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Results for “Belmont Report”

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At least 19 recordsLinked to original sources
PubMed1989

Informed consent in the practice of acupuncture.

Early records reveal a parental, beneficent attitude, but an uncommunicative approach to the patient. The Nuremberg trials of 1946 demonstrated the need for ultimate responsibility of the physician, and for a well-informed, consenting patient in experimental procedures (Nuremberg Code of 1947). A later report, the Belmont Report (1975) emphasized the difference between therapeutic research and research unrelated to improving the patient's state of health. Acupuncture has the status of an experimental modality, and requires the informed consent discussion and signature on the form by the patient for each procedure.

Acupuncture Therapy↗
PubMed2001

Ethical research issues: going beyond the Declaration of Helsinki.

La Vaque and Rossiter made a strong, supported argument that it is unethical to use a "no treatment" control group in a research study if a known, effective treatment is available. Their argument is based on the supposition that the Declaration of Helsinki is the ethical world standard for research with humans. Their argument appears to be straightforward, but is not simple to apply. The issues are very complex, include issues not discussed in their argument, and can lead to a different conclusion as pointed out in this paper. The World Medical Association developed the Declaration of Helsinki as one of their official policies. The Declaration of Helsinki, however, is not accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations or even by the United States Federal Government. Perhaps it is not mentioned because its ethical provisions are aspirational rather than mandatory as implied by La Vaque and Rossiter. Researchers and clinicians should also be aware of other ethical issues not directly discussed in the La Vaque and Rossiter paper. The Belmont Report is the basis for the ethical protection of human research subjects for at least 17 federal agencies and does not mention the Declaration of Helsinki. The Belmont Report mentions several ethical principles that form the basis for informed consent, risk/benefit assessment, confidentiality of data, subject selection, Institutional Review Boards, and other protections needed when doing research with human subjects. At least 2 of these core principles have direct implications to the discussion related to the use of placebo controls. The ethical principle of fidelity is also important in guiding research activities with human subjects. Researchers should be familiar with the La Vaque and Rossiter argument, the Belmont Report, and the federal policies developed to implement the provisions of that report, for example, Regulation 45 CFR 46.

Ethics↗
PubMed2004

Protection of human subjects in intervention research for suicidal behavior.

OBJECTIVE: Three domains of ethical conduct outlined in the U.S. Food and Drug Administration's 1998 Belmont Report on protection of human research subjects-respect for persons, beneficence, and justice-have posed specific dilemmas in the design of intervention studies for suicidal behavior. These issues include questions about suicidal patients' capacity to provide informed consent, the risk of some lethal outcomes, the possibility of imminent suicide risk associated with patients' right to discontinue the study treatment, and the need for a higher level of monitoring of suicidal patients. The authors examine these and other issues and discuss ways they can be addressed in research design. METHOD: To illustrate solutions to these bioethical tensions, the authors describe the design of a randomized, controlled trial of pharmacotherapy for suicidal behavior in bipolar disorder. RESULTS: Using surrogate outcome measures, allowing prescription of rescue medications, integrating psychosocial interventions, and providing close clinical monitoring enable researchers to conduct research on suicidal behavior while maximizing adherence to the ethical recommendations outlined in the Belmont Report. Alternative study designs, such as add-on trials, in which the study treatment or placebo is added on to known effective treatment, may also be used in research on suicidal behavior. CONCLUSIONS: It is possible to design a randomized, controlled trial that minimizes the risk of morbidity and mortality for suicidal patients with bipolar disorder, but deliberation is required to address the bioethical tensions that arise.

Biomedical Research↗
PubMed2000

Research misconduct--an indictment and possible solution.

The core problems of scientific misconduct are systemic to the infrastructure of the conduct of scientific research itself, and therefore are probably immune to any short-term solutions. Renaming federal agencies, reorganizing monitoring activities, appointing new personnel, and other similar proposed remedies are necessary but insufficient measures. Indeed, the etiological factors in misconduct include an erosion of trust that stands in the way of the ethical integrity flowing from the major ethical principles identified in the Belmont Report. To make those principles applicable and useful to meet the challenges of current research activities, especially those involving human subjects, depends on our ability to foster an unprecedented cooperation of community resources.

Academies and Institutes↗
PubMed2002

A critical appraisal of protections for aboriginal communities in biomedical research.

As scientists target communities for research into the etiology, especially the genetic determinants of common diseases, there have been calls for the protection of communities. This paper identifies the distinct characteristics of aboriginal communities and their implications for research in these communities. It also contends that the framework in the Belmont Report is inadequate in this context and suggests a fourth principle of respect for communities. To explore how such a principle might be specified and operationalized, it reviews existing guidelines for protecting aboriginal communities and points out problems with these guidelines and areas for further work.

Cultural Characteristics↗
PubMed2005

Conducting research on sensitive topics with adolescents: ethical and developmental considerations.

Promotion of adolescent health requires well-designed scientific studies that determine the prevalence of the problem of interest, identify risk and resilience factors, and evaluate methods for prevention and intervention. Many adolescent-related health problems are typically considered sensitive by society (e.g., sexual and substance use behaviors), thus further complicating the research process. Using the principles of the Belmont Report as its framework, this paper draws on developmental theories to discuss ethical issues specific to the conduct of research with adolescents. Our ability to use developmentally sensitive research practices will be enhanced by further understanding of issues associated with risk and benefit assessment by the adolescent, their parents, and institutional review boards, and by delineating ways to ensure that adolescent participants are adequately protected and have a developmentally affirming experience.

