Review Vaz et al.'s "Diffusion of ethical governance policy on sharing of biological materials and related data for biomedical research"

[Daniel-Mietchen]

Earlier this month, I was contacted by Wellcome Open Research (which uses public post-publication peer review) about reviewing the following paper:

Vaz M, Palmero AG, Nyangulu W et al. Diffusion of ethical governance policy on sharing of biological materials and related data for biomedical research [version 1; peer review: awaiting peer review]. Wellcome Open Res 2019, 4:170 (https://doi.org/10.12688/wellcomeopenres.15480.1)

My deadline to do this is December 30, but I will try to do it earlier. In doing so, I will follow my approach from #494 , i.e. I will combine annotations of the HTML version of the preprint with a more classical reviewer report.

[Daniel-Mietchen]

Scholia comparison of the four authors: https://tools.wmflabs.org/scholia/authors/Q79503536,Q79502205,Q58035049,Q56799534,Q79512496 .

[Daniel-Mietchen]

I'm done with a first read.

I have used Hypothesis for annotations. They give https://hyp.is/go?url=https%3A%2F%2Fwellcomeopenresearch.org%2Farticles%2F4-170&group=__world__ as the address under which to find the annotations, but this is a bit unwieldy and my annotations are public (i.e. group "world") anyway, so I'll go for the older format https://via.hypothes.is/https://wellcomeopenresearch.org/articles/4-170/v1 instead .

Some additional comments:

things I missed

• stronger methodological outline
• stronger connections of the case studies to the methodological framework
  • what about an illustration?
• other determinants of policy diffusion,
  • e.g.
  • open licensing (cf. Wikimedia OA policy)
  • availability of easily customizable templates for
    • model policy (cf. Harvard OA policy)
    • MTAs etc.
  • FAIRness (cf. 10 maDMP Principles, Rule 3?)
    • metadata
    • persistent unique identifiers
    • reference to FREE-FAIRER
• concrete examples of data / materials reuse
  • check some data archeology examples, e.g.
  • 1970s and ‘Patient 0’ HIV-1 genomes illuminate early HIV/AIDS history in North America
    • reused blood samples to sequence patient genomes to analyze the spread of HIV
  • Human Sera Collected between 1979 and 2010 Possess Blocking-Antibody Titers to Pandemic GII.4 Noroviruses Isolated over Three Decades
• metadata aggregation
• role of research as a process (mentioned for Argentina)
• how can policy learning/ diffusion frameworks help address challenges commonly raised throughout the manuscript?
  • training
  • community engagement
• data sovereignty
• differences in policy learning/ diffusion for different types of biobanks (alluded to in the text)?
• balancing specific interests (e.g. "scientific progress (in India) and safeguarding individual rights (in Malawi)")

would be great to have

• a standard set of entries that every biobank should have, e.g. as per http://orcid.org/0000-0002-1825-0097
• some entries in a given biobank being showcased, which would help with the need for public engagement that pervades various parts of the manuscript

Refer to the final paragraph "International ethical policy on sharing of biological materials and related data has been an important source of guidance for domestic countries, particularly during an infectious disease outbreak. The four case studies illustrate the different degrees of diffusion in governance standards, requirements and practices from international ethical / policy documents to national policies on the subject. While all four countries have made significant progress in establishing accountable governance arrangements for the responsible sharing of biological materials and related data, still more needs to be done in raising the level of public understanding and trust, and to ensure that the ethical goal of equitable sharing of benefits is realised. There is at the same time a need for researchers and those responsible for ethics review to be appropriately trained, and more generally, for health systems to be adequately capacitated to enable ethically sound research."

For referee guidelines, see also my earlier notes on them at https://github.com/Daniel-Mietchen/ideas/issues/494#issuecomment-333277973 .

[Daniel-Mietchen]

When trying to access the review form at https://wellcomeopenresearch.org/my/referee/report/37324 on my laptop (13.3-inch, 2560 x 1600pixels), I am getting an error message

Your browser window is too small to load the Peer Review Form, please select fullscreen

[Daniel-Mietchen]

Here are the questions from the review form:

• Is the rationale for the Open Letter provided in sufficient detail?
• Does the article adequately reference differing views and opinions?
• Are all factual statements correct, and are statements and arguments made adequately supported by citations?
• Is the Open Letter written in accessible language?
• Where applicable, are recommendations and next steps explained clearly for others to follow?

I do not find them very clear.

[Daniel-Mietchen]

Apart from the above questions, the review form has the following instructions:

Please provide a full report, including a summary of the article and expanding on your answers to the questions above. In particular, if you answered “no” or “partly” to any of the questions, please give constructive and specific details as to how the authors can address any criticisms. Please indicate clearly which points must be addressed to make the article scientifically sound.

[Daniel-Mietchen]

OK, so here is my draft review:

---

The manuscript "Diffusion of ethical governance policy on sharing of biological materials and related data for biomedical research" by Vaz et al. addresses the issue of how national policies on ethical governance of biobanking and the sharing of biological samples broadly defined have been shaped in four countries in recent years and how that reshaping has been influenced by pre-existing policies and infrastructures — or sometimes the lack thereof — in the individual target countries as well as internationally.

It references the work by Dobbins, Simmons and Garrett (2007) on four potential mechanisms underlying policy diffusion and claims to "apply" their analytical framework, but I found that methodological part rather weak, as it is not introduced in sufficient detail, nor used to frame, structure or analyze the case studies in detail.

