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6 Critical ethical principles associated with research in traditional medicine

Dr. Garima Pandey | Oct 10, 2016 | 10,620 views
Ethical principles of publishing traditional medicine research

In recent years, there has been a substantial debate on the ethics of research in traditional medicine (TM). In general, the controversies have revolved around the unreasonable harvesting of medicinal plants from the wild, ethical accountability of researchers towards local knowledge holders, and the credibility of TM as a complementary and alternative mode of treatment [1]. Since increased publications are the only way to maximize research outreach, it is important to understand the ethical principles governing publication in TM journals. There are six broad things to consider here:

  1. Ethical policies and declarations
  2. Sustenance
  3. Scientific validation
  4. Informed consent
  5. Proprietary issues
  6. Reporting standards

1. Ethical policies and declarations

The Helsinki declaration outlined the basic ethics of human experimentation and marked the beginning of resolutions and policies in research studies. However, the Chiang Mai declaration (March 1988), the WHO Traditional Medicines Strategy 2002–2005, and the WHO general guidelines for Methodologies on Research and Evaluation of Traditional Medicine have a greater focus on the ethical principles for research in TM. For example:

2. Sustenance is key

Fundamentally, traditional knowledge and expertise should be approached in respectful and ethnically appropriate ways that benefit the involved communities without disturbing the community ecosystem. The research design must have some social value and inculcate awareness to help improve health and socio-economic conditions of the community. Ultimately, there should be a balance between the need to document traditional knowledge and the need to ensure protection against unfair or harmful use of the knowledge and exploitation of interrelated biocultural resources. However, respect for parallel processes is also about ensuring that one belief, process, or system of knowing does not undermine the other. Thus, while the research methodology should guarantee the safety and efficacy of herbal medicines and traditional procedure-based therapies, it should not thwart the application and development of TM [7].
 
3. Scientific validation

Scientific validation is the prerequisite for useful interpretation and wider acceptance of TM. Institutional recognition and support must be provided to Research Ethics Boards or Review Boards. Since the same TM may be used by different communities to cure different ailments, scientific validation in each case using standard or modified methods is imperative. Validation studies must consider adequate sample sizes and ensure unbiased outcome measurements. Validation studies should include dosage and standardization, and ensure the safety and efficacy of biologically active substances before large-scale clinical trials are conducted [3].

 

Randomized controlled trials should be presented according to the CONSORT guidelines. During manuscript submission, authors must provide the CONSORT checklist accompanied by a flow diagram illustrating the progress of patients through the trial, including recruitment, enrollment, randomization, withdrawal and completion, and a detailed description of the randomization procedure [6].

4. Informed consent

Informed consent is a term used to mean informed, voluntary, and decisionally-capacitated consent obtained from study participants. The simplest rationale for informed consent is that it protects participants' health, welfare, and personal integrity. Alternatively, informed consent safeguards the informants against such deontological offenses as assault, deceit, coercion, and exploitation [7].

The ethical principles governing TM research demand that researchers must respect, preserve, and maintain traditional knowledge, innovations, and practices. Studies on patients or volunteers require ethics committee approval and informed consent, which should be documented in the published research article. It is mandatory to share the objectives and method outline of the study as part of the informed consent procedure. The individuals should be made aware of their right to refuse to participate in the research. Additionally, the researcher is ethically bound to maintain the confidentiality of the information collected (in the case of clinical studies) [6].
 
5. Proprietary issues

Researchers evaluating traditional medicines need to recognize that the customary owner, and often that owner’s country of origin, holds rights over the knowledge being evaluated. This has consequences for patenting. If a patent is sought by a nonindigenous group, prior informed consent and benefit-sharing with customary owners must be established. TM journals protect intellectual property rights by ensuring that the origin of traditional knowledge is traceable, prior informed consent of knowledge holders and source communities is documented, knowledge holders retain rights over knowledge, due credits are given to knowledge holders, and benefits are shared equitably among contributors [8].

6. Reporting standards

Unfortunately, there is no widely accepted template for documenting TM knowledge. However, such studies must be supported by extensive data, especially if the knowledge is documented to develop innovations. Information on gathering, cultivation, preparation, storage, and seasonal and altitudinal variation of active compounds is of prime importance in TM studies. Likewise, clinical information on TM must state symptoms, dosages, toxicity, efficacy and side-effects, as well as methods of administration. While there is no universal rule stating the level of individual or community contributions that must be included in documentation efforts, failing to acknowledge TM knowledge holders with a claim to the knowledge may lead to charges of misappropriation of  intellectual property [9].

To develop a reliable and coherent body of knowledge in TM, or for that matter, in any field, it is essential to publish articles in peer reviewed journals. Publication ethics are an essential part of research dissemination as ethical principles lend support, adequacy, and credibility to the scientific method. It is, therefore, extremely important for researchers in the field of traditional medicine to understand, agree upon, and follow the standards of expected ethical behavior as outlined in this article for publishing in peer reviewed TM journals.

References

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