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At least 19 recordsLinked to original sources

New draft code for research involving humans proved a major challenge.

A new draft code of conduct for research involving humans aims to bring a fresh vision to the ethics field. The code is a joint endeavour of the Medical Research Council, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council and supersedes all three agencies' earlier ethics statements. Once the draft code is revised and approved, likely by the end of the year, investigators will have a more refined understanding of the ethical limits of acceptable research.

Advisory Committees↗

Research ethics committees and public dissemination of clinical trial results.

Biomedical research involving human beings is subject to codes of ethical conduct that mandate review, approval, and monitoring of clinical trials by research ethics committees (RECs). The role of RECs in public dissemination of results of research is not addressed explicitly in international codes or national regulations governing human research. I contend that RECs should have a prominent role in ensuring that trial results are publicly disseminated. I also propose specific responsibilities and actions that should be assumed and implemented by RECs to promote this objective.

Bioethics↗

Double agency in clinical research.

The current focus on evidence-based practice in nursing may result in nurses playing 2 roles concurrently--that is, acting as researcher and caregiver at the same time and with the same people. Given the fiduciary nature of the patient-caregiver relationship, this double agency can give rise to problems, both real and perceived. In this paper, the issues associated with assuming dual roles in research with humans will be examined, particularly in relation to recruitment and informed consent, data collection, and participant withdrawal from a study. In addition, strategies to prevent or minimize problems related to double agency are identified, with attention to the guidance provided by professional codes of ethics and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.

Ethics, Nursing↗

The revised Declaration of Helsinki--is justice served?

The World Medical Association revised the Declaration of Helsinki in October 2000. The Declaration is intended to provide a universal set of principles, which direct the ethical conduct of clinical medical research involving human subjects throughout the world. Previous research ethics codes emphasized the principles of informed consent and beneficence toward research subjects. The revised Helsinki Declaration places a premium not only upon these values but also the principle of distributive justice. The new Declaration demands that scientists see to it that the risks and benefits of scientific inquiry are distributed fairly to those that participate in research and to the communities from where participants are drawn. The authors of the Declaration have sought to establish justice by minimizing the use of placebo controls, insisting that populations from where research subjects are drawn stand to benefit from the research, and by requiring that therapeutic agents be made available to all trial participants long after a trial is completed. This paper argues that the aim of seeking a morejust distribution of the risks and benefits of research may actually be undermined by the tools that the Declaration employs to enforce justice.

Clinical Trials as Topic↗

US medical researchers, the Nuremberg Doctors Trial, and the Nuremberg Code. A review of findings of the Advisory Committee on Human Radiation Experiments.

The Advisory Committee on Human Radiation Experiments (ACHRE), established to review allegations of abuses of human subjects in federally sponsored radiation research, was charged with identifying appropriate standards to evaluate the ethics of cold war radiation experiments. One central question for ACHRE was to determine what role, if any, the Nuremberg Code played in the norms and practices of US medical researchers. Based on the evidence from ACHRE's Ethics Oral History Project and extensive archival research, we conclude that the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subjects research. Although some clinical investigators raised questions about the conduct of research involving human beings, the medical profession did not pursue this issue until the 1960s.

Advisory Committees↗

Nursing research in the United States: the protection of human subjects.

In the United States the protection of the rights of human subjects in experimentation has evolved at three levels: professional, public, and private. At the professional level, codes, guidelines and the Patient's Bill of Rights address the issues of protecting the dignity, privacy and autonomy of individuals who serve as research subjects. At the public level, regulations promulgated by the Food and Drug Administration and the Department of Health and Human Services have become the standard for protecting human subjects. At the private level, United States common law regulates the conduct of individual researchers by requiring them to act in a manner consistent with generally accepted standards of care. As professionals, nurses must be actively involved in the formation of public policy regarding the conduct of research and strive to formulate a research agenda that will ensure that the ethics of research in nursing is above question.

