I soggetti vulnerabili nella ricerca clinica europea: dalla Convenzione di Oviedo al Regolamento (UE) N. 536/2014 / Vulnerable subjects in European clinical research: from the Oviedo Convention to Regulation (EU) No 536/2014

2018 ◽  
Vol 66 (6) ◽  
pp. 793-809
Author(s):  
Antonio Rimedio
Keyword(s):  
Clinical Trials ◽  
Belmont Report ◽  
Minimal Risk ◽  
Respect For Persons ◽  
Protection Measures ◽  
Direct Benefit ◽  
Legal Standard ◽  
International Bioethics ◽  
Vulnerable Subjects ◽  
Reference Document

Il confronto tra la Convenzione di Oviedo e il Regolamento (UE) N. 536/2014 ha consentito di strutturare lo “standard etico-giuridico” europeo relativo alle misure di protezione dei soggetti vulnerabili coinvolti nelle sperimentazioni cliniche. Tale standard è stato analizzato seguendo il filo conduttore dei tre principi fondamentali della ricerca, enunciati dal Belmont Report: rispetto per la persona, beneficialità e giustizia. Le discrepanze riscontrate al suo interno hanno fatto emergere le criticità di talune categorie di base, ad esempio la distinzione tra beneficio diretto o beneficio sul gruppo e la nozione del rischio minimo. A 20 anni di distanza dalla Convenzione di Oviedo, documento di riferimento della bioetica europea ed internazionale, viene argomentata la necessità di ripensare criticamente quella dimensione “difensiva” della vulnerabilità, che prevale nella normativa europea e occidentale. ---------- The comparison between the Oviedo Convention and the Regulation (EU) No. 536/2014 has allowed to discover and structure the European “ethical-legal standard” on the protection measures for vulnerable subjects involved in clinical trials. This standard was analyzed following the three fundamental principles of research, as outlined by the Belmont Report: respect for persons, beneficence and justice. The discrepancies found inside have highlighted the criticalities of some basic categories, such as the distinction between direct benefit or benefit on the group and the notion of minimal risk. Twenty years after the Oviedo Convention, a reference document for European and international bioethics, there is a need to rethink critically the “defensive” dimension of vulnerability, that prevails in European and Western legislation.

Human Rights and the Vulnerability of Rights-bearers

2021 ◽  
Vol 65 (1) ◽  
pp. 49-67
Author(s):  
Diana Tietjens Meyers ◽  
Keyword(s):  
Human Rights ◽  
Human Dignity ◽  
Respect For Persons ◽  
Human Vulnerability ◽  
Vulnerable Subjects ◽  
Autonomous Agency ◽  
The Relationship

I seek to understand the relationship between human vulnerability and human rights as something more than a problem that respect for human rights solves. After characterizing vulnerability and noting that human rights are generally regarded as entitlements that respect the dignity of persons by securing their autonomous agency, I draw out the implications of these premises. I argue that human vulnerabilities are constitutive of the capacity for autonomous agency and therefore that the circumstances of respect for persons must include persons’ vulnerability to many sorts of harms. Given that the opportunity to lead one’s life in one’s own way—that is, the opportunity to exercise autonomous agency—is indispensable to human dignity, respect for persons entails respect for the vulnerability that underwrites autonomous agency. If so, rights-bearers are necessarily vulnerable subjects. I further defend this conception of rights-bearers by arguing that it comports with three types of human rights theory: agency-centered, needs-centered, and practice-based accounts of human rights.

scholarly journals Identifying Predictors of Parents’ and Children's Participation and Barriers in Randomized Clinical Trials

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 596-596
Author(s):  
Priscilla Clayton ◽  
Cristina Palacios,
Keyword(s):  
Children And Adolescents ◽  
Randomized Clinical Trials ◽  
Health Benefits ◽  
Health Benefit ◽  
Time Constraint ◽  
Personal Health ◽  
Minimal Risk ◽  
Direct Benefit ◽  
Recruitment And Retention ◽  
Parents And Children

Abstract Objectives Background: Randomized controlled trials are considered the ‘gold standard’ to assess the efficacy and effectiveness of health care and dietary interventions, however, challenges with recruitment and retention of participants can be detrimental to the validity and generalizability of the study. Children and adolescents play a role in the decision to participate, although parents are the primary decision-makers. Exploring children and parent's knowledge, attitudes, and perceptions towards research can help to understand factors that influence participation and retention. Objective: To identify predictors of recruitment and retention in RCTs involving both parents and children to assist in the implementation of recruitment and retention strategies. Methods A systematic review of RCTs was conducted to explore the available evidence to compose a qualitative meta-summary. Studies were identified from 3 databases and restricted only to English language publications. Data reporting participant's predictors and barriers of recruitment and retention in RCTs involving children and adolescents aged 0 to 21 were identified. Year of publication ranged from 2006 to 2019. Studies not including children and studies not involving participant feedback were excluded. Results 53 records were identified; 32 were excluded due to exclusion of child and/or parent feedback, therefore 21 studies were included. Several themes were identified between parents and children that mentioned predictors: personal health benefit, altruism, trust in the research, contact with staff, benefit for parents themselves, benefit for the community, minimal risk to the child, monetary benefits, felt as the only option, influence by family and friends, recommendation from physician, and increase in knowledge. Barriers mentioned were: felt as the “guinea pig,” burden for child, decision too stressful, fear of randomization, no direct benefit, and time and financial constraints. The most common themes identified in several of the studies were personal health benefits, the risk to the child, altruism, time constraint, and no direct benefit. Conclusions Important predictors of recruitment and retention in RCTs are children's personal health benefits and risks, altruism, time constraint, and no direct benefit. Funding Sources NIH