Adolescent↗
PubMed2004

Practical moral codes in the transgenic organism debate.

In one study funded by the United States Department of Agriculture, people from North Dakota were interviewed to discover which moral principles they use in evaluating the morality of transgenic organisms and their introduction into markets. It was found that although the moral codes the human subjects employed were very similar, their views on transgenics were vastly different. In this paper, the codes that were used by the respondents are developed, compared to that of the academically composed Belmont Report, and then modified to create the more practical Common Moral Code. At the end, it is shown that the Common Moral Code has inherent inconsistency flaws that might be resolvable, but would require extensive work on the definition of terms and principles. However, the effort is worthwhile, especially if it results in a common moral code that all those involved in the debate are willing to use in negotiating a resolution to their differences.

Advisory Committees↗
PubMed2004

The research misconception.

Recently, several researchers and philosophers argued that clinical research trials are not therapy. Their position is based on foundational research ethics documents, such as the Belmont Report, on conceptual analysis, and on the general way clinical trials are conducted. After examining and rejecting these arguments, we claim that good research is consistent with good therapy; that often trials are good therapy; and that a blanket attack on clinical trials as non-therapeutic creates a research misconception. This misconception is potentially harmful because it could weaken trial recruitment, could adversely affect funding for trials, and could overturn needed moral safeguards on therapeutic trials. Our more careful and accurate analysis of the nature of clinical trials can avoid such problems.

Adult↗
PubMed1995

Principlism and the ethical appraisal of clinical trials.

For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belmont Report, and later articulated more fully by Beauchamp and Childress in their Principles of Biomedical Ethics. Recently, the use of ethical principles for deliberating about moral problems in medicine and research, referred to in the pejorative sense as "principlism", has come under scrutiny. In this paper we argue that these principles can provide a foundation for the source of ethical appraisal of human research, but are not themselves wholly adequate for this purpose. Therefore, we further propose that (1) principles should be understood as heuristics that can be "specified" as described by De Grazia (1992), and (2) that the principle-based approach should be supplemented by formally incorporating "sensitivity to context" into the evaluation of clinical trials.

Altruism↗
PubMed2003

Are the rationale and regulatory system for protecting human subjects of biomedical and behavioral research obsolete and unworkable, or ethically important but inconvenient and inadequately enforced?

Many critics of U.S. regulation to protect human subjects of biomedical and behavioral research deem the system inherently unworkable and variously inadequate or unnecessary. Many deem its rationale, the Belmont Report, outdated and philosophically deficient. Some would scrap or revamp the system. These criticisms and prescriptions are challenging factually, legally, and ethically. Similar minimalist, audited self-regulation operates smoothly elsewhere in life science. Events suggest Belmont's continuing validity in its administrative-law role as interpretive touchstone for human subjects protection regulations. U.S. human subjects protection and related regulations are constitutionally grounded and consistent with U.S. obligations under human rights law. Criticisms that the system is inconvenient do not respond to ethical and legal duties--to acknowledge the innate dignity of human subjects of research, to recognize and squarely face ethical issues in human subjects research, to heed applicable domestic and international law, to say no to projects when no is warranted, to foster researcher involvement in the system, to focus on substance rather than form, and to resist automaticity. If the system is to function protectively and reasonably efficiently, then the legitimacy of the pertinent law and Belmont's legal role should be recognized as the primary resource for interpreting the human subjects regulations; the system and proposed changes should be viewed critically for efficacy rather than convenience; and policy and practice should emphasize (a) predictability, stability, and clarity of the regulatory system, and (b) resources and will to comply and enforce.

Behavioral Research↗
PubMedDate not supplied

Promoting respect for persons: developing a brochure for research participants.

The Institute of Medicine report Responsible Research: A Systems Approach to Protecting Research Participants noted that research participants require educational materials and ongoing interactions with investigators and healthcare professionals to have sufficient information to make a choice and be empowered to ask questions regarding their research participation. One of the ethical principles outlined in the Belmont Report, Respect for Persons, provided the framework for developing a brochure for research participants specific to the Department of Veterans Affairs (VA). The intent was to provide veterans and their families information about research in the VA and a list of basic questions to guide them through the complex decision making about their rights as research participants.

Humans↗
PubMed2006

Vulnerable populations in research: the case of the seriously ill.

This paper advances a new criterion of a vulnerable population in research. According to this criterion, there are consent-based and fairness-based reasons for calling a group vulnerable. The criterion is then applied to the case of people with serious illnesses. It is argued that people with serious illnesses meet this criterion for reasons related to consent. Seriously ill people have a susceptibility to "enticing offers" that hold out the prospect of removing or alleviating illness, and this susceptibility reduces their ability to safeguard their own interests. This explains the inclusion of people with serious illnesses in the Belmont Report's list of populations needing special protections, and supports the claim that vulnerability is the rule, rather than the exception, in biomedical research.

Critical Illness↗
PubMed2004

The limitations of "vulnerability" as a protection for human research participants.

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.

Child↗