The most beneficial method of human genome
research has been that of which human candidates are used. These participants are protected under NIH
regulations and the NIH assumes responsibility for the welfare of these
When studies are conducted using the participation
of human subjects these people are protected by the United States government
under the Federal Policy for the Protection of Human Research Subjects also
known as ‘Common Rule’ (Code of Federal Regulations Tutle 45, Part 46).
All participants of experiments must be fully
aware of the studies at hand, what these studies include, what to expect to
experience in the duration of the studies, and any potential harmful concerns
they might face in the future. A signature
of consent must be obtained by the researcher before any studies can
commence. The Common Rule ensures that
there is a clear agreement between researcher and participant, with a full
understanding of the study and consequences, all legally signed as proof.
For history not to repeat itself the US has
formally developed regulations and protections for participants of
research. An example is shown with the
Tuskegee syphilis experiment where uninformed civilians were infected with the
disease only to be left without medical aid or compensation. The Common rule protects patients against
this type of medical harm, trauma, and discrimination.
After a 26 year gap The
Common Rule finally had a revision made and it was just published a year ago on
Janary 19, 2017. As times change
policies and regulations must be simplified and modernized for the overall
benefit of the research studies at hand.
As we learn more about the use of human
participants and their interactions in the study of genomics we can see that
each person is different and not all can be medically treated with general
care. The overall success of the work in
the research relies on more itemized treatment for each individual.
Given that The Common Rule
is a contract between patient and researchers it is important that the privacy
of each patient is protected. The
studies include many aspects of a patient’s personal data all of which must be
protected. The NIH commits to protect each patient participating in research
under the Informed Consent for Genomics Research Resource.
Because of the extent of the
research done, the studies might go back and reveal not only that individual’s
medical history but also that person’s family medical history down to those who
might carry traits causing illnesses.
These family members might not be involved in these studies yet they are
also protected under these guidelines for the safety of their privacy Although it may be tempting to warn affected
family members of the potential risks found in the studies, their privacy must
be protected, raising controversy and ethical questions for those that have