Research Ethics Roundup: The future of the CTSA program, sharing scientific data, and more

by Maeve Luthin, JD, Professional Development Manager

Hopkins, UMD Await Word on Grant Funding Key in Medical Treatment Discoveries: In June, the Institute of Medicine (IOM) released a report detailing recommendations to the National Institutes of Health (NIH) regarding its administration of the Clinical and Translational Science Awards (CTSA) program, including that it should consolidate program leadership, establish clearer evaluation standards for applications, and encourage collaborating among participating institutions. CTSA decisions are expected in September. Now, institutions are waiting to see how the report will affect their funding.

Jerry Brown’s Egg Donor Veto Draws Fire From Measure’s Author: California Governor Jerry Brown vetoed a bill that that would have allowed women to sell their eggs for medical research, citing the concern that informed consent for egg harvesting procedures is limited by inadequate knowledge of long-term risks. Supporters of the bill have stated that the veto will stifle fertility research as well as studies on the impact of cancer-fighting drugs on fertility.

How to Share Scientific Data: With government agencies facing an increasing demand for transparency of federally-financed research results, a mechanism for making meaningful data accessible to the public is needed. Some believe that the current system gives private companies an unfair advantage, as they are more likely to be able to synthesize raw data sets. To solve this dilemma new cost sharing models for storing and aggregating digital research data, which emphasize the need for public, private, and academic research communities to share the financial and technical burden of investing in infrastructure, are being explored.

Japan Investigations Allege Misconduct in Large-Scale Clinical Studies: The Japanese Ministry of Health is investigating claims of data manipulation and conflict of interest involving five large-scale, post-marketing clinical studies on valsartan, a hypertension drug produced by Novartis. Six papers based on the study findings, which suggested the drug significantly decreased the chance of stroke and angina, have been retracted. The individual sites involved in the studies have all launched their own investigations as well.