TAG ARCHIVES FOR human subjects research

13
Aug2018

You are the chief human research protections officer at a prestigious academic medical center (AMC). You have just discovered that two doctors on your staff have been secretly conducting a clinical study on their patients. The doctors have broken every rule in the human subjects protection book. They did not even tell their patients they were in a clinical study, and some of them died. The president of the AMC has called a meeting this afternoon where you will have to explain the situation and make your recommendations. What a nightmare! To complicate things, it turns out that the study treatment is an astonishing medical breakthrough that can save thousands of lives. The doctors want to submit a paper to a major medical journal by the end of the week. A Nobel Prize could be in order. Read more

13
Jul2018

On May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) became effective in the 28 member states of the EU and the three additional countries (Iceland, Liechtenstein, and Norway) that, together with the EU member states, constitute the European Economic Area (EEA). (It replaces the Data Protection Directive 95/46/EC.) The GDPR affects US-based life science and academic research communities engaged in various arrangements, such as US-sponsored clinical trials occurring in the EEA, or studies that involve transferring personal data from the EEA to the US. To comply with the GDPR, all institutions need to be equipped with strategies for determining whether the GDPR will apply to them and, if it applies, how to process and transfer personal data to the US lawfully. Read more

9
Jul2018

You are a member of an IRB that is reviewing a study on the effectiveness of placebo “treatments.” It is well known that different sizes, shapes and colors of pills cause different levels of the placebo effect, which also varies by the therapeutic indication and the country/culture. The investigators want to test the placebo effect across a broad range of diseases and countries. The placebo pill will be presented as a “booster” to their current treatment--not a placebo.  Read more

27
Jun2018

Providing payment for participation in research studies is an accepted practice, but until recently little guidance existed on the ethical aspects when deciding research payments. Gelinas et al recently presented a framework that researchers and IRBs can use when deciding ethical payments. Yet one major gap remains beyond the framework: data on the types and amounts of incentives provided historically in research studies. Read more

28
May2018

The rapid proliferation of new digital health applications, tools, and technologies is reshaping the health care and research environments. Companies that develop these products may not have strong foundations in health care norms and ethics standards, and, in the the absence of FDA oversight, these products may not have been developed with an explicit focus on safety and effectiveness. It is important for IRBs to have the knowledge and strategies for evaluating these tools' adequacy to protect the data, privacy, and confidentiality of research subjects in trials involving digital health technologies. On February 8, PRIM&R hosted the webinar to provide guidance for IRBs in the assessment of new technologies in the health care field. Presenters answer follow-up questions from the webinar for readers of Ampersand. Read more

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