Know various state regulations to avoid obstacles during IRB process
It's important to ask for legal interpretations
IRBs often are involved with studies that involve sites in other states, which raise a host of concerns and complications.
For example, these questions might be considered:
- What is the state's age of consent?
- Does the state have specific informed consent requirements?
- Are there disclosure/privacy concerns of the state that go beyond federal regulations?
"Another big question involves HIV testing because each state's laws are different," says Terri Majors, administrator and president of the Ethical Review Committee of Independence, MO.
"If you do HIV testing in your research study, there are some states that require a special consent," Majors adds. "And some require pre-test counseling."
Other examples of specific state laws include a state's requirement that research organizations have patients sign a specific consent form before their medical records can be accessed for research, Majors says.
"If the patient objects to the release then the records must not be released," she says. "And the release might be open-ended and not have a date of expiration, but the patients must be told they can revoke it at any time."
Also, some states have detailed hierarchies about who can act as a legally authorized representative, and some of these are applied to research while others do not specify research studies, says John Isidor, JD, chief executive officer of Schulman Associates IRB in Cincinnati, OH.
Some of the most complicated state regulations about research involve decisionally impaired participants and surrogate decision makers, Isidor notes.
For example, in New York there are different rule interpretations about legally authorized representatives within the state, Isidor says.
"Within different institutions in New York, they have different interpretations of what the law is," he says. "In the end, the IRB in concert with the investigator will decide what is appropriate."
Generally, there are four different types of laws that impact IRBs, says Cami Gearhart, JD, chief executive officer of Quorum Review in Seattle, WA. Gearhart also is the 2008 chair of the Consortium of Independent Review Boards (CIRB) in Washington, DC. They are as follows:
1. Laws that affect the IRB's ability to function in the state: The state of Massachusetts is a good example of a state that has these types of laws, Gearhart says.
Massachusetts requires IRBs to make annual site visits and submit regular reports throughout the year, Gearhart explains.
"It's not always clear from the regulations or guidance the state provides us exactly how we're supposed to conduct those site visits," she notes. "Fortunately there are experienced site visitors in the state of Massachusetts to help us."
2. Laws that affect the criteria the IRB uses when reviewing a study: State laws regarding the age of majority are an example of this, Gearhart says.
Other examples include circumstances where minors can consent to research and limitations on research involving pregnant women and the fetus.
3. Regulations regarding the language included in informed consent forms: These types of regulations include the HIV testing and disclosure conditions, Gearhart says.
For instance, consent forms sometimes must have special language that warns participants that the results of an HIV test or a sexually transmitted disease test might be reported to public health officials, Gearhart says.
"There is one state where for HIV testing a separate consent process is required," she adds.
Another specific example can be found in California, where there is a requirement that the informed consent form contain a description of the participant's recovery time during certain clinical trials, Gearhart says.
This type of requirement is difficult to interpret, so IRBs often end up working with sponsors on a study-by-study basis to interpret it as best they can, she adds.
4. Laws that affect how a site conducts clinical research: While IRBs sometimes do not have to get as involved in ensuring that those laws are followed, there are times when the boards must pay attention to these.
For example, these types of laws include state regulations that require a separate consent process for HIV testing, and this is something an IRB would want to know about, Gearhart says.
Gearhart, Isidor, and Majors offer these suggestions for how an IRB might learn and interpret various state laws impacting research and ethical reviews:
• Know your own state's requirements. "Local IRBs need to know their own states," Majors says. "Regulations change."
Majors has come across instances where there is a discrepancy between the information that a state commonly requires from an IRB and what the regulations suggest.
So in addition to knowing what the state requires on paper, IRBs need to know how state officials have generally interpreted this knowledge.
"I've gone on the state's web site trying to verify information," Majors says.
State officials might be able to accurately answer questions about whether there is a state law on a particular subject and where to find it, but they cannot provide legal opinions, Isidor says.
• Rely on professional legal advice when interpreting state regulations. That's why the best and most accurate way to determine how a state interprets its own regulations is to hire an attorney for this role and make a rational decision based on this legal interpretation, Isidor says.
"To me if you obtain a law from a state where there are no legal interpretations about how that law has been applied through case law, and you act on it in a rational way and justify it, you should be fine," Isidor says.
"Interpretation of laws are left to the courts," Isidor says.
This is why it's best to ask for legal advice.
"You cannot call the state to find out how they interpret the regulation," Isidor says. "State officials would be exposing themselves to liability."
"I don't think you can be a competent IRB in the United States without having a competent lawyer as a participant on your board or as a consultant to the board if the board raises an issue that needs legal interpretation," Isidor says.
Schulman Associates IRB has four lawyers, three of whom are health care lawyers, and when they need to research state laws they have access to a variety of legal web site services, Isidor says.
• Invest in a guide or service that provides updates. It might save an IRB staff's time if the IRB subscribes to a service that provides updates on state laws regarding research, Majors says.
For example, Barnett Educational Services, a division of PAREXEL International Corporation, has a guide, called the State-by-State Clinical Trial Requirements Reference Guide.
The guide has 50 detailed state profiles, detailing mandatory notifications, age of consent standards, informed consent and IRB standards, and other pertinent information.
CIRB has a legally vetted service that provides regular updates on state research laws, and it's available through CIRB or through subscription to the Guide to Good Clinical Practice," Isidor says.
"The cost to develop it was substantial," says Isidor, who was involved in its creation. "The cost to maintain it also is substantial because there are areas of laws that can change [often], and you have to keep on top of it."
CIRB was the first organization to collect state law requirements of clinical research, Gearhart says.
"CIRB built this repository and then realized it was quite a task to keep it up," Gearhart says. "So we transferred the information to a commercial undertaking, and www.clinlaw.com now is managed by Thomson Publishing as a subscription service that is free for CIRB members."
• Ask for information from other IRBs, researchers, or sponsors. "One approach we use, and a number of multi-site IRBs use it, is to ask researchers themselves to notify us of laws they're aware of," Gearhart says. "We have to take the information with a grain of salt because we've had one state where folks keep notifying us of a provision that affects recruitment materials, and as far as we can tell the provision was repealed years ago."
Likewise, IRBs should let researchers know about particular laws and requirements when the IRB learns about them.
"One multi-state, independent IRB will send information to a researcher if requested about laws of their state," Gearhart notes.
Quorum Review also will send information to researchers occasionally.
"One of the most difficult areas for researchers is knowing when it's appropriate to use a legally authorized representative to provide proxy consent on the behalf of an adult who can't provide it on their own," Gearhart says. "When we have a researcher who wants to use a legally authorized representative, we do send them a summary of state laws so they're aware of laws across the country, as well as in their own state."
Sometimes sponsors will have contacts within a state that could help with identifying and interpreting state regulations, Gearhart says.
"Sometimes they want to help address the state law issue for the sites, and other times they want to leave it to the sites to tailor their consent forms to conform to state laws," Gearhart adds.
It's wise to check with IRBs within a state when there's a question about that state's research regulations, Gearhart suggests.
"For example, some years ago we were looking into a medical records release law in Maryland that seemed more restrictive than federal law or other state regulations, so we contacted a Johns Hopkins University IRB," Gearhart recalls. "They explained their rationale."
Majors has contacted national organizations, such as CIRB, with questions about state regulations.
"I'll contact other CIRB members and say, 'Can you give me guidance on this?' or 'This is what I found out, what is your interpretation? What is your experience?'" she says.
IRBs often are involved with studies that involve sites in other states, which raise a host of concerns and complications.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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