Are you up on your state's research requirements?
July 1, 2006 6 minutes read
Are you up on your state's research requirements?
You may be surprised by how it affects your IRB
As if it weren't enough keeping track of the intricacies of federal regulation of human subjects research, IRBs also must keep a sharp eye on state law, and the various areas where it puts additional or simply different demands on them.
In general, states don't wade into the federal regulation of research to add more restrictions on researchers and IRBs, says John Isidor, JD, chief executive officer of Schulman Associates IRB, an independent institutional review board in Cincinnati. Isidor is also on the editorial board of IRB Advisor.
Isidor, whose IRB often does work in different states, says that states such as California have added minor wrinkles to research review that savvy IRBs and investigators need to be aware of.
States often make laws regarding delivery of health care that can wind up affecting research, particularly in areas such as age of consent, privacy, and who can make decisions for adults who are unable to consent.
Like Isidor, Paul Below, a clinical research consultant in Burnsville, MN, has kept abreast of various state laws and their implications for researchers. When he speaks to research staff at various sites, he says, "My general impression is that a lot of the doctors are not aware of the nuances. Their expectation is that the local IRBs will know all this stuff, and if it's an issue they'll tell them. I find that that's not a great assumption."
Direct regulation of research
In 1979, the state of California adopted its own Experimental Subjects' Bill of Rights, and required that any person participating in research be given a copy of the document. The listed rights, which include the right to know details about the study and its potential risks and benefits, closely mirror those existing in federal regulations, Isidor says. "It's a pretty benign requirement that just adds another form with little or no value, as far as I'm concerned, to the end of the consent document," he says.
Isidor says that after the 2001 death of Ellen Roche in an asthma study at Johns Hopkins University in Baltimore, lawmakers passed a bill requiring that all research conducted in the state be held to the same level of safeguards as those regulated by OHRP or the FDA.
"I think the [Maryland] attorney general and research participant advocates were the driving force behind this," Isidor says. "They had the legislature's attention because of this well-publicized tragedy at Hopkins."
In Massachusetts, the state's Department of Public Health regulates the use of investigational drugs, requiring investigators to have a special registration to dispense the drugs as controlled substances.
Isidor says that Massachusetts law also requires that when an external IRB not affiliated with a research institution approves an investigational new drug trial, it must visit the investigator's site once a year. Central IRBs operating in the state also have reporting requirements about the extent of their work, he says.
"I'm not sure what Massachusetts does, if anything, with this information, but it is in their administrative regulations," Isidor says.
Age of consent
More commonly, IRBs and investigators run into state requirements that were not directly targeted at research, but spill over from state regulation of health care in general, say Isidor and Below.
For example, rules regarding when and under what circumstances children can consent to health care procedures vary from state to state. While many states use the standard age of consent — 18 years old — in Alabama and Nebraska, the age is 19.
"When I talk to physicians in those states, they generally don't know that," Isidor says. "They just assume it's 18. If they're doing an adult research study and the FDA regulations reference state law in terms of determining the age [of consent], and they enroll an 18-year-old without parental consent, that would be a real problem."
On the other hand, in California, any child older than 7 who is participating in research must give assent, in addition to researchers obtaining parental consent, he says.
Below notes that in many states, minors still can consent to health care procedures and to participation in research if they meet different requirements: marrying, becoming pregnant, joining the military, becoming legally emancipated, or in some states, merely proving that they live independently of their parents or guardians.
Another area where state laws can affect research is in determining who has the right to make medical decisions for adults who cannot make such decisions themselves because they are incapacitated — for example, unconscious from an accident or because of decisional impairments such as mental illness or dementia.
Most states have mechanisms such as advance directives or health care proxies by which people can designate who will make those decisions for them, but in the absence of a document, many states also create a hierarchy of people close to the patient to determine who has the authority to make decisions.
Typically, that hierarchy will include a spouse, parents, adult siblings and adult children. In some states, even close friends or someone in a non-traditional relationship such as a gay or lesbian partner may make decisions for the potential research participant, Isidor says.
Often, this hierarchy only becomes an issue when there are disagreements among the relatives over a health care decision. Below says the most notable recent example of this type of disagreement came not in research, but in the Florida case of Terri Schiavo over a decision to withdraw life support. Schiavo's husband, Michael, eventually prevailed, gaining approval to withdraw life support over the objections of his wife's parents.
"The parents were fighting the spouse and the spouse won, and that was according to the hierarchy defined by Florida state law," Below says. "That would certainly be the case if it were a clinical research issue as well. If a spouse was willing to enroll a patient with Alzheimer's into a trial, but the adult children objected, then the wishes of the spouse would win out."
Isidor says the issue of surrogate decision-making is one that IRBs frequently find themselves grappling with.
"IRBs are concerned about it on a fairly ongoing basis and get opinions from institutional counsel or IRB counsel as to that issue," he says.
Other areas of state law that IRBs should review, according to Isidor and Below:
• Privacy. States may have slightly different, or even more stringent requirements about confidentiality of personal medical information than even the IRBs' usual bane, HIPAA; however, the differences are often minor. Washington state and California, for example, require that a privacy authorization include an expiration date, Isidor says. Some states require a certain type of font on the authorization document.
"Under HIPAA regulations, you can incorporate both the HIPAA authorization and the consent authorization with one signature," he says. "In California, it requires two separate signatures on separate pages."
• Genetic testing. Isidor says some states have specific laws related to informed consent and genetic research, including requiring the use of a specific form when genetic testing is conducted. In some states, the subject has the right to be informed of the results of any genetic testing.
• Referral fees and gifts to doctors. Although both practices are in decline, it's worth learning about any particular state laws that may prohibit fees for referring patients for research or limit gifts from sponsors of studies.
Isidor notes that with the advent of stricter privacy laws, referrals fees are less of an issue these days. "HIPAA has made people more sensitive that they shouldn't be referring patients, particularly referring [protected health information] for compensation or other reasons."
Below says there are a number of useful resources for learning about state laws that apply to IRBs (see box).
He says IRBs should use those resources to find out where in their own state code the relevant laws are found. IRBs should check the citations themselves, to be sure that no new legislation has been passed that may affect them.
State court decisions can create common law that affects IRBs as well, Isidor says.
As if it weren't enough keeping track of the intricacies of federal regulation of human subjects research, IRBs also must keep a sharp eye on state law, and the various areas where it puts additional or simply different demands on them.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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