657cover information about data security and about the governance structure and the
mechanism for considering research protocols in the future. The right to withdraw
consent at any time, for any reason, and without repercussions is a central compo-
nent of existing research ethics statements. That right, which must include the
destruction of tissue samples and written information, must, so far as possible, be
respected and be part of the whole-genome research ethics process. In addition, the
fact that this right may be severely limited once data are disseminated must be
clearly communicated as part of the initial informed consent process.
Scientists also must look into the connection between how data and samples are
collected, stored, and disseminated and the participant’s ability to withdraw from
subsequent use. This issue will need to be considered on a case-by-case basis per
project. In addition, the process of disclosing results to participants should provide
them with suffi cient interpretive information. These results should be scientifi cally
valid, confi rmed, and should have signifi cant implications for the subject’s health
and well-being. The studies also should be structured with plans to return other forms
of signifi cant non-health-related data as well. Data-release policies must balance the
benefi ts and requirements of access and privacy interests, and the rationales for these
policies must be explained, justifi ed, and considered acceptable by an ethics review
entity. For potential participants in whole-genome association studies, the implica-
tions of this data release must be disclosed, and the fi nality of the release process and
its potential implications on privacy must be explained to the participant.
Ethical Aspects of Direct-to-Consumer Genetic Services
Advertising for direct-to-consumer (DTC) genetic screening tests that lack indepen-
dent professional oversight raises troubling questions about appropriate use and
interpretation of these tests by consumers and carries implications for the standards
of patient care (Geransar and Einsiedel 2008 ). Concern has been expressed that
these premature attempts at popularizing genetic testing neglect key aspects of the
established multifaceted evaluation of genetic tests for clinical applications and
could confound treatment or complicate doctor-patient relations (Hunter et al. 2008 ).
A statement released by the American College of Medicine Genetics Board of
Directors in 2003 states: “Genetic tests of individuals or families for the presence of
or susceptibility to disease are medical tests. At the present time, genetic testing
should be provided to the public only through the services of an appropriately quali-
fi ed health care professional. The health care professional should be responsible for
both ordering and interpreting the genetic tests, as well as for pretest and posttest
counseling of individuals and families regarding the medical signifi cance of test
results and the need, if any, for follow-up. Due to the complexities of genetic testing
and counseling, the self-ordering of genetic tests by patients over the telephone or
the Internet, and their use of genetic “home testing” kits, is potentially harmful.
Potential harms include inappropriate test utilization, misinterpretation of test
results, lack of necessary follow-up, and other adverse consequences.”
Ethical Aspects of Genetic Information