TAG ARCHIVES FOR legal

17
May2019

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

17
Dec2018

The question of whether and how to return individual research results to subjects has been an ongoing area of uncertainty for investigators and research institutions. The recent report from the National Academies of Science, Engineering, and Medicine (NASEM), Return of Individual-Specific Research Results to Participants: Guidance for a New Research Paradigm, offered recommendations for “a process-oriented approach to returning individual research results that considers the value to the research subject, the risks and feasibility of return, and the quality of the research laboratory.” On October 3, 2018, PRIM&R hosted a webinar to summarize the recommendations of the report, and provide guidance specifically on its potential implications for IRBs. Read more

30
Jul2013

by Maeve Luthin, JD, Professional Development Manager

In June’s Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) decision, the Supreme Court determined that human genes fall within the “laws of nature” exception to patentable material. This decision invalidated Myriad’s exclusive claim to BRCA 1 and BRCA 2 tests that can be used in determining a woman’s risk in contracting breast and ovarian cancer. However, Myriad wasn’[...] Read more