Page 19 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

c. Consent should be taken from the Parent or legal guardian (If,
parents are not alive / unable to give concern) of each child before
inclusion in the study.
d. Consent from each child should be taken to the extent of the child’s
intelligence and capabilities, such as in the case of mature minors
from the age of seven years up to the age of 18 years.
e. Study should be well designed that ensure adequate medical and
psychological support to the parent and children.
f. The parent or guardian is given the opportunity to observe the
research as it proceeds, so as to be able to withdraw the child if they
decide that it is in the child’s best interest to do so. (Forum of Ethics
Review Committees - Sri Lanka, 2007)
g. Any child at any moment want to withdraw / refused to participate
from the study even their parent / guardian has been given consent
should be respect unless there is no acceptable alternative
medically recognized therapy.
h. Participation of children in a clinical evaluation of new drug trial is
permitted only after phase III clinical trial in adult. On the basis of
a therapeutic value of a drug in a primary disease of children, study
can be carried out earlier.
i. Study design of intervention to the individual child participant for
the benefit of diagnostic, preventive or therapeutic purpose should
be justified in relation to anticipated risks involved in the study and
anticipated benefits to society.
j. Intervention that applied to the individual child participant for the
therapeutic benefit should be at least advantageous as any
available alternative interventions.
k. The benefit & risk of the individual child participant should be
intended before intervention. Otherwise benefit will be low when
compared to the knowledge that is to be gained.

5.3 Vulnerable groups:

Effort may be made to ensure that individuals or communities invited
for research be selected in such a way that the burdens and benefits of the

research are equally distributed.
a. Racial equalities should be maintained on genetic research.

b. For the benefit of research economically or socially disadvantaged

persons should not be used when there are person better off them.
c. Rights and welfare of mentally challenged and mentally differently
able persons who are incapable of giving informed consent or those
with behavioral disorders must be protected. Appropriate proxy

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 15