Research Ethics Roundup: Harmonizing FDA and HHS Regulations, Diversity Issues in Cancer Trials, Animal Research Reproducibility Concerns, and Accelerating Research with Open Access Publishing

This week’s Research Ethics Roundup examines what the new 21st Century Cures law means for harmonization efforts, why cancer trials struggle with minority enrollment, a new study on reporting of bias-reducing methodologies in animal research, and the argument for open access publishing.   

Cures Law Requires FDA, HHS to Harmonize Regs
Jeannie Baumann reports for Bloomberg BNA about a provision in the new 21st Century Cures law that requires the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to address any differences between their corresponding human subject research regulations within three years. PRIM&R Board of Directors member, Heather H. Pierce, noted that any harmonization efforts would be affected by whether HHS decides to issue its revisions to the Federal Policy for the Protection of Human Subjects, the “Common Rule.”

In Cancer Trials, Minorities Face Extra Hurdles
In this New York Times article, Denise Grady finds that minorities are less likely to participate in cancer trials because researchers often fail to enroll them. In addition, prominent cancer centers are often located in affluent areas and the cost of participating in a cancer trial may be prohibitive for minority patients with low incomes. However, physicians are also concerned that studies with diversity enrollment requirements may result in minority patients being unfairly pressured to enroll.

How Can We Solve Animal Research’s ‘Reproducibility Crisis’? 
In this ALN Magazine article, Elizabeth Doughman highlights two new studies arguing for more data on experimental methodologies. Treatments that prove successful in animal research may later fail in clinical trials with human subjects. One of the studies conducted with Swiss preclinical researchers found low rates of reporting of bias-reducing methodologies.

Let’s Speed Up Science By Embracing Open Access Publishing
 In this STAT First Opinion piece, Richard Wilder and Melissa Levine argue that more research should be published freely and that paywalls and time embargoes delay important scientific advances. They believe that open access publishing would increase the likelihood that a diverse set of researchers from across the world could more quickly review research and provide feedback. In response to credit and attribution concerns, they point out that frameworks like the Creative Commons Attribution-Only license for open-access works require that the original creator be cited too.