Viability is defined as the ability of
the fetus to survive, given the benefit of available medical therapy, to the
point of independently maintaining heart beat and respiration.
of uncertain viability may be involved in research only if there is no added
risk to the fetus, or the purpose of the research is to enhance the possibility
of survival to the point of viability.
Informed consent must be
obtained from the legally competent mother or father, or either parent’s
legally authorized representative.
a fetus is determined to be non-viable, it may only be involved in research if:
vital functions of the fetus will not be artificially maintained.
experimental activities which of themselves would terminate the heartbeat or
respiration of the fetus will be employed.
will be no additional risk to the neonate.
purpose of the research is the development of important biomedical knowledge
that cannot obtained by any other means.
a fetus is viable after delivery, it is a child. Federal regulations governing research involving a viable
newborn is explained under research involving children.
(END TEXT UNDER LINKS FROM PARAGRAPH 3/THE
FOLLOWING IS PARAGRAPH 4 AND CONTINUED TEXT UNDER “Risk and Levels of IRB
Note: depending on the research, other subjects may be deemed as
vulnerable as well. Before submitting
an application to the IRB, you should understand the protections you must
employ in your research protocol to protect these groups of people.
Federal regulations mandate other safeguards to protect human subjects
when research involves: confidential records and/orpathological/diagnostic specimens, previously collected data, research
subjects are being audio and/or videotaped, ethnographic research, or international studies (research conducted in foreign countries).