scholarly journals Involuntary Consent: Conditioning Access to Health Care on Participation in Clinical Trials

2016 ◽  
Vol 44 (3) ◽  
pp. 445-461 ◽  
Author(s):  
Ruqaiijah A. Yearby
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Informed Consent ◽  
Impact Assessment ◽  
Economically Disadvantaged ◽  
Access To Health Care ◽  
Assessment Tool ◽  
Respect For Persons ◽  
Undue Influence ◽  
Access To Health

American bioethics has served as a safety net for the rich and powerful, often failing to protect minorities and the economically disadvantaged. For example, minorities and the economically disadvantaged are often unduly influenced into participating in clinical trials that promise monetary gain or access to health care. This is a violation of the bioethical principle of “respect for persons,” which requires that informed consent for participation in clinical trials is voluntary and free of undue influence. Promises of access to health care invalidate the voluntariness of informed consent not only because it unduly induces minorities and the economically disadvantaged to participate in clinical trials to obtain access to potentially life saving health care, but it is also manipulative because some times the clinical trial is conducted by the very institutions that are denying minorities and the economically disadvantaged access to health care. To measure whether consent is voluntary and free of undue influence, federal agencies should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the “respect for persons” principle.

Research with Minors in Germany

2008 ◽  
Vol 15 (2) ◽  
pp. 127-134 ◽  
Author(s):  
Dieter Hart ◽  
Benedikt Buchner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
German Law ◽  
European Level ◽  
Direct Benefit ◽  
Individual Participant ◽  
Long Time ◽  
The Individual

AbstractThe European GCP Directive has been implemented into German law in sect. 40 ff. AMG (German pharmaceutical law). Unlike the Directive, German pharmaceutical law basically differentiates between three constellations of clinical trials on minors: clinical trials on healthy minors, clinical trials on ill minors with an individual benefit for the individual participant, and clinical trials on ill minors without direct benefit for the individual participant, but with a so-called “group benefit”. Particularly the latter possibility of conducting clinical trials on minors even if no individual benefit can be expected is not a matter of course in Germany since due to historical experiences a sceptical attitude towards clinical research on humans prevailed for a long time. German legislature has availed itself of the option granted by Article 3 of the GCP Directive to establish a higher level of protection of clinical trial subjects than the European level.

Surrogate Decision Making for Severely Cognitively Impaired Research Subjects: The Continuing Debate

1994 ◽  
Vol 3 (4) ◽  
pp. 539-548 ◽  
Author(s):  
Evan DeRenzo
Keyword(s):  
Ethical Issues ◽  
Individual Autonomy ◽  
Cognitively Impaired ◽  
Minimal Risk ◽  
Feminist Ethics ◽  
Research Subjects ◽  
Theoretical Terms ◽  
Direct Benefit ◽  
Surrogate Decision ◽  
Psychiatric Impairments

As research into Alzheimer's disease and other dementing disorders becomes more complex, risky, invasive, and commonplace, the need intensifies for discussion of the ethics of involving persons with dementia in research, specifically research of greater than minimal risk and of no expected direct benefit to the subject. (It is beyond the scope of this paper to consider the ethical issues related to research involvement of cognitively impaired children or children or adults with intermittent and/or reversible cognitive or psychiatric impairments. For such discussions, refer to the references in notes 1–6.) Reviewing such studies pushes our traditional analysis tools to their limits. Simply balancing and prioritizing the basic ethical principles of respect for persons, beneficence, and justice that serves us well in reviewing the vast majority of studies is inadequate when reviewing research of such ethical complexities as studies with marked risks and no expectation of direct benefit to subjects unable to consent or withdraw. Moving up to the level of theory, placing these principles within the commonly applied frameworks of consequentialism, deontology, or virtue ethics bring us no closer to reducing the tensions such research creates between upholding individual autonomy and advancing society's need to learn how to treat and cure these devastating diseases. What is needed is the introduction of more contemporary moral analyses. Specifically, we need to become more inclusive of the diversity of values perspectives of our general citizenry. In more theoretical terms, we ought to elevate to a more central role a communitarian perspective and a feminist ethics emphasis on relationships and context as we rush to keep in step, ethically, with this rapidly expanding area of medical inquiry.

