Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: providing transparency; allowing control and authorization; promoting concordance with participants' values; and protecting and promoting welfare interests. Three other functions are systemic or policy focused: promoting trust; satisfying regulatory requirements; and promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)
Highlights of this edition include: / Important new material addressing federal privacy regulations, disclosure of medical errors, limits on residents'...
We wholeheartedly agree with Schmidt and colleagues’ efforts to promote equity in intensive care unit triage. We also take issue with their characterisation of the New Jersey allocation framework for ICU beds and ventilators, which is modelled after the multi-principle allocation framework we developed early in the pandemic. They characterise it as a two-criterion allocation framework and claim—without evidence—that it will ‘compound disadvantage for black patients’. However, the NJ triage framework—like the model allocation policy we developed—actually contains four allocation criteria: (...) the two criteria that the authors mentioned and two criteria that they failed to mention which we included to promote equity: giving priority to frontline essential workers and giving priority to younger patients. These omissions are problematic both for reasons of factual accuracy and because the two criteria they failed to acknowledge would likely mitigate rather than exacerbate racial disparities during triage. (shrink)
When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or reliable results for minorities and other disadvantaged groups.
Stricter policies regarding conflicts of interest policies will increase transparency but have limitations and unintended adverse consequences. Physicians and the medical profession should take the lead in developing policies, rather than responding to external regulations. The goal is to reduce significant risks of undue influence, while keeping the burdens and opportunity costs of policies acceptable.
Financial relationships between physicians and industry are widespread. Highly publicized financial relationships between physicians and industry raised disturbing questions about the trustworthiness of clinical research, practice guidelines, and clinical care decisions. Recent incidents spurred calls for stricter conflict of interest policies and led to new federal laws and NIH regulations. These stricter policies have evoked praise, concerns, and objections. Because these new federal requirements need to be interpreted and implemented, spirited discussions of conflicts of interest in medicine will continue.
Web 2.0 innovations may enhance informed patient decision-making, but also raise ethical concerns about inaccurate or misleading information, damage to the doctor-patient relationship, privacy and confidentiality, and health disparities. To increase the benefits and decrease the risks of these innovations, we recommend steps to help patients assess the quality of health information on the Internet; promote constructive doctor-patient communication about new information technologies; and set standards for privacy and data security in patient-controlled health records and for point-of-service advertising.
Stem cells derived from pluripotent cells offer the hope of new treatments for diseases for which current therapy is inadequate. Clinical trials are essential in developing effective and safe stem cell therapies and fulfilling this promise. However, such clinical trials raise ethical issues that are more complex than those raised in clinical trials using drugs, cord blood stem cells, or adult stem cells. Several clinical trials are now being carried out with stem cells derived from pluripotent cells, and many more (...) can be expected in light of the rapid scientific progress in the field.Degenerative neurological diseases are desirable targets for stem cell clinical trials. The FDA has approved Phase 1 clinical trials of neural stem cell transplantation for Batten Disease, Pelizaeus-Merzbacher Disease, and spinal cord injury. In Parkinson Disease, stem cell transplantation could correct the primary pathophysiological defect — inadequate levels of the neurotransmitter dopamine. Current treatment is unsatisfactory in late-stage PD. (shrink)
Clinical trials of stem cell transplantation raise ethical issues that are intertwined with scientific and design issues, including choice of control group and intervention, background interventions, endpoints, and selection of subjects. We recommend that the review and IRB oversight of stem cell clinical trials should be strengthened. Scientific and ethics review should be integrated in order to better assess risks and potential benefits. Informed consent should be enhanced by assuring that participants comprehend key aspects of the trial. For the trial (...) to yield generalizable knowledge, negative findings and serious adverse events must be reported. (shrink)
We appreciate the opportunity to respond to Schneiderman and colleagues’ opinions on the recent Multiorganization Policy Statement, “An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to Requests for Potentially Inappropriate Treatments in Intensive Care Units”. We will first point out three areas in which Schneiderman and colleagues seem to perceive a disagreement where there is none, then we will respond to their main criticisms of the Multiorganization Policy Statement. In doing so, we will point out areas in which we believe Schneiderman and (...) colleagues have either misunderstood or misrepresented the statement. First, we agree with Schneiderman and... (shrink)
Physicians and patients rely on medical journals as trusted sources of medical information. Unfortunately, in multiple instances conflicts of interest have undermined the credibility of the medical literature.The primary sources of conflict of interest at medical journals are authors, reviewers, editors, and journals. Consider these examples.
Physicians and patients rely on medical journals as trusted sources of medical information. Unfortunately, conflicts of interest may undermine the credibility of the medical literature. Improved policies and practices at journals should address the conflicts of interest of authors, reviewers, editors, and journals. Medical journals should manage and eliminate conflicts, not just improve the disclosure of financial relationships.
Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission. However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are infected (...) perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves. (shrink)
Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission. However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are infected (...) perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves. (shrink)
Adequate treatment of pain is essential to alleviate suffering, yet studies show that patients with terminal or serious illness receive inadequate pain relief. In the case of terminally ill patients, adequate palliation of pain may be likely to reduce requests for physician-assisted suicide. This issue of the journal addresses barriers to effective pain relief and suggests how treatment of pain can be improved. The symposium features the Pain Relief Act, which is designed to provide practitioners who prescribe controlled substances for (...) pain with protection from inappropriate legal sanctions. The Act is the product of the Project on Legal Constraints on Access to Effective Pain Relief, whose principal investigators were Nancy Neveloff Dubler, LL.B., Sandra H. Johnson, J.D., LL.M., Robert J. Levine, M.D., and Benjamin W. Moulton, J.D., M.P.H.The Project was supported by the Mayday Fund and the Emily Davie and Joseph S. Kornfeld Foundation. (shrink)
Adequate treatment of pain is essential to alleviate suffering, yet studies show that patients with terminal or serious illness receive inadequate pain relief. In the case of terminally ill patients, adequate palliation of pain may be likely to reduce requests for physician-assisted suicide. This issue of the journal addresses barriers to effective pain relief and suggests how treatment of pain can be improved. The symposium features the Pain Relief Act, which is designed to provide practitioners who prescribe controlled substances for (...) pain with protection from inappropriate legal sanctions. The Act is the product of the Project on Legal Constraints on Access to Effective Pain Relief, whose principal investigators were Nancy Neveloff Dubler, LL.B., Sandra H. Johnson, J.D., LL.M., Robert J. Levine, M.D., and Benjamin W. Moulton, J.D., M.P.H.The Project was supported by the Mayday Fund and the Emily Davie and Joseph S. Kornfeld Foundation. (shrink)
“[A] murder prosecution is a poor way to design an ethical and moral code for doctors,” observed the California Court of Appeal in 1983. Yet, physicians who have chosen to help terminally ill patients to commit suicide have trespassed on illegal ground. When skilled medical care fails to relieve the pain of terminally ill patients, some people believe that physicians may assist in these suicides. Others reject any kind of physician involvement. The debate on assisted suiczide and active euthanasia has (...) focused on whether these acts can ever be acceptable. We propose to shift the debate to a less divisive issue: whether a caring physician who provides a suffering and ill patient with a prescription for a lethal dose of medication should be prosecuted as a felon. Even assisted suicide's opponents may object to such criminal prosecution. We propose to modify existing criminal laws to give physicians who assist their terminally ill patients in suicide, under carefully defined circumstances, a legal defense against criminal charges. (shrink)
Last month, a fifty-eight-year old man developed bleeding into his cheek and oozing from sites where previously he had had blood samples drawn. This bleeding was caused by disseminated intravascular coagulation, a complication of colon cancer that had spread to his liver and lungs. This complication occurred even though he was on chemotherapy for the cancer. In the hospital, he received transfusions and was administered medicine to stop the bleeding. However, his condition did not improve. He developed more bruises. When (...) he tried to go to the bathroom without assistance, he fell, struck his head, requiring stitches, and developed a black, swollen eye. The patient, a successful businessman, had already overcome another type of cancer—lymphoma—through chemotherapy, twenty-five years ago. In a few days, this dynamic individual who expected to start experimental chemotherapy now saw his quality of life deteriorate steadily.We talked about more chemotherapy, about hospice, and about withholding attempts at resuscitation if his heart should stop. (shrink)
Last month, a fifty-eight-year old man developed bleeding into his cheek and oozing from sites where previously he had had blood samples drawn. This bleeding was caused by disseminated intravascular coagulation, a complication of colon cancer that had spread to his liver and lungs. This complication occurred even though he was on chemotherapy for the cancer. In the hospital, he received transfusions and was administered medicine to stop the bleeding. However, his condition did not improve. He developed more bruises. When (...) he tried to go to the bathroom without assistance, he fell, struck his head, requiring stitches, and developed a black, swollen eye. The patient, a successful businessman, had already overcome another type of cancer—lymphoma—through chemotherapy, twenty-five years ago. In a few days, this dynamic individual who expected to start experimental chemotherapy now saw his quality of life deteriorate steadily.We talked about more chemotherapy, about hospice, and about withholding attempts at resuscitation if his heart should stop. (shrink)
“[A] murder prosecution is a poor way to design an ethical and moral code for doctors,” observed the California Court of Appeal in 1983. Yet, physicians who have chosen to help terminally ill patients to commit suicide have trespassed on illegal ground. When skilled medical care fails to relieve the pain of terminally ill patients, some people believe that physicians may assist in these suicides. Others reject any kind of physician involvement. The debate on assisted suiczide and active euthanasia has (...) focused on whether these acts can ever be acceptable. We propose to shift the debate to a less divisive issue: whether a caring physician who provides a suffering and ill patient with a prescription for a lethal dose of medication should be prosecuted as a felon. Even assisted suicide's opponents may object to such criminal prosecution. We propose to modify existing criminal laws to give physicians who assist their terminally ill patients in suicide, under carefully defined circumstances, a legal defense against criminal charges. (shrink)
