TAG ARCHIVES FOR IRBs

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

11
Sep2018

In July of this year, the National Academies of Science, Medicine, and Engineering (NASEM) released a report titled, “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” It’s a comprehensive report that raises many important considerations and proposes a number of thoughtful recommendations on this very timely topic. I won’t be able to do justice to all of its details and nuance here. Instead, I’ll share what I take to be some key themes and takeaways, including for IRBs. Read more

3
Oct2017

While it may be a common complaint among researchers that IRBs overregulate, many IRBs opt to “uncheck the box” by building additional flexibility into the regulations that allows them to reduce investigator burden while still ensuring equivalent protections for human subjects. Read more

16
Aug2017

You are the director of human research protection at a community hospital. You have one IRB with seven members. Six of the members are physicians with staff privileges at your hospital. The seventh member, a representative from the community, just resigned from the IRB. Six qualified people have applied to fill the empty seat: a bioethicist, a minister, a former study participant, a community leader, a sociologist, and a member of a disadvantaged group served by the hospital. Because of a hospital policy that is set in stone, you can accept only one new IRB member. Read more

15
Jun2017

From sequencing the human genome to discovering the underlying causes of many diseases, genetic research has the ability to profoundly influence the health of individuals and populations. However, despite genomics’ exceptional capacity to contribute to our understanding of disease, the nature of genetic research introduces many ethical considerations that may not arise in other types of biomedical research. Read more