Approval for TeQfor1

Governance Activity Reviews
#1

I’m starting this thread and request for approval on behalf of the TeQfor1 team that reached out via email:

The TeQfor1 citizen science project is conducted, managed, and lead by a team of citizen scientists (more specifically, people with type 1 diabetes (T1D) using an Open Source Artificial Pancreas System (OSAPS) from the German-speaking community) and academic researchers. The focus of TeQfor1 is the scientifically valid evaluation of these systems by the citizen scientists and according to their criteria as they are the experts of living with T1D and their knowledge and expertise is of crucial relevance when it comes to the evaluation of technologies for T1D.

The TeQfor1 citizen scientists decided that they want to collect and analyze their blood glucose data to show the impact of the OSAPS on their glycemic control and therefore on their quality of life and their life in general. Therefore, we would like to access data from the selected data sources. Some TeQfor1 citizen scientists are already data donors on openhumans.org so it was an obvious choice.

“Raw” data access via openhumans.org will be only visible to a ‘core group’ of citizen scientists (2 persons) and academic study staff (1 person) that either signed an informed consent or are obliged by GDPR and/or federal law to ensure data privacy. The aforementioned group will ensure that the provided data contains no personal and/or identifiable information. However, we expect that the provided data is already anonymous for us. We do NOT intend or plan to link the blood glucose data to specific participants of the TeQfor1 projects.

The anonymized data set is then provided to those TeQfor1 citizen scientists who want to further explore and analyze the development of blood glucose levels of the community. But one important thing, the dataset is not publicly available!

Members joining the Open Humans TeQfor1 project are supposed to be exclusively members of the TeQfor1 project. Therefore, issues of security, privacy, and data management are entirely managed through the TeQfor1 project. All members joining the TeQfor1 Open Humans project will have signed the (paper-based) informed consent.

We can offer to send that form of the informed consent over to you, but we can only provide it in German. The German approval of the ethics committee of the University Hospital in Tübingen [has been submitted to OH but we’ll find out if we can share it publicly].

In case there are any questions left, please feel free to ask any time, best by using this email address (as a crew of our citizen scientists and academic researchers has access to it): teqfor1@omux.de

TeQfor1 Details:

Explain the data you’ll receive: Data from the sources 1) AndroidAPS Uploader and 2) Nightscout Data Transfer
Explain what you will do with it: Evaluate the impact of OSAPS on glycemic control and therefore on quality of life and life in general.
Explain you data privacy and security: “Raw” data access via openhumans.org will be only visible to a ‘core group’ of citizen scientists (2 persons) and academic study staff (1 person) that either signed an informed consent or are obliged by GDPR and/or federal law to ensure data privacy. The aforementioned group will ensure that the provided data contains no personal and/or identifiable information. It can not be excluded that a person might be identifiable by the data but we will conduct measures to impede this (eg, random identifiers, random dates, delete all personal or identifiable information, aggregate information and/or increase granularity) before conducting further data analysis steps.
Explain what happens with the data after a user leaves your activity: If we receive notice of a person leaving the group and can identify this person’s data points we will delete this data from the data set.
Be aware of existing de-identification standards: See above.
Don’t ask for more data than you need: We will only ask for data of the two sources 1) AndroidAPS Uploader, and 2) Nightscout Data Transfer. At no point in time will we link this data to the specific participants of the TeQfor1 community.
Share data with activity members: TeQfor1 citizen scientists will be shared a fully anonymous data set for own research. However, this data set will not be accessible publicly! It will be only share via secured channels and via password protected archive(s).
Minimize the use of personal data: We do not want personal data of the data donors! We expect the raw data via the AndroidAPS Uploader and Nightscout Data Transfer sources to be ‘quite anonymous’, ie, will not contain any personal information. To further insure data privacy before any data analysis we will check an this premise and delete any information that might be personal or identifiable.

Should this project be visible and available for all Open Humans members to join?

Please vote Approve or Deny , and/or comment.

