TAG ARCHIVES FOR human subjects research

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

16
May2018

Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated increasing interest and debate over the last several years. Currently, US federal regulations allow manufacturers to provide Investigational New Drugs (INDs) to patients with serious diseases or conditions who have exhausted approved therapeutic options, and cannot participate in a clinical trial. As key players in the pre-approval access process, IRBs must review and approve expanded access protocols in accordance with FDA guidelines. Moreover, the new “Right to Try” laws currently taking effect on both the federal and state levels make it especially crucial that IRB members stay informed about ongoing developments and potentially thorny ethical issues. Read more

16
Mar2018

You are the chairperson of an IRB overseeing a study comparing three diabetes drugs. Some of the study participants have been talking about the study on social media. The investigator believes their posts have affected study enrollment, adherence and retention. How should the investigator deal with study participants who are sharing their study experiences online? Read more

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