Some advocates of traditional and herbal medicine are convinced that herbal products can be used without subjecting them to the same rigorous scientific evaluation (e.g., requirement for pre-clinical trials) required in Western medicine. It is argued that the current universal scientific procedures and standards are not applicable to remedies with a long history of use in and have been accepted by communities.
However, despite all the arguments against treating research on indigenous herbal medicines differently from Western Medicine, the safety and well- being of participants in herbal research must remain paramount over the desire by any researcher to prove their effectiveness. Thus, basic ethical guidelines, as espoused by many international instruments, are applicable.
The formulation of these ethical guidelines is guided by the TAMA as its policy framework, and the ICH-GCP Guidelines for its scientific and quality underpinnings.
1. In a research that aims to validate the therapeutic or diagnostic value of a traditional herbal preparation,
1.1. There shall be proof of a long history of use of the herbal plant or remedy to be tested. An exhaustive literature search about the therapeutic or diagnostic value of the herbal plants must serve as the background, or justification to the research proposal. Any documents supporting its putative actions and traditional use in the community must be incorporated in the research proposal. Proof of its use may be both in the written, oral, or video form. Evidence regarding usage of the herbal preparation shall be validated with the National Commission on Indigenous Peoples (NCIP), the National Museum, or by an expert opinion, should the need arise.
1.2. The original herbal preparations and manner of use by people in the community shall be similar to the intended form and use in the proposed research. For example, if the herbal plant is applied as a poultice for a condition to be studied, then it shall be given in the same form to the research participants.
1.3. The geographic area, maturity of collection of the plant, and
the method of its preparation must be clearly described.
2. Research in herbal remedies shall include standardization of the preparation and identification of markers to ensure that the ingredients being studied and assessed are the same. This method must be followed all throughout the conduct of research.
3. When the traditional herbal preparation is modified in some way—
either shape or form—including dose, dosage form, mode of administration, herbal medicinal ingredients, methods of preparation and medical indications, it is classified as a herbal product.
4. Herbal product research shall undergo Phases I and II studies prior to Phase III.
4.1. Phase I/II studies shall require the inclusion of the following information in the protocol:
Amount of herbal component;
List of excipients/diluents;
Type of product (tablet, capsule, etc.) and its method of manufacture;
Analysis of putative active ingredient(s) via chemical or biological parameters;
Analysis of a sizeable chemical constituent (analytical marker compound);
Analysis via chemical fingerprint (analytical markers);
Analysis for absence or lack of contamination by pesticides, herbicides, heavy metals;
Presence of synthetic drug adulterants, microbials, toxins, etc.;
Results of dissolution studies; and
Storage conditions and stability over the length of the trial.
4.2. Phase III studies shall require the same information in Phase I/II clinical trials and an environmental impact statement.
5. Once an active principle is identified from the herbal preparation, and there are intentions to synthesize it for research and eventual commercial purposes, any studies thereafter, need to be reviewed, based on the ICH-GCP and Good Manufacturing Practice (GMP) Guidelines.
Informed consent
6. Uncertainty regarding the herbal preparation or product adulteration, interactions between herbal remedies and other entities, minimal toxicity data, and incomplete prior dose finding must be clearly disclosed to all concerned, particularly in the informed consent process (WHO Traditional Medicine Strategy 2002-2005).
Recruitment of volunteers
7. When normal volunteers are recruited, participants must preferably come from the community where the herbal preparations are frequently used.
Participation of traditional healers
8. Cultural settings and expectations must be considered in the review of the proposal, and this may require inviting a traditional healer, or a known scholar of herbal medicines in the REC. The traditional healer is the community’s steward of indigenous knowledge.
Research design
9. Placebo-controlled trials may be accommodated in consonance with the guidelines on the use of placebo as indicated in Guidelines for Clinical Research (page 70).
10. Effectiveness of herbal preparations may not only be measured with improvements in health or disappearance of physical symptoms, and other disease-related variables. It may also be measured in terms of overall health and well-being. However, measuring the quality of life or improvement in well-being shall be objectively measured.
11. Although efficacy of herbal preparations is a major objective of herbal research, adverse reactions such as side effects, tolerance profile, and interaction with other administered preparations shall always be part of herbal research.
12. Blinding in herbal research may be challenging because of the difficulty in preparing control galenicals/concoctions indistinguishable from the herbal preparation being tested. In this case, it is acceptable to “blind”
the health status assessor or evaluator in support of objectivity.
Transport
13. No indigenous materials used in the research may be transported outside the country unless the source (represented by the community leader, government agency, or institution) of the material and the recipient sign a material transfer agreement (MTA).
14. Researchers shall comply with the MTA if plant products or herbal preparations will be tested outside the country. (See International Collaborative Research, Guideline 15)
Benefit sharing
15. When possible, the community from where the herbal preparation/product originates shall be consulted during the course of the research, and the results and benefits of the research shall be shared with this community (WHO, 2005).
16. A memorandum of agreement regarding benefit sharing and patenting conditions, especially for indigenous plant products, shall be set as early as the planning stage of the research.
Commercialization of herbal preparations
17. Researchers shall include provisions for conditions when the herbal preparation or product may likely be commercialized. They shall be guided by existing laws and regulations of the Intellectual Property
Office of the Philippines (IPOPHL).
Safeguarding indigenous knowledge
18. It is recommended that the rich knowledge about indigenous herbal plants in a community must be documented, appropriately recorded, and archived for posterity.