Re: PLOS ONE: Your submission entitled openSNP - a crowdsourced web resource for personal genomics

[Bastian Greshake]

Hi there,
two issues about our manuscript have come up with PLOS ONE:

On 31 October 2012 12:49, PLOS ONE <plo...@plos.org> wrote:

Thank you for submitting your manuscript entitled "openSNP - a crowdsourced web resource for personal genomics" to PLoS ONE.  Your manuscript files have been checked in house but before we can proceed, we need you to address the following issues:

1) Thank you for stating the following financial disclosure [The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.].
 Please complete the financial disclosure on the online submission form (via Edit Submission) to state all the funding that you received for this study, or state "No current external funding sources for this study", as detailed online in our guide for authors at http://www.PLOSone.org/static/submissionInstructions.action

Right, we need to list the Wikimedia foundation grant on this, this is pretty easy to add and nothing to worry about and I can fix this easily on the submission backend. But the second issue, IRB approval for the survey, is a bit

2) Thank you for including your ethics statement:  "N/A" and also stating "The survey was performed using Google Docs and was distributed to possible participants through the 23andMe community forums, the DIYBiology mailing list, blogs which focus on genetics and DTC genetic testing and social media websites like Twitter, Google+ and Facebook. The survey included demographics such as age, chromosomal sex and ethnicity of the participants. Furthermore, it included questions on their (planned) customership with a DTC company."
 a)     Did you obtain approval from your ethics committee (also known as an institutional review board, or IRB)? Please name this ethics committee or IRB.
b)     If you did not obtain ethics approval for your study, did you consult with the ethics committee and receive a formal written waiver?
c)     If you did not obtain approval, or a formal waiver, please explain in your manuscript why ethics approval was deemed unnecessary. In your explanation, please cite legislation or a section code that would exempt you from needing ethical approval.

I guess we can deem the IRB approval unnecessary according to US and german law.
For the US law it's the 45 CFR 46.101(b) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 Especially subnumber (2) of this code: "Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy: [...]  (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation."

We should fall into this category with our survey. Similarly the Hessian "Datenschutzbeauftragte" states "Die datenschutzrechtlichen Bestimmungen finden nur Anwendung, wenn für ein Forschungsprojekt personenbezogene Daten benötigt werden. Forschung mit anonymisierten Daten ist jederzeit ohne datenschutzrechtliche Vorgaben möglich." (http://www.datenschutz.hessen.de/wf001.htm#entry2223), so we're inside the framework of the Bundesdatenschutzgesetz as well. 

I'd say we add/edit following text of the manuscript in the following way:

=== start ===

The survey was performed using \textit{Google Docs} and was distributed to possible participants through the \textit{23andMe }community forums, the \textit{DIYBiology} mailing list,

blogs which focus on genetics and DTC genetic testing and social media websites like \textit{Twitter}, \textit{Google+} and \textit{Facebook}. The survey was taken anonymously by the participants, thus IRB approval was deemed unnecessary according to US regulations in \text{45 CFR 46.101(b)} and according to the Hessian data protection officer (http://www.datenschutz.hessen.de/wf001.htm#entry2223).

The survey included demographics such as age, chromosomal sex and ethnicity of the participants. Furthermore, it included questions on their

(planned) customership with a DTC company.

=== end ==

Do you think that will do? Should we add more on this?

Cheers,
Bastian

[Fabian Zimmer]

Thanks for pointing this out! 

Well I have only a *very limited* understanding of both laws thus I am not capable on making a really educated guess on this. On the other side my gut feeling is that because the survey was anonymously (and we did not log anything beside that) it should be fine.

Cheers,
Fabian

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[Bastian Greshake]

Okay. I made the changes and resubmitted. I also think we're fine. In the worst case (that they won't accept this as an answer) we will just remove the survey. Would suck but be the only way I guess.

Cheers,

Bastian

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