The other comments are on point. From my perspective as someone in the digital health &#x2F; clinical research industry, the site (as is) raises a bunch of red flags:<p>- There&#x27;s no indication this study has received IRB (Institutional Review Board) approval, which is a baseline. Here&#x27;s a handy reference when asking the question, &quot;Does my research need IRB approval?&quot;:
<a href="http:&#x2F;&#x2F;www.irb.umn.edu&#x2F;research.html" rel="nofollow">http:&#x2F;&#x2F;www.irb.umn.edu&#x2F;research.html</a><p>Based on several factors, the study&#x2F;experiment qualifies as research (it meets the requirements for being a systematic investigation, contributing generalizable knowledge, and involving human subjects). IRB review&#x2F;approval can be fairly straightforward, but does cost a non-trivial amount of money.<p>Chris, if you need to work with an IRB, I recommend getting in touch with Copernicus Group (<a href="http:&#x2F;&#x2F;www.cgirb.com&#x2F;" rel="nofollow">http:&#x2F;&#x2F;www.cgirb.com&#x2F;</a>). I&#x27;ve worked on 20+ projects where they&#x27;ve been the IRB and they&#x27;ve always been responsive and pretty open to innovative ideas.<p>Echoing rgejman, if you don&#x27;t have IRB approval, stop everything. Now.<p>- There&#x27;s no mention on the site of participants completing an informed consent, which should really be done prior to collecting their money for the kit.<p>- Has any thought been given to how the team will handle adverse event reporting? This deserves serious consideration and is sometimes overlooked (there are a slew of FDA guidelines&#x2F;regulations around this). Even for something that seems benign or where &quot;nothing could ever go wrong&quot; - you&#x27;d be surprised.<p>- The site doesn&#x27;t instill a ton of confidence that data security is a high priority. Using SquareSpace to host the public facing informational portion of the site isn&#x27;t necessarily a problem, but it leads me to wonder how the team is handling surveys and how the survey data will be stored. It seems like participants will likely provide personally identifiable information (PII) and personal health information (PHI) within surveys, and that&#x27;s when things start to get a bit more interesting.<p>It&#x27;s certainly possible to use an off the shelf survey tool (like SurveyGizmo), but there are a few more hoops you&#x27;ll have to jump through. Take a look at the following link: <a href="https:&#x2F;&#x2F;www.surveygizmo.com&#x2F;survey-blog&#x2F;online-survey-hipaa-safe-harbor-certification&#x2F;" rel="nofollow">https:&#x2F;&#x2F;www.surveygizmo.com&#x2F;survey-blog&#x2F;online-survey-hipaa-...</a><p>- There doesn&#x27;t seem to be a privacy policy. The About Us page mentions, &quot;We will have a complete policy online before we start taking orders for the first experiment.&quot; The SquareSpace checkout appears to be up and running, but I&#x27;m unable to find the privacy policy.<p>There&#x27;s a more or less standard process for designing, developing, and getting a study out the door (highly simplified, and skewed heavily towards direct to patient studies):
1. Develop your protocol.
2. Get your protocol approved by an IRB
3. Develop&#x2F;configure the tech to implement the mechanics outlined in the protocol (this can be done in parallel to IRB review and&#x2F;or protocol development)
4. Recruit patients
5. Collect informed consent, enroll patients
6. Collect data
7. Everything else...<p>One of the tricks here is that <i>all</i> of the content a patient might see has to be IRB approved.<p>Want to run ads soliciting your study? They have to be IRB approved.<p>Want to optimize your ads? Make sure your content is submitted modularly for review (ie, list all your headlines, body content, and images separately - and throw the kitchen sink at any variations you can think of to save yourself another round of review).<p>Want patients to pay for their kit via a SquareSpace checkout? Probably requires IRB approval, and likely needs to occur <i>after</i> a participant has completed an informed consent doc.<p>Need to send password reset emails to patients in the event they can&#x27;t remember their login to access the study survey tool? Has to be IRB approved.<p>If you wanted to use efficacy tracking as a marketing tool for your supplement business, you might have a bit more leeway if you were to reposition what you&#x27;re offering. You could (and there&#x27;s a good chance I&#x27;m wrong as this is off the top of my head) simply offer your customers a tool to track the effects of their supplements. This would also help you with reorders by providing an adherence mechanism.<p>Unfortunately, you&#x27;d likely have to scrub using the Double Blinded site, referring to what you&#x27;re offering as an experiment, or mentioning that the results will be aggregated and published. Data protection issues would still be a serious consideration though.<p>All of that said, the concept of citizen science and open&#x2F;transparent studies is very cool. It&#x27;s just a (minor) hassle to dot all the i&#x27;s and cross all the t&#x27;s.<p>Also, brilliant idea to offer customers a way to track efficacy. I&#x27;ve been toying with similar ideas, so it&#x27;s cool to see someone else implementing something.