TAG ARCHIVES FOR human subjects research

13
Jun2019

PRIM&R’s Response to FDA’s Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device

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13 Jun
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In April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” The paper represents FDA’s response to the growing number of medical device manufacturers who are utilizing artificial intelligence and machine learning technologies to continuously improve their products. On June 3, PRIM&R submitted comments in response to the discussion paper, thanking the FDA for their consideration of the public health implications of the use of these technologies, but also cautioning that any new regulatory approach in this area must address the protection of individuals whose personal information and data are being used in the creation and ongoing testing of these technologies. Read more

11
Jun2019

PRIM&R’s Response to FDA’s Draft Guidance on “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients”

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11 Jun
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In March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients." The guidance is one of the latest moves by the agency to expand eligibility criteria, and hence the knowledge base for how drugs work in various populations, for the clinical trials they regulate. It makes recommendations not only for sponsors but also for IRBs. On May 13, PRIM&R submitted comments in response to the draft guidance. PRIM&R also has an upcoming webinar, Pediatric Risk Determination: IRB Considerations and Cases, on Thursday, September 19 that will review considerations for IRBs in assessing the risks and benefits of pediatric studies. Read more

24
May2019

Research and Social Media: Finding Subjects and Keeping Trust

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24 May
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Approximately 80% of the US population has a social media account. Social media can be a powerful research tool for recruiting subjects and for conducting research. As regulatory professionals tasked with protecting research subjects, it’s important to understand the unique risks and benefits of social media use for research.Luckily, at PRIM&R’s 2018 Advancing Ethical Research Conference, there was a session devoted solely to the complex issues related to research on social media. Read more

17
May2019

Clinical Research Ethics Question of the Month: May 2019

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17 May
Comments: 1

In collaboration with First Clinical Research, we bring you the Clinical Research Ethics Question of the Month: You are a member of an IRB reviewing a study of a marketed drug for treating depression. Previous studies of this drug have shown minimal side effects. They have also shown a very high, enduring placebo effect. In fact, the symptoms of most study participants improved, regardless of whether they received the study drug or the placebo. This study has a twist: The goal is not to assess the efficacy of the drug, but to assess the efficacy of participating in a study of the drug. In other words, the study itself is the treatment under investigation. Read more