[robbiep]

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 unscrupulous merchants.

Now I'm not saying there's anything wrong with your study, or your proposed aims. But if you want to be taken seriously and not shut down by whatever regulatory authority governs your territory, you need to think long and hard about this on both this study and any future studies/products you intend to sell.

Do not screw this up, and do not make the mistake of approaching human health and clinical trials as though something critical like ethics review is something that can be 'patched' further down the line after the release date

[chrisrxth]

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.

[robbiep]

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.

[xenophonf]

    [L-Theanine] has no known toxic dose.

You keep saying this like it means something. Even _water_ has a toxic dose:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1770067/

It really makes me wonder whether you have adequate human subject protections in place or if you just hand-waved those away by assuming L-Theanine was completely safe.

[ska]

   While we work through our protocol we will continue to dive into ethics and safety.

This part, for what it's worth, is ass backwards.