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PubMed2000

The ambiguity and the exigency: clarifying 'standard of care' arguments in international research.

This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting rationales, and even to locate the crux of the disagreement in some instances. The goal of the present discussion, therefore, is to disambiguate the concept of a 'standard of care' and to highlight the areas of genuine disagreement among different standards. In the end it is argued that one standard of care argument in particular is more complex than either its proponents or its critics may have recognized and that understanding this possibility opens up a potentially promising avenue of inquiry that remains to be carefully explored.

Clinical Trials as Topic↗
PubMed2000

Children as research subjects: a dilemma.

A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, and many other national policies. They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like "minimal risk." Paths to the improvement of balancing or consequentialist approaches include (1) improving standardizing of risk assessment, (2) rejecting crude utilitarianism, (3) identifying and justifying normative or moral judgments, and (4) acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children.

Bioethics↗
PubMed2004

Minimal risk as an international ethical standard in research.

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of "minimal risk." If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of "minimal risk" are untenable. The "absolute" interpretation of the "routine examination" standard is defended as best.

Ethics Committees, Research↗
PubMed2001

Clinical trials integrity: a CRO perspective.

When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.

Advisory Committees↗
PubMed2001

Current issues in clinical research and the development of new pharmaceuticals.

As a normal part of the drug development process, U.S. pharmaceutical companies conduct many thousands of clinical trials each year. Only after a reasonable assurance of safety is made can the drug be given to patients who have the underlying medical condition that the drug is designed to treat. Patient welfare is assured by adhering to the Food and Drug Administration's interpretation of the "common rule" if the data will be used to support a licensing application. 21 CFR Part 50 sets forth the regulations along with the principles of informed consent and the use of institutional review boards (IRBs) that assure patients' rights are protected. Any potential conflict of interest on the part of a clinical investigator must be reported to the FDA. Pharmaceutical companies extensively monitor ongoing clinical trials for compliance with appropriate regulations. The recent revision of the Declaration of Helsinki governing placebo-controlled clinical trials may adversely impact drug development.

Advisory Committees↗
PubMed2006

Stopping nutrition and hydration technologies: a conflict between traditional Catholic ethics and church authority.

This article focuses on the troubling effects of the secular values of individual freedom and autonomy and their impact on laws regarding suicide and euthanasia. The author argues that in an increasingly secularized culture, death and dying are losing their meaning and are not thought of within a moral framework. The debate regarding the provision of artificial nutrition and hydration is critically considered in light of the history of Catholic morality as well as within the modern healthcare context, and finally with new insight from the recent statements made by the late pope. Drane argues that the pope's insistence on providing artificial nutrition and hydration despite irreversible persistent vegetative states in unconvincing.

Alzheimer Disease↗
PubMed2005

Rethinking research ethics.

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.

Beneficence↗
PubMed2026

Elastic tape as an add-on strategy to potentiate pulmonary rehabilitation outcomes in nonobese males with moderate-to-very severe COPD: A randomised clinical trial.

BACKGROUND AND OBJECTIVE: Pulmonary rehabilitation (PR) improves exercise capacity but has limited effects on ventilatory constraints in severe COPD. Application of elastic tape (ET) is a potential adjunctive strategy that improves ventilatory efficiency, but its effects during PR remain un lear. This study investigated whether ET potentiates PR benefits on exercise capacity, health status, psychological symptoms, and health-related quality of life (HRQoL) in individuals with COPD. METHODS: Forty-two nonobese men with moderate-to-very severe COPD were randomised to ET or Sham groups during an 8-week PR programme. The primary outcome was endurance shuttle walk test (ESWT) time; secondary outcomes included COPD Assessment Test (CAT), Chronic Respiratory Questionnaire (CRQ), and Hospital Anxiety and Depression Scale (HADS). RESULTS: ESWT improved by +329s in the ET group, exceeding the MCID. Greater CAT improvements (p = 0.02), and a higher proportion achieving minimal clinically important difference (MCID) (48% vs. 29%; p = 0.02) were observed in the ET group. Only ET group achieved MCIDs for depression (p = 0.003) and anxiety (p = 0.02). HRQoL improved similarly in both groups. The only outcome with a significant time × group interaction was HADS-D (p = 0.001), improved by ET. Only This study was performed in accordance with the Declaration of Helsinki. This human study was approved by Ethics Committee for Analysis of Research Projects (CAPPesq) of School of Medicine of the University of São Paulo - Hospital das Clínicas (approval 55 617 321.20000.0068). All adult participants provided written informed consent to participate in this study. Clinical Trial Registration number NCT05939999 (https://clinicaltrials.gov), registered on October 26th, 2025.ET group presented moderate-to-large effect sizes for ESWT (d = 0.89), HADS-A (d = 0.51) and HADS-D (d = 1.02). CONCLUSIONS: ET potentiates PR benefits on exercise capacity, health status, and psychological symptoms in individuals with moderate-to-very severe COPD.

Humans↗
PubMed2000

Demoralisation, depression and desire for death: problems with the Dutch guidelines for euthanasia of the mentally ill.

OBJECTIVE: Given the recent publication of Dutch guidelines for euthanasia of the mentally ill, our aim in this paper is to review the clinical role of the psychiatrist in assessing patients who seek euthanasia or physician-assisted suicide. METHOD: Three areas are examined that are informative of the role of the psychiatrist in assessing patients who desire death: recent surveys of psychiatrists' attitudes, empirical and clinical studies, and treatment issues. RESULTS: Demoralisation and depression emerge as pertinent clinical issues worthy of psychiatric intervention. The role of the psychiatrist is complex and includes issues of assessment, systems, countertransference and treatment. CONCLUSIONS: Dutch guidelines for physician-assisted suicide in the mentally ill generate serious concern given the uncertainty of prognosis, potential range and variability of outcome of treatments of suicidality and the boundary violations that are involved for the psychiatrist. The guidelines have the potential to dangerously alter the practice of psychiatry and should be condemned.

Attitude to Death↗
PubMed2003

Of consents and CONSORTs: reporting ethics, law, and human rights in RCTs involving monitored overdose of healthy volunteers pre and post the "CONSORT" guidelines.

Randomized controlled trials (RCTs) of therapeutic interventions in acute drug overdose present a significant challenge for ethical, legal, and human rights protections of research subjects, particularly when healthy volunteers are involved. The CONSORT statement on the uniform reporting of clinical trials was published in 1996 with the overall aim of improving the reporting of RCTs, both individually and to facilitate their inclusion into systematic reviews. In CONSORT, reporting of ethical, legal, and human rights protections, including prior evaluation of the study by an ethics committee and provision of informed consent, was largely an implicit requirement. Those drafting CONSORT may have assumed such protections and the rights of study subjects were secured by existing doctor-patient relationships. Alternatively, CONSORT may have been viewed as likely to indirectly enhance such protections, as a flow-on effect of improved RCT design and reporting. We wished to examine whether such assumptions were justified by examining the reporting of RCTs of simulated overdose in healthy volunteers. We reviewed all reported RCTs involving activated charcoal in healthy human volunteersfor three years before the CONSORT statement (1989, 1990, and 1991) and three years afterwards (1999, 2000, 2001). Presence of documentation of inclusion and exclusion criteria, stopping rules, protocol deviations, information sheets, consent documentation, ethical approvals, conflicts of interest, understanding, refusal, inducements and coercion were recorded. We found a very poor level of reporting of some key ethical, legal, and human rights protections for healthy volunteers in toxicological RCTs. Reporting did not improve with the publication of CONSORT even in relation to requirements specifically included in the guidelines.

Antidotes↗