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This case study involves the ethical concerns of Direct-to-Consumer (DTC) genetic testing at Veritas Diagnostics, Inc. (VDI) from the perspective of an Ethics Officer. There are a number of recommendations that I have for VDI that will serve to protect its standing as a reputable, quality, and ethical company with this roll-out of DTC genetic testing, all of which I will discuss independently starting with legal requirements surrounding this industry. There are some federal, international, and state laws that address DTC genetic testing that we must review and adhere to where applicable. None of these laws are “crystal clear”, but nonetheless do provide some guidance as to how DTC genetic testing should be offered to the public. The Federal Trade Commission (FTC) is responsible on a federal level to protect consumers from deceptive marketing and advertising, but have not thus far enacted any public policy on DTC genetic testing kits other than regulating lab created kits (what they call medical devices) insofar as the DTC company must undergo premarket review prior to the product being marketed. The United States and Europe both have laws in place that prevent false advertisements on a variety of consumer products, but there have not yet been any specific laws passed pertaining to DTC genetic tests specifically. On the state level DTC genetic testing is actually illegal in some states, such as New York and California, and they have served cease and desist letters to several DTC companies. Being so, our website must clearly state that consumers from these states and others like them are not permitted to purchase our DTC testing kits, and further to that, we must have measures in place to not mail any kits to addresses in those states. We also must be aware of our advertising campaigns and stay away from making false claims of testing utilities as other companies in our industry have not. An example of this is a DTC company, Myriad, that has been involved in scandals pertaining to false advertising of their BRAC testing kits; they have likely lost some of their consumer trust due to this, which is not something that VDI should do. Consumers, after all, are our revenue, and breaking their trust will result in loss of revenue. Due to the fact that the laws are not very specific when it comes to DTC genetic testing, I think the best that we can do is to rigidly follow the laws that do pertain to our DTC market, which cover our advertising practices. This will ensure that we are operating in a legal manner as well as an ethical one. Our consumers will not continue to respect us if they see that we are trying to trick them with puffery and false advertising practices. Other than the limited legal requirements that must be followed, one of the biggest issues in this industry is privacy. As noted by the Vice President of VDI, privacy is indeed a prime concern when it comes to DTC genetic testing, and rightfully so. DNA is a unique identifier for every person on the planet, with no person’s being the same as another’s. Being so, how can genetic information ever be truly private or anonymous once collected? VDI cannot solve this, nor can any other DTC genetic testing company, but at least we can take measures to protect our consumers’ privacy to the fullest extent possible. There are three key areas of privacy that should be addressed: genetic data submitted by consumers, security of genetic data, and third party disclosures of genetic data. Regarding the genetic data submitted by consumers, there is little control over the data being submitted – whose DNA is it? The consumer’s, or someone else’s? Like most companies, VDI should require the consumer to verify that they have legal authority to request genetic testing when submitting DNA samples, but there do not seem to be additional provisions in place to ensure that they truly do have that authority. Furthermore, does the consumer understand the legal ramifications of submitting DNA...
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