Quick links

Project info

  • Title : TeQfor1

  • Managed by: Silvia Woll & TeQfor1 community members

  • Description: People with type 1 diabetes using an Open Source Artificial Pancreas System (OSAPS) for themselves with T1D are often criticized for using systems without regulatory approval. To date, only few studies evaluate the impact of OSAPS on blood glucose levels and quality of life. TeQfor1 is a Citizen Science project for German-speaking people, in which the users of OSAPS first define the criteria according to which the OSAPS are examined and then investigate the impacts of OSAPS with scientifically valid methods. The TeQfor1 Citizen Scientists decided that one of the core elements is the collection and analysis of blood glucose data by the citizen scientists to show how OSAPS influence glycemic control. A team of academic scientists from the fields of medicine, computer science, and technology assessment supports the TeQfor1 citizen scientists regarding selection of methods and appropriateness of the chosen tools.

  • Project website: TeQfor1

#2

Regarding the IRB documentation: As it’s not 100% clear if the letter itself can be made publicly available we won’t be uploading it here. But if you want to see a copy of it you can email teqfor1@omux.de.

As it’s in German I’ll also happily provide the gist of it: The ethics review committee of the university hospital of Tübingen considers the study exempt from detailed review as they consider the collected data de-identified. :slight_smile:

1 Like
#3

Re-posting feedback from Slack, where @danamlewis raised the following points:

“Members joining the Open Humans TeQfor1 project are supposed to be exclusively members of the TeQfor1 project”
…I am wondering if this is a translation thing or if they are going to block people from sharing data with other OH projects? If so, how? And why?
Also, what happens if someone sees the project in OH and joins digitally - they won’t have done the paper consent, will the project still use that data or are they only using datasets matching a paper consent form?

#4

Members joining the Open Humans TeQfor1 project are supposed to be exclusively members of the TeQfor1 project”
…I am wondering if this is a translation thing or if they are going to block people from sharing data with other OH projects? If so, how? And why?

Thank you for pointing out this sentence. Indeed, it‘s a misunderstanding and our choice of words was not clear here. For better understanding, we will now differentiate between “TeQfor1 on OH” (meaning the TeQfor1 project specifically on Open Humans) and just “TeQfor1” (meaning the “actual”, underlying TeQfor1 project for the German-speaking Looper community).

We do absolutely not want to restrict or block users or ‘demand’ that they will not join other OH projects. We wanted to express that the members joining TeQfor1 on OH are supposed to be members of the underlying TeQfor1 project. In fact, we are going to encourage the TeQfor1 members to join other OH projects and share their data. Some of our community members are already sharing data via OH, and we consider that being great. We will express this more clearly in the description of the project.

Also, what happens if someone sees the project in OH and joins digitally - they won’t have done the paper consent, will the project still use that data or are they only using datasets matching a paper consent form?

Again, thank you, for bringing this to our attention. Our idea was that only TeQfor1 members will share their data via the TeQfor1 on OH project. But – you are right – maybe an interested user discovers this project on the OH website and wants to join. In fact we don’t want to set any link/connection between the members and their shared data, for example via an identifier. Therefore, at the moment we don’t see a possibility how we could tell if an OH user is previously registered at TeQfor1 – or not. We propose to provide a contact email address and ask people to get in contact before sharing data (if they are not TeQfor1 members). Then, we can send them the (unfortunately only German) papers and ask them to join our community forum as well. For non-German speaking persons… that’s a tricky one. We don’t think it’s possible to provide the forms in other languages. We are not allowed to simply translate the papers because they were (partly) mandated by the legal departments of the academic institutions of the project partners. If someone doesn’t get in contact with us, we won’t have the paper consent and only have the consent users give us via the OH website / information text.

If you have any idea what would be a better approach here, please let us know. We are happy to learn from your ideas and experiences and we are open to change our approach as far as it is possible for us.

… On behalf of the TeQfor1 group that created this approval request :slight_smile:
CuriousFox

#5

Thanks for the clarifications.

No objections.

#6

Based on feedback, as well as having an ethics board approval, I’m going to mark this as “approved” and close this. Thanks all!

#7