Approval for Survey on the Human Skin Microbiome

Governance Activity Reviews
#1

Hello everyone,

I am Nicolas Levrier from the Quaranskin Team, posting this project for review.
Participating to the iGEM competition of 2020, our team has been working since the beginning of the confinement in France (end of March) on a survey around the skin microbiome.

We think that the lockdown that followed the pandemic, and the social distancing measures that we are still experiencing today, are impacting our skin microbiome. To explore this hypothesis, we are carrying a study in which volunteers, throughout Europe, are asked to sample parts of their skin microbiome with cotton swabs (provided by us).

The study is organized as follow :
Step 1: To participate, volunteers are first sent a consent form (which you can find here 1) that specifies what use will be made of their data. If the volunteer gives his or her informed consent, we move onto the next step. We make sure to be available to answer any question and to withdraw from the study people that desire so.
Step 2: Participants registered in our study are being sent a participation kit containing all the material needed to sample their skin microbiome. After, sampling themselves, participants ship the swabs back to us and they answer a questionnaire to provide us with important information regarding their environment, age, and social/hygiene habits that could impact their skin microbiome (e.g. how much time they spend at home / outside, how frequently they wash, etc.).You can find this questionnaire here 2.

Step 3: Upon collection of all the cotton swabs, we send them to a sequencing company, Genewiz, that will sequence all the bacteria contained in the samples and send us the results.

Step 4: Once we have the results of the sequencing, we will analyze the sequencing data combined with the participant’s answers to provide context.

The results of this analysis will be used to understand better the dynamics of the skin microbiome, its evolution in the context of limited human interactions, and potentially identify unusual variations between different group of people, or potential rises of dysbiosis.

The participation to our study does not take longer than one hour to sample and answer the questionnaire. The participation to our study is also free for our participants, we are covering all the costs for the study.

Our study is currently being reviewed by the French Comités de Protection des Personnes (CPP).

To respect people’s privacy, all personal data will remain anonymous. To fit this guideline, we have assigned to each participant a random ID number through our Open Humans project page. This unique ID is used to link someone’s samples to his or her questionnaire.

As we plan to have about 70 participants, having our Open Humans project approved could allow us to reach our goals, the registrations being currently limited to 40 people.

Should this project be visible and available for all Open Humans members to join?

Participants need to register through a participation form, thus not available for all Open Humans members. However, some results will be published and available for all.

Please vote Approve or Deny , and/or comment.

Quick links

· Activity page: https://www.openhumans.org/activity/quaranskin/

· Project review guide: https://forums.openhumans.org/t/project-review-guide/15

· Project guidelines: https://www.openhumans.org/community-guidelines/#project

Project info

· Title : Quaranskin

· Managed by: Ariel Lindner, Jake Edwin Wintermute, Radoslaw Ejsmont

· Description: The Quaranskin project is a 1-hour-long participation where volunteers are asked to sample their own skin microbiome and answer a questionnaire about personal informations such as age, sex but also hygiene and social habits. This study is one-of-a-kind as volunteers are actively participating in generating the sequencing data of their skin microbiome. The goals of this project is to see if citizen science can be applied in genomic studies and if yes, to gain a better understanding of skin microbiomes in the era of COVID-19 and social distancing.

We hope to see interesting correlations between specific behaviors and specific skin microbiome composition. No correlations at all would be also satisfying to see as it would support the hypothesis that social distancing and confinement had no impact on our skin microbiomes.

· Project website: quaranskin.cri-paris.org

· Data received: Skin microbiome data, pandemic related activities, personal informations and skin health status.

· Data added: Skin microbiome profile of each participants will be linked to their OpenHumans accounts

· Ethics review: Currently under the review of the French Comité de Protection des Personnes. As our project only involves skin swabbing and as we took care of the anonimity of our participants, our project should not generate concerns about the safety of the participants.

I hope this project has captured your interest and enthusiasm,

Je vous remercie,
Nicolas, on behalf of iGEM Paris-Bettencourt

#2

Thanks @Nicolas_Levrier!

Can you explain this step in more detail?

How can they request a copy of this form?

The drafted activity you’ve shared is an “on-site” format, where consent is expected to be presented on the Open Humans website. There’s a markdown-format field for this. Currently it’s empty – if you go to the activity page & click “view informed consent” it’s blank.

To get an idea of what that looks like, this activity has a longer form: https://www.openhumans.org/activity/openaps-data-commons/

If consent is occurring elsewhere – and you expect to be running a separate web app – you probably want an OAuth2 activity.