Codes of Ethics↗

Cardiovascular regulation: a modelling approach.

A detailed analysis of autonomic cardiovascular control (ACVC) may provide a key to a better understanding of the mechanisms underlying postflight orthostatic hypotension. The central substrate of human ACVC is not directly accessible to measurements and observation in space research. Modelling--supporting inference and physiological reasoning--is a valuable tool to disclose its involvement We are currently determining the suitability of artificial neural networks (ANN's) as a model of the central substrate of ACVC. Having conducted a number of experiments with simulated tilt test data to clarify the choice of input coding and of architectural biases in network training we will now report on the approximation of data obtained from human subjects during preparation of the German MIR'97 and D-2 missions.

Adaptation, Physiological↗

Ethics of psychological research: new policies; continuing issues; new concerns.

The implementation over the past year within Canadian universities of the new Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) ushers in a new era in the oversight of the ethics of psychological research in Canada. Although these new policies apply to all human research, our interest in how they apply to psychology, primarily to deception, undergraduate subject pools, and other continuing concerns. Why have the granting agencies decided that government regulation of research ethics is necessary and what is the relationship between federal regulations and discipline codes? The history of CPA's involvement in protecting psychology's interests in the final revisions to the TCPS is recounted. In spite of what has been achieved, many psychologists feel that the TCPS has created new concerns for the discipline. Although there is the potential for startup problems, it is in our collective and individual best interests to make the policy work, thereby ensuring that escalation of government regulation or legislation will not be pursued.

Advisory Committees↗

Protection of research subjects with emphasis on protocols involving radiation.

Approval by an institutional review board (IRB) or human studies committee must be obtained prior to conducting human subject research. Historically this was not the case, and human subjects were injured as a result. Because there has been and still remains an inevitable conflict of interest for researchers, instititions that perform human research must follow regulations designed to protect human subjects contained in the Code of Federal Regulations, if the research is federally funded. Two federal agencies provide oversight for IRB activities: the Food and Drug Administration (FDA) and a National Institutes of Health Office for Human Research Protection (OHRP), formerly the Office for Protection from Research Risks (OPRR). These agencies are charged with the implementation of rules related to ethical and legal obligations of researchers and their institutions. The institution's role, by means of an IRB, is to adhere to principles of the Belmont Report and to set forth ethical principles, policies, and procedures for protecting the rights and welfare of human subjects. The researchers' role is to conduct their research ethically while maximizing benefits and minimizing harm. Studies involving radiation exposure of human subjects add another level of risk that must be evaluated by an IRB with assistance of a radiation expert or radiation safety committee (RSC). This paper will look at regulatory aspects of human research, IRB responsibilities overall and as they relate to radiation exposure of subjects, and the role of the RSC.

Child↗

Identifying and Prioritizing Core Components of Relationship Education Programs: a Case Study of an Artificial Intelligence (AI) Assisted Systematic Review.

The field of prevention science seeks to identify and implement effective strategies to address social, emotional, and health challenges. A critical aspect of this endeavor is determining the core components of prevention programs that drive positive outcomes. This article presents a case study utilizing artificial intelligence (AI)-assisted systematic review methods to identify key components of healthy marriage and relationship education programs. Given the growing body of research in this domain, AI tools offer a promising means to enhance the efficiency and accuracy of literature reviews. This study employed AI to screen, code, and validate research articles, demonstrating its effectiveness in expediting systematic reviews while maintaining high accuracy in inclusion screening. This case study involved a systematic review of 22,028 resources (identified from PsycINFO, Academic Search Ultimate, and Google) and a final data set of 268 relevant studies. AI screening was integral in effectively conducting multiple rounds of screening. However, findings also highlight challenges in AI-assisted qualitative data abstraction, underscoring the continued need for human expertise in complex coding tasks. The study contributes to the ongoing discourse on integrating AI into prevention science methodologies and offers insights for optimizing AI applications in systematic reviews.

Artificial Intelligence↗