Thread by @gringene_bio

The National Ethics Advisory Committee's National Ethics Standards for Health and Disability Research are now open to the public for feedback:

consult.health.govt.nz/neac/national-…

I'll comment on the initial principles of this now in regards to the recommendations I've previously made public:

gringer.gitlab.io/presentation-n…

In short, they're great. My main comments are around needing more emphasis on participant control - making that implicit principle explicit.

"Researchers are expected to learn as well as gather data in research, to collaborate and to give back to the community (eg, through koha and sharing ideas)." [S 5.7] - a good principle to have; I think a minimal sharing protocol needs to be specified in ethics applications.

But I also think it needs to go a bit further than this: researchers should have a specified means of communication directly to the *participants*, rather than just the community that they are members of.

Also S 5.7: "The relationship between researchers and participants (and New Zealand communities) must involve trust, respect and integrity."

Definitely. *Informed* control, and *informed* trust, is important in research.

Although in S 5.7, the "Tika" and "Mana" sections do not have a prescriptive final sentence, as in other sections: "Researchers must / are expected to...." Adding such a sentence would do well to clarify the meaning of the terms.

S 5.8: "An important mechanism for respecting participants’ autonomy in research is for researchers to seek their free, informed and ongoing consent." -- Yes. Approval is a continual process, and can be revoked by participants at any time. Researchers need to be aware of this.

As a small side note (outside the principle section), it's good to see that the ability of participants to withdraw their consent for biobanking of samples is implied [S 16.2]; it'd be nice if that could be made more explicit.

Reading further on, I've found a part I disagree with, S 9.22:

"If they do not significantly amend the study, researchers should consider participants’ consent to be ongoing unless they have reason to believe a participant is withdrawing consent."

I think the researchers actively need to maintain consent:

"public disclosure in any form must be be authorised by participants.... Agreements made for blanket approval of public disclosure (e.g. 'there is no need to approve every student presentation') should not be allowed."

One of the issues with the research that I did was that the participant's representatives didn't feel they were sufficiently informed about dissemination of research, even though that was authorised in the initial agreement.

9.31: "not overburdening participants with information that reduces their ability to provide effective informed consent"

vs

9.32: "the higher the risks participants face... the more detailed the information"

That should be, "the higher the risks, the more clarity required"

I will reiterate my distrust of biobanking; it removes control from participants to satisfy the demands of centralised management and academic efficiency. This is not, "You participate in this research", it's, "Here's what we're doing; if you don't like it, that's your problem".

S 13, Standards. I would also add:

* Full research results must be made available to all participants at no cost

Of course, the easiest and cheapest way to do this (in most cases) would be to make the results available to *everyone* at no cost.

13.44 "dual-role researchers can face several significant ethical challenges.... Some options for managing these issues are... recognising the conflict and declaring it, and mitigating risks to informed consent"

I like that this is explicit; it's a good way to do research.

Ooh, I found a finger-slip typo:

14.37 "5esearchers should establish"

14.49 :When research involves the special features identified above, researchers should carefully consider whether they should undertake robust, active and ongoing engagement with relevant communities and stakeholders to establish whether the proposed data use is acceptable." 👍

Aside: engagement and communication of this nature requires active communication from both sides. Silence and stonewalling by the communities and stakeholders prevents this, is an indication that consent should be re-evaluated, and may suggest the project should be stopped.

14.56 "Obtaining informed consent to link data must always be the default starting point... researchers may link data only if an ethics committee is satisfied that they meet the conditions for waiver of consent."

*cough* Dropbox *cough*

https://twitter.com/cfiesler/status/1022103087098388480

I find it interesting that the databank protocols seem to be more descriptive than the biobanking protocols. There's even one "this shouldn't have happened" example; I think the severity of this is understated.

Regarding tissue samples... when a tissue has been donated, and genetic research is then carried out on the donated tissue, who *should* give their consent for that research?

Cancel that... the expanded biobanking discussion section is fairly verbose

Okay, I've read through the whole document now. One omission that I can think of at the moment is in the area of personal research. If I'm studying myself, what do I need to do to demonstrate informed consent? Do I need ethics approval for publishing results of such a study?

Let's see if I can do this properly this time:

@threadreaderapp unroll