We developed a standard TCRB informed consent document that explained open access databases and their associated risks, and gave participants the option to choose whether or not to allow genomic data obtained from their specimens to be released to open access databases. The consent form explained both open access and controlled access databases, and specified that, because open access databases are freely available to the public, the privacy risks associated with open access databases may be greater than with controlled access databases.
The consent form covered the following main points with regard to open access databases:
- An open access database is a scientific database that anyone on the Internet can access.
- If the participant agreed, we may submit his or her genetic and health information into an open access database. We would not deposit any personal information, like name, address, or social security number, into any scientific database.
- Depositing genetic and health information into an open access database makes it easier for more researchers to access it and use it for their studies.
- Because genetic information is unique to an individual, it is possible for someone to trace it back to that person.
- Though the risks to participants may be small, if someone were to trace genetic information back to an individual, that information could be used to discriminate against that participant. It is also possible that someone could trace genetic information back to participants’ biological family members. There may also be other risks that cannot be predicted at this time.
The informed consent process involved a discussion with a member of the research team, during which the participants were encouraged to ask any questions they had. It was our goal that by providing potential participants with this information, as well as the opportunity to opt out of open access data sharing, to respect participant autonomy and help them to make educated decisions about the use of their samples and genomic data.
Participant Education & Understanding Assessment
To further ensure participant understanding of open access databases and the related privacy risks, we developed an education session that reviewed some of the main points of the consent form in a question and answer format, using visual aids where appropriate. You can download the open access database education session here.
Immediately following the education session, we asked participants to complete a short, 15-question survey that assessed: 1) objective understanding of open access databases and related privacy risks, 2) subjective understanding, 3) comfort with decision to participate, 4) risk tolerance, and 5) perspective toward balancing privacy with utility of genomic data in research. At the end of the survey participants reviewed the correct answers to the objective understanding questions.
Once the participants completed the education session and survey, they were given the opportunity to change their decision regarding open access data release.