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Standards for maintaining integrity in functional medicine research are the same as for other types of biomedical and psychosocial research:

  1. Describe all treatments fully: Two major components of research integrity are 1) clarity, and 2) reproducibility. With vague descriptions within research, the rationale and protocols are neither well-communicated nor amenable for validation by other researchers.

  2. Describe assessments and diagnostic criteria: Meaningless diagnostic terms are the nadir of clinical research.

  3. Laboratory methodology must be detailed: Analytical methodology must be described in detail if the research is to have any chance at being validated; providing an infomercial for the laboratory by simply referencing the laboratory that performed the testing is not scientifically adequate and is unprofessional, especially when the author(s) have financial interests in the selfsame laboratory.

  4. Any dangerous or questionable treatments need to be justified, explained, and applied ethically, ie, with informed consent, description of potential adverse effects, warning signs, appropriate clinical and laboratory follow-up, limitations to duration of treatment, patient selection/exclusion criteria.

  5. Use accurate definitions

  6. Control for external influences: Failure to control for external factors can render outcomes unattributable to the intervention(s).

  7. Disclose commercial conflicts of interest

  8. Human clinical trials should be registered, eg, clinicaltrials.gov and clinicaltrialsregister.eu

  9. If treatments are “personalized” then explain and describe the personalizations: Don’t hide behind the phrase “treatments were personalized” to avoid the discipline of accurately and fully communicating details of the interventions; the purpose of publishing legitimate science is to communicate clearly, not simply “score a publication” for promotional purposes. As such, if the very same protocol that is being researched is “customized” or “personalized”—which thereby at least partially violates the integrity of the described protocol—then the rational must be explained, and the customized interventions much be described; otherwise—since “customization” and “personalization” can mean anything when undefined—the publication becomes utterly meaningless because the intervention being described is being confused and obfuscated by the authors themselves.

  10. Use appropriate doses and durations for the interventions

  11. Use proper study design, and appreciate the limitations of each; note that  “an uncontrolled case series” is not the same as a controlled trial, etc.

 

Source: Vasquez A. Ethical and Intellectual Standards in Functional Medicine Clinical Research. Int J Hum Nutr Funct Med 2016 PDF of final version

Original article: Vasquez A. Correspondence regarding Cutshall, Bergstrom, Kalish's “Evaluation of a functional medicine approach to treating fatigue, stress, and digestive issues in women.” Complementary Therapies in Clinical Practice 2016 [in press] DOI: http://dx.doi.org/10.1016/j.ctcp.2016.10.001

Maintaining Ethical and Intellectual Standards in Functional Medicine Clinical Research: Checklist of the Obvious & Insights from the recent publication by Dr Vasquez in Complementary Therapies in Clinical Practice 2016 Oct PDF of final version

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