No abstract

We identified a substantial increase in participation rates postwaiver of written informed consent and HIPAA authorization in a minimal-risk survey. The need for written documentation for minimal-risk surveys may negatively impact recruitment of blacks, women, and patients < 75 years old.

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. A questionnaire was distributed via email to 170 AAHRPP-accredited IRBs in the United States. Responses were analyzed using statistical and qualitative methods. Nineteen of 59 respondents reported viewing N-of-1 trials as research. Twelve respondents reported having a policy regarding N-of-1 trials, and in all cases, such policies did not consider N-of-1 trials as meeting the definition of research. This topic deserves wider examination in the IRB literature and community to inform policies and guidance as N-of-1 trials become more common in the pursuit of personalized, precision medicine.

Background: 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. Methods: 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. Results: 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. Payments from the pharmaceutical industry to physicianinvestigators are transparent because of the Sunshine Act, and patients can easily determine if their personal physicians have received money from industry. Research subsidies from industry should represent fair market value for the work performed. Postmarketing trials with the primary goal of increasing familiarity with a drug and prescribing rates should be avoided. Medical societies play an important role in establishing standards for professional conduct. Conclusion: Ethically sound actions in physician relationships with industry should be guided by professional standards, medical society guidelines, and local institutional policies.