Insights

Operationalizing the NIH Single IRB Mandate

The National Institutes of Health’s (NIH) new policy mandating the use of a single Institutional Review Board (sIRB) for all multi-site studies goes into effect in September 2017. Are you ready?   Many hospitals and academic medical centers (AMCs) are scrambling to plan for the complex and burdensome process surrounding multi-site, single IRB review. In […]

Fifty Years of Change: Henry K. Beecher and Protecting Human Subjects

In June of 1966, physician-researcher Henry K. Beecher published a paper entitled “Ethics and Clinical Research” in the New England Journal of Medicine.  His paper listed 22 examples of clinical research that raised ethical questions about the conduct of research by physicians at major universities, published in major medical journals, demolishing the widely-held position that […]

Compensating Participants in Clinical Research: Current Thinking

Sponsors, researchers and Institutional Review Boards (IRBs) are often wary about payments in research participation, citing concerns about coercion and undue influence, whether real or perceived, and have avoided payments that are “too high.” New research on how people make decisions about research participation, and new approaches to this question, bring a new perspective; are […]

Pragmatic Clinical Trials: What You Need to Know

The concept of a pragmatic clinical trial was developed to create a trial that can practically answer questions like, “Is the healthcare we are delivering really safe and effective?” and, “Which of the healthcare options should we use in practice to provide the best care to the patient?”. While the pragmatic clinical trial design has […]

Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations

Recruitment practices for clinical trials have evolved significantly over the last few decades. In addition to the advances in recruitment advertising through social media and other technologies, there are a number of practices that used to be considered acceptable, and even standard, which are no longer considered acceptable. At the same time, other practices, such […]

Investigational Drugs Outside of Clinical Trials – Understanding Expanded Access and Right-to-Try

Expanded access, the system through which the FDA provides access to investigational drugs outside of clinical trials, was designed for patients who have no known effective treatment options for serious diseases or conditions. There is a delicate balance between helping desperately ill people access treatments that could be potentially beneficial in a timely manner and ensuring that […]

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