Research ethics consultation: ethical and professional practice challenges and recommendations.

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research.

An analysis of online messages about probiotics.

Internet websites are a resource for patients seeking information about probiotics. We examined a sample of 71 websites presenting probiotic information. We found that descriptions of benefits far outnumbered descriptions of risks and commercial websites presented significantly fewer risks than noncommercial websites.

'Someone should oversee it': patient perspectives on the ethical issues arising with the regulation of probiotics.

Background: Although many probiotic products are currently available in yogurt or pill form in the United States (US), there is uncertainty surrounding the structure of regulation of these products. As more therapeutic probiotics are developed, changes to existing regulatory process in the United States may be required to meet the needs of patients and users in the population.

Objective: This study examined how patients with chronic gastrointestinal (GI) diseases view the regulation of probiotics.

Ethical Discourse about the Modification of Food for Therapeutic Purposes: How Patients with Gastrointestinal Diseases View the Good, the Bad, and the Healthy.

BACKGROUND: Researchers have the potential to utilize genetic modification (GM) technologies to create a hybrid of "food" and "medicine" that may challenge traditional understandings of what is "natural". Moral and ethical concerns are likely to arise in any discussion of these therapeutic foods and will affect the integration of products into clinical care and daily life. This study examined how patients with chronic gastrointestinal (GI) diseases view probiotics as future bioengineered therapeutic foods.

How disease advocacy organizations participate in clinical research: a survey of genetic organizations.

Purpose: Disease advocacy organizations may assist in the conduct of research in a variety of ways. We sought to characterize how disease advocacy organizations participate in clinical research and perceive their contributions.

Methods: Postal and electronic surveys administered to leaders of disease advocacy organizations for genetic conditions identified through the Genetic Alliance's Disease InfoSearch.

How patients view probiotics: findings from a multicenter study of patients with inflammatory bowel disease and irritable bowel syndrome.

Background: Patients with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) have access to a growing number of probiotic products marketed to improve digestive health. It is unclear how patients make decisions about probiotics and what role they expect their gastroenterologists to play as they consider using probiotics. Understanding patients' knowledge, attitudes and expectations of probiotics may help gastroenterologists engage patients in collaborative discussions about probiotics.

Helping patients make informed choices about probiotics: a need for research.

Applications of probiotics in the treatment of gastrointestinal disorders are gaining acceptance among patients, despite evidence that probiotics can present substantial health risks, particularly for patients who are immunocompromised or seriously ill. Patients will likely formulate their attitudes and beliefs about probiotic therapies with reference to interpretive frameworks that compare probiotics with more familiar therapeutic modalities, including complementary and alternative medicines, pharmacological therapies, and gene-transfer technologies. Each of these frameworks highlights a different set of benefit-to-risk considerations regarding probiotic usage and reinforces extreme characterizations of both the therapeutic promise and peril of probiotics.