The shell game: how institutional review boards shuffle words.

Concepts like coercion, vulnerability, and dignitary harm have acquired specialized meanings in the research ethics literature. Institutional Review Boards (IRBs), also called Research Ethics Committees (RECs), sometimes use these concepts in two different ways without acknowledging or even realizing what they are doing. IRBs mislabel any language that encourages subject participation in trials as "coercive," then demand its removal as if it were actually coercive in the sense of a threat of force.

"Snake-oil," "quack medicine," and "industrially cultured organisms:" biovalue and the commercialization of human microbiome research.

Background: Continued advances in human microbiome research and technologies raise a number of ethical, legal, and social challenges. These challenges are associated not only with the conduct of the research, but also with broader implications, such as the production and distribution of commercial products promising maintenance or restoration of good physical health and disease prevention. In this article, we document several ethical, legal, and social challenges associated with the commercialization of human microbiome research, focusing particularly on how this research is mobilized within economic markets for new public health uses.

Elderly patients' experiences using adaptive conjoint analysis software as a decision aid for osteoarthritis of the knee.

Background: Decision making in knee osteoarthritis, with many treatment options, challenges patients and physicians alike. Unfortunately, physicians cannot describe in detail each treatment's benefits and risks. One promising adjunct to decision making in osteoarthritis is adaptive conjoint analysis (ACA).

Perspectives on human microbiome research ethics.

Study of ethical, legal, and social implications (ELSI) of human microbiome research has been integral to the Human Microbiome Project (HMP). This study explores core ELSI issues that arose during the first phase of the HMP from the perspective of individuals involved in the research. We conducted semi-structured in-depth interviews with investigators and NIH employees ("investigators") involved in the HMP, and with individuals recruited to participate in the HMP Healthy Cohort Study at Baylor College of Medicine ("recruits").

Promoting knowledge of statins in patients with low health literacy using an audio booklet.

Background: Statins are generally well tolerated and effective at reducing a patient's risk of both primary and secondary cardiovascular events. Many patients who would benefit from statin therapy either do not adhere to or stop taking their statin medication within the first year. We developed an audio booklet targeted to low health literacy patients to teach them about the benefits and risks of statins to help the patients adhere to their statin therapy.

Equipoise lost: ethics, costs, and the regulation of cancer clinical research.

Cancer is the leading cause of death in Americans younger than 85 years of age and kills one American every 56 seconds. Advances in understanding of cancer biology have given us the potential to develop new, effective targeted therapies. However, progress is slowed by suboptimal/outdated clinical trial design paradigms and by regulatory complexity and rigidity.

Whose decision is it? The microstructure of medical decision making.

Medical decision making is sometimes viewed as a relatively simple process in which a decision may be made by the patient, by the physician, or by both patient and physician working together. This two-dimensional portrayal eclipses the important role that others, such as other professionals, family, and friends, may play in the process; as an example of this phenomenon, we trace the evolution of a decision of a teenager with cancer who is contemplating discontinuing chemotherapy. This example also shows how a decision can usefully be understood as consisting of a number of identifiable substeps--what we call the "microstructure" of the decision.

Beyond shared decision making: an expanded typology of medical decisions.

The most popular current models of medical decision making, identified by names such as shared decision making, informed decision making, and evidence-based patient choice, portray an empowered patient actively involved in his or her medical choices and generally assume that patient and physician reach agreement. These models are limited to a specific type of decision (in which there is more than one choice) and a specific process (in which agreement is reached). The authors extend the model of medical decision making beyond shared decisions in 2 dimensions.

Beyond breaking bad news: the roles of hope and hopefulness.

Background: Hope is important to patients, yet physicians are sometimes unsure how to promote hope in the face of life-threatening illness.

Analysis: Hope in medicine is of two kinds: specific (hope for specific outcomes) and generalized (a nonspecific sense of hopefulness). At the time of diagnosis of a life-ending condition, the specific goal of a long life is dashed, and there may be no medically plausible specific outcome that the patient feels is worth wishing for.

Principal investigator views of the IRB system.

We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations.

Association of spirituality and sobriety during a behavioral spirituality intervention for Twelve Step (TS) recovery.

Twelve-Step (TS) recovery utilizes spirituality to promote sobriety, yet there are no proven programs designed to facilitate spiritual involvement. We developed a seven-week behavioral spirituality intervention titled "Knowing Your Higher Power" for implementation along with usual TS care. Twenty-six participants from a recovery center enrolled.

Physicians' silent decisions: because patient autonomy does not always come first.

Physicians make some medical decisions without disclosure to their patients. Nondisclosure is possible because these are silent decisions to refrain from screening, diagnostic or therapeutic interventions. Nondisclosure is ethically permissible when the usual presumption that the patient should be involved in decisions is defeated by considerations of clinical utility or patient emotional and physical well-being.

The physician's role in the assessment and treatment of spiritual distress at the end of life.

Objective: Patients at the end of their life typically endure physical, emotional, interpersonal, and spiritual challenges. Although physicians assume a clearly defined role in approaching the physical aspects of terminal illness, the responsibility for helping their patients' spiritual adaptation is also important.

Methods: This article (1) describes the terms and definitions that have clinical utility in assessing the spiritual needs of dying patients, (2) reviews the justifications that support physicians assuming an active role in addressing the spiritual needs of their patients, and (3) reviews clinical tools that provide physicians with a structured approach to the assessment and treatment of spiritual distress.

Alcohol recovery and spirituality: strangers, friends, or partners?

Alcoholics Anonymous, with its steady but nonspecific promotion of belief in a higher power and its emphasis on the group process, long held a near-monopoly in the outpatient alcohol recovery field, but its hegemony has now been challenged by two very different perspectives. The first is a nonspiritual approach that emphasizes the individual's capability to find a personal pathway to sobriety, exemplified by Rational Recovery. The second is a faith-based method, built on a religious understanding of alcoholism, of which Celebrate Recovery is a prominent example, based upon Christianity.

Decision making in pediatric oncology: who should take the lead? The decisional priority in pediatric oncology model.

Decision making in pediatric oncology can look different to the ethicist and the clinician. Popular ethical theories argue that clinicians should not make decisions for patients, but rather provide information so that patients can make their own decisions. However, this theory does not always reflect clinical reality.

Missed expectations? Physicians' views of patients' participation in medical decision-making.

Objective: Physicians are encouraged to actively involve patients in clinical decision-making, but this expectation has not been adequately examined from the physicians' perspective. Our objective was to identify and characterize physicians' attitudes toward patient participation in decision-making and to gain insight into how they consequently think about and structure the decision-making process.

Design: This was a qualitative cross-sectional study of physicians' reported attitudes and practices.

A typology of shared decision making, informed consent, and simple consent.

Enhancing patient choice is a central theme of medical ethics and law. Informed consent is the legal process used to promote patient autonomy; shared decision making is a widely promoted ethical approach. These processes may most usefully be seen as distinct in clinically and ethically important respects.

A new model of medical decisions: exploring the limits of shared decision making.

This article proposes a model of medical decisions based on 2 fundamental characteristics of each decision--importance and certainty. Importance reflects a combination of objective and subjective factors; certainty is present if 1 intervention is superior and absent if 2 or more interventions are approximately equal. The proposed model uses these characteristics to predict who will have decisional priority for any given decision and shows how one class of decisions lends itself particularly well to shared decision making.