For instance, Dobbins et al. distinguish "policy learning" from "social construction", "coercion" and "competition", none of which are commented on in the manuscript, although it could be argued that they might have played some role in the observed cases of policy diffusion.

Vaz et al. also observe that policy changes came about under "strenuous" conditions in two of the analyzed countries (Ghana and Argentina) in contrast to more "peacetime" conditions in the other two (India and Malawi), and no commentary is provided as to how that would fit with Dobbins et al.'s analytical framework.

The main value of Vaz et al.'s work is thus in providing

• observations of policy diffusion regarding ethical governance of biobanking and the sharing of biological samples in the four countries
• some details about the practical context of these observations

rather than in elucidating the theoretical underpinnings. This is valuable as such but should be better reflected in the abstract and introduction. There would also be good value in strengthening the theoretical part, though I could see that this might shift the nature of the manuscript too much, so I could imagine this to be handled in follow-up work.

What I would like to be considered for the theoretical part includes

• adding an illustration of the diffusion of certain policy elements described in the text
• comparing the four national and reference policy frameworks with respect to how they would handle some standard epidemiological use cases like post-epidemic analyses of sera from long-term storage to
  • measure antibody levels before, during and after relevant outbreaks, e.g. as per Sharma et al. (2017)
  • perform genetic analyses of pathogens from individuals involved in the early phase of an epidemic, e.g. as per Worobey et al. (2016)
• discussing
  • how policies in the four countries and beyond can, do or should handle "research as a dynamic process" (as suggested in the Argentina case study)
  • how policy learning/ diffusion frameworks can help address challenges commonly raised throughout the manuscript
  • training
  • community engagement
  • the balancing of specific interests (briefly mentioned as "scientific progress (in India) and safeguarding individual rights (in Malawi)")
  • differences in policy learning/ diffusion for different types of biobanks (alluded to in the manuscript)
  • the effect of the availability (or not) of model policies or MTA templates
  • for instance, the availability of the Harvard model policy on open access did likely contribute to the broad adoption of similar policies around the globe
  • the role of open licensing of such model text, e.g. that Harvard model policy is available under the terms of the Creative Commons Attribution License 4.0
  • the FAIR principles for the sharing of scientific data and metadata (Wilkinson et al., 2016)
  • along with the standardization of metadata and the sharing and aggregation thereof, e.g. through the use of persistent identifiers
    • that standardization could include
    • some test content, similar to how http://orcid.org/0000-0002-1825-0097 is used for testing and demoing ORCID-related matters
    • some showcase content, which could help with public engagement, e.g. as per Project H.M.
  • their applicability to epidemiological contexts, as discussed in Pisani, Ghataure and Merson (2018) (especially their Table B) and also highlighted in the Zika case study in the report "Turning FAIR into reality"
    • that report also discusses machine-actionable policies, as do Miksa et al. (2018), which have a strong potential to modulate policy diffusion
  • data sovereignty - between countries, it is somewhat implied throughout the manuscript, albeit not explicitly mentioned, but there are also important policy considerations for data sovereignty of different communities within a country, e.g. as per the Good Data Practices for Indigenous Data Sovereignty and the CARE Principles for Indigenous Data Governance

While reading the manuscript, I annotated it using https://hypothes.is/ , and these annotations — which include comments beyond classical peer review — can be found via https://hypothes.is/search?q=url%3Ahttps%3A%2F%2Fwellcomeopenresearch.org%2Farticles%2F4-170%2Fv1 and have been archived at http://web.archive.org/web/20191227174305/https://hypothes.is/search?q=url%3Ahttps%3A%2F%2Fwellcomeopenresearch.org%2Farticles%2F4-170%2Fv1 . I also took some notes on my review process, which can be found at https://github.com/Daniel-Mietchen/ideas/issues/1263 .

Some more comments on the above questions from the review form:

• Is the rationale for the Open Letter provided in sufficient detail?
  • The authors provide a rationale for addressing the issue of policy diffusion with respect to biobanking. They provide no rationale as to whether an Open Letter is the most appropriate manuscript type for that, but upon checking the Guidelines for Open Letters, I find the choice appropriate.
• Does the article adequately reference differing views and opinions?
  • It does not cover differing views and opinions in much detail, but highlights issues where there is a practical need for reconciling them.
• Are all factual statements correct, and are statements and arguments made adequately supported by citations?
  • What is written appears correct and supported by suitable citations. Lots more could be added — see comments above and annotations.
• Is the Open Letter written in accessible language?
  • Yes. A few minor linguistic issues are pointed out in my annotations.
• Where applicable, are recommendations and next steps explained clearly for others to follow?
  • Here, I chose "partly" because this is sometimes unclear, as highlighted in my annotations, e.g. for the example from Ghana which does not provide sufficient details to find out whether the platform exists and where to find it.

[Daniel-Mietchen]

I just submitted the review (with slight modifications as compared to the draft above) and got a thank you note both via https://wellcomeopenresearch.org/my/referee/report/37324/thank-you and email.

As usual, it does not yet seem to be live though, so I'll keep this ticket open until the review appears.

[Daniel-Mietchen]

The review is now available via https://doi.org/10.21956/wellcomeopenres.16933.r37324 .