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Jeremy Sugarman

Publications and source records attributed to Jeremy Sugarman.

At least 19 recordsLinked to original sources
PubMed2007

Educational approaches to the responsible conduct of clinical research: an exploratory study.

PURPOSE: To identify best practices in education related to the responsible conduct of clinical research (RCCR). METHOD: American Society for Bioethics and Humanities (ASBH) members involved with teaching RCCR were asked to complete an online survey, followed by an in-depth telephone interview. The online survey asked about respondents' RCCR teaching, trainees, and institutional context. The phone interview involved discussions about teaching strategies, institutional context, and needs. The study was conducted between 2003 and 2005. RESULTS: Forty-eight respondents to the online survey indicated a breadth of topics being covered in RCCR curricula; 35 respondents indicated that their RCCR teaching applied toward institutional RCCR requirements. Among the 21 instructors interviewed, many described a wide variety of teaching responsibilities. Recommended teaching strategies included fostering interactive discussion, using skills-based exercises such as designing IRB applications, accommodating students' individual interests in curriculum design, involving experienced researchers, involving trainees early in their careers as well as requiring continuing education, and designing a curriculum with a clear view of educational objectives. Interviewees described the institutional supports they needed, and they noted that insufficient support sometimes undermines RCCR teaching goals. Participants generally agreed that RCCR education should be required. CONCLUSIONS: Strong agreement among participants concerning recommended strategies for teaching RCCR provides useful, if provisional, guidance to instructors and institutions charged with providing such training. The study suggests a need for substantial investments in RCCR training, studying outcomes, and developing mechanisms to ensure the quality of instruction.

Attitude↗
PubMed2006

Risk in drug trials.

Explore the source record for details and available documents.

Antibodies, Monoclonal↗
PubMed2006

Formative research in clinical trial development: attitudes of patients with arthritis in enhancing prevention trials.

In preparation for randomised controlled trials (RCTs) of disease-modifying antirheumatic drugs in patients with early inflammatory arthritis (EIA), formative research was conducted to enhance the design of such trials. The objectives of this research were to (1) determine patients' educational needs as they relate to the necessary elements of informed consent; and (2) assess patients' interest in enrolling in a hypothetical prevention trial. In-depth interviews were conducted with nine patients. Seven patients were women and all but one white. The mean age was 48 years. During the 4-month enrolment period, only three patients with EIA were identified; six patients with longer duration of symptoms were also interviewed. Most patients were able to express the primary aim of a hypothetical prevention trial presented. Factors cited by patients favouring enrolment were potential for direct medical benefit and knowledge that they would be withdrawn from the trial if they developed symptoms. Factors cited by patients against enrolment were the inclusion of a placebo and general uncertainty regarding treatment required by the RCT design. Pending larger-scale empirical projects to explore patients' attitudes about prevention trials, small-scale formative research in advance of such trials ought to be conducted.

Adult↗
PubMed2006

Factors that affect infertility patients' decisions about disposition of frozen embryos.

OBJECTIVE: To describe factors that affect infertility patients' decision making regarding their cryopreserved embryos. DESIGN: Forty-six semistructured in-depth interviews of individuals and couples participating in IVF programs. SETTING: Two major southeastern academic medical centers. PATIENT(S): Fifty-three individuals, including 31 women, 8 men, and 7 couples. MAIN OUTCOME MEASURE(S): Qualitative analysis of interview transcripts. INTERVENTION (S): None. RESULT(S): Seven broad themes informed participants' decisions about embryo disposition: family and personal issues, trust, definition of the embryo, prospective responsibility to the embryo, responsibility to society, adequacy of information, and lack of acceptable disposition options. Many wished for alternative options, such as a ceremony at the time of disposal or placement of embryos in the woman's body when pregnancy was unlikely. CONCLUSION(S): Recent debates regarding embryo disposition do not reflect the range of values that infertility patients consider when deciding about frozen embryos. In addition to questions about the embryo's moral status, decision making about embryos is informed by a range of factors in the lives of individuals who created them. These perspectives may have important implications for the content and timing of informed consent, facilitating embryo disposition, and advancing policy debates about the ethics of frozen embryo use.

Adult↗
PubMed2006

Ethical issues in evidence-based surgery.

Evidence-based medicine, although ostensibly concerned with the research evidence underlying claims of efficacy for surgical procedures,has a direct connection with the ethics of surgical decision making. Questions of whether new procedures should ever be performed on patients outside of a formal research protocol, what the patient should be told about the uncertainties inherent in the use of nonvalidated innovative procedures, when formal evaluation is necessary, what form that evaluation should take, and how the burdens and results of such research can be distributed fairly all involve balancing competing ethical principles. Good ethics requires good facts, and evidence from well-controlled experiments provides best information upon which to base decisions in these areas and to build ethical surgical practice.

Clinical Trials as Topic↗
PubMed2006

Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.

PURPOSE: To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure. METHOD: The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure. RESULTS: Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant. CONCLUSIONS: Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.

Academic Medical Centers↗
PubMed2006

Variability in the costs of institutional review board oversight.

