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;
(c) 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
apply.
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.