If choosing to perform a clinical study in the US, there are a few things that should be kept in mind. The Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) regulate several different laws that can affect a clinical study. In addition, there are numerous state-specific laws concerning clinical studies.
Understanding these laws is a very important step in the process of selecting a clinical trial site. Though there are many laws that come into play when performing clinical trials in the US, the following information defines only a few of the laws that manufacturer’s should be aware of.
The Health Insurance Portability and Accountability Act (HIPAA) was established by US Congress in 1996 to improve the efficiency and effectiveness of the health care system in the US. This law gives HHS authority to create and enforce a system of regulations to maintain the accountability and standards for patient information. Clinical laboratories are subject to HIPAA if associated with a health care provider or other HIPAA defined covered entity. Other covered entities are defined as health plans, health care clearinghouses and health care providers who execute certain transactions electronically.
The HIPAA Privacy Rule protects the privacy of patient health information. Failure to implement these standards in a timely manner can result in civil or criminal penalties. However, this rule does not replace Federal, State or other law that offers greater patient privacy protection.
Code of Federal Regulations Title 21 Part 50 (21 CFR Part 50) regulates the protection of human subjects. The code describes the general requirements for informed consent as well as the exceptions, elements and documentation. Subpart D of 21 CFR Part 50 describes additional information for the protection of children in a clinical investigation.
As mentioned previously, the states in the US also have laws that can affect a study. It is highly important to review the different state laws before designating a location. For example, in California it is necessary for a subject participating in the research to sign the Patients’ Bill of Rights along with the informed consent form during the consenting process. The informed consent must include witness signature, statement of placebo used, if any, recovery time, and several other items. Certain states also have laws that dictate language requirements for the Informed Consent and HIPAA forms, who can act as a translator for a non-English speaking person and who can sign if the subject is considered vulnerable.
EN ISO 14155 is the recognized standard for conducting clinical trials for medical devices in EU member states. Similar to the US, there are several variations that are unique across the different member states.
To read the next blog in the series, Selecting an Optimal Study Site in the EU, click here.
Also, check out the previous blog in this series, Responsibilities of an Authorized Representative and US Agent.