BACKGROUND: Previous studies have shown wide differences between institutions in economies of scale with regard to the costs of institutional review board (IRB) oversight of research. In this study, the authors explored variability among IRB costs, taking into account organizational size, components of the costs of oversight, and protocol type. METHOD: The authors conducted a survey of academic medical centers to collect information on resource utilization associated with IRB oversight in 2002. They used national cost weights to assign a cost to each type of resource used, and summed weighted resource utilization for IRB costs. Descriptive statistics were generated for costs over all, tertile of protocol volume, cost component, and type of review. They also determined where the greatest cost variability is found. RESULTS: IRB costs per protocol reviewed are highly variable both overall and within tertiles of volume. Higher-volume institutions have lower costs, which is indicative of economies of scale. However, not all components of IRB costs (e.g., board time) are subject to economies of scale. Expedited reviews of protocols are not less expensive at low-volume institutions. CONCLUSIONS: IRB costs for oversight are highly variable, and only some of the variation may be attributable to economies of scale. Given such wide variation in costs, the authors conclude that some institutions are conducting reviews in a manner that is inefficient or of low quality. Future work is needed to determine specific practices in reviews, and what leads to the best quality and most efficient oversight and review system.

Biomedical Research↗
PubMed2006

Measuring trust in medical researchers.

BACKGROUND: Concern is widespread that the public's and participants' trust in medical research is threatened, but few empirical measures of research trust exist. This project aims to enable more rigorous study of researcher trust by developing and testing appropriate survey measures. METHODS: Survey items were developed based on a conceptual model of the primary domains of researcher trust (safety, fidelity, honesty, global trust). Pilot testing was conducted on a regional convenience sample of adults (n = 124). Exploratory factor analyses of the data were performed, and an item selection procedure reduced the number of survey questions. A final set of 12 items was validated, and a 4-item short version of the researcher trust scale was selected and tested in a national web-based survey of asthma and diabetes patients (n = 3623). Further factor analysis and validation were performed on this larger sample. RESULTS: Both the full and short scales have a single-factor structure with acceptable internal reliability (alphas of 0.87 [12 items] and 0.72 [4 items]). Trust in physician researchers and trust in medical researchers generally were found not to be separate constructs. In the national sample, the short scale was positively associated with better health status, prior participation in medical research, and willingness to participate in a hypothetical medical research study, and negatively associated with African-American race and higher education. CONCLUSIONS: Trust in medical researchers is a measurable single-factor construct including trust in safety, researcher fidelity, and honesty. This new scale provides an empirical tool for informing the ethics and public policy of medical research.

Adult↗
PubMed2006

Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure.

BACKGROUND: There is little guidance regarding how to disclose researchers' financial interests to potential research participants. OBJECTIVE: To determine what potential research participants want to know about financial interests, their capacity to understand disclosed information and its implications, and the reactions of potential research participants to a proposed disclosure statement. DESIGN AND PARTICIPANTS: Sixteen focus groups in 3 cities, including 6 groups of healthy adults, 6 groups of adults with mild chronic illness, 1 group of parents of healthy children, 1 group of parents of children with leukemia or brain tumor, 1 group of adults with heart failure, and 1 group of adults with cancer. APPROACH: Focus group discussions covered a range of topics including financial relationships in clinical research, whether people should be told about them, and how they should be told. Audio-recordings of focus groups were transcribed, verified, and coded for analysis. RESULTS: Participants wanted to know about financial interests, whether or not those interests would affect their participation. However, they varied in their desire and ability to understand the nature and implications of financial interests. Whether disclosure was deemed important depended upon the risk of the research. Trust in clinicians was also related to views regarding disclosure. If given the opportunity to ask questions during the consent process, some participants would not have known what to ask; however, after the focus group sessions, participants could identify information they would want to know. CONCLUSIONS: Financial interests are important to potential research participants, but obstacles to effective disclosure exist.

Adolescent↗
PubMed2006

Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators.

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.

Attitude of Health Personnel↗
PubMed2006

The inescapable relevance of bioethics for the practicing clinician.

KEY POINTS: 1. Historically, medical ethics focused on the proper conduct of physicians as members of a profession. 2. Bioethics has emerged as a distinct field over the past several decades and has a broader scope than traditional medical ethics. The field of bioethics includes research ethics, public health ethics, organizational ethics, and clinical ethics. 3. Several factors contributed to the emergence of bioethics, helping to shape it, including the following: abuses of human subjects in research; advances in medical therapeutics and medical technology; and complex societal changes. 4. Principlism is an important approach to ethics, and in bioethics it includes the following core principles: respect for autonomy; beneficence; nonmaleficence; and justice. 5. Clinical ethics is a major part of bioethics and is concerned with ethical issues encountered in the care of patients. 6. Clinicians should recognize that every interaction between a doctor and a patient has a moral component, and that competency in bioethics is required to competently practice medicine. 7. Deficiencies exist in bioethics knowledge and performance among practicing clinicians and trainees; therefore, bioethics education is needed for learners at all levels (i.e., medical students, trainees, and practicing clinicians). 8. Bioethics is a dynamic, multidisciplinary field with several dedicated journals, a national organization, and numerous centers and institutes. 9. Important scholarly work in bioethics, both empirical and conceptual, is being conducted and disseminated, providing important information for practicing clinicians.

