As the biomedical research enterprise increasingly moves to a more participatory model of research, where research participants are treated more as partners than passive subjects, we can expect greater emphasis on returning individual-level results of research to participants. A prominent example is the All of Us Research Program. Read more
This week’s Research Ethics Roundup reviews how experts think data sharing can be accelerated with data authorship attribution, how southern Africa’s San people are combatting exploitative research, the President’s plan for National Institutes of Health (NIH) grants, and a better way to transport laboratory mice. Read more
This week’s Research Ethics Roundup examines why legal experts are advising against voluntary compliance of Common Rule changes, President Trump’s plan for the National Institutes of Health (NIH)’s budget, the debate over whether technology can replace animal models in research, and the reaction to President Trump’s pick for Food and Drug Administration (FDA) Commissioner. Read more
On January 18, 2017, the final rule from the Department of Health and Human Services (HHS) and the National Institute of Health (NIH)’s corresponding policy on reporting to ClinicalTrials.gov will take effect. ClinicalTrials.gov, which is run by NIH, is a searchable registry of clinical trials. It is a federal requirement that sponsors of certain clinical studies that either have one American research site or are conducted under an investigational device exemption (IDE) or an investigational new drug (IND) application register and report the summary results on ClinicalTrials.gov. However, currently very few pharmaceutical companies, academic institutions, and government agencies are complying with the requirement. The regulatory changes taking effect will only have a meaningful impact if the incoming Administration chooses to enforce them. Read more
In Case You Missed It (ICYMI): From time-to-time, PRIM&R will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, PRIM&R Executive Director Elisa Hurley explores the complex issue of clinical trial data sharing and its implications for the protection of human research subjects.
Though not a new issue, clinical trial data sharing has over the past several months taken center stage within the medical research community. In December 2015, a STAT Read more
