18
Dec2018

As research activities go, the use of archival tissue has ranked pretty low on my list of ethical concerns. After all, the tissue has been or will be collected during a clinical procedure that patients would undergo regardless of their participation in research; there is no additional physical risk to subjects, and the primary ethical dilemma (or so the thinking goes) is the potential for a breach of confidentiality. By the end of the full-day preconference program Biobanking in an Era of Precision Medicine Research: Approaches to the Ethical, Regulatory, and Practical Challenges, the presenters had changed my thinking on this topic. I now have a much better appreciation of the complex relationship between researchers, patient-participants, pathologists, and IRBs, particularly when specimens will be used to investigate precision medicine applications. 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

12
Dec2018

PRIM&R recently hosted a full-day preconference session at the 2018 Advancing Ethical Research Conference (AER18) discussing the challenges and strategies for successfully implementing single IRB review. Conferences like PRIM&R’s are an important venue for institutions to get together to discuss these challenges and find solutions. Read more

7
Dec2018

Scientists have created entities using artificial intelligence technology. These “betas” appear to have human-like intelligence and emotions so they could, for example, serve as companions for people who are lonely. The scientists want to conduct psychological experiments on them to improve their performance and reliability. While betas are not protected by human subjects protection regulations, the scientists have asked your institutional review board to review the ethics of the experiments anyway. Read more

4
Dec2018

On October 10, the National Institutes of Health (NIH) published a Request for Information (RFI) from the public on Proposed Provisions for a Draft Data Management and Sharing Policy for NIH Funded or Supported Research. According to the NIH, it will take into account the feedback received as it develops a draft of a new NIH policy for data management and sharing. That draft will also be open for public comment, at a future date. Comments on this first stage of policymaking, the proposed provisions, are due December 10, 2018. Read more