Hardening the ethics and data protection compliance of opencare

The UK has a NHS-spawned website that assists researcher to seek ethical approval for medical research: https://www.myresearchproject.org.uk/ELearning/index.html

I went through it, but I do not think opencarefits any of the boxes. The whole thing is (rightly) meant for people who do medical research: sample patients, give them treatment, monitor their condition with and without the treatment etc.

I wrote to the Health Research Authority seeking guidance, with @markomanka in cc.

I also found out that the EU produced ethics guidelines for antrhopological and ethnographical research (here is the paper). I read it and found our approach very consistent with it. @Amelia , can you have a look too? And while you are at it, can you ask around who is the research ethics regulator in the UK for anthro/ethno? I strongly suspect there isn’t one, or rather Universities have ethical boards that play that role. Edgeryders does not have that, but we might be able to make the case that we are OK as long as we go through opencare ethics advisors.

The author of said EU guidelines (Ron Iphofen) is British. He quotes policy guidelines for qualitative research in the UK as being available at http://www.qualidata.essex.ac.uk and http://www.dipex.org.uk. Since he wrote it, both sites have changed: qualidata redirects onto www.ukdataservice.ac.uk (also contains quantitative data). Qualitative ethics guidelines are here. The text appears to assume that the university running the research will have its own ethical board. This is not the case for Edgeryders. Dipex redirects to http://www.healthtalk.org/, which does not seem to have any policy guidance but it does have interesting health stories in text form. Good to know.

Heads up @Costantino: you are going near a danger zone with InPe (vulnerable people etc.). By making it clear that it is only a prototype, and that it is not used for human testing, you should be OK. But don’t take my word for it!

UPDATE: Data protection is much more straightforward. We registered with the Information Commission’s Officer (data protection regulator in the UK); it is unclear whether it is compulsory for a multiauthor blog, but we did it anyway. I took our data protection policies through the ICO’s self-assessment toolkit and it checks green, with seven policies in place, some not applicable, none not implemented nor partially implemented. The report is uploaded on opencare’s GitHub: https://github.com/opencarecc/data-protection-self-assessment

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On it

From first skim it looks pretty standard, but i’ll give it a closer read today.  Having gone through the ERB process in the UK a few times, I would also suspect that it operates on the university level (unless you are messing with the NHS---- they have their own review board and we should stay very clear of it. The shortest process is something like 7 months with them). I’ll find out what happens when you are doing research outside of a university context.

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Appreciate that

As I said, I wrote to the HRA, but frankly I do not even expect an answer. It’s clear that we are without their scope.

Update on ethics

I just had a call with @markomanka . We talked about the upcoming ethics deliverable that we are supposed to be sending to our ethics advisors at the end of the year. Marco is to make a draft available on some kind of shared document (Google Docs would be the simplest). We should then add our contributions as needed. We agreed on the following.

Ethical approval of the research as run on edgeryders.eu

We heard back from the Health Research Authority. They say:

If it is not your intention to identify and recruit NHS users but to recruit any participant who fits your inclusion criteria, although you may discover that a participant is a NHS user, then the research is not in the scope of the Governance Arrangements for Research Ethics Committees (GAfREC) section 2.3.2 and the study should not require NHS REC review. I would strongly advise that you review the section 2.3 of GAfREC. A copy can be downloaded at http://www.hra.nhs.uk/resources/research-legislation-and-governance/governance-arrangements-for-research-ethics-committees/

The logic is clear. Being healthy or unhealthy is neither a requirement nor an exclusion criterion for participating in opencare, and anyway we do not ask. Therefore, we are not doing medical research and we do not fall within the remit of the HRA. See section 2.3.2 below, it’s very short.

So who is our regulator? If we were a university, we would approach our own ethics board. Since we are not, we fall back on the opencare ethics advisors (this is what we did in CATALYST). @Amelia is checking if we have an Ethics board for anthro/ethno research outside of universities.

I intend to write these things (as well as the progress made in Data protection compliance) in the Ethics report.

2.3.2 REC [Research Ethics Committee] review as described in this document is required if a specific research project involves:

(a) potential research participants identified from, or because of, their past or present use of the services listed above (including services provided under contract with the private or voluntary sectors), including participants recruited through these services as healthy controls;

(b) potential research participants identified because of their status as relatives or carers of past or present users of these services1;

© collection of tissue (i.e. any material consisting of or including human cells) or information from users of these services1; or

(d) use of previously collected tissue or information from which individual past or present users of these services could be identified, either directly from that tissue or information, or from its combination with other tissue or information in,

or likely to come into, the possession of someone to whom the tissue or information is made available,

unless any of the exceptions or other exclusions described in paragraph 2.3.9–2.3.14


Ethics in offline environments

We discussed this in Milan. We need consent forms (and we need to keep the papers for 10 years). Marco told me that consent forms have already been produced for some Milano workshop. We agreed these (and the improved versions that will be produced) will be collected in a GitHub repo, which also becomes something we can show to reviewers.


Thanks for soliciting the relevant authoriies. The answer is indeed quite clear, and makes our life easy. Thanks to @Amelia for checking on the anthro/ethno research side.