Controversial ME study: Ethical approval withdrawn!

A Norwegian study in which 120 ME patients were to be treated with the alternative method Lightning Process received ethical approval in October. Today, the approval has been withdrawn.

On November 16th   2020, the Regional Ethics Committees for Health Research, REK Midt, decided to give ethical approval to the study where 100 ME patients were to be treated with the alternative method Lightning Process.

Read more about the study design here: Study on ME patients: Cynical, unethical and indefensible

REK Midt received 8 complaints about the decision. In January, it was stated that REK Midt did not find grounds to reverse or change the decision. The case was therefore sent to the National Research Ethics Committees (NEM) for final assessment.

The case was on the agenda in a NEM-meeting on 19 March 2021. Today, June 4th 2021, it is stated in a letter to the Norwegian ME Association that NEM has decided to accept the complaint from the ME association.

The justification states, among other things. that «NEM believes that the project’s greatest weakness is the research fellow’s active role in all stages of the project, and the conflict of interest that arises because the research fellow has strong business interests in the project giving positive results.»

«REK midt’s decision dated 16.11.2020 is revoked. The committee’s decision was unanimous. The decision is final and cannot be appealed.

The entire decision (in Norwegian) can be read here:

Written by

Nina E. Steinkopf

Formerly HSE and Quality Director

Now; ME-patient and writer

2 tanker på “Controversial ME study: Ethical approval withdrawn!

  1. Tilbaketråkk: Trial By Error: Norway Rejects New Clinical Trial of Woo-Woo Lightning Process

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