• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

Dr David Tuller: How BMJ Enabled Bristol's Ethics Exemptions

Countrygirl

Senior Member
Messages
5,398
Location
UK
http://www.virology.ws/2018/12/04/t...50jsIt1XIVWBZ8dfd8KiSWGtUH6eFqNpx90ayIi10bi10

Trial By Error: How BMJ Enabled Bristol’s Ethics Exemptions
4 DECEMBER 2018
By David Tuller, DrPH

Earlier today, I sent the following e-mail to Dr Fiona Godlee, editorial director of BMJ. I cc’d Carol Monaghan MP, Darren Jones MP, and Nicky Morgan MP. I also cc’d Teresa Allen of the Health Research Authority.

**********

Dear Dr. Godlee—

As you know, I have spent some time criticizing a 2011 BMJ Open study involving the use of school absence records to identify children with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME, or what many now refer to as ME/CFS). The investigators exempted the study from ethical review on the false grounds that it was “service evaluation” rather than “research.” To support this claim, they cited an unrelated 2007 letter from the regional research ethics committee.

The school absence study was conducted by investigators from the University of Bristol. As it turns out, members of this team of investigators have cited the same 2007 REC letter to exempt ten other studies (or parts of studies) from ethical review on similar grounds. Five of them, including the school absence study, were published in BMJ journals—two in BMJ Open, and three in Archives of Disease in Childhood. The first was published in 2009, with others following in 2011, 2013, 2015 and 2017.

(I am cc-ing Carol Monaghan MP, Darren Jones MP, and Nicky Morgan MP. All three are involved in parliamentary inquiries into issues related to ME/CFS, including some of the questionable research that has characterized this field. I am also cc-ing Teresa Allen from the Health Research Authority.)