Management of pregnancy in nih intramural clinical trials that pose more than minimal risk to women of childbearing potential (WOCP)

2010 ◽  
Vol 94 (4) ◽  
pp. S94
Author(s):  
P. Stratton ◽  
M.R. Vieira ◽  
S. Liu ◽  
A. Idriss ◽  
A. DeCherney ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Minimal Risk ◽  
Childbearing Potential

Creating a National Cohort of Myeloproliferative Disorders Using the Internet: A Feasibility Study.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 270-270
Author(s):  
Martha Wadleigh ◽  
Tarrah Kirkpatrick ◽  
Arnold Gonzales ◽  
Ross Levine ◽  
D. G. Gilliland ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Support Group ◽  
Medical Records ◽  
Myeloproliferative Disorders ◽  
The United States ◽  
The Internet ◽  
Cell Transplant ◽  
Minimal Risk ◽  
Blood Samples ◽  
National Cohort

Abstract The Internet is a potentially useful tool for recruiting patients with rare diseases to clinical trials. It facilitates the rapid and efficient recruitment of subjects, allowing patients to participate in minimal risk clinical trials who may not otherwise enroll because of lack of available studies, age, health, or proximity to a major medical center. In this study we recruited patients with the myeloproliferative disorders polycythemia vera (PV), essential thrombocytosis (ET) and agnogenic myeloid metaplasia (AMM) through the aid of an Internet support group. Our goal was to test the feasibility of using an internet-based support group to recruit 600 patients to a national cohort that collected clinical, demographic, and quality of life data as well as blood samples for tissue banking. Information on the trial was emailed to the mailing list and posted on the website of the MPD support group www.mpdinfo.org. Participants emailed the study investigator with their interest in the study, their diagnoses and mailing addresses. Information packets with consent forms, questionnaires, and release of medical records were sent through the U.S. postal service to participants. Once signed informed consents and questionnaires were returned, patients were mailed blood sample kits with pre-paid return postage to obtain blood samples. Patients were eligible if they had a diagnosis of PV, ET or AMM, lived in the United States, were >18 years old, and had not had a stem cell transplant. From January – July 2004, 497 people responded with initial interest. At each stage of the enrollment process there was a decrease in the number of participants: 23 were excluded because they lived outside of the United States. 474 were sent information packets, of which 360 were returned. Of these, 2 patients were excluded because of prior stem cell transplant and 12 opted out of the study. 344 patients consented to having blood samples drawn and 247 of these samples have been received in our tissue bank to date. Thus, the overall retention rate from initial response to receipt of blood sample is 52%. The median age of the cohort is 58 (range 20– 84 years) and the majority (58%) are female, in contrast to recent clinical trials in PV, ET and AMM where the majority of participants are older and male. Similar to recent studies 98% are white; and the median duration of disease for these patients is 63 months (range 3–543). The Internet recruitment method did select for a highly educated and more affluent population than in other series: 60% of participants are college graduates and 47% reported annual incomes >$75,000/year. PV was the most common self reported diagnosis (50%) followed by ET (35%) and then AMM (14%). Of 269 participants on whom we have received medical records thus far, we have been able to verify diagnosis on 136 participants; 53/136 (39%) have PV; 58/136 (42%) have ET; and 25/136 (18%) have AMM or myelofibrosis. Despite provision of a signed medical records releases, HIPAA restrictions have interfered with our ability to obtain medical records in some cases. In conclusion we have found that using the Internet for recruiting participants with rare diseases was efficient and feasible, and has produced a large cohort willing to provide self-reported information, medical records and research specimens. Issues of incomplete data collection, selection bias, and HIPAA restrictions remain barriers to optimal use of the Internet for minimal risk studies.

scholarly journals Facebook Recruitment and the Protection of Human Subjects

2019 ◽  
Vol 41 (9) ◽  
pp. 1270-1281 ◽  
Author(s):  
Kendra Kamp ◽  
Kayla Herbell ◽  
William H. Magginis ◽  
Donna Berry ◽  
Barbara Given
Keyword(s):  
Social Media ◽  
Data Security ◽  
Human Subjects ◽  
Ethical Principles ◽  
Belmont Report ◽  
Respect For Persons ◽  
Ethical Challenges ◽  
Recruitment Method ◽  
Research Participants ◽  
Protection Of Human Subjects

Social and behavioral scientists increasingly use Facebook to recruit research participants. Given the everchanging social media landscape, it is important to consider the ethical principles of using such a strategy. The aims of this methodological article are to (a) examine Facebook recruitment in light of the ethical principles of the Belmont Report (respect for persons, beneficence, and justice), (b) describe ethical challenges that may be faced in Facebook recruitment, and (c) provide recommendations for researchers interested in adopting this recruitment method. Ethical challenges inherent in Facebook recruitment include selecting subjects fairly, privacy, and data security. Overall, Facebook is a beneficial resource for recruiting participants into research; however, researchers need to be aware of their responsibility in protecting human subjects.

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