Would you be interested in having the consent form within Open Humans itself? Then you can send the user to a Google Form to collect information you want, e.g. shipping address.

#3

Hello,

Yes of course, here is how volunteers’ consent is obtained. We send to them by mail a link to a participation form, made on the platform called Framaform (to avoid using Google Form). There they can download the consent form. After they have signed it, they need to upload it on the Framaform so we can have access to it.

Because we could not upload our form (Framaform and not Google Form) on Open Humans, we did not put it on the platform at first. However, in order to have the consent certificate displayed here too, we have now put the links that direct to the consent certificate in the box “project informed consent” !
This way, in addition to having the consent form available through our participation form, participants can directly access it on Open Humans.

Have I answered correctly to your inquiry and do you think this method presents enough precautions?

Thanks for your involvement!

#4

We send to them by mail a link to a participation form called Framaform (to avoid using Google Form)

Mail or email? (Usually one emails links?) Are you expecting them to (1) print the form (2) sign it (3) scan and upload it? If so, for (3) are you accepting photographs of the form?

If that’s the plan, I’d caution against doing it this way. Many people don’t have easy access to a printer. Scanning is even more difficult (photographs are easier, though). Expecting someone to print and sign a paper form creates “friction” and is likely to lose potential participants.

Because we could not upload our form (Framaform and not Google Form) on Open Humans, we did not put it on the platform at first.

I guess I don’t understand what you mean by this. You can use Markdown to create fairly extensive text, including links (e.g. to a certificate), in a consent document on Open Humans. Would you like me to try implementing this for you? (I’m happy to help!)

You can also send people to a URL post-signup (they go to this after consenting/authorizing), or email a link to them (via their Open Humans ID). That URL can optionally include a pre-filled field with the participant’s anonymous identifier – info on this is here: https://github.com/OpenHumans/open-humans/wiki/Sending-members-to-surveys-and-forms

Collecting names on consent forms

Another consideration is whether you need their names on the consent form and literal signatures? This is identifying information, and isn’t always required for consent to human subjects research – at least in the US – otherwise it would be impossible to do many forms of online research. Indeed, sometimes protocols deliberately avoid collecting this identifying information, to maintain anonymity of participants.

A consent form within Open Humans would be linked to the participant identifier and account, and not to their name/email (although you could also collect that). (They can also withdraw on Open Humans via that identifier.) If you collect consent via name/signature – and if you keep that information unlinked from participant identifiers – you’ve created a disconnect between the consequences of participation in the study (communications, samples, and data) vs. your documentation of consent.

#5

Mail or email? (Usually one emails links?) Are you expecting them to (1) print the form (2) sign it (3) scan and upload it? If so, for (3) are you accepting photographs of the form?

By email, sorry. People can either scan the form, take a picture or draw an electronic signature. This way, people write their name, the date and sign, which seems to be a requirement for a consent form linked to research on the human person in France.

I guess I don’t understand what you mean by this. You can use Markdown to create fairly extensive text, including links (e.g. to a certificate), in a consent document on Open Humans. Would you like me to try implementing this for you? (I’m happy to help!)

Well I’m not the best person to explain this, but with the help of Bastian it had seemed more complicated to upload the consent form on Open Humans than the way we did it … But if in the end we need to, we would be pleased if you could help us, thank you!

This leads me to the question whether we need or not a consent form on Open Humans, to be able to connect the couple (sample ; questionnaire) to one consent form!

Ensuring a consent form is linked to each sample + questionnaire

First, I have not been clear on the following point : the volunteers receive the samples to their postal address only once they have signed the consent form. Therefore we know that to one sample corresponds one consent certificate signed. We suppose that the person who then fills the questionnaire has also received the sample, and thus signed the form. But to ensure no one has got an 8 digit ID and filled a questionnaire without signing anything, we can cross check data and only keep to questionnaires that have the same ID as one of the samples.
To sum up:

  1. sample --> consent form
  2. sample --> questionnaire
  3. sample <-- questionnaire
    So (sample ; questionnaire) --> consent form !!

Secondly, it is true that Open Humans offers a quite simple alternative. However, our concern is that it would mean for participants to re-log on the platform to sign another certificate, and, overall, we are not certain how valuable this approval would be without a real signature, name, etc. (which cannot be ade here to preserve anonymity I suppose).

