During this webinar, speakers demonstrated how to identify, develop, and successfully implement tools, templates, and checklists to aid in streamlining aspects of protocol review that often present challenges for human research protections programs (HRPPs) and their staff. Read more
This week’s Research Ethics Roundup covers two new research ethics concerns—the implications of crowdfunding research and conducting research on tattoos—as well as updates on the USDA’s animal research statistics and the federally funded Genomic Data Commons. Read more
On Tuesday, June 21, the National Institutes of Health (NIH) published the “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.” The policy “establishes the expectation that a single IRB of record will be used to conduct ethical reviews for domestic sites of multi-site, non-exempt human subjects research protocols that are funded by NIH.” The single IRB (sIRB) will be responsible for carrying out the review requirements at 45 CFR part 46 for participating sites involved in the study. (The sIRB may also serve as a Privacy Board for HIPAA [...] Read more
For several decades, scientists have reasoned that stem cells—and human embryonic stem cells (hESC) especially—have the potential to improve human health. In particular, research indicates that the properties unique to hESC (e.g., plasticity, potency) can benefit our understanding of, and approaches to, regenerative medicine and embryology. For instance, understanding how these cells might (i) mitigate or treat diseases such as Alzheimer’s, Parkinson’s, cancer, and diabetes, and (ii) produce vital insights into human development, is a priority within the scientific research enterprise, but one whose methodologies and ethics should be thoroughly monitored and reviewed in accordance with advances in medicine. Read more
In May, members of PRIM&R’s staff attended The Petrie-Flom Center's Conference, "Big Data, Health Law, and Bioethics" at Harvard Law School. Several of the panel presentations addressed what the move towards big data means for the research ethics community. To recap the event for those unable to attend, we begin with a summary of some of the privacy concerns about big data, and then highlight several panel presentations that explored what these concerns mean for human subjects and IRBs. Read more
From the role of women in research to a poll that found the majority of Americans don’t approve of an expedited drug approval process in exchange for lower standards, this week’s Research Ethics Roundup examines some of the latest controversial issues occurring in research. Read more
