The age of consent for a clinical trial is 16 in Texas and 18 in most other states. However, in Minnesota, a pregnant or married person of any age is legally eligible. Welcome to the sometimes bewildering maze of disparate state laws governing good clinical practice (GCP) in trials across the country.
“Practitioners don’t always realize there is such a wide discrepancy” in some state laws, says Paul Below, principal clinical research specialist with Astora Women’s Health. “Or, if they know, they don’t always know where to get the precise information for a particular state.”
Broadly speaking, California, Florida, and Texas are the toughest states in terms of requirements meant to ensure patient protection and oversee informed consent. “That’s partially because the biggest states tend to have the most infrastructure” to monitor and regulate clinical trials, Below says. Some of the widest gaps between requirements in different states revolve around protections for relatively more vulnerable patient populations, such as those who are incapacitated, suffer from mental illness, or are in prison, he adds.
“These nuances aren’t defined by the Food and Drug Administration,” Below noted. Further, it’s particularly complicated to navigate different GCP requirements when dealing with drugs or devices related to Alzheimer’s disease or studies involving children.
Below will lead an ACRP webinar focusing on disparate informed consent requirements in states across the country, State Laws that Impact Good Clinical Practice: Focus on Informed Consent, May 4, 2016.