Search PubMed⌕ Search

Biomedical subjects

R Macklin

Publications and source records attributed to R Macklin.

At least 19 recordsLinked to original sources
PubMed2001

International clinical trials with applicability to mentally impaired individuals: the conundrum of third world sites.

Research on the effectiveness of treatment programs in early stages of severe mental illness raise significant ethical questions when conducted in industrialized countries that have adequate protections for the human subjects of biomedical and behavioral research. Before embarking on similar trials in developing countries, researchers face formidable barriers that must first be addressed and overcome. The challenges to external sponsors of research in conducting ethically responsible clinical trials in developing countries include at least the following: the existence of alternative belief systems regarding the causes and treatment of mental illness; difficulty in implementing the results of successful research in resource-poor countries; providing for adequate prior ethical review in the host country of the proposed study; and problems in ensuring that voluntary, informed consent is properly obtained from research subjects or their legally authorized representatives. Global justice demands that we not adopt one ethical standard for rich countries and another for resource-poor countries.

Clinical Trials as Topic↗
PubMed2001

Defining home care.

Explore the source record for details and available documents.

Home Care Services↗
PubMed2001

Growth hormone in short children: medically appropriate treatment.

Bolt and Mul argue persuasively against the "disease" approach and the "client" approach in addressing the question of whether growth hormone for short children properly belongs in the medical realm. Their own preferred approach, the "suffering" approach, is superior to the others but has practical problems that would arise in its application. An additional ethical issue, not addressed by Bolt and Mul, relates to justice in providing access for children from families of limited financial means to growth hormone treatment.

Child↗
PubMed2001

After Helsinki: unresolved issues in international research.

Following a long process of revision, a new version of the Declaration of Helsinki was approved by the World Medical Association in 2000. Two provisions of the Declaration address ongoing international controversies regarding research sponsored by industrialized countries and conducted in developing countries. Despite the issuance of the final version of the Declaration, opponents remain locked in debate. Moreover, the Declaration remained silent on other prominent controversies concerning international research. An analysis of these current controversies reveals reasons why they are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles.

Clinical Trials as Topic↗
PubMed2000

Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS).

Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered "developing" countries. Safeguarding the rights and welfare of individuals participating as research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS (UNAIDS) embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process.

AIDS Vaccines↗
PubMed2000

Ethical dilemmas in pediatric endocrinology: growth hormone for short normal children.

Ethical questions surrounding the administration of synthetic growth hormone (GH) to short normal children can be grouped into the following four categories: 1) appropriateness of medical treatment when no disease or biological deficiency is present; 2) how to proceed in the face of ambiguity or uncertainty of research results; 3) difficulty in weighing the risks and benefits of treatment; and 4) who should decide? This article seeks to determine whether GH administration to normal short children is properly considered an 'enhancement', and, if so, whether such treatment would be ethically wrong.

Body Height↗
PubMed2000

Informed consent for research: international perspectives.

Problems in obtaining and documenting informed consent are especially difficult to resolve in countries whose cultures differ considerably from those of most Western nations. Confusion between the research and therapeutic contexts are widespread. Two departures from widely accepted ethical standards are discussed: withholding information about the research and requiring a husband's permission for his wife to participate. Supporters of such departures claim that they are justified by the cultural context of the country in which the research is carried out. One program at the World Health Organization has developed guidelines stating that requiring partner agreement or authorization for an individual to participate in research violates the autonomy of research subjects and their right to confidentiality. A study carried out at one reproductive health clinic in Chile describes a process of obtaining informed consent to research that could serve as a model for US investigators interested in making informed consent a meaningful and ethically respectable aspect of their research activities. Research involving human subjects should adhere to a single, universally applicable standard of informed decision making by participants.

Adult↗
PubMed1999

Understanding informed consent.

Properly understood, informed consent is a process of communication between researcher and subject. The purpose of the informed consent form is to document the informed consent discussion. The place of informed consent in leading international codes of research ethics is reviewed. Some prominent examples of past violations of informed consent are discussed. Even when properly understood, informed consent presents an array of ongoing problems and unanswered questions. These include the question of how much information must be given to research subjects, and how much is too much; and how to ensure the full voluntariness of subjects' consent, especially when the researcher is also the patient's physician. An ongoing problem is the 'therapeutic misconception'--the belief that proposed research is a promising treatment intended to benefit the subjects. The complexity of the technical language in which consent forms are written remains a problem, though this can easily be remedied.

Communication↗
PubMed1996

Ethics and reproductive health: a principled approach.

Universal ethical principles can be used to analyse problems in reproductive health. The principle of beneficence obligates people to strive to bring about more beneficial consequences than harmful ones. The principle known as respect for persons presumes that all human beings have dignity and are worthy of respect. Showing equal respect for women as persons means recognizing their autonomy and treating them as capable decision-makers and full participants in medical decisions. A third leading concern of bioethics is justice, which requires a fair distribution of family planning methods, including access to safe abortion in cases of contraceptive failure.

Adolescent↗
PubMed1995

Ethics, informed consent, and assisted reproduction.

Informed consent to treatment is an ethical requirement often misunderstood or not fully appreciated by physicians. The purpose of obtaining informed consent is to ensure that patients know what doctors propose to do and freely grant their permission. Although the purpose of informed consent and the standards by which it is to be employed are the same in all areas of medical practice, special problems arise in assisted reproduction. Voluntary, informed consent is an instance of a reproductive right that should be recognized by the international medical community, and not limited to Western and European countries.

Bioethics↗
PubMed1995

Cloning without prior approval: a response to recent disclosures of noncompliance.

In September 1994, the Kennedy Institute of Ethics Journal published a special issue on the ethics of embryo splitting or "cloning," which included papers originally prepared for a workshop on embryo splitting sponsored by the National Advisory Board on Ethics in Reproduction (NABER) and NABER's report, Human Cloning through Embryo Splitting. The impetus for the project was embryo-splitting research conducted by Drs. Jerry L. Hall, Robert J. Stillman, and others, at George Washington University and presented in October 1993 at a joint meeting of the American Fertility Society and the Canadian Fertility and Andrology Society. Media coverage at the time reported that the research had been approved by the university's formal review committees. However, it came to light in December 1994 that the researchers had not obtained approval from the university's institutional review board prior to conducting the research. Following a university investigation, the researchers were disciplined and instructed to destroy their data. The university also voluntarily forwarded the records of the incident to the Office for Protection from Research Risks at the National Institutes of Health. Dr. Hall resigned from George Washington University in September 1994. In the following postscript to her article on the ethics of embryo splitting (KIEJ, September 1994), Ruth Macklin discusses these events. The letters and memoranda that she cites were obtained from NIH through the Freedom of Information Act.

Clone Cells↗