TAG ARCHIVES FOR informed consent

14
Feb2019

The 2018 Advancing Ethical Research Conference (AER18) was my second PRIM&R conference, and this year I came armed with questions for specific organizations and agencies. At the top of my list was a question regarding the 2015 NIH Genomic Data Sharing (GDS) Policy: When children’s data is submitted to a national genomic data sharing repository, such as the database of Genotypes and Phenotypes (dbGaP), what are the consent expectations when those subjects reach the age of majority?  Read more

5
Feb2019

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations," which was published in the Federal Register on November 15, 2018. Comments are due February 13. Read more

9
Nov2018

In 2010, a little-known research institute, the Patient Centered Outcomes Research Institute (PCORI), began funding hundreds of clinical studies with the aim of increasing the value of medical innovation. These studies included patients and family members in every step of the research process. This approach, called patient-centered outcomes research, has become a novel tool for conducting health care investigations; but, it raises ethical issues, which have largely been pushed to the background. Read more

13
Aug2018

You are the chief human research protections officer at a prestigious academic medical center (AMC). You have just discovered that two doctors on your staff have been secretly conducting a clinical study on their patients. The doctors have broken every rule in the human subjects protection book. They did not even tell their patients they were in a clinical study, and some of them died. The president of the AMC has called a meeting this afternoon where you will have to explain the situation and make your recommendations. What a nightmare! To complicate things, it turns out that the study treatment is an astonishing medical breakthrough that can save thousands of lives. The doctors want to submit a paper to a major medical journal by the end of the week. A Nobel Prize could be in order. Read more

20
Jun2018

On May 10, PRIM&R hosted a webinar, Forward-Looking Strategies for IRBs in the Genomic Age: Preparing for Shifting Concepts of Identifiability, to provide expert input on the impact of breakthroughs in genomics research on traditional notions of identifiability.The panel consisted of Jiayan Chen, JD, a partner at McDermott Will & Emery, LLP, and Suzanne Rivera, PhD, MSW, vice president for research and technology management at Case Western Reserve University. After the webinar, Ms. Chen and Dr. Rivera responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more