Maybe this actually part of a study to research whether having your research subjects pay you (rather than the other way around) has an effect the results of a study.
Could you elaborate?
L-Theanine Experiment (1 Month)
31–40 of 56 posts
Re: L-Theanine Experiment (1 Month)
#32Earlier quoted context omitted.
You bring up a good point! We will be adding some outlines about ethics soon. Thanks for reminding us of the importance!
I'm sorry, you have a website called doubleblind, you are asking people to pay to participate in the study, and you need to be reminded of the importance of thinking about ethics? There's a reason why science and medicine don't move the same way Web 2.0 does (ie move quickly and break things). It's because people have died from poor implementations, and people trialing drugs are prone to exploitation from unscrupulou…
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Re: L-Theanine Experiment (1 Month)
#33This website almost certainly violates FDA rules on human subject experimentation because it collects data on the effect of a drug on human subjects. I would stop working on this project until you have advisors (and lawyers) who have experience with regulatory oversight from the FDA. At the bare minimum you are going to need (a) procedures to gain informed consent from trial enrollees and (b) an Institutional Review…
As an aside: it's a cool idea and worth trying--but you are going to need to make sure that you are compliant with this country's laws regarding the responsible conduct of human subjects research!
Re: L-Theanine Experiment (1 Month)
#34Earlier quoted context omitted.
I'm sorry, you have a website called doubleblind, you are asking people to pay to participate in the study, and you need to be reminded of the importance of thinking about ethics? There's a reason why science and medicine don't move the same way Web 2.0 does (ie move quickly and break things). It's because people have died from poor implementations, and people trialing drugs are prone to exploitation from unscrupulou…
We chose L-Theanine because it has an excellent safety record, is well studied, and has no known toxic dose. We are very aware of safety and ethics. There are many nootropics and supplement companies safely distributing the same L-Theanine. While we work through our protocol we will continue to dive into ethics and safety.
What you have stated here you have stated in your previous thread announcing doubleblind and presumably elsewhere.
I don't have an issue with what you are choosing, or why.
In fact, it doesn't really matter.
What matters is that you have a clear and transparent ethics approval process, that you clearly state the steps your protocol had been through, and preferably that you submit your protocol to a human ethics review board, and identify that process openly and transparently.
It sounds like you have already developed your protocol, since you are offering your product for sale shipping from the start of this month. So have you written an ethics proposal? Have you considered submitting it to a HERC? Or are you 'continuing to dive into ethics and safety' now that you have been 'reminded of the importance' of it?
Don't get me wrong, I think your idea and platform is potentially great. But it really seems that you haven't thought about this, and now you're trying to scramble?
If you don't have a science background and aren't partnering with anyone who is, I'd be more than happy to lend my 2c outside of this thread (see profile). Otherwise, I wish you every success with a full and detailed examination of your ethics approach. Medical research (which you are conducting by calling your product an experiment) has a poor history when it comes to blurring the lines between researcher and pharmaceutical company/monetisation, of which you could be said to be doing both at the moment.
Re: L-Theanine Experiment (1 Month)
#35This website almost certainly violates FDA rules on human subject experimentation because it collects data on the effect of a drug on human subjects. I would stop working on this project until you have advisors (and lawyers) who have experience with regulatory oversight from the FDA. At the bare minimum you are going to need (a) procedures to gain informed consent from trial enrollees and (b) an Institutional Review…
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.
Re: L-Theanine Experiment (1 Month)
#36Maybe this actually part of a study to research whether having your research subjects pay you (rather than the other way around) has an effect the results of a study.
Could you elaborate?
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.
Re: L-Theanine Experiment (1 Month)
#37This website almost certainly violates FDA rules on human subject experimentation because it collects data on the effect of a drug on human subjects. I would stop working on this project until you have advisors (and lawyers) who have experience with regulatory oversight from the FDA. At the bare minimum you are going to need (a) procedures to gain informed consent from trial enrollees and (b) an Institutional Review…
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…
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 $250k/record if I recall correctly) for you to get caught on the wrong side of that one.
You should also (already) have a proper formal ERB.
Re: L-Theanine Experiment (1 Month)
#38This website almost certainly violates FDA rules on human subject experimentation because it collects data on the effect of a drug on human subjects. I would stop working on this project until you have advisors (and lawyers) who have experience with regulatory oversight from the FDA. At the bare minimum you are going to need (a) procedures to gain informed consent from trial enrollees and (b) an Institutional Review…
Thanks for the thoughts. We've spoken with a lawyer who specializes in FDA issues. We will have informed consent waivers for participants. Rob does have formal training in scientific ethical issues and is more than competent on the subject. Also, L-Theanine is something that you can purchase at the grocery store as a food supplement and it has an excellent safety record and no known toxic dosage. If it makes you feel…
I don't think your platform is exempt from the "common rule" requirement to obtained oversight from an IRB.
The fact that L-theanine is obtainable over the counter is not material. If you study the effects of aspirin on cancer outcomes, you must still obtain consent and IRB review.
A supplements distributor that records whether supplements work is still engaging in human subjects research.
Re: L-Theanine Experiment (1 Month)
#39How do you propose to analyse the data you collect?
I'm guessing that they're more interested in the collected cash. It's all about the chee$e!
Re: L-Theanine Experiment (1 Month)
#40I tried taking L-Theanine for about 5 days. 30 minutes after taking it each day, I would get very nauseous and usually throw up. I tried varying the dosage from 200mg down to 100mg and then 75mg, I would still get the nausea, no matter if I had an empty stomach or not. I also get the same symptom when drinking more than a cup or so of green tea, and has for years (though I do remember being able to stomach the stuff…
I get the same effect from drinking Starbuck's "Awake" or black tea, whatever they call it now. An empty stomach usually makes it worse.