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Massachusetts Form 872: What You Should Know

R.8546 — Clinical Trial Coverage Act of 2023 — Congress.gov. What Is This Act All About? The Act seeks to revise the definitions of “covered clinical trial” and “experimental clinical trial” to provide more certainty for participants and researchers and improve the clinical trial process by streamlining the approval process for clinical trials and streamlining disclosure of clinical trial information to participants and researchers. Who Qualifies as the Qualified Individual for a Clinical Trial or a Trial of Experiments and New Developments in Drugs? Qualified individuals can be eligible for a clinical trial, a clinical trial that is part of a larger ongoing or parallel system of research or treatment, or a clinical trial in response to a new or emerging condition. Qualified individuals can be individuals, organizations, partnerships, or corporations. No more than 50 participants per clinical trial are allowed to be eligible to enroll in the trial. If an individual is a participant in more than one clinical trial that is part of a larger study or research project, at least one of the clinical trials the participant participated in will be considered a “covered trial” or an “experimental clinical trial.” Who Needs to Provide Evidence of Eligibility When The Qualified Individual Qualifies for a Clinical Trial? The individual who qualifies for the clinical trial must provide the following when qualifying for participation in a clinical trial: a copy of the Individual Health Care Responsibility Act (the IH CRA), a description of the type of health care payment the individual is eligible to receive; a signed affidavit by the individual that they are eligible for any health care payment (including the premium or other form of payment the individual is eligible to receive); a signed and notarized statement by the qualified individual indicating that the qualified individual is either (1) not receiving health insurance coverage that is not a qualified health plan or (2) the individual is an individual who falls within one of the exempt categories (defined below); and a signed document stating that the individual is a victim of domestic violence, stalking, or human trafficking. The written statement must be provided within a year of receiving the IH CRA; provided more than 180 days; or provided no later than 90 business days after receiving an IH CRA.

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