Page 47 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

10.5.3 Quality Control

For the maintenance of the quality control of the herbaland herbo-
mineral formulation, Contaminating herbicides and pesticides
levels as well as toxic contaminations must be particularly
addressed. The presence of adulterants should also be ruled out.

For traditional ASU formulations extraction may be done as per
classical method or by a special SOP prepared for it. Information on
each individual plant species used as ingredient must be collected
and authenticated and maintained as voucher specimens. The plant
ingredient should be subjected to pharmacognosy and other
relevant analysis in phytochemistry.

Formulations intended for administration in clinical trials should
be prepared in bulk after standardization, and quality control. The
stability and shelf life studies should also be carried out
simultaneously for marketing purposes.

Regarding informed consent, inducements for participation,
information to be provided to the participant, withdrawal from
study and research involving children or persons with diminished
autonomy, the recommendation should be made earlier. All apply to
trials on plant drugs also. These trials have also got to be approved
by the appropriate scientific and ethical committees of the
concerned Institutes. However, it is preferable that such clinical
trials be carried out with a competent Ayurveda, Unani physician
as a co-investigator in such a clinical trial.

When a Folklore medicine / ethno medicine is ready for
commercialization after it has been scientifically found to be
effective, then the legitimate rights/share of the Tribe or
Community from which the knowledge was gathered should be
taken care of appropriately while applying for the Intellectual
Property Rights and /Patents for the product.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 43