Bioethical Issues↗
PubMed2005

Ethical goals of community consultation in research.

In response to the traditional emphasis on the rights, interests, and well-being of individual research subjects, there has been growing attention focused on the importance of involving communities in research development and approval. Community consultation is a particularly common method of involving communities. However, the fundamental ethical goals of community consultation have not been delineated, which makes it difficult for investigators, sponsors, and institutional review boards to design and evaluate consultation efforts. Community consultation must be tailored to the communities in which it is conducted, but the purposes of consultation-the ethical goals it is designed to achieve-should be universal. We propose 4 ethical goals that give investigators, sponsors, institutional review boards, and communities a framework for evaluating community consultation processes.

Community Participation↗
PubMed2005

The importance of cultural considerations in the promotion of ethical research with human biologic material.

Although ethical consideration has been given to a wide variety of issues that arise in the collection and storage of human biologic material for research, little attention has been focused on the ethical implications of the diverse cultural meanings often associated with these materials. We explore the rich social meanings of the placenta across cultures and contrast these meanings with the assumption that the placenta is typically considered waste tissue that may find value in biomedical research. We suggest that the incorporation of sensitivity to the cultural meanings people give human biologic material and the use of empirical research, where necessary, to delineate these meanings should enhance the ability to craft and conduct ethically appropriate research.

Cross-Cultural Comparison↗
PubMed2005

Untying the Gordian knot: policies, practices, and ethical issues related to banking of umbilical cord blood.

Since the first successful transplantation of umbilical cord blood in 1988, cord blood has become an important source of hematopoietic stem and progenitor cells for the treatment of blood and genetic disorders. Significant progress has been accompanied by challenges for scientists, ethicists, and health policy makers. With the recent recognition of the need for a national system for the collection, banking, distribution, and use of cord blood and the increasing focus on cord blood as an alternative to embryos as a source of tissue for regenerative medicine, cord blood has garnered significant attention. We review the development of cord blood banking and transplantation and then discuss the scientific and ethical issues influencing both established and investigational practices surrounding cord blood collection, banking, and use.

Blood Banks↗
PubMed2005

Evaluating the quality of informed consent.

CONTEXT: Although informed consent is a critical means of protecting the rights and interests of participants in clinical research, effective and efficient means of evaluating the quality of consent are needed. Having such means will be important to monitoring consent and testing potential improvements in the consent process. OBJECTIVE: To develop and test a practical and general means of evaluating the quality of informed consent for clinical research. Methods We developed and tested the Brief Informed Consent Evaluation Protocol (BICEP), a short telephone-based assessment of informed consent. As soon as patient-participants completed the informed consent process for a participating VA Cooperative Studies Program clinical trial they called an interviewer who administered the BICEP. RESULTS: 632 participants completed BICEP, representing eight ongoing studies from 14 VA and one non-VA medical centers across the country. Site coordinators reported little to no difficulty implementing BICEP. The average duration of BICEP was 8.8 minutes (SD 3.6). Overall, patient-participants evaluated the informed consent process positively. A reliable coding system was then developed to analyze the verbatim responses of the final 191 participants. An Informed Consent Aggregate Score (ICAS) had a mean score of 8.23 (SD 1.17) with a range of 0-10, with 10 a perfect score; and a Therapeutic Misconception Aggregate Score (TMAS) had a mean of 1.62 (SD 0.93) with a range of 0-5, with 5 a perfect score. CONCLUSIONS: The BICEP is an efficient means of evaluating informed consent that is acceptable to research participants and research personnel. While participants tend to be satisfied with the informed consent process, the BICEP indicates there is room for improvement in the informed consent process for research.

Consent Forms↗
PubMed2004

Ethical issues in identifying and recruiting participants for familial genetic research.

Family-based research is essential to understanding the genetic and environmental etiology of human disease. The success of family-based research often depends on investigators' ability to identify, recruit, and achieve a high participation rate among eligible family members. However, recruitment of family members raises ethical concerns due to the tension between protecting participants' privacy and promoting research quality, and guidelines for these activities are not well established. The Cancer Genetics Network Bioethics Committee assembled a multidisciplinary group to explore the scientific and ethical issues that arise in the process of family-based recruitment. The group used a literature review as well as expert opinion to develop recommendations about appropriate approaches to identifying, contacting, and recruiting family members. We conclude that there is no single correct approach, but recommend a balanced approach that takes into account the nature of the particular study as well as its recruitment goals. Recruitment of family members should be viewed as part of the research protocol and should require appropriate informed consent of the already-enrolled participant. Investigators should inform prospective participants why they are being contacted, how information about them was obtained, and what will happen to that information if they decide not to participate. The recruitment process should also be sensitive to the fact that some individuals from families at increased genetic risk will have no prior knowledge of their risk status. These recommendations are put forward to promote further discussion about the advantages and disadvantages of various approaches to family-based recruitment. They suggest a framework for considering alternative recruitment strategies and their implications, as well as highlight areas in need of further empirical research.

Bioethics↗