TAG ARCHIVES FOR human subjects research

7
Dec2018

Clinical Research Ethics Question of the Month: December 2018

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7 Dec

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Scientists have created entities using artificial intelligence technology. These “betas” appear to have human-like intelligence and emotions so they could, for example, serve as companions for people who are lonely. The scientists want to conduct psychological experiments on them to improve their performance and reliability. While betas are not protected by human subjects protection regulations, the scientists have asked your institutional review board to review the ethics of the experiments anyway. Read more

25
Oct2018

Clinical Research Ethics Question of the Month: October 2018

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25 Oct

Comments: 1

You are a member of an IRB reviewing a study with an unusual feature: Because the study population will be very diverse economically, the investigator wants to vary the stipend based on each study participant’s financial situation. Her reasoning is that a fixed stipend for everybody would exploit high-income people but unduly influence low-income people. For the purposes of this survey, the investigator knows everyone's income. Read more

20
Sep2018

Clinical Research Ethics Question of the Month: September 2018

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20 Sep

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You are a physician at a Catholic hospital investigating a new treatment for a women’s health condition. This healthy volunteer study requires an unpleasant and somewhat risky procedure, so you do not expect to meet your enrollment target. The first five participants are nuns who say their primary motivation is altruism. What, if anything, should you do? Read more

11
Sep2018

From the Director: Taking a look at the National Academies’ report on returning individual research results to participants

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11 Sep

Comments: 5

In July of this year, the National Academies of Science, Medicine, and Engineering (NASEM) released a report titled, “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” It’s a comprehensive report that raises many important considerations and proposes a number of thoughtful recommendations on this very timely topic. I won’t be able to do justice to all of its details and nuance here. Instead, I’ll share what I take to be some key themes and takeaways, including for IRBs. Read more

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