Page 40 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

 Research should be performed on patients undergoing the
procedures for diagnostic or therapeutic purposes and safety
measures should be taken for those as well as for others who may
be exposed to radiation

 The protocol should make adequate requirements for detecting
pregnancies to avoid risks of exposure to the embryo.

 Non-radioactive diagnostic agents are considered as drugs and the
same guidelines that are used for drugs should be followed when
using them.

10.5 TRADITIONAL AYURVEDA, UNANI (AU) REMEDIES AND
MEDICINAL PLANTS

Ethical Issues in Clinical Trials with Herbal Products

Herbal and other traditional pharmacologic therapies are in widespread
use throughout the world. Such widespread use suggests, but does not
assure, that traditional medicines have a favorable risk-benefit ratio.
Rather, traditional medicines may be regarded as a rich source of
potentially attractive therapies. The actual benefits and risks remain to be
evaluated by clinical trials supported and conducted according to the
principles of modern clinical science.

All of the fundamental ethical principles of human participation in
research apply equally to herbal remedies and research involving these
compounds. Consent must be obtained, subject selection must be equitable,
risks and benefits must be weighed and must be favorable to the potential
participant, and experimental design must be sound.

Concerns that particularly apply to clinical trials with herbal products
include:

- Product adulteration
- Interactions between herbal remedies and other entities
- Reproductive and organ toxicity data
- Prior dose finding

The uncertainty in these areas must be clearly disclosed to all concerned,
particularly during the informed consent process.

In many regions of the world, strong belief that herbal medicines will be
beneficial and safe may introduce bias, which can be minimized by careful
attention to study design including appropriate control groups. Where
possible, the community from whom the medicine originates should be
consulted during the course of the research, and the results and benefits of
the research should be shared with this community.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 36