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Biomedical subjects

Jeffrey Kahn

Publications and source records attributed to Jeffrey Kahn.

17 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↗
PubMed2005

Informed consent in the context of communities.

This article discusses the history of institutional review boards and the change from a focus on protection of subjects from harm from research to a concern for equitable access to research protocols and potential benefits from participating in a study. The concern about an overemphasis on potential benefits to the detriment of individual subjects is discussed. Finally, the distinction between protection of individuals as it is separate from communities, issues that are raised about obtaining informed consent in communities, as well as the need for trust among researchers, individuals, and communities is examined.

Biomedical Research↗
PubMed2004

Live donor liver transplantation without blood products: strategies developed for Jehovah's Witnesses offer broad application.

OBJECTIVE: Developing strategies for transfusion-free live donor liver transplantation in Jehovah's Witness patients. SUMMARY BACKGROUND DATA: Liver transplantation is the standard of care for patients with end-stage liver disease. A disproportionate increase in transplant candidates and an allocation policy restructuring, favoring patients with advanced disease, have led to longer waiting time and increased medical acuity for transplant recipients. Consequently, Jehovah's Witness patients, who refuse blood product transfusion, are usually excluded from liver transplantation. We combined blood augmentation and conservation practices with live donor liver transplantation (LDLT) to accomplish successful LDLT in Jehovah's Witness patients without blood products. Our algorithm provides broad possibilities for blood conservation for all surgical patients. METHODS: From September 1998 until June 2001, 38 LDLTs were performed at Keck USC School of Medicine: 8 in Jehovah's Witness patients (transfusion-free group) and 30 in non-Jehovah's Witness patients (transfusion-eligible group). All transfusion-free patients underwent preoperative blood augmentation with erythropoietin, intraoperative cell salvage, and acute normovolemic hemodilution. These techniques were used in only 7%, 80%, and 10%, respectively, in transfusion-eligible patients. Perioperative clinical data and outcomes were retrospectively reviewed. Data from both groups were statistically analyzed. RESULTS: Preoperative liver disease severity was similar in both groups; however, transfusion-free patients had significantly higher hematocrit levels following erythropoietin augmentation. Operative time, blood loss, and postoperative hematocrits were similar in both groups. No blood products were used in transfusion-free patients while 80% of transfusion-eligible patients received a median of 4.5+/- 3.5 units of packed red cell. ICU and total hospital stay were similar in both groups. The survival rate was 100% in transfusion-free patients and 90% in transfusion-eligible patients. CONCLUSIONS: Timely LDLT can be done successfully without blood product transfusion in selected patients. Preoperative preparation, intraoperative cell salvage, and acute normovolemic hemodilution are essential. These techniques may be widely applied to all patients for several surgical procedures. Chronic blood product shortages, as well as the known and unknown risk of blood products, should serve as the driving force for development of transfusion-free technology.

Blood Transfusion↗
PubMed2004

Twenty-two nondirected kidney donors: an update on a single center's experience.

At the University of Minnesota, we have defined 'nondirected donation' as organ donation by a volunteer who offered to donate an organ to anyone on the cadaver waiting list. From October 1, 1997, through October 31, 2003, we have had 360 inquiries about nondirected donation, have completed 42 detailed nondirected donor (NDD) evaluations for kidney donation, and have performed 22 NDD transplants. We herein review our program policies and how they have evolved, describe our evaluation and the motivation of our potential donors, summarize the outcome of NDD transplants, and raise issues requiring further attention and study. Our experience continues to support nondirected donation for kidney transplants.

Academic Medical Centers↗
PubMed2003

Evolution of a nondirected kidney donor program: lessons learned.

