Page 76 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

• Research to derive, induce or study human stem cell
lines of a pluripotent nature from human somatic tissues,
provided that:

When the tissue is from a legally competent person, there was free
and informed consent from the prospective research participant.

When the tissue is from a legally incompetent person (the tissue
has been obtained from a surgical, diagnostic or other legitimate
practice) there was appropriate legally competent third party has
authorized its availability for research.

When the tissue is from a cadaver, there is a legally appropriate
advance directive that appropriately specifies the use of tissue for
stem cell research, or there is authorization from an appropriate
legally competent third party.

• Research involving the grafting of human ES cells, EG
cells, induced pluripotent stem (iPS) cells, or other human
cells that are likely to be pluripotent into non-human
animals, from birth to adulthood, provided that:

The research is designed to reconstitute a specific tissue or organ to
derive a pre-clinical model or to demonstrate that the cells are
pluripotent (e.g., teratoma formation).

These non-human animals grafted with human stem cells will not
be used for reproductive purposes.

There is overwhelming evidence from pre-clinical models for safety
and efficacy. The research is carried out in well-designed clinical
trials.

There is free and informed consent from the prospective research
participants. (CIHR,2010,Canada).

13.9.2 Research that restricted with the Guidelines

The types of research that do not conform to the Guidelines
include:

❑ Research involving the creation of human embryos
specifically to derive stem cell lines or other cell lines of a
pluripotent nature.

❑ Research involving somatic cell nuclear transfer into human
oocytes (cloning) or involving stimulation of an unfertilized egg
to produce a human embryo (parthenogenesis) for the purposes of
developing human embryonic stem cell lines or other cell lines of a
pluripotent nature.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 72