Pitfalls and Safeguards in Industry-Funded Research.

Physicians should follow ethical principles in their relationships with industry and be mindful that such relationships-if they are perceived as conflicts of interest-can undermine trust in the patient-physician relationship. By identifying potential pitfalls and safeguards that can help prevent problems, this article focuses on ensuring that physician-industry relationships do not result in ethical transgressions or cause damage to doctor-patient relationships. Patient trust in physicians can be undermined by the perception that a physician-investigator is operating in the best interest of the research rather than the best interest of the patient.

An Analysis of Informed Consent Form Readability of Oncology Research Protocols.

Twenty-two percent of adults in the United States have only basic health literacy skills. We used a multiple linear regression model to identify associations between readability of informed consent documents with study sponsor, study phase, and approval year using a sample of 143 oncology studies at Ochsner Medical Center. The M ± SD Flesh-Kincaid Reading Grade Level (RGL) was 10.

Do N-of-1 Trials Need IRB Review?

There is no standard policy regarding the regulatory or institutional approval of N-of-1 trials in the United States. The objective of this study was to examine whether institutional review boards (IRBs) accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) consider N-of-1 trials as meeting the definition of human subjects research (45CFR46.102) and requiring IRB approval.

DNR, DNAR, or AND? Is Language Important?

The American Heart Association in 2005 moved from the traditional do not resuscitate (DNR) terminology to do not attempt resuscitation (DNAR). DNAR reduces the implication that resuscitation is likely and creates a better emotional environment to explain what the order means. Allow natural death (AND) is the name recommended in some settings to make the meaning even clearer.

Protecting human research subjects: the past defines the future.

The creation of Institutional Review Boards to assure the protection of research subjects came out of terrible research abuses that resulted in the Belmont Report and federal regulations establishing rules for federally funded research and its independent review. The Common Rule became widely accepted as the way to oversee human research that is funded by federal agencies, or used in FDA submissions. The Office of Human Research Protections, now under the Secretary of DHHS, created Federalwide Assurances with groups that receive federal funding and others, the vast majority of which have agreed to apply the same ethical rules to all research regardless of funding source.

Data mining a diabetic data warehouse.

Diabetes is a major health problem in the United States. There is a long history of diabetic registries and databases with systematically collected patient information. We examine one such diabetic data warehouse, showing a method of applying data mining techniques, and some of the data issues, analysis problems, and results.