WRONG

6 Ethical Principles to Follow

RIGHT

When Writing a Paper on Traditional Medicine

WRONG

What is Traditional Medicine (TM)?

What will you learn from these slides?

Why is ethics important in TM?

6 ethical principles of research in TM

What is Traditional Medicine (TM)?

“the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures,

whether explicable or not, used in the maintenance of health as well

as in the prevention, diagnosis, improvement or treatment of physical and mental illness”

(WHO, 2000a).

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Are you familiar with these examples of TM ?

AyurvedaOriginating in India, it is based on the notion of

balance between the body, mind and the environment.

Traditional Chinese Medicine

It holds that disease and illness are caused due to imbalances in the life

force ‘Qi’ which flows through the body

Herbal Medicine

St. John's wort - is known to be effective in cases of mild to moderate depression.

Gingko biloba – a herb used to treat circulatory diseases and conditions which involve memory lossGarlic – used for high cholesterol conditions and to reduce hypertension

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According to the WHO, TM is widely used and a rapidly growing health system. It is gaining popularity, especially in developing countries, because it is relatively affordable and easily accessible.

Why is ethics important in TM? (1/2)

Here are some interesting facts…..

• TM meets the healthcare needs of around 80% of the African population.

• People in Asian and Latin American countries use TM even today, owing to their cultural beliefs.

• TM accounts for approximately 40% of all the health care delivered

in China.

Why is ethics important in TM? (2/2)

1. Support 3. Adequacy 2. Credibility

Ethical principles are an essential part of research publication and dissemination because they give the scientific method:

Therefore, as a researcher in the field of TM, you must:

- Understand- Agree upon- Follow

the 6 principles of expected ethical behaviour while

conducting research in TM.

Reporting standards

Proprietary issues

Ethical policies and

declarations

Sustenance Scientific validation

Informed consent

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4 5 6

6 Ethical Principles of TM

What does sustenance imply?

1. Sustenance (1/3)

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• Ethical research must have social value; it should have the potential to improve health, by generating knowledge.

• If research lacks social value, then it would unnecessarily expose participants to risks and would also involve a waste of resources.

NOTE: You must identify the specific beneficiaries of the research and assess its potential value for each beneficiary.

How should you approach traditional knowledge?

Always approach traditional knowledge and expertise respectfully and in ethnically appropriate ways.Ensure that the involved communities are benefitted without disturbing their community ecosystem.

1. Sustenance (2/3)

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1. Sustenance (3/3)

• have some social value• inculcate awareness to help

improve the health and socio-economic conditions of the community.

• guarantee the safety and efficacy of herbal medicines and traditional procedure-based therapies

• not thwart the application and development of TM

Your research design must: Your research methodology should:

The need to document traditional knowledge

The need to ensure protection against unfair or harmful use of the

knowledge and exploitation of interrelated biocultural resources

THERE NEEDS TO BE A BALANCE BETWEEN

2. Scientific validation (1/3)

To ensure useful interpretationand wider acceptance of TM.

Purpose of scientific validation

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What is scientific validation?

Scientific Validity is an ethical requirement. This is because research on TM has no social value unless it

generates reliable and valid data and can be interpreted and used by relevant beneficiaries.

2. Scientific validation (2/3)

Guidelines

1. Provide institutional

recognition and support to

Research Ethics Boards or

Review Boards

3. Present randomized

controlled trials according to the

CONSORT guidelines

2. Consider adequate sample

sizes and unbiased outcome

measurements

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6. Include recruitment, enrolment,

randomization, withdrawal &

completion and a detailed description of the randomization

procedure

2. Scientific validation (3/3)

Guidelines

4. Include dosage & standardization, and

ensure the safety and efficacy of biologically

active substances

5. During manuscript submission, provide the

CONSORT* checklist along with a flow

diagram illustrating the progress of patients through the trial

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* http://www.consort-statement.org/

3. Informed Consent (1/3)

• The term informed consent refers to consent obtained from study participants.

• It is Voluntary Decisionally - capacitated

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It protects participants' health, welfare, and personal integrity.

It safeguards the informants against such moral offenses as assault, deceit, coercion, and exploitation.

Rationale:

3. Informed Consent (2/3)According to the ethical principles governing TM research,

Respect, preserve, and maintain traditional knowledge, innovations, and practices.

Secure approval from the ethics committee, for studies conducted on patients or volunteers.

