TAG ARCHIVES FOR human subjects research


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


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


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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