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Biomedical subjects

J Sugarman

Publications and source records attributed to J Sugarman.

At least 19 recordsLinked to original sources
PubMed2001

Teaching professional development in medical schools.

Doctors must increasingly be aware of what they should be, as well as what they should know. Professionalism, including a value system that supports the compassionate care of patients, is a means of encapsulating and prioritising these competing responsibilities. Accordingly, in this article, we assume that professionalism is an essential aspect of medical practice that needs to be taught to those entering medicine. We first describe critiques of professionalism and current challenges to it, in practice and in medical education. We then assess the current efforts of curriculum reform to incorporate professionalism and the methods used to teach it. Adopting and assessing such approaches to ensure that they are effective is of central importance in the education of future clinicians.

Clinical Competence↗
PubMed2001

Monitoring and ensuring safety during clinical research.

Increased numbers of clinical trials, many of which are large, multicenter, and sometimes international, and the marked shift of funding for clinical trials to industry have made apparent the inadequacy of mechanisms for protecting human subjects that were developed when clinical research was generally carried out on a small scale at single institutions. To address concerns regarding the protection of human subjects, a group of professionals with expertise in various aspects of clinical trials was assembled in May 2000. Participants described and evaluated the mechanisms by which clinical trials are monitored, focusing on adverse event reporting and the processes by which various parties with oversight responsibilities interact in the course of these trials. In this article, we describe the manner in which adverse event reporting might function to enhance safety and the role of data monitoring committees in using aggregate data from these reports, outline the problems that now exist for institutional review boards as they are faced with multiple adverse event reports from clinical trials while conducting continuing review, and offer recommendations for improving the current approach.

Clinical Trials as Topic↗
PubMed2001

Toward the ethical evaluation and use of maternal-fetal surgery.

BACKGROUND: Important clinical, social, and ethical questions are associated with the evaluation and use of surgical approaches aimed at correcting fetal anatomic abnormalities. In particular, the expansion of maternal-fetal surgery to ameliorate nonlethal fetal conditions has intensified the need to address issues about the adequacy of technology assessment and the safety of those who undergo these novel procedures. APPROACH: After discussions at a multidisciplinary conference, we reviewed the development and current practices of maternal-fetal surgery and analyzed the relevant ethical issues concerning the use of maternal-fetal surgery for nonlethal conditions, focusing on the correction of myelomeningocele. FINDINGS: Characterizing nonvalidated maternal-fetal surgery procedures as "innovative therapy" blurs the boundaries between research and therapy and creates uncertainty about the obligations of clinicians and researchers. Further, maternal-fetal surgery raises ethical issues related to maternal risks and benefits, informed consent, distinguishing lethal from nonlethal conditions, withholding unproven treatments, entrepreneurship, and prioritization. RECOMMENDATIONS: To help ensure that maternal-fetal surgery will be studied and eventually applied in a scientifically and ethically sound manner, we offer several recommendations. First, innovation in maternal-fetal surgery should be conducted and evaluated as research. Second, women must be considered research subjects in these trials. Third, the informed consent process must ensure adequate comprehension and genuine voluntariness in those considering participation. Fourth, discriminatory and fearful attitudes toward individuals with disabilities should be addressed explicitly prior to making a decision to proceed with maternal-fetal surgery in an attempt to correct such disabilities. Fifth, maternal-fetal surgery should not be performed for cosmetic indications unless and until there is reliable evidence that maternal-fetal surgery can be performed safely and that long-term side effects on women and their offspring are minimal. Sixth, centers of excellence should be established for conducting research and providing maternal-fetal surgery. Seventh, funding for research on maternal-fetal surgery should be considered in the context of societal needs.

Congenital Abnormalities↗
PubMed2001

How proxies make decisions about research for patients with Alzheimer's disease.

We examined the proxy decision-making and informed consent processes for clinical research involving 49 patient-subjects with dementia in an outpatient setting by performing serial in-depth, structured, open-ended telephone interviews. Interviews were tape recorded and transcribed. Transcripts were then coded and analyzed. Although in all cases proxy consent was obtained for research from a legally authorized representative, proxies reported considerable ambiguity regarding who made the decision to participate in research, or to what degree the decision was that of the proxy or of the patient. Reasons proxies gave for participating in research included: hope of direct or indirect benefits to the patient, caregiver, or patient's descendents; desperation; trust in the investigator; belief in the goodness of research; and altruism. These reasons varied according to the type of research. For instance, in drug trials hope of direct benefit prevailed; in studies not evaluating a potential therapy more altruistic concerns predominated. Being a proxy decision maker for research can be burdensome. The degree of burden related to making a decision to participate in research seems influenced by a number of intersecting factors, most importantly, the risk and nature of the study, the extent to which patients were able to participate in the decision, and the duration and severity of dementia. Proxy decision-making concerning participation in research for patients with dementia can be a difficult task. The process might be improved by emphasizing that proxy consent is being sought because the nature of the patient's underlying medical condition can preclude the ability to make meaningful decisions. In addition, clinical researchers should recognize that giving proxy consent might place additional burdens on caregivers and discuss this explicitly when proxy consent is solicited.

Aged↗
PubMed2001

Attitudes of maternal-fetal specialists concerning maternal-fetal surgery.

