Phoenix Rising: The Gift That Keeps on Giving All Year Long
This holiday season Jody Smith turns her eyes to the people of Phoenix Rising and gives thanks for you all ...
Discuss the article on the Forums.

Dr Nath's intra-mural study at NIH is currently recruiting

Discussion in 'Active Clinical Studies' started by Kati, Dec 9, 2016.

  1. viggster

    viggster Senior Member

    Messages:
    340
    Likes:
    2,715
    Yes, volunteers to the ME/CFS study will have (online) access to all of those types of test results. But we won't have access to results from, say, the deep cytokine profiling investigation or the blood cell-to-neuron (brains in a dish) experiment, or the metabolomics stuff that NIH does. Those are experimental techniques and there's no way to interpret individual results until the whole study is complete and the healthy patients are compared to the sick patients.
     
    Zombie_Lurker, Sasha, mango and 2 others like this.
  2. duncan

    duncan Senior Member

    Messages:
    1,709
    Likes:
    3,645
    Very cool. Thank you for checking, @viggster.
     
  3. Hutan

    Hutan Senior Member

    Messages:
    737
    Likes:
    3,486
    I'm not expecting the results to necessarily be handed out to patients on the day they are measured. But certainly once the particular study is complete e.g. metabolomics or measurement of cytokines or fMRI, individual patients could be given their results.

    These results could help the patient and their doctors compare the individual situation with the reported findings and may therefore help the patient understand their illness better. It may possibly even result in some insights of use to the wider population of people with ME. For example, a particular referring doctor may be able to notice a pattern of response to a particular treatment in patients with a certain cytokine or metabolomic result. And that insight could trigger breakthrough research.

    The principles of data transparency and collaboration with patients should be adhered to unless there are strong reasons not to. The facts that these studies are experimental or technical are not reasons to never give the participants their own results.

    What do we know about when the anonymised data will be available to other interested parties?
     
    Valentijn and duncan like this.
  4. viggster

    viggster Senior Member

    Messages:
    340
    Likes:
    2,715
    The study is scheduled to run through 2018, probably longer. The NIH policies for data sharing for intramural (on campus) human studies is here:
    https://oir.nih.gov/sourcebook/intr...ht/intramural-data-sharing/human-data-sharing

    "...data developed in the NIH Intramural Research Program (IRP) should be collected in a manner that permits and promotes the broadest sharing possible."
     
    Valentijn and Hutan like this.
  5. duncan

    duncan Senior Member

    Messages:
    1,709
    Likes:
    3,645
    If issues present with volunteers' results, that may well show in these early basic results such as MRI's and neuro-psych evaluations - areas where interpretation can come into play. It would be a shame if bias played a role, and I think we need to be vigilant against that possibility, while at the same time hoping for the best. Now that we know serology results and imaging results and neuro-psych results WILL be made available to participants, we need to make sure each volunteer is aware of this, as well as the procedures they must follow to access their data.

    Personally, I would like to see ME/CFS volunteers share these data as they become available with agreed-upon ME/CFS advocates - so long as volunteers are amenable to that. Alternatively, if privacy is an issue, each is informed as to what to look for in terms of red flags. This way, should interpretive questions/differences emerge, they can be confronted and hopefully resolved in real-time, and early on into the research process. Everyone benefits this way.

    Trust but verify.
     
    Last edited: Jan 10, 2017
  6. Hutan

    Hutan Senior Member

    Messages:
    737
    Likes:
    3,486
    Thanks @Viggster.
    Intramural Research Program Human Data Sharing (HDS) Policy

    Key Points of Policy

    1. This Policy applies to all human data in the NIH IRP, including the NIH Clinical Center as well as NIH Institutes and Centers.
    2. A Data Sharing Plan (PDF File) must be developed for any research involving human data.
    3. Data Sharing Plans will be included in the institute scientific review process for research involving human data.
    4. The Institute Scientific Director (SD) or their designee is responsible for approving all Data Sharing Plans.
    5. All IRP-supported clinical investigators are expected to develop protocols and consent processes/forms to enable broad data sharing for secondary research consistent with this Policy.
    6. Sharing data for secondary research purposes shall comply with human subjects research regulations and procedures, if applicable.
    7. All IRP investigators are encouraged to deposit data in publicly accessible research repositories for sharing to the extent feasible and appropriate.
    8. This Policy is effective as of October 1, 2015. Any intramural research involving human data undergoing scientific review after October 1, 2015 must have a data sharing plan.
    The policy does look to be a good foundation. It would be good to see the Data Sharing Plan(s) for the ME research and to know how item 7 (use of publicly accessible research repositories) is addressed.
     
  7. halcyon

    halcyon Senior Member

    Messages:
    1,957
    Likes:
    4,087
    My understanding is that to give patients access to this type of data at this point would possibly run afoul of FDA/CMS CLIA regulations.
     
    Hutan likes this.
  8. Kati

    Kati Patient in training

    Messages:
    4,757
    Likes:
    14,142
    I think that in general, patients want to know whether they 'fit the profile', belong in the cohort, and that there are distinct and measurable abnormalities that shows that indeed they are sick.

    There are currently no mainstream biomarkers, none accepted by the medical community, and beliefs that it's all in our heads. Having a proof on paper cannot come soon enough for our community.

    Complicating matters, there is distrust in at least one NIH team members, with the history that we have been wronged more than once by government bodies. The stakes are high, and probably more so for the study participants who will submit to testing that will most certainly set them back weeks, if not months and that is not counting the stress of not knowing riht away what their results are.

    Having read a few research consents myself, there is always this one sentence which I do not want to believe to be true, which says: there will not be personal benefits to you in participating in the study, but there might be benefits for the community in gaining knowledge. --> there are no promises made, there might be no conclusive results, though I do not believe that this is going to be true. I will give the example of the pathogen study in Vancouver. I think most patients were convinced they would find something. But they didn't. The paper took a good 2 years to publish. So disappointing but then, this is how it goes. No promises. It is hard to have no expectations, especially when the opportunities of government research are so few and scarce.

    I hope they find something. Fingers crossed.
     
    Last edited: Jan 11, 2017
    Zombie_Lurker, Hutan and TiredSam like this.
  9. Hutan

    Hutan Senior Member

    Messages:
    737
    Likes:
    3,486
    Good point. But Naviaux has been providing patients with metabolomic data - so it can't be an impossible problem to solve.
     
    Webdog likes this.
  10. halcyon

    halcyon Senior Member

    Messages:
    1,957
    Likes:
    4,087
    Right, I think they are violating the FDA and/or CMS CLIA regulations in doing so unless they have met these requirements:
     
    Hutan likes this.

See more popular forum discussions.

Share This Page