Page 68 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

• That genetic information derived from human specimens might,
upon anonymization, be publicly announced in an academic society,
etc.
• The methods of preserving and using the human specimens.
• The method of preservation, use or disposal of human specimens
after the completion of research (including the possibility of using
them in other research and the details of the predicted research).

• When human specimens might be provided to a human cell, gene or
tissue bank for division and distribution as general research
resources, the academic significance of the bank concerned, the
name of the organization operating the bank, the method of
anonymization for the human specimens being provided, and the
name of the responsible person at the bank.

• Information related to the use of genetic counseling (for instance,
that genetic counseling is available in the case of single-gene
disorders or the like).

• The method of raising research funds.

• That the donation of human specimens is without compensation.

• Information regarding the address and other details of contact
points for inquiries (for instance, the correction of personal
information and the revocation of consent) and complaints, etc.

13.7 Human Genome/ Gene analysis, Genetic screening and
diagnosis

Genomic research is an upcoming field which is fast emerging after the
results of human genome project were made publicly accessible. It involves
the study of genes (ANNEXURE –A). Advances in technology such as
microarray, RT-PCR, flow cytometry etc and ample funding opportunities,
both national and international, increase in commercial interest, more
public awareness on personalized medicine, and media coverage have
increased genetic research as well as whole genome research. These
developments have raised many ethical issues associated with genetic
research those are needed to be addressed.

13.7.1 Prenatal Diagnosis

Screening for genetic defects in a fetus or embryo during pregnancy
has evolved significantly over the last decade. It may involve
investigations carried out in the mother or the fetus. Prenatal
diagnosis refers to tests carried out in the embryo or fetal tissue
before it is born to detect certain genetic features or defects. In
contrast, prenatal screening is testing for diseases or conditions in
a fetus and carried out in mother or on fetal biological material for
suspected genetic conditions through standard protocols.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 64