Page 33 - Genomic Medicine in Emerging Economies

22 CHAPTER 2: Taking Genomics From the Bench to the Bedside in Developing Countries

linked to the health care consumers’ understanding and acceptance of this
relatively new concept. Individuals must be willing to gather and use genetic
information in their health decisions, to share this information with their
health care providers, and also to self-monitor and manage their health-related
behaviors. Understanding how the public perceives genetics and genomics
research, what their concerns and expectations are, and their attitude toward
using genetic information in health decisions is critically important for the
planning and provision of genetic services (Etchegary et al., 2013; Zimmern
and Khoury, 2012).
j Set up regulatory frameworks to oversee the ethical conduct of genomic
research.

Limited research infrastructures and poorly developed research and eth-
ics governance mechanisms have posed challenges for both researchers and
ethics committees, especially in the developing world (Dissanayake and
Barash, 2016). A sustainable and equitable process from genomics research
to public health interventions requires well-established ethics standards and
policies, especially in developing countries. Research in this field must meet
the highest ethical, legal, and socially appropriate standards, and also be
accompanied by effective policies to ensure that products and outcomes tar-
get the greatest needs of public health and of individuals (Pang, 2013). For
genomic medicine research to be fully translated into clinical care, it is essen-
tial for researchers to engage stakeholders who ultimately regulate the use of
genomic technologies and therapeutics within health care practice (O’Daniel
and Berg, 2016). Genome sequencing research and clinical applications can
involve sensitive information such as personal data (e.g., name, gender, date
of birth, and race), medical history, and family history of disease. Such infor-
mation should be handled carefully with restricted regulations to protect the
privacy and maintain the anonymity of the source of the sample, as is the
case in most parts of the developed world. However, in the developing world,
genome research is rare or negligible. In addition, the overall weak infrastruc-
ture and the weak or nonexistent regulatory frameworks (such as established
legal and ethical conventions that stipulate quality and proficiency standards,
and specimen shipment requirements) pose major hindrances that limit the
capacity of a country to participate in genomic research. Often the scrutiny and
rules set by international research ethics communities are not imposed, and
resources for strict enforcement of these regulations are almost nonexistent.
It is therefore necessary to set up regulatory frameworks to oversee the ethical
conduct of genomic research as well as increase the capacity of existing eth-
ics review committees to review and monitor genomic research. Thus research
ethics committees must be put in place to guide clinicians and researchers in
conducting research within the boundaries of ethical regulatory frameworks.
There is also the need for development of a greater understanding of genomics