussion ◽  
Study Population ◽  
Equity Model

OBJECTIVES/SPECIFIC AIMS: Discuss ethical and policy issues that will impact clinical research. Raise awareness of the need to understand internal policies at home institutions Encourage further examination of ways to facilitate clinical research participation. METHODS/STUDY POPULATION: Ethical and policy analysis. RESULTS/ANTICIPATED RESULTS: Ideally, clinical research participants should not be required to pay to participate in research. However, if we go with an equity model, as opposed to an equality model, policies should be changed to allow equal access to research participation. This is a matter of justice and also will enhance the quality of the science. DISCUSSION/SIGNIFICANCE OF IMPACT: Unless steps are taken to make participation in clinical research less burdensome financially for participants, research may slow or results may be biased, because only those who can pay will be able to participate.

Why Is Therapeutic Misconception So Prevalent?

2015 ◽  
Vol 24 (2) ◽  
pp. 231-241 ◽  
Author(s):  
CHARLES W. LIDZ ◽  
KAREN ALBERT ◽  
PAUL APPELBAUM ◽  
LAURA B. DUNN ◽  
EVE OVERTON ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Care ◽  
Therapeutic Misconception ◽  
Medical Problems ◽  
Cognitive Frames ◽  
Intervention Efficacy ◽  
Cognitive Frame ◽  
The Difference

Abstract:Therapeutic misconception (TM)—when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care—has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants’ incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers’ frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.

‘Who is going to put their life on the line for a dollar? That’s crazy’: community perspectives of financial compensation in clinical research

2021 ◽  
pp. medethics-2020-106715
Author(s):  
Amie Devlin ◽  
Kirsten Brownstein ◽  
Jennifer Goodwin ◽  
Emily Gibeau ◽  
Mariana Pardes ◽  
...  
Keyword(s):  
Clinical Research ◽  
Low Income ◽  
Research Participation ◽  
Semistructured Interview ◽  
Financial Compensation ◽  
Black African ◽  
Research Participants ◽  
Study Results ◽  
Study Participants ◽  
Available Information

BackgroundFinancial compensation of research participants has been standard practice for centuries, however, there is an ongoing debate among researchers and ethicists regarding the ethical nature of this practice. While these debates develop ethical arguments and theories, they fail to incorporate input from those most affected by financial compensation: potential research participants.MethodsTo identify attitudes surrounding clinical research, participants of a long-standing cohort completed a one-time interview. Open-ended questions stimulated a participant-driven discussion surrounding medical research. Following a grounded theory methodology, 58 semistructured interview transcripts were coded, focusing on attitudes surrounding financial compensation of research participants.ResultsOf the interviews coded, the majority of participants identified as Black/African American (n=44) and were women (n=40). Five major themes emerged. In support of financial compensation, participants felt that study participants should be compensated for time, effort and risk. However, participants were concerned that compensation may differentially impact low-income populations and entice them to hide potentially harmful side effects. Participants also mentioned that financial compensation may invalidate study results if participants knowingly provide false information to subvert inclusion/exclusion criteria.ConclusionThe emergence of both positive and negative themes reiterates the complicated issue of providing financial compensation for study participation. While compensation as a motivator for research participation raises ethical concerns, participants discussed weighing the benefits with the risks in order to make an informed decision. To avoid paternalistic behaviours, research staff must allow potential research participants to review the available information and make the decision that best reflects their wishes.

Healthy Volunteers

2020 ◽  
Author(s):  
Jill A. Fisher
Keyword(s):  
Healthy Volunteers ◽  
Biomedical Research ◽  
Clinical Care ◽  
Research Participation ◽  
Vulnerable Groups ◽  
Biological Processes ◽  
Healthy Individuals ◽  
Ethical Problems ◽  
The Difference ◽  
Healthy Participants

This chapter describes the involvement of healthy volunteers in biomedical research. Healthy individuals are valuable to research because they can offer data about biological processes or investigational products that are not distorted by illness or disease. In addition, healthy individuals are generally much easier to recruit to research than are ill patients. Recruitment of healthy participants is aided by the offer of financial compensation in exchange for their participation. The involvement of healthy individuals in research is meant to resolve ethical problems associated with enrolling patients, such as exposing sick individuals to risk and creating misunderstandings for patients about the difference between research and clinical care. However, as this chapter details, using healthy individuals in biomedical research raises different concerns about risk exposure as well as ethical dilemmas associated with paid research participation, the exploitation of vulnerable groups, and the validity of the data produced.

scholarly journals Patient Experience in Home Respiratory Therapies: Where We Are and Where to Go

2019 ◽  
Vol 8 (4) ◽  
pp. 555 ◽  
Author(s):  
Cátia Caneiras ◽  
Cristina Jácome ◽  
Sagrario Mayoralas-Alises ◽  
José Ramon Calvo ◽  
João Almeida Fonseca ◽  
...  
Keyword(s):  
Clinical Research ◽  
Patient Experience ◽  
Clinical Care ◽  
Research Priorities ◽  
Specific Patient ◽  
Quality Healthcare ◽  
Body Of Knowledge ◽  
Number Of Patients ◽  
Patient Reported ◽  
System Sustainability

The increasing number of patients receiving home respiratory therapy (HRT) is imposing a major impact on routine clinical care and healthcare system sustainability. The current challenge is to continue to guarantee access to HRT while maintaining the quality of care. The patient experience is a cornerstone of high-quality healthcare and an emergent area of clinical research. This review approaches the assessment of the patient experience in the context of HRT while highlighting the European contribution to this body of knowledge. This review demonstrates that research in this area is still limited, with no example of a prescription model that incorporates the patient experience as an outcome and no specific patient-reported experience measures (PREMs) available. This work also shows that Europe is leading the research on HRT provision. The development of a specific PREM and the integration of PREMs into the assessment of prescription models should be clinical research priorities in the next several years.

scholarly journals Primary care doctor fostering and clinical research training in Sweden: Implications for Japan

2018 ◽  
Vol 20 (1) ◽  
pp. 4-8 ◽  
Author(s):  
Takashi Watari ◽  
Masahiro Hirose ◽  
Patrik Midlöv ◽  
Yasuharu Tokuda ◽  
Hideyuki Kanda ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Research ◽  
Research Training ◽  
Primary Care Doctor

Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

2019 ◽  
Vol 14 (5) ◽  
pp. 475-478
Author(s):  
Matthé Scholten ◽  
Jochen Vollmann
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Research Participation ◽  
Research Participant ◽  
Involuntary Commitment ◽  
Proxy Consent ◽  
Undue Influence ◽  
Research Participants ◽  
Manic Symptoms ◽  
Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

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