Navigating the Perfect Storm: Ethical Guidance for Conducting Research Involving Participants with Multiple Vulnerabilities.

The development of ethical guidelines and regulations regarding human subjects research has focused upon protection of vulnerable populations by relying on a categorical approach to vulnerability. This results in several challenges: First, Institutional Review Boards (IRBs) struggle to interpret and apply the regulations because they are often vague and inconsistent. Second, applying the regulations to subjects who fit within multiple categories of vulnerability can lead to contradictions and the rejection of research that would be permissible if only one category were applicable. Finally, some potential subjects have social and other context-based vulnerabilities that are not described in the federal regulations and therefore not considered in IRB deliberations. IRBs and investigators lack guidance on how to address the problem of multiple vulnerabilities in a way that strikes a balance between protection and respect for persons. In this essay, we evaluate the acceptability of the existing federal regulations with respect to research participants with multiple vulnerabilities, offer strategies for rethinking the concept of vulnerability, and outline a context-based normative framework to account for the compounding effects of multiple vulnerabilities.

"Do we have to replace the balloon pump when it fails?"

Mrs. Duong had coronary artery disease, ischemic cardiomyopathy, and mildly altered mental status when her case was presented before an advanced heart therapy medical review board. She was accepted for left ventricular assist device placement pending additional insight into her cognitive state. Before the LVAD could be implanted, however, Mrs. Duong went into cardiogenic shock, and her heart failure team placed an intra-aortic balloon pump in her subclavian artery. Within two weeks, Mrs. Duong became IABP dependent and deconditioned. The attending deemed her as lacking capacity to make complex medical decisions, and the medical review board officially declined her for LVAD placement. The heart failure and CICU teams feel that Mrs. Duong is not being helped by the care they are giving her. They recommend terminal weaning of the IABP and initiation of comfort care. Her family disagrees, pointing to activities like continued eating and interacting with family. At an impasse after yet another family meeting, the attending for the heart failure team asks the clinical ethics consultant, "Do we have to replace the balloon pump when it fails?"

Navigating Ethical Conflicts Between Advance Directives and Surrogate Decision-Makers' Interpretations of Patient Wishes.

There is little guidance on what clinicians should do when advance directives (or living wills, specifically) are challenged, particularly when surrogate decision-makers' interpretations of patients' wishes conflict with the living will. In our commentary, we make a controversial argument suggesting that overriding living wills can be ethically preferable to the alternative of strictly adhering to them. We propose four ethical considerations for determining whether it is ethically supportable to override living wills.

Management of the Jehovah's Witness in Obstetrics and Gynecology: A Comprehensive Medical, Ethical, and Legal Approach.

IMPORTANCE: Obstetricians and gynecologists frequently deal with hemorrhage so they should be familiar with management of patients who refuse blood transfusion. Although there are some reports in the literature about management of Jehovah's Witness patients in obstetrics and gynecology, most of them are case reports, and a comprehensive review about these patients including ethicolegal perspective is lacking. OBJECTIVE: This review outlines the medical, ethical, and legal implications of management of Jehovah's Witness patients in obstetrical and gynecological settings. EVIDENCE ACQUISITION: A search of published literature using PubMed, Ovid Medline, EMBASE, and Cochrane databases was conducted about physiology of oxygen delivery and response to tissue hypoxia, mortality rates at certain hemoglobin levels, medical management options for anemic patients who refuse blood transfusion, and ethical/legal considerations in Jehovah's Witness patients. RESULTS: Early diagnosis of anemia and immediate initiation of therapy are essential in patients who refuse blood transfusion. Medical management options include iron supplementation and erythropoietin. There are also some promising therapies that are in development such as antihepcidin antibodies and hemoglobin-based oxygen carriers. Options to decrease blood loss include antifibrinolytics, desmopressin, recombinant factor VII, and factor concentrates. When surgery is the only option, every effort should be made to pursue minimally invasive approaches. CONCLUSION AND RELEVANCE: All obstetricians and gynecologists should be familiar with alternatives and "less invasive" options for patients who refuse blood transfusions.