DNA testing has gained popularity after it became available on the web. The act of swabbing the inside of a cheek or spitting into a tube then placing the specimen in the mail made discovering genetic traits accessible. 23andMe, a web-based genetic testing company, has opt-out forms on their site but they were difficult to find and often people were unaware their information was being used for unspecified research studies.
Social media giant Facebook revealed that the data of up to 87 million users might have been improperly shared with a political consulting firm. Facebook’s users trusted Facebook to keep their information private and this breach has users wondering how much of their data has been harvested by outside companies. In light of the Facebook information gathering and sharing debacle I wondered if sites such as 23andMe made their opt out of research information easily accessible. I went to 23andMe’s website and took time to navigate and read through all of their consent information. 23andMe cannot be accused of not informing the public of their intent to use DNA samples for research. The research consent document details the numerous ways in which genetic information may be used. The form discloses the diverse questions that may be asked by a person consenting to the use of their DNA for research. In most cases, identifiers would be stripped from the genetic results, but sexual orientation, health information, etc., would be passed along for an undetermined amount of time. Another exception noted was identifiers would be removed in the United States, but if the information gathered was given to researchers in another country, personal information would be shared according to the laws of that country. Consumers have the option to opt out of research studies at any point, yet I don’t believe this is enough.
Websites, whether they are social media or genetic testing sites, are used to connect to others.
Facebook and 23andMe have user agreements and the act of setting up an account implies consent to the user agreement. Users of these sites consent to the rules of the website but are not informed of how their information will be processed. Therefore, they agree to the terms of use but are not informed when they create accounts of the benefits and harms that may come from using the website's tools. Implied consent does not equal informed consent.
Informed consent is more than a consent form. It is a procedure in which a person is given sufficient information about a study so that they may make an absolute informed decision about their participation in a research study. The FDA has outlined requirements for informed consent in 21 CFR 50.20 and 21 CFR 50.25.
General Requirements for
Informed Consent Except as provided in §§ 50.23 and 50.24, no investigator may
involve a human being as a subject in research covered by these regulations
unless the investigator has obtained the legally effective informed consent of
the subject or the subject’s legally authorized representative. An investigator
shall seek such consent only under circumstances that provide the prospective
subject or the representative sufficient opportunity to consider whether or not
to participate and that minimize the possibility of coercion or undue
influence. The information that is given to the subject or the representative
shall be in language understandable to the subject or the representative. No
informed consent, whether oral or written, may include any exculpatory language
through which the subject or the representative is made to waive or appear to
waive any of the subject’s legal rights, or releases or appears to release the
investigator, the sponsor, the institution, or its agents from liability for
negligence. (21 CFR 50.20.)
Research paradigms consist of various forms.Some may argue informed consent may not be necessary for the use of data gathered from mining large datasets or de-identified biospecimens, because risks are low for those whose specimens or information is being used in the study. If individual informed consent is mandatory for the use of the mined data or specimens there is the potential research would be impeded or made infeasible or selection bias may occur.
On the other hand, people use social media and mobile devices contributing their data to large databases in numerous ways and may be unaware of multiple companies gathering and storing their information for future use. Occasionally people are notified in general terms about the use of their data. However, when Facebook and Twitter were found to have gathered and shared data and empirical research about its users’, reactions from users of the sites were strong. Some people feel strongly about being asked to consent to research projects especially those which may not reflect their personal beliefs.
Companies that mine data from large data sets or de-identified biospecimens face potential problems. Facebook is currently being reviewed by Congress for sharing user information with others. Companies like 23ndMe may face the same issues. Mining and sharing of information from large data sets or de-identified biospecimens may be considered low risk to the individual but it conflicts with the ethics and laws surrounding research. Informed consent allows a subject to understand and choose to participate in a study whereas mining large data and de-identified biospecimens reduces the subject’s autonomy.