citizen science Archives

One of primary tasks of the IRB is the evaluation of the informed consent process to make sure it facilitates participant understanding of the research project. The revised Common Rule emphasizes this responsibility and includes several new provisions focused on highlighting key information meant to improve participant understanding. It is clear that there are areas for improvement in conveying information about research involvement and explaining the choice participants need to make. But, how do we know whether these efforts are truly improving understanding and how do we assess participants’ views on their experiences in research? Read more

For this month's question, you are a principal investigator in a very promising Phase 3 pancreatic cancer study. The sponsor has just informed you that you can enroll only one more patient before enrollment closes. Enrolling in this study might save your patient’s life. Ten of your patients are eligible for the study. Who do you invite to participate in the study, and how do you decide? Read more

This month’s question places you in the FDA commissioner’s seat: You are the Commissioner of the FDA. A friend has informed you of the following situation: Over 1,000 people with severe, refractive emphysema have banded together to test a drug that is approved for asthma but not emphysema. Participants “drew straws” to determine which of them would ask their physicians for a prescription. While the FDA has no authority over the practice of medicine, it does have authority over clinical studies that create generalizable knowledge. Read more

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The Importance of Listening

Clinical Research Ethics Question of the Month: May 2017