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Measuring the quality and performance of IRBs requires clarity about what IRBs are supposed to do. Although many agree that IRBs are supposed to protect the rights and welfare of human subjects, exactly how review by an IRB contributes to protection is not always clear. Originally, ethics review was instituted as a way to check the interests, possible conflicts, and enthusiasm of investigators whose relationship to participants is different from physicians' relationship to patients. IRB performance might include evaluating how well IRBs do this.

SummaryWomen's decision-making autonomy has been poorly studied in most developing countries. The few existing studies suggest that it is closely linked to women's socio-demographic characteristics and the social settings in which they live. This study examined Nigerian women's perceived decision-making autonomy about their own health care using nationally representative data from the 2013 Nigerian Demographic and Health Survey. The study sample consisted of 27,135 women aged 15–49 years who lived with their husbands/partners. Responses to questions about who usually makes decisions about the respondent's health care were analysed. Factors associated with women's health care decision-making were investigated using logistic regression models. Only 6.2% of the women reported making their own decisions about health care. For most women (61.1%), this decision was made by their husband/partner alone and 32.7% reported joint decision-making with their husband/partner. Factors independently associated with decision-making by the woman included: geographical region, rural/urban residence, age, education, religion, wealth index, occupation, home ownership and husband's occupation. A strong association between women making their own health care decision was seen with region of residence (χ2=3221.48,p<0.0001), even after controlling for other factors. Notably, women from the South West region were 8.3 times more likely to make their own health care decisions than women from the North West region. Factors that were significantly associated with joint health care decision-making were also significantly associated with decision-making by the woman alone. The study found that individual-level factors were significantly associated with Nigerian women's decision-making autonomy, as well as other factors, in particular geographic region. The findings provide an important perspective on women's health care decision-making autonomy in a developing country.

Institutional review boards (IRBs) are integral to the U.S. system of protection of human research participants. Evaluation of IRBs, although difficult, is essential. To date, no systematic review of IRB studies has been published. We conducted a systematic review of empirical studies of U.S. IRBs to determine what is known about the function of IRBs and to identify gaps in knowledge. A structured search in PubMed identified forty-three empirical studies evaluating U.S. IRBs. Studies were included if they reported an empirical investigation of the structure, process, outcomes, effectiveness, or variation of U.S. IRBs. The authors reviewed each study to extract information about study objectives, sample and methods, study results, and conclusions. Empirical evidence collected in forty-three published studies shows that for review of a wide range of types of research, U.S. IRBs differ in their application of the federal regulations, in the time they take to review studies, and in the decisions made. Existing studies show evidence of variation in multicenter review, inconsistent or ambiguous interpretation of the federal regulations, and inefficiencies in review. Despite recognition of a need to evaluate effectiveness of IRB review, no identified published study included an evaluation of IRB effectiveness. Multiple studies evaluating the structure, process, and outcome of IRB review in the United States have documented inconsistencies and inefficiencies. Efforts should be made to address these concerns. Additional research is needed to understand how IRBs accomplish their objectives, what issues they find important, what quality IRB review is, and how effective IRBs are at protecting human research participants.

The spiraling cost of cancer care, in particular the cost of cancer therapeutics that achieve only marginal benefits, is under increasing scrutiny. Although health-care professionals avoid putting a value on a life, our limited resources require that society address what counts as a benefit, the extent to which cost should factor in deliberations, and who should be involved in these decisions. Professional societies, such as the American Society of Clinical Oncology, government agencies, including the Food and Drug Administration, and insurance companies should be involved. However, no segment of society is better qualified to address these issues than the oncology community. Oncologists must offer clear guidance for the conduct of research, interpretation of results, and prescription of chemotherapies. We review recent drug approvals and clinical trials and comment on their relevance to the issue of the spiraling cost of oncology therapeutics. We suggest some standards that would serve as a starting point for addressing these issues.