OBJECTIVE: We examined the attitudes of members of the Society for Maternal-Fetal Medicine regarding the clinical, scientific, ethical, and policy issues in maternal-fetal surgery. STUDY DESIGN: A 43-question survey was distributed to all members of the Society for Maternal-Fetal Medicine. Two mailings and one electronic mail reminder were sent, each with instructions to submit the survey either via US mail or the Internet. The survey included questions in six categories: physician demographic data, experience with maternal-fetal surgery, views on innovative therapies, scientific validation of currently used and proposed procedures, ethical issues, and future directions in public policy. RESULTS: Of the 1639 United States members sent questionnaires, 943 replied (response rate = 59%). Forty-seven percent had referred patients for open fetal surgery for nonlethal conditions, and 69% believed physicians were obligated to inform patients of this option. Seventy-eight percent believed that innovative therapies should be performed only under institutional review board-approved protocols. Although the majority of respondents believed that certain proposed benefits of open fetal surgery for myelomeningocele could offset the risks, the majority (56%) also indicated that the procedure has not been validated. Fifty-seven percent believed that a moratorium should be imposed on open fetal surgery for nonlethal conditions, such as myelomeningocele, until a multicenter-controlled clinical trial is completed. CONCLUSIONS: The use of maternal-fetal surgery for nonlethal conditions is highly controversial. The majority of maternal-fetal specialists we surveyed support further research before such procedures are integrated into clinical practice.

Adult↗
PubMed2001

So much for keeping secrets: the importance of considering patients' perspectives on maintaining confidentiality.

Little data are available from patients' perspectives regarding the maintenance of confidentiality by care providers. Such data may be useful in determining the importance of confidentiality to patients and in developing appropriate policies and procedures regarding confidentiality. Three focus groups were conducted with support groups of rural HIV-positive patients. Text was coded inductively and analyzed with software designed for qualitative analysis. Participants perceived breaches of confidentiality in hospitals, clinics and health departments that occurred by word of mouth, computers, facsimile and written materials. Patients included sharing stigmatizing medical information among medical providers without prior consent as a breach. They made decisions about where to seek care based on the degree of professionalism of medical staff (which included respecting confidentiality), clinic location or the level of security of the organization's computer network since they believed that computers increase information access. Finally, participants believed that medical personnel should be taught the importance of maintaining confidentiality and that those who violated confidentiality should be punished. Patients would like confidentiality policies that require providers to: (1) explain procedures for sharing information, (2) request patients' specific consent for access to their medical records, even among other providers, and (3) punish those who breach confidentiality.

Attitude↗
PubMed2001

Variability among institutional review boards' decisions within the context of a multicenter trial.

BACKGROUND: Institutional review boards (IRBs) are given discretion to interpret and apply the federal regulations governing the protection of human subjects in research. OBJECTIVE: To determine the extent of the variability among different IRBs on their approved research practices and informed consent forms within the context of a multicenter trial that used a common protocol. DESIGN: Descriptive analysis of survey information and informed consent forms. SETTING AND PARTICIPANTS: Sixteen IRBs from the institutions participating in a multicenter trial comparing lower vs. traditional tidal volume ventilation in patients with acute lung injury. MEASUREMENTS: Analysis of survey information on IRBs' approved research practices. Analysis of informed consent forms for the presence and the adequacy of description of each basic element of informed consent specified in the federal regulations. Reading levels of informed consent forms. MAIN RESULTS: Surveys and IRB-approved consent forms were obtained from all of the contacted IRBs (n = 16). Variability was observed among several of the research practices; one IRB waived the requirement for informed consent, five IRBs permitted telephone consent, and three IRBs allowed prisoners to be enrolled. Three consent forms contained all of the basic elements of informed consent outlined in the federal regulations, and 13 forms had varying numbers of these elements absent (six forms without one element, four without two, one without three, and two without four). Reading levels of the consent forms ranged from grades 8.2 to 13.4 (mean +/- sd was 11.6 +/- 1.2 grade level). CONCLUSIONS: Within a multicenter trial, IRBs reviewing a common protocol varied in several of their approved research practices and in the extent to which the basic elements of informed consent were included in their consent forms.

Clinical Protocols↗
PubMed2000

Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications.

Quality improvement initiatives have become a major force in shaping health care. These initiatives are diverse but share a common goal of generating knowledge that will guide improvements in health care. Although quality improvement occupies an uncertain territory between clinical care and research, this difference is extremely important. If a quality improvement initiative is research, federal regulations require a variety of procedures that must be followed to protect the human subjects involved. Conversely, if the same initiative is not research, the regulations outlining these procedures are not applicable. This article proposes 2 criteria to determine whether a quality improvement initiative should be reviewed as research. Such an initiative should be reviewed and regulated as research if (1) the majority of patients involved are not expected to benefit directly from the knowledge to be gained or (2) if additional risks or burdens are imposed to make the results generalizable. Implementation of these criteria offers the possibility that the rights and interests of those who participate in quality improvement initiatives will be protected.

Ethical Review↗
PubMed2000

The role of institutional support in protecting human research subjects.

Institutional review boards (IRBs) and the federal "assurance" procedures play critical roles in the current research and regulatory environments for clinical research in academic medical centers and other institutions. The author focuses on what institutions can and ought to do to create an infrastructure that assures the protection of human subjects. Specifically, an institution should (1) create an ethics infrastructure in which both IRBs and the function of protecting human subjects are respected; (2) assure that adequate resources (space, staff, equipment) are available; (3) support IRB members with appropriate recognition and time, since their IRB workloads can be heavy; and (4) provide adequate and appropriate education for IRB administrators, members, and staff, and for investigators and research staff. Academic medical centers should also use their expertise in analyzing the current system and developing means of improving it. Nevertheless, providing adequate resources for proper research conduct will be challenging, given the current financial limitations within academic medical centers.

Academic Medical Centers↗