In early March 2015, the U.S. Food and Drug Administration (FDA) released a new draft guidance document on informed consent for clinical trials. The document discusses a variety of ways to present information and gain informed consent from trial patients — including podcasts, interactive websites, graphics and audio visual aids. Electronic signatures are also permitted. The information must be both understandable and adequate. Moreover, the subject’s privacy and all electronic systems must be secure.
In late February 2015, the FDA also approved a personal genetics test for a rare disorder — the first direct-to-consumer genetics test ever approved by the FDA. The FDA had previously not allowed personal genetics tests sold directly to consumers. However, the FDA has now announced that it will classify such tests as Class II devices and not require these tests to go through premarket review.
To sell a genetic screening test directly to consumers, a company may only be required to submit a notification to the FDA. The test must adhere to Clinical Laboratory Improvement Amendments and meet validity requirements. Also, the company will need to notify users of potential risk and provide information on access to genetic counseling.