Ethical approval of Lightning Process-study is maintained

On 16 November 2020, Norway’s The Regional Committees for Medical and Health Research Ethics, REK Midt, decided to give ethical approval to the study where 120 ME patients will be treated with the alternative method Lightning Process.

Read more here: Controversial study on ME patients receives ethical approval.

REK Midt has received 8 complaints about the decision, 2 complaints from the Norwegian ME Association and 6 complaints from private individuals. Today, REK informs about its decision:

Complaints from private individuals are rejected on the basis that the complainants do not have the right to complain, cf. the Public Administration Act § 28. The committee has reviewed all complaints and the applicant’s responses in detail, and have decided to uphold previous decisions approving the project.

REK writes:

«The Norwegian ME Association and the Norwegian ME Association Oslo and Akershus have been given the right to appeal, but REK finds no basis for reversing or changing previous decisions. We forward the case to the National Research Ethics Committee for Medicine and Health Sciences (NEM) for final assessment. REK Midt finds it appropriate to forward all the complaints received to NEM for the sake of completeness. «

NEM has a meeting on 19th March 2021.

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

and here: More concerns about controversial study on ME patients: In Norwegian, use Google translate: Flere bekymringer ved kontroversiell studie på ME-syke

Written by

Nina E. Steinkopf

Formerly HSE and Quality Director

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