Professional standards, training and membership.
Professional standards, training and membership.
Ethics in IEMT Practice: Appendix D
The Declaration of Helsinki
What is the Declaration of Helsinki?
The Declaration of Helsinki is a statement of ethical principles for medical research involving human participants, including research on identifiable human data or material. The World Medical Association (WMA) first adopted it in June 1964 at its 18th General Assembly in Helsinki, Finland. It has been revised many times since, most recently in October 2024 at the 75th WMA General Assembly, also in Helsinki. It is not law, but it is the most influential statement of research ethics in the world, and it has shaped ethics committees, journals and national rules.
It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research.
World Medical Association, Declaration of Helsinki (October 2024), paragraph 4
Why it appears in this course
The Declaration was written for research, not for everyday practice, so it does not tell an IEMT practitioner what to do in a session. It matters here for three reasons. First, its core ideas are the same ones that run through this course: consent, privacy, protection of vulnerable people and honesty. Second, IEMT is an emerging technique with limited research behind it, so practitioners may be asked to take part in studies, to collect outcome data or to write up cases. Third, the Declaration sets a standard for honest reporting of results that is useful when you describe your own.
Key principles and what they mean for you
| Paragraph | Principle | What it means for IEMT practitioners |
|---|---|---|
| 4 | The physician’s duty is to promote and safeguard the health, well-being and rights of patients. | Your client’s wellbeing comes first, ahead of your own interests, your curiosity or your business. |
| 7 | Research purposes “can never take precedence over the rights and interests of individual research participants.” | A wish to gather a case study, a testimonial or data never outweighs the interests of the person in front of you. |
| 19 and 20 | Some people are more vulnerable and at greater risk of being wronged or harmed. Vulnerable groups should be included in research only where it responds to their health needs. | Take extra care with people who are distressed, young, very ill or under pressure. See Lessons 2.1 and 3.1. |
| 21 and 23 | Research must be scientifically sound and reviewed by an independent research ethics committee before it starts. | Do not run informal “studies” on clients. If you want to do research, work with a university or other body that can provide proper design and ethical review. |
| 24 | “Every precaution must be taken to protect the privacy of research participants and the confidentiality of their personal information.” | Treat client information, case notes and any feedback with the same care. See Lessons 2.3 and 2.5. |
| 25 and 26 | Free and informed consent is essential. People must be given clear information, in plain language, about aims, methods, risks and benefits, before agreeing. | Consent to take part in a study or to share their story is separate from consent to a session, and it must be freely given and easy to withdraw. |
| 33 | New interventions should be compared with the best proven alternatives, unless none exists or there are compelling reasons not to. | Be careful with claims that IEMT is better than, or a substitute for, other approaches. See Lesson 1.4. |
| 35 | Research must be registered in a publicly accessible database before recruitment starts. | If you take part in research, expect it to be registered and open to scrutiny. |
| 36 | Results must be reported honestly. “Negative and inconclusive as well as positive results must be published or otherwise made publicly available.” | Describe your results fairly, including that responses vary. See Appendix C. |
| 37 | Where proven options are inadequate or unavailable, an unproven intervention may be tried with expert advice, a careful weighing of harm and benefit, and informed consent. Outcomes should then be studied, recorded and shared. | A useful model for an emerging technique. See the box below. |
Paragraph 37 is written for physicians, and IEMT practitioners are not physicians. Even so, its approach is a sound ethical guide when you use a technique whose evidence is limited and emerging:
- Be open with clients that the evidence is limited, and do not present IEMT as proven.
- Seek advice when a case is complex or you are unsure.
- Weigh possible harms against possible benefits, and make sure the person understands both.
- Obtain informed consent and make sure the person has not been steered away from established care they need.
- Record outcomes honestly and share what you learn.
The 2024 revision
The 2024 revision made a number of changes. In general terms, it speaks of “participants” rather than “subjects”, places more weight on engaging participants and communities, gives greater attention to justice and vulnerability, addresses research data and sustainability, and restates that ethical standards apply during emergencies. For practitioners the most useful change is the emphasis on treating people as partners rather than as sources of data.
If you want to do research
- Do not collect data from clients informally and then present it as research.
- Find an academic or clinical partner and obtain ethical approval before you begin. In the UK the Health Research Authority guides how research is reviewed.
- Get separate consent for research, which must not be a condition of receiving a session.
- Protect personal data. Health information is special category data under the UK GDPR.
- Report everything honestly, including results that are negative or inconclusive.
Limits and debates
The Declaration is a statement of principle, not a rulebook, so it leaves room for judgement and has attracted debate over the years, for example about the use of placebos. It is not itself law, and the legal requirements for research differ between countries. For practitioners it is best seen as a standard of integrity: put the person first, ask for consent, protect privacy, avoid exaggeration and tell the whole story.
Self-Reflection Exercise
Questions to consider
- Have you ever been asked to take part in research or to collect outcome data? How would you check that it was properly reviewed and that clients could say no?
- How would you explain to a client that the evidence for IEMT is limited and emerging, without frightening or discouraging them unfairly?
- If you described your results to a colleague, would you mention the people who did not benefit?
- Where would you draw the line between gathering feedback to improve your service and carrying out research?
Key Takeaways
- The Declaration of Helsinki is the leading international statement of ethics for research on people. It is not law.
- Its principles of consent, privacy, protection of vulnerable people and honest reporting apply well beyond research.
- Research should be independently reviewed. Do not run informal studies on clients.
- Negative and inconclusive results should be reported as well as positive ones.
- With an emerging technique like IEMT, be open about the limits of the evidence and record outcomes honestly.
Next Steps
Continue to Appendix E, The Declaration of Geneva, a short pledge that sums up the values you have met throughout this course.