Thanks for the thoughts. We've spoken with a lawyer who specializes in FDA issues. We will have informed consent waivers for participants.
Rob does have formal training in scientific ethical issues and is more than competent on the subject.
Also, L-Theanine is something that you can purchase at the grocery store as a food supplement and it has an excellent safety record and no known toxic dosage.
If it makes you feel better, we are a supplement distributor that happens to help you record whether or not the supplements actually work.
I don't think your platform is exempt from the "common rule" requirement to obtained oversight from an IRB.
The fact that L-theanine is obtainable over the counter is not material. If you study the effects of aspirin on cancer outcomes, you must still obtain consent and IRB review.
A supplements distributor that records whether supplements work is still engaging in human subjects research.
Cool idea, but as many have pointed out there are some potential issues with the execution.
I'd suggest you get an additional formal legal opinion on applicability of HIPPA as well, it would be financial painful (up to something like $250k/record if I recall correctly) for you to get caught on the wrong side of that one.
You should also (already) have a proper formal ERB.
The other comments are on point. From my perspective as someone in the digital health / clinical research industry, the site (as is) raises a bunch of red flags:
- There's no indication this study has received IRB (Institutional Review Board) approval, which is a baseline. Here's a handy reference when asking the question, "Does my research need IRB approval?":
http://www.irb.umn.edu/research.html
Based on several factors, the study/experiment qualifies as research (it meets the requirements for being a systematic investigation, contributing generalizable knowledge, and involving human subjects). IRB review/approval can be fairly straightforward, but does cost a non-trivial amount of money.
Chris, if you need to work with an IRB, I recommend getting in touch with Copernicus Group (http://www.cgirb.com/). I've worked on 20+ projects where they've been the IRB and they've always been responsive and pretty open to innovative ideas.
Echoing rgejman, if you don't have IRB approval, stop everything. Now.
- There'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.
- 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/regulations around this). Even for something that seems benign or where "nothing could ever go wrong" - you'd be surprised.
- The site doesn'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'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's when things start to get a bit more interesting.
- There doesn't seem to be a privacy policy. The About Us page mentions, "We will have a complete policy online before we start taking orders for the first experiment." The SquareSpace checkout appears to be up and running, but I'm unable to find the privacy policy.
There'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/configure the tech to implement the mechanics outlined in the protocol (this can be done in parallel to IRB review and/or protocol development)
4. Recruit patients
5. Collect informed consent, enroll patients
6. Collect data
7. Everything else...
One of the tricks here is that all of the content a patient might see has to be IRB approved.
Want to run ads soliciting your study? They have to be IRB approved.
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).
Want patients to pay for their kit via a SquareSpace checkout? Probably requires IRB approval, and likely needs to occur after a participant has completed an informed consent doc.
Need to send password reset emails to patients in the event they can't remember their login to access the study survey tool? Has to be IRB approved.
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're offering. You could (and there's a good chance I'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.
Unfortunately, you'd likely have to scrub using the Double Blinded site, referring to what you'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.
All of that said, the concept of citizen science and open/transparent studies is very cool. It's just a (minor) hassle to dot all the i's and cross all the t's.
Also, brilliant idea to offer customers a way to track efficacy. I've been toying with similar ideas, so it's cool to see someone else implementing something.
Thanks! Digital health can be incredibly fun and rewarding, but there are plenty of opportunities to run head first into walls you may not have realized even existed.
Aside from the ethics considerations, privacy regulations (and the desire to tread conservatively) can lead to some odd implementation decisions...especially if you're coming into the industry from a general or consumer oriented tech background.
I once worked on a medication adherence project for patients in Italy where patients needed to complete bi-weekly assessments and generally track their medication adherence. We set up a secure portal/website for patients, but were prohibited from emailing them reminders when their next assessment was due.
The sponsor (aka pharma co) was extremely conservative re: patient privacy laws and more or less left it at, "well, the patient will just have to remember to return to the website, log in, and complete their survey at the appointed time." After a couple of months of sub-optimal survey completion rates, they re-evaluated their position and let us send out survey reminder emails.....which is a baseline thing to do when you need to retain participants over the life of a study.
Oddly enough, this was for a commercial project (medication was available on the market, physicians were referring their patients to this website as a value added sort of service) and the commercial side is a bit more wild west than phase 2/3 research. Well, as wild west as the pharma/clinical research industry gets :)
There are parallels between customer acquisition/retention in SaaS and patient recruitment/retention in clinical trials that are pretty interesting...but I think most folks on the Saas side would think the healthcare folks are trying to solve problems with one (if not two) hands tied behind their backs - and in some cases, wouldn't be wrong in thinking so.
Maybe they are taking the money that people pay him on this side and paying some other research subjects to do the same thing and is going to compare the results.
It's weird to ask people to pay to be part of a study. So maybe that is actually part of what this person is studying.
Maybe all the capsules are placebos and they are studying something else.
Can you tell I like conspiracy theories? :)
Oh I just noticed you are the person who posted this. You should do that, if this isn't what you're doing.
This made me curious so I checked the FDA site. In case anyone else is interested:
From a very cursory review, it appears that health claims on the packaging are quite heavily regulated by the FDA[1], but advertising for dietary supplements and foods seems to fall outside their mandate and regulatory responsibility lies instead with the FTC:
"The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws."[2]
I'm not sure what's on the bottle, but presumably the websites falls under the jurisdiction of the FTC. A brief review of their site seems to indicate a far more relaxed approach is taken. For example:
"The FTC's standard for evaluating substantiation is sufficiently flexible to ensure that consumers have access to information about emerging areas of science"
"These factors are often weighed together to ensure that valuable product information is not withheld from consumers because the cost of developing substantiation is prohibitive"
"...the FTC gives great weight to accepted norms in the relevant fields of research and consults with experts from a wide variety of disciplines, including those with experience in botanicals and traditional medicines" [3]
We're going to keep adding more trials - but there's no timeframe for when you have to start and end the trial. You can order it and start it whenever you receive it in the mail.
Not yet :( Like Steer said, you can still order Theanine independently of our company but I can let you know when we are ready for international orders if you send me your email!
Indeed it's difficult to tell - exactly the reason why a double-blinded trial on yourself can help you determine if it's making a significant difference or not :)
