Page 58 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

13. HUMAN GENETIC AND GENOMIC RESEARCH

13.1 Areas of Concern

Highly sophisticated molecular biological tools, gene sequencing
techniques, high throughput microarray generated information have led to
the deciphering of the human genome and understanding diseases and
traits linked to mutations which result in a host of dysfunctions related to
not only autosomal and recessive disorders but also can determine genes
that are abnormal or atypical in a variety of disorders. This has set the
scene for rapid availability of understanding the knowledge on genetics
related to public health, regenerative organ transplantation therapy,
infertility, malignancy, gene therapy, general well being and can
pinpoint defects and genetic traits in the individual and predict
consequences on future progenies. Thus, human genetics and genomics are
powerful tools in the biomedical field and Funding from public and
private resources has become available to rapidly facilitate
research in this area. It is important to understand that there
should be no limitation in the use of latest gene based technology
in understanding genetic factors related to health which are
beneficial but also have the capacity for dangerous ethical consequences
relating to security and potential risk to individuals and families.

Therefore, control and proper guidelines for human genetics and genomic
research are of great importance to communities and populations globally.
It is of even more importance for people living in regions where the
capacity to understand the consequences of genetic research is limited due
to lack of education. Thus all countries, especially populations living in the
developing and under developing regions of the world need to follow
strict guidelines on research on human genetics so as to control and
carefully use and disseminate information generated such that it does not
lead to misuse or commercial acquisition and thereby damage lives of
individuals and populations.Based on the negative repercussions that such
research generates a strict ethical guideline is needed universally and in
the national context.

The requirement of careful monitoring and scrutiny of progress and
advances in the field of genetics/genomics is needed for development and
response to emerging ethical issues promptly and with extreme caution.
Due to the very quick pace that developments are happening in the field
all ethical guidelines related to this field needs to be constantly updated
and guidelines modified effectively. Therefore, emphases are given for
developing ethical guidelines in areas where genetic/genomic
information can be most sensitive and include:

a. What controlling, monitoring and regulatory bodies/organizations
should be there regarding various aspects of genetic research at the

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 54