Page 41 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

As in other types of research, a well trained, ethical investigator is the best
assurance of patient safety in research. Therefore, skilled clinicians should
be chosen as investigators to assure prompt recognition and appropriate
treatment of any observed adverse event or worsening of a pre-existing
condition.
Ethics committees must apply the same vigilant attitude towards herbal
studies as they do towards conventional treatment protocols.

Nowadays, usage of traditional remedies has increased due to
comparatively more costs of modern medicine healthcare and self
medication and greater orientation of traditional remedies towards
preventive health and also the desire of the aging population to stay young
and healthy. However, media publicity together with the improved
research technology tools and growth deciders like new Biotechnology
developments for producing the evidence has thrown traditional knowledge
to the status of a hidden treasure worth exploring. To establish the safety
and efficacy of traditional remedies like other synthetic drugs with the
same procedure is a difficult, as most of them are complex combinations
leading to difficulty in assessment of their activity and risk/benefit ratio.
This involves four sets of issues - chemical-manufacturing-control (CMC)
issues, non-clinical issues, clinical issues, and ethical issues.

Besides Yoga and Naturopathy and Homeopathy, the recognized
traditional systems in Bangladesh are Ayurveda, and Unani. The two
unique features of herbal products used in the traditional Bangladeshi
medical systems are that they are mostly used in compound forms and are
multi-component mixtures including minerals in some of the formulations,
and that important information is available regarding their former human
use, granting safety and efficacy of these formulations. Therefore, a
different approach is required which concerns two groups, namely, clinical
investigators evaluating the benefits and risks of herbal products and the
regulatory authorities.

For the herbal remedies and medicinal plants that are to be clinically
evaluated for use in the Allopathic System and which may later be used in
allopathic hospitals, the procedures laid down by the office of the
Directorate General of Drug Administration for allopathic drugs should be
followed. This does not pertain to guidelines issued for clinical evaluation
of Ayurveda, Unani (AU) drugs or formulations by experts in those
systems of medicine, which may be used later in their own hospitals and
clinics. All the general principles of clinical trials described earlier pertain
also to herbal remedies. However, when clinical trials of herbal drugs used
in recognized Bangladeshi Systems of Medicine and Homeopathy are to be
undertaken in Allopathic Hospitals, physicians from the concerned system
as co-investigators/ collaborators/ members of the expert group is desirable

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 37