Can you tell me if the first option is, according to you, satisfying?

#6

No problem with consent occurring in that order. I think I’m just sharing general advise against collecting names if a study is operating with anonymous participation, but I don’t know what your requirements are locally. And it’s unavoidable for you to at least get mailing addresses.

For clarity I think it might be an improvement for the consent on Open Humans to replicate the text participants already signed (in theory). It could note that this is a duplicate (i.e. they’ve signed it before, but this time it’s as an anonymous participant), and link to the original text.

Happy to meet up if I can help with advise, I’ll send a message with my availability. :slight_smile:

#7

@Nicolas_Levrier FYI: as a quick fix because you may have users hitting the user limit cap, I’ve temporarily moved this to 80 so people no longer encounter that error.

I think some further improvements to the activity page would be best before it’s visible on Open Humans to various users – maybe once the study website is up. :slight_smile:

Note/update for the review/approval process: (I met up with the project group, so this is from our discussion.) While this project has not yet been approved by the ethics board, they were advised to move ahead with consent and sample collection given project deadlines – provided they do not analyze the samples.

It’s unusual in human subjects research to solicit participation and consent in a study prior to ethics review and approval. (I’ve never seen this done in the US, and I have seen a US ethics board react very poorly to a study advertising & recruiting prior to review and approval – it triggered a outright rejection, not an “improve and resubmit” – it might be the only time I’ve seen that happen.) Sorry this has probably created some confusion, as it’s an unusual order to do things.

#8

Following up with more items from our meeting…

Updates I made for the Open Humans activity…

Please look these over and see if you like the changes!

  • I updated the “general information” URL to http://quaranskin.cri-paris.org/
  • I updated the post-join URL to the same – if/when someone joins on Open Humans they are sent to this URL, I’m not sure if there’s a “better option” here. Maybe you want to change this to a form where people log their sample IDs? (It can pre-fill their anonymous member ID, and it can link to the framaform if someone hasn’t requested a kit yet.)
  • I updated the consent text on Open Humans to be a duplicate (and linked originals), see what you think?

“Reconsent” to document new consent/permissions

I checked on the question “can people re-consent to update the recorded consent?” I think currently the only method is to leave the project and rejoin. This might change (I’d like to improve the activity page), but I think it’s also not really an issue for your project since it’s just a duplicate.

Instructions to withdraw

This wasn’t a TODO from conversation, but I noticed the consent form’s withdrawal instructions just give an email to contact. I wanted to be sure you’re able to point withdrawals in the right direction, so these withdrawal instructions might be helpful. :slight_smile:

For someone to withdraw and remove their data from the project, they should log in to Open Humans and go to the project’s activity page (https://www.openhumans.org/activity/quaranskin/). On that page, click the button “Leave project”. They can choose to retain a copy of their data in their Open Humans account after withdrawal (it will no longer be accessible by the project), or choose to delete it entirely.

#9

Hello !

Thank you very much for updating our Open Humans (OH) project with these modifications and moving forward the limit number of participants. :slightly_smiling_face:
The consent form at the beginning with the header is perfect, and it’s nice people can now access our website from their OH Quaranskin page.
Concerning the redirection to the website after joining our project on OH, this seems to be the best option for further participants. We had tried with Bastian to prefill with people’s IDs directly, but there is a problem linked to API with Framaform, so I think this way is good!
The only thing I am concerned about is that we have about 6 participants that have already signed the participation form, and only need to access their Open Humans account to get their IDs. Nevertheless for these people, I can just specify to them not to fill the participation form again and simply get their IDs on the OH page. So I think this will be fine too!

Yes absolutely I think since volunteers can keep a copy of their consent form, it should be OK.

Thank you again for these precisions! We’ll just just tell them the procedure by email if they ask for withdrawal then.

#10

@Nicolas_Levrier glad the updates helped! :slight_smile:

As noted above, the user cap has been raised. The only remaining consequences right now for the activity are (1) not listed & visible to users browsing the site, and (2) the “in development” warning.

Is it possible to update the description to specify some major reasons someone shouldn’t try to join this study? That information is otherwise buried in a consent form, and easy to miss. In particular – needing to reside within the EU? Or France?

I’m assuming you have some limit on where you ship kits? (But I think the consent form doesn’t mention a location restriction? Surely there is one?) I want to avoid people wasting time & energy signing up to something they can’t participate in. :slight_smile:

#11

All right, the description is updated :slight_smile: