Richard Curtin, a Defense Department budget analyst living in Falls Church, does not usually open his daughter Allison's mail, but in the fall of 1998 she was away at college and the envelope was large and thick.
He pulled out a 25-page questionnaire from a researcher at Virginia Commonwealth University who was studying twins, like Allison and her brother Kevin. Curtin read the questions. The more he saw, the less he liked. His daughter was being asked, among other things, if her father had ever suffered from depression or had abnormal genitalia. This seemed to him an invasion of his privacy.
Curtin complained to the Virginia Commonwealth researcher, who wrote back that there was nothing to worry about because the study was voluntary and names were kept confidential. Curtin also got nowhere when he wrote to VCU officials.
So he contacted federal regulators. As a result of his complaint and at least one other, most of VCU's medical research has been shut down. About 1,100 out of 1,500 VCU research projects have been halted while the Richmond university responds to demands from two federal agencies to improve its procedures for protecting research subjects' privacy and safety.
The Food and Drug Administration last month suspended 1,000 VCU studies involving human subjects, saying that a university review board had failed to adequately document its monitoring of the experiments. The FDA also required the school to hire an independent panel to review research policies and bring them into compliance with federal rules.
Yesterday, the federal Office for Protection from Research Risks ordered VCU to stop another 100 projects that are not FDA-regulated, citing similar problems. The agency told the university it had violated Curtin's rights by not seeking his consent before sending a questionnaire that asked for personal information about him, and it said that in another study VCU had broken rules on how blood samples should be taken.
VCU President Eugene P. Trani has told his faculty that he and research administrators "will work around the clock" to satisfy federal regulators and permit resumption of the 1,100 studies, which bring in more than $10 million a year in federal funding.
The federal actions "do not adversely reflect on the care of our research participants," William L. Dewey, vice president for research at VCU, said in an interview yesterday. "The participants in our research studies are our number one priority, and their safety has not been compromised."
Dewey said it could take as long as a year before the school has addressed all of the FDA's concerns and received permission to resume the FDA-regulated experiments. The other projects might be restarted in a couple of months, he said.
He said the researcher who was working on the twins project was following university rules that are among those now being reviewed. Dewey said he has not spoken to Curtin, whose identity had been kept confidential by federal regulators. But he said of the Falls Church father, "I can relate to his being concerned about this issue and I hope this will help us correct our procedures for everyone."
The disciplinary action against Virginia Commonwealth follows similar orders last year affecting Duke University, the Los Angeles Veterans Administration Hospital, the University of Illinois at Chicago and the University of Colorado Health Sciences Center. Health experts say the moves stem from growing concern among government officials and advocacy groups that federal protections for human research subjects are inadequate or poorly enforced.
Curtin said he is happy to see VCU take action, particularly against a review board "that was just not doing its job."