Page 18 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

05. PREGNANT / NURSING WOMEN AND CHILDREN IN A
RESEARCH

5.1 Pregnant / nursing women:

It is always best to avoid involvement of pregnant or nursing mother in
a research except if any trial which gatherer new knowledge on pregnancy,
fetus & lactation where non-pregnant or non-nursing women are not
suitable participant. The research should be well designed in such a way
that protect or advance the health of pregnant or nursing women or fetus
or nursing infants and no more than minimal risk.

a. Justification of participation:

● It is mandatory to describe the opportunity and benefits to
the women as a participant in a study e.g. Investigations, drugs,
vaccines or therapeutic or preventive benefits. Example: Trials are-
test the efficacy and safety of a drug for reducing perinatal
transmission of HIV infection from mother to child; trials for
detecting fetal abnormalities and for conditions associated with or
aggravated by pregnancy etc. Deprivation from any opportunity
and benefit is unethical.

● Women should not be encouraged to discontinue nursing
without proper assessment where breast feeding is harmful to the
infant and compensation of supplementary food should be
considered.

b. Termination of pregnancy: In any time or as a research participant
women who desire to undergo Medical Termination of Pregnancy (MTP)
should be strictly fallow the Penal Code 1860 and Bangladesh Institute of
Law and international Affairs, 1979.

c. Pre-natal diagnostic procedure: Research involved in prenatal
diagnostic technique to detect foetal genetic disorders or any abnormalities
should follow WHO guideline. (Genomic resource center, Gender &
Genetics, Sex Selection & Discrimination, http://www.who.int/ genomics/
gender/en/index4.html)

5.2. Children:

Consideration should be taken before involve a children as study
participant.

a. Involvement of children in a research as a participant should not
be carried out equally well with adults.
b. Children participate in the research to obtain knowledge regarding
their health needs.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 14