Federal rules governing clinical trials—they’re a little important. That doesn’t mean you get a pass on state law, which covers the licensure of every health care professional involved in every trial.

John Serio has just revised his own tome on the topic,

. To help, he enlisted his colleague Dorothy Puzio. They work at Brown Rudnick, a 200-attorney firm with offices in Dublin, Hartford, Boston, London, New York, Providence and Washington, D.C. The firm takes seriously the donation of pro bono services to worthy causes. You don’t see that every day.

The scope of the book goes well beyond clinical trial research involving prisoners and residents of mental hospitals. There is an impressive amount of nuance, owing to the endless creativity of the political animal when it comes to regulating a) medicine and b) family relations. It covers the state-by-state intricacies of the following topics:

• Statutory structures for clinical trials

• Required notifications to state officials/offices

• Legal representative standards

• Age of consent

• Drug dispensing/administration requirements

• Informed consent, IRB, and clinical protocol requirements

• State licensing authorities (medical, nursing, pharmacy)

• Special state rules for cancer research

• HIV testing rules

Serio comes from a family of pharmacists, a profession he practiced before switching to the law. About half of his practice is devoted to clinical trials, with the remainder being a patent-oriented workload.

“Most people think that if they’re in compliance with federal regulation, they’ve done what needs to be done,” says Serio. “You’re about 90 percent there. But that last 10 percent is a very important part.”

As longtime clinical trial veterans know, federal rules are largely silent on big-picture concerns around informed consent. “The capacity to consent, the person’s cognitive ability to enter into a knowing consent, is something that is governed by state law, not federal law,” Serio says. “Whether you have an effective consent is based on the state law you’re operating in.”

In today’s torn social fabric, Serio notes, it’s possible for divorced parents or squabbling siblings to have quite different views about whether a child or an elderly relative has the cognitive ability to decide to participate in a clinical trial. Indeed, when 18-year-old Jesse Gelsinger perished in a clinical trial at the University of Pennsylvania in 1999, his family sued and won partly over consent issues.

“What our guide allows you to do is map out the clinical sites or the locations of the clinical sites that are strategically more favorable,” Serio says. “The guide allows you to go into those areas of the country that have less onerous requirements or more realistic requirements.”

For all its reputation as stem-cell-friendly and pro-science, California has an intimidating body of state law, and its own miniature replica of the FDA. “One could write a book just on the regulations in California,” sighs Serio. In some cases, the golden state does encourage research. But for researchers working with controlled substances, there is a state task force underneath the attorney general’s office that approves every trial. Many people in the state are unaware of this additional layer of bureaucracy.

After California, Serio says, Florida has the most extensive rules, as local politicians have tried to protect the elderly retirees who live there.

For cultural and political reasons, New Mexico is a particularly difficult state in which to involve pregnant women in clinical trials. The New Mexicans don’t want neonatal studies to happen on their turf.

In Georgia, a state tough on minor criminal acts, state legislators have enacted rules to speed up trials using cannabinoids, the natural derivatives of marijuana. That could come in handy in oncology or Alzheimer’s studies.

In the age of pharmacogenetics, of course, it’s no longer unusual for genetic tests to be part of a clinical trial. (Your correspondent fondly remembers working for a magazine organized around the premise that that sort of testing would magically transform drug discovery.) On the legal front, Serio explains, selected states have entirely separate consent forms required just for a genetic test.

In Massachusetts, for example, “even if you have signed an informed consent to participate in a clinical trial, there must be a second consent to undergo genetic testing. Some states are very quiet on these requirements. Others aren’t.”

In general, Serio says, state law is likely to be especially important in the event that something goes awry. “When clinical trials go wrong, and they occasionally do, and people are sued, the central issue is whether or not somebody consented to the therapy they received,” he says. “If you haven’t effectively consented a clinical human subject to a clinical trial, there are many theories of tort that arise and are available to the injured party or the estate of the injured party.”

You won’t find Serio’s book on Amazon.com. Readers can purchase the $49 volume by Barnett International.