From October 1, 1997 through November 30, 2003, the University of Minnesota received 362 inquiries from potential NDDs. Of these, 53 (15%) then underwent partial or full donor evaluation at our transplant center. Of these 53 potential NDDs, 24 have been accepted (23 donated, and one donation is pending), 23 were denied (15 for medical reasons, 8 for psychosocial reasons), and 6 chose not to pursue donation. Most of our potential NDDs were motivated by altruistic reasons. Their decision-making process was not impulsive or instantaneous, but rather rational and deliberate. They were self-educated about donation before contacting our transplant center. After donation, all 23 of our NDDs said they were glad they donated and were grateful for the opportunity to help another. Many desired to become involved in the transplant community by promoting donation. All NDDs who heard from their recipient appreciated the contact and the chance to learn how the recipient was doing posttransplant. An NDD program clearly mandates a dedicated donor team and additional time and resources, given the high number of inherent practical, logistical, and ethical issues. Our protocol has been a work in progress and continues to evolve with our ever-growing experience. Transplant centers interested in using NDDs must develop NDD protocols to address specific issues and must examine their available staffing and resources.

Academic Medical Centers↗
PubMed2002

Financial incentives for cadaver organ donation: an ethical reappraisal.

A panel of ethicists, organ procurement organization executives, physicians, and surgeons was convened by the sponsorship of the American Society of Transplant Surgeons to determine whether an ethically acceptable pilot trial could be proposed to provide a financial incentive for a family to consent to the donation of organs from a deceased relative. An ethical methodology was developed that could be applied to any proposal for monetary compensation to elucidate its ethical acceptability. An inverse relationship between financial incentives for increasing the families' consent for cadaver donation that clearly would be ethically acceptable (e.g., a contribution to a charity chosen by the family or a reimbursement for funeral expenses) and those approaches that would more likely increase the rate of donation (e.g., direct payment or tax incentive) was evident. The panel was unanimously opposed to the exchange of money for cadaver donor organs because either a direct payment or tax incentive would violate the ideal standard of altruism in organ donation and unacceptably commercialize the value of human life by commodifying donated organs. However, a majority of the panel members supported reimbursement for funeral expenses or a charitable contribution as an ethically permissible approach. The panel concluded that the concept of the organ as a gift could be sustained by a funeral reimbursement or charitable contribution that conveyed the appreciation of society to the family for their donation. Depending on the amount of reimbursement provided for funeral expenses, this approach could be ethically distinguished from a direct payment, by their intrusion into the realm of altruism and voluntariness. We suggest that a pilot project be conducted to determine whether this kind of a financial incentive would be acceptable to the public and successful in increasing organ donation.

Cadaver↗
PubMed2002

Pharmacogenetics: ethical issues and policy options.

Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. Before the benefits of pharmacogenetics can be realized, the ethical issues that arise in research and clinical application of pharmacogenetic technologies must be addressed. The ethical issues raised by pharmacogenetics can be addressed under six headings: (1) regulatory oversight, (2) confidentiality and privacy, (3) informed consent, (4) availability of drugs, (5) access, and (6) clinicians' changing responsibilities in the era of pharmacogenetic medicine. We analyze each of these categories of ethical issues and provide policy approaches for addressing them.

Confidentiality↗
PubMedDate not supplied

The ethics of organ transplantation for prisoners.

Organ transplantation for prisoners raises numerous ethical issues. Questions immediately emerge about how to justify the use of scarce organs for prisoners when law-abiding citizens are waiting. The answer to whether and why we ought to perform organ transplants for prisoners lies in how we understand society's commitments to prisoners' health and health care, and whether being incarcerated changes the priority of a patient waiting for a transplant. While prisoners forfeit many freedoms, access to and the provision of adequate health care are guaranteed to them, and ought to include access to organ transplants.

Humans↗
PubMedDate not supplied

Pharmacogenetic challenges for the health care system.

Pharmacogenetics--the effect of genotype on drug response--holds the promise of safer and more effective drug therapy. Genetic tests would be routinely given to patients prior to prescription of a drug, with therapeutic decisions based on the patient's drug-response profile. This paper examines the operational changes and the ethical, legal, and policy challenges that pharmacogenetic medicine poses for key actors in the health care system. Adaptation by drug companies, regulatory agencies, physicians, patients, insurers, and public funding agencies will be necessary to integrate pharmacogenetic medicine into health care.

Delivery of Health Care↗