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Biomedical subjects

L H Glantz

Publications and source records attributed to L H Glantz.

At least 19 recordsLinked to original sources
PubMed2000

Pregnancy and informed consent to research.

Federal regulations governing research with human subjects have limited a pregnant woman's authority to decide to participate in research since 1975 by requiring the consent of the fetus's father. Recognition of pregnant women's legal rights has increased since then, in particular, their right to be treated no differently from other adults. In 1998 the Department of Health and Human Services proposed amendments to these regulations that recognize women as the sole decision makers in this area and eliminate requirements for paternal consent. These regulations have not been adopted, however.

Adult↗
PubMed1996

Conducting research with children: legal and ethical issues.

Research with children and mentally disabled individuals raises difficult legal and ethical issues. It is the obligation of researchers and those who review research to protect both the rights and welfare of research subjects. Ethicists, legal scholars, and national commissions have examined the circumstances under which it is acceptable to use incompetent people as research subjects, since they are unable to provide consent for participation. Furthermore, there is an extensive set of federal rules that govern the use of children as research subjects. Children may be used as research subjects after a careful weighing of risks and benefits, and as long as they participate in the decision to the extent they are able to do so. However, research projects that will not provide children with direct benefit, such as some placebo-controlled trials, raise particularly difficult issues concerning the protection of these subjects. While biomedical research is an important and socially desirable undertaking, it must proceed only when the rights and welfare of the subjects are scrupulously protected.

Adolescent↗
PubMed1994

Physician assessment of patient competence.

OBJECTIVE: To determine if physicians know and can apply the legal standard for determining competence; to determine if physician assessment of competence varies by physician age or specialty. DESIGN: Mail survey with specific questions about a patient scenario and general questions about the law. PARTICIPANTS: 2100 randomly selected Massachusetts internists, surgeons, and psychiatrists. MEASUREMENTS: In Part I, the survey presented a scenario adapted from a court case that involved an elderly woman's refusing lifesaving surgery. The scenario was divided into three sections: the medical history, the patient's rationale, and a psychiatrist's opinion that the patient was incompetent. Respondents were not told that an appellate court later decided the psychiatrist applied the wrong standard of competence and the patient was indeed competent. Respondents were asked whether the patient was competent, whom they would consult, and how they would respond. Part II posed a series of theoretical questions about competence. Group differences were tested by chi-square. MAIN RESULTS: Surveys were returned by 823 (41%) of the sample. In Part I, before the psychiatrist's opinion, 58% thought the patient was competent, 92% would consult a psychiatrist to help assess competence, and only 17% would to go to court. After the psychiatrist's opinion, only 30% thought she was competent and 55% would go to court. In Part II, 89% knew the correct standard for competence; however, most incorrectly responded that conditions such as dementia and psychosis establish incompetence. Psychiatrists performed significantly better on theoretical, but frequently worse on scenario, questions. CONCLUSIONS: Physicians in general, and psychiatrists in particular, know the standard for competence but may apply it incorrectly. This suggests that the common clinical practice of relying on expert medical opinion may introduce bias and produce inaccurate results that undermine patient autonomy.

Age Factors↗
PubMed1992

Risky business: setting public health policy for HIV-infected health care professionals.

An analysis of the restrictive proposals provoked by the case of Kimberly Bergalis and four other patients apparently infected with HIV during the course of dental treatment reveals that they resulted from an inability to evaluate appropriately the infinitesimal risk of HIV transmission from practitioner to patient. The proposals also resulted from an effort to create risk prevention policy without appreciating the distinction between regulating things or procedures, which have no human rights, and regulating people, who have rights that should not be infringed without serious justification. This analysis demonstrates that the proposed restrictive policies are not justified because they do nothing to prevent the spread of HIV, and they cause unnecessary and substantial harm to health care practitioners.

American Medical Association↗