| Challenges to the Value of the Communication |
Individual findings are not “information” worth communicating. These arguments appear likely to fail at Step Two of Central Hudson analysis (no substantial governmental interest in suppressing low-worth communications that are not inherently misleading). Policies to suppress the return of results that lack well-established clinical validity and utility appear particularly likely to fail at Step Two of the analysis. Concerns about analytical validity may also be subject to challenge at Step Two but, if they survive Step Two, appear likely to fail at Steps Three–Four on the basis that suppressing speech is not the least restrictive means to address uncertainty about the value of the information being returned. Returning results is ineffective: even if participants are not harmed by it, they may fail to gain any benefits. Such arguments fail at Step Two (no substantial governmental interest in suppressing low-worth communications that are not inherently misleading).
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| Concerns About Listener Vulnerability |
3. Returning results may expose participants to anxiety. This argument fails at Step Two (no substantial governmental interest in preventing people from feeling anxiety in response to unpleasant factual statements). 4. Participants may misunderstand their results. Some courts reject this justification at Step Two; other courts reject it at Steps Three–Four. The government cannot ban speech that is not inherently misleading. However, the government may be justified in requiring disclosure of the uncertainty and limited clinical validity and utility of experimental genetic test results. Another appropriate speech-preserving response would be for the government to ensure adequate services are available to help people understand their test results. 5. Returning results may cause participants to make bad healthcare decisions that harm them. This argument fails at Steps Three–Four. The proper response is not to suppress speech but instead to regulate physicians and healthcare organizations to deter provision of unneeded and harmful health care. 6. Returning results exposes participants to the risk of stigmatization or discrimination. This concern fails at Steps Three–Four. Proper response is not to suppress communication of genetic test results but instead to pass laws such as the Genetic Information Nondiscrimination Act to tackle stigmatization and discrimination directly. 7. Participants' preferences to receive return of results may not reflect what they actually want. This has not been litigated. First Amendment doctrine accepts that listeners are the best parties to assess their own desire to partake of communication, and First Amendment law generally does not second-guess them. The exception would be if the listener meets criteria for decisional incompetence under the law of the state where the communication takes place—a standard that few people who have been permitted to participate in genetic research would meet.
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| Concerns About Broader Economic and Social Harms to the Public |
8. Returning results may cause participants to over-consume follow-up healthcare services. Arguments that “speech has bad consequences” generally fail at Steps Three–Four. The proper response is not to suppress speech but to regulate physicians and healthcare organizations to deter provision of wasteful healthcare services. 9. The cost of returning results may harm the research enterprise. This is another “speech has bad consequences” argument that would fail at Steps Three– Four. Suppressing speech is neither a direct nor least-restrictive way to address the national challenge of financing biomedical research. More-over, the alleged high cost of returning results often reflects bioethicists' assumption that researchers must fully validate research results before they return them. Returning less-fully validated results with appropriate disclosure of the uncertainties would address the cost problem effectively without burdening free speech. 10. Participants may corrupt genetic understanding as they attempt to decipher the meaning of their test results. This argument implicates core First Amendment speech. It fails not as an intrusion on commercial speech, but as an intrusion on core First Amendment speech.
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