Intro -- Preface -- Acknowledgments -- Contents -- Introduction -- References -- What Are Acceptable Risks during a Pandemic? -- 1 How Have Acceptable Risks Been Defined in Other Contexts? -- 2 Defining Risks-And Acceptable Risks-In the Provision of Healthcare -- 3 How Do Nurses View and Accept Risk? -- 4 Moral Harms to Nurses -- 5 Factors of Safety: How Should we Think about and Plan for the Next Pandemic and its Risks? -- 6 Conclusion -- References -- Dying in Isolation -- 1 Palliative Care in the Context of COVID-19 -- 2 Telepalliative Care -- 3 End-of-Life Care in the Context of the Pandemic -- 4 Grief and Bereavement -- 4.1 Impact on Clinicians -- 5 Future Implications -- References -- Preparing to Make Difficult Choices: Nursing Triage Decisions and Crisis Standards of Care during COVID-19 -- 1 Introduction -- 2 Managing a Crisis and the Duty to Care -- 2.1 Drafting Crisis Standards -- 2.2 Triage Teams and Officers -- 2.3 A Modified Resuscitation Standard -- 3 The Environment of Material Scarcity -- 3.1 Personal Protective Equipment -- 4 Nurse Redeployment and Role Changes -- 5 The Spring Surge (March 2020 to June 2020) -- 5.1 Elective Procedure Cancellation and Impact on Preoperative Nurses -- 5.2 Role of Certified Nursing Assistants -- 5.3 Creative Use of Available Space -- 5.4 The Fall Surge (September 2020-December 2020): Changes and Challenges -- 6 Practice Changes for Advanced Practice Providers -- 7 Patient Family Caregiver Presence and Visitation Guidelines -- 8 Leadership and Communication -- 9 Conclusion -- References -- The Emotional and Moral Remnants of COVID-19: Burnout, Moral Distress, and Mental Health Concerns -- 1 Moral Distress -- References -- Unanticipated Consequences: Lack of Essential and Nonessential Patient Care, Furloughs of Health Care Providers, and Institutional Financial Losses.

Interesting and important ethical questions confront researchers, regulators, institutional review boards, support personnel, and research participants committed to the ethical conduct of human subjects research at all stages of research. Questions encompass - but are not limited to - study design, enrolling participants, balancing the clinical needs of participants against the research agenda, ending trials, discharging post-trial obligations, and resolving conflicts. Straightforward solutions to these types of questions are often not found in regulations, ethics codes, or the bioethics liter

Ethics education in nursing provides a critical foundation for addressing ethical questions that arise in the patient-provider relationship. These questions are many and often include central concerns surrounding truth-telling, informed consent, and protecting the rights and welfare of patients and families in decision making. The lack of ethics preparation at both the undergraduate and graduate level hampers nurses' ability to work collaboratively with other team members and share their voices when ethical issues confront clinicians and their patients and families. The purpose of this article is to discuss the importance of ethics education in nursing, identifying gaps in ethics education in nursing curricula, and review specific content issues within ethics curricula and future directions. We highlight the research and clinical opportunities that support ethics education, and offer innovative methods for ethics pedagogy. We also examine what we may learn from medicine. The article ends with recommendations and a conclusion to address ways to incorporate ethics inquiry in nursing curricula for educating future generations of nurses.

In response to the increasing need for research ethics expertise in low- and middle-income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection.

ABSTRACTPrivacy and confidentiality of personal medical information are cornerstones of ethical clinical care and ethical research. But real‐world research has challenged traditional ways of thinking about privacy and confidentiality of information. In today's world of "big data" and learning health care systems, researchers and others are combining multiple sources of information to address complex problems. We present a case study that highlights the ethical concerns that arise when a patient who is employed by an academic medical center learns through a research invitational letter that her private information was accessed at this center without her consent. We discuss the ethical challenges of balancing patient privacy with advancing clinical research and ask, what level of privacy and confidentiality can and should patients expect from their clinician providers, fellow research colleagues, and institutions?

U.S. regulations governing pediatric research do not specify the assent process. To identify best practices, it is important to examine parents' and adolescents' views. The present study focuses on parents' and adolescents' views regarding possible research risks and the influence of financial compensation on their willingness to accept research procedures. Interviews were conducted with 177 adolescents participating in clinical research for a medical or psychiatric illness, or as healthy volunteers, and a parent. Significant discordance was found between how bothered the teen would feel from research-related side effects and procedures compared with parental report. Most teens were willing to accept non-beneficial procedures without compensation. Payment had significantly greater influence on healthy volunteers and their parents compared with those with a medical or psychiatric illness. Discordance between adolescent and parental views about risks recommends obtaining direct input from adolescents during the assent process. Modest payments should not raise concerns of undue inducement, especially in teens with pre-existing conditions.