Breach of confidentiality: reseach project

I have recently taken part in a severely affected CFS/ME research project that entailed a home visit to take blood and detailed medical questionnaire. Unfortunately the blood tests included all my thyroid tests although I had already taken my dose that day - I assumed that as it was a research project and that as I had not given them consent to communicate with my GP then they would contact me if a result were a cause for alarm. How wrong was I: they gave all the results to my GP who has taken the time to write to me lowering my levo does without even talking to me. Sod discussion of the clinical feature and symptoms obviously the blood test of TSH no doubt is all that they require. I am currently waiting to resolve an issue before doing an NDT trial and now have the added stress of a levo dose reduction to deal with and a doctor that was just waiting for the ammunition. I was waging the battle with research and info letting her know the real facts rather than the dogma. And now all is for nothing. SO ANGRY!! So beware researchers.

10 Replies

  • Cwill,

    Perhaps your GP will agree to retest you before reducing your dose.

    If you are certain you did not give permission for the researcher to contact your GP with your results make a formal complaint about the data breach to the Information Commissioner's Office

  • Were the researchers doctors or other medical practitioners? As you can complain to the institution that regulates them as well.

    They may actually take a stronger action than the Information Commissioner as the Information Commissioner tends to be better at getting companies to cough up data rather than penalise them.

  • Thanks Clutter and Bluebug: I am still furious at present that they can dabble in my life so easily. Consent is never to be assumed and is tho be obtained in every change of circumstance - if my results were alarming I should have been given the data before my GP and given the chance to address it - a low TSH is not actually life threatening for someone on longterm levo. Yes once I have calmed down a bit and have rested I will make sure that everyone knows about my complaint. i have already emailed the research team to let them know my complaint and withdrawn my data - with this cavalier attitude who know where it will be shared and for what purpose? Researchers all medical professionals so really should know better. I signed my consent forms on December last year and obviously I don't have a copy - another breach. AND they are dealing with severely effected CFS/ME patients who are vulnerable as we have dreadful memories so they should be behaving to an exemplary standard.

  • Do you know the university or hospital they were doing their research for?

    It is worth writing a letter sent by recorded delivery to the head of that institution if you do, mentioning the breach of confidentiality, issues with consent forms and removing the consent to use your data.

    Letters to a head are more effective than just an email to the team as the team will just bury it. You need to ensure the head gets your complaint so the team cannot do that.

    Also not all researchers are medical professionals some of them are just research scientists and this can include students.

    Finally also notify the forum/website (if you can remember) who advertised the research project.

  • Yep I am plotting as I read this. thanks

  • Hi cwill - I'm so sorry this happened to you. I agree with the other commenters that you should set your doctor straight or request a new test before altering your dose.

    I am also concerned that this sounds like it could be a breach of the study's ethical clearance. The researchers should have provided you with a Participant Information document that details under what circumstances they would contact your GP. They must allow you to read this document before signing a Consent Form, and you should keep a copy of the document.

    Somewhere on that document (probably towards the end) is the contact number for the institutional ethics office that approved the research. If the researchers have not done what they told you they would do, or have done something they did not tell you they would do, this is a breach of their ethical clearance and should be reported.

    I work for a university ethics office and I would encourage you to follow up with them if you have any concerns at all about the study.

  • Thanks Hippotamus. I will look for the detail and I will follow this up everywhere as I feel strongly that this is my data, I own it and I have not given consent for them to share it outside the study. Especially when it has got in the way of my Gps treatment - she now feels that she has sufficient ammunition to alter my dose without speaking to me. Double whammy of lack of control/consideration. Severe CFS/ME and other health problems are bad enough without the 'researchers' making us all feel even more powerless and vulnerable.

  • Update: they have been phoning incessantly as they are obviously worried: the consent form that I signed said that they may share my results with my doctor. I think that gives them an incredibly weak position as they were not sharing anything life threatening and I still maintain that as the patient and the effected it was for me to know first. I didn't teach undergrads applied ethics and the law for nothing... Although a bit fuzzy informed consent is the backbone of my sort of clinical practice/research and how bloody dare they try to play god. The fight is on.

  • I would also write to the Practice Manager, also phone the Care Quality Commission as this info will be useful for when the surgery is inspected and GP is revalidated.

    Who is actually behind the study ie is it funded by Big Pharma?

  • Well my day just got better. I have prescriptions saying Actavis only and guess what? My 75mg prescription is with two brands so in effect my levo has now been halved. The pharmacist insisted that I had to have 75mg this way despite my husband putting up a spirited argument. The research is called 'Cure ME' and is carried out at London School of Hygiene and Tropical Medicine. Anyone else on this trial beware - they have no interest in their lab rats. Still fuming. Ned to locate the ethics committee and anyone that I can write to. Not how I wanted to spend a hot and tiring day. Thanks everyone it is good to have someone to understand my outrage.

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