Gain informed consent from participants and document it in the published research article.

You must:

3. Informed Consent (3/3)

According to the ethical principles governing TM research,

Share the objectives and method outline of the study as part of the informed consent procedure. Make participants aware of their right to refuse to participate in the research. Maintain the confidentiality of the information collected, especially in the case of clinical studies.

APPROVAL

You must:

TM researchers must focus on:

Gathering Data Refining Data

Preparing Results from

Data

Storage of Data

Seasonal & altitudinal variation of active compounds

4. Reporting Standards (1/2) Although there is no widely accepted template for documenting TM knowledge, such studies must be supported by extensive data.

4. Reporting Standards (2/2)

What should clinical

information on TM state?

Dosages

Symptoms

Toxicity

Efficacy

Side effects

AdministrationMethods

5. Proprietary issues (1/3)

Why must intellectual property be protected?

• There is no universal rule dictating the level of individual or community contributions that you must include when documenting your efforts in TM.

• However, if you fail to acknowledge TM knowledge holders and instead claim the knowledge, you may be charged with misappropriation of intellectual property.

5. Proprietary issues (2/3)

How do TM journals protect intellectual property rights ?

They ensure 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• knowledge holders are given due credit• benefits are shared equitably among

contributors

5. Proprietary issues (3/3)When evaluating traditional medicines,

REMEMBER:

The customary owner, and that owner’s country of origin, holds rights over the knowledge being evaluated.

If a nonindigenous group seeks a patent, it must establish prior informed consent and benefit-sharing with customary owners.

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6. Ethical policies and declarations (1/4)

The Helsinki declaration* outlined the basic ethics of research involving human participants. This marked the beginning of resolutions and policies in research studies.

* http://jamanetwork.com/journals/jama/article-abstract/1760318

Ethical principles for research specifically in TM have been outlined by:-

Chiang Mai declaration (March 1988)

The WHO Traditional Medicines Strategy (2002-05)

The WHO general guidelines for Methodologies on Research and Evaluation of TM

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• To ensure that medicinal plants are adequately available for future generations, the Chiang Mai declaration* endorsed international cooperation and coordination for the conservation of these medicinal plants.

6. Ethical policies and declarations (2/4)

Cooperation

CoordinationCONSERVATION

*http://www.who.int/hrh/nursing_midwifery/chiang_mai_declaration.pdf

The WHO Traditional Medicines Strategy* mainly focuses on policies related to: • Safety • Efficacy • Access to • Rational use of

6. Ethical policies and declarations (3/4)

Medicinal Plants

• The Consolidated Standards of Reporting Trials (CONSORT) offer a standard format for authors to prepare reports of trial findings

• They facilitate complete and transparent reporting • They help authors critically appraise and interpret data

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*http://www.wpro.who.int/health_technology/book_who_traditional_medicine_strategy_2002_2005.pdf

6. Ethical policies and declarations (4/4)

The WHO guidelines for Methodologies on Research and Evaluation of Traditional Medicine:• Raise and answer some challenging questions

concerning the evidence base• Present national regulations for the evaluation

of herbal medicines• Recommend new approaches for carrying out

clinical research

DID YOU KNOW? As per these guidelines, traditional medicines with a

history of use can be directly taken to phase 3 clinical trials, after a toxicity study has been conducted.

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* http://apps.who.int/iris/bitstream/10665/66783/1/WHO_EDM_TRM_2000.1.pdf

• 6 Critical ethical principles associated with research in traditional medicine: http://www.editage.com/insights/6-critical-ethical-principles-associated-with-research-in-traditional-medicine

• General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine: http://apps.who.int/iris/bitstream/10665/66783/1/WHO_EDM_TRM_2000.1.pdf

• WHO Traditional Medicine Strategy 2002–2005: http://www.wpro.who.int/health_technology/book_who_traditional_medicine_strategy_2002_2005.pdf

• The Chiang Mai Declaration: http://www.who.int/hrh/nursing_midwifery/chiang_mai_declaration.pdf

• What is Ayurveda? https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=85&contentid=P00173

Sources (1/2)

Sources (2/2)• Herbal medicine: http://

umm.edu/health/medical/altmed/treatment/herbal-medicine

• Chinese Medicine: https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=85&contentid=P00176

• Acupuncture: https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=85&contentid=P00171

• Herbal Medicine: https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=85&contentid=P00181

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