RESEARCH

Four years ago, renouned prostate cancer researcher William Catalona moved from Washington University in St. Louis to Northwestern University. He had spent years gathering blood and tissue samples from patients to be used for prostate cancer research. Upon his departure, he contacted about 50,000 of those patients and asked that they release their samples to him to take to Northwestern. About 6,000 patients indicated they wanted him to take their samples with him.

Washington University fought in a lower court, and won, the right to keep the samples. Catalona's appeal was recently heard before the US Court of Appeals, and Wednesday, the higher court upheld the lower court's ruling. The patients gifted their samples to the University, not to Catalona. Furthermore, the court ruled that while they do maintain the right to request that their samples be destroyed, these patients do not have the right to authorize the transfer of the material.

Link: http://www.stltoday.com/stltoday/news/stories.nsf/stlouiscitycounty/story/0F581BA1FE58A4598625730100107659?OpenDocument

OHRP has posted a new set of Frequently Asked Questions (FAQs) on informed consent. These FAQs provide guidance on OHRP’s current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. View the informed consent FAQs at: http://www.hhs.gov/ohrp/faq.html.

The NSF has recently released a report of recent audits conducted by its Office of Inspector General (OIG) on effort reporting. The report cites California Institute of Technology (Caltech) for the failure of some principal investigators to accurately report work on grant-funded projects, particularly time they had volunteered to spend.

The report of the Caltech audit is based on a review of fiscal year 2005 NSF grants. The OIG made a number of recommendations, including the development of a better system to track voluntary time. Caltech accepted most of the recommendations and agreed to resolve nearly $11,000 in questioned costs.

The OIG audit also noted that Caltech needs to improve the timeliness of its effort report distribution and certification. Caltech has institutionally established a 150-day timeframe for certification of reports — 120 days to distribute a report, followed by a 30-day turnaround time for the PI to certify it. However, according to the report, none of the sample of effort reports reviewed by the auditors were certified within the 150 days.

On June 15, 2007, NIH published a revised document entitled Notes, Tips, and Validations for Grants.Gov Components. This document describes all of the validations performed by NIH upon receipt of an application through grants.gov. It lists in detail all of the conditions under which the validation system at NIH will generate a warning or error message when processing a grants.gov application.