The poster above indicates that institutional IRB approval would cover things, but that can actually be a bit tricky depending on the regulatory board and the specific situation. For example, I am a member of our IBC (Institutional Biosafety Committee). We approve all scientific research done on our campus for safety reasons (chemical and biological). However, the legalities behind this are a bit unclear. The NIH and institution require this board, and you can't do research if you don't get our approval, but what is unclear is what would happen if something unfortunate occurred? Right now, we have legal backing from the institution which should cover all scenarios, but in speaking with said legal council, we are actually all personally liable for consequences from approvals we sign off on. Board members at other institutions have been personally sued, so there is precedent for this happening. However, with the backing of the University legal team it is much easier to swallow. It is difficult to see how Microryza will be able to replicate this without documenting full legal support.
I am not trying to be a Debbie Downer here, and I really like the concept. For most of your research topics this will not be an issue, but I would hate to hear how the entire organization got burned to the ground over some regulatory law suit, and I certainly would not like to see someone get harmed. Particularly since all of the hard work has already been done for you by other organizations. You just need to take advantage of it.
If handled correctly, this could actually be a marketing point for your organization over others. You would need to balance the headache of implementing these regulations against the real and perceived benefits, but I think folks would be much more confident in the process from an investigator or potential investor perspective if you implemented a transparent but rigorous system.
As an investigator myself I see huge promise for this type of program. However, I have a major and immediate concern for this funding mechanism. There is tremendous potential for unethical research to be performed here. Some of the projects currently receiving funding and presented on the web-site are already in potential violation of public safety and patient/animal rights violations. Asking people on the internet to participate in these research efforts is not only unwise, but unethical and at worst, potentially illegal.
For example, the project titled, "Viral Causes of Lung Cancer" featured on the homepage proposes to analyze, "...blood from a nine-year study of over 9,000 men.". As indicated in the background material, "People living with AIDS and transplant patients are at higher risk for lung cancer." Therefore, I am to assume that some of these blood samples may contain infectious HIV. At this point, this is only an assumption, but how am I to know that the research is being processed under required biosafety conditions? Equally as important, how am I to know that the patient data has been protected and adequately de-identified? I can make these assumptions, but when dealing with disease control and patient rights assumptions are not a place where I want to dedicate my money.
What happens if the investigator accidentally inoculates himself with patient blood via a contaminated needle? The entire proposal is predicated with the idea that the samples are laden with virus, so unless the investigator is wrong, there are at least some infectious samples. Similarly, what controls are in place to prevent the association of patient data with viral load and cancer status amongst other things?
How is Microryza going to prevent the investor from law suits in the case of a biosafety incident or patient/animal rights violation?
Regulatory committees are a blessing and a curse to all researchers. They are a curse in that it means a lot of paperwork, boring courses and regulatory meetings. But they are there for a reason, specifically to protect the individuals working on the research, the patients from which samples are obtained (when applicable) and the funding agencies supporting the work. Many regulatory requirement are put into place only following an accident or tragedy. I hope that Microryza is able to respond to this proactively instead of retroactively after someone has been harmed.
Perhaps this has all been thought out by the founders, but I was unable to find any information on the web-site about any of these issues. My general assumption is that when funding is provided to an investigator at a University that it will all be handled under the universities regulations. However, all funding agencies have a set of rules that must be complied to in order to protect themselves from these exact scenarios. And I can't even begin to imagine a mechanism to properly monitor 'citizen science' projects. These will largely not involve patient data, but may involve topics such as environmental monitoring of plants and animals. These also have their own issues of regulatory concern for the welfare of the environment and animals under study.
I am not trying to be a Debbie Downer here, and I really like the concept. For most of your research topics this will not be an issue, but I would hate to hear how the entire organization got burned to the ground over some regulatory law suit, and I certainly would not like to see someone get harmed. Particularly since all of the hard work has already been done for you by other organizations. You just need to take advantage of it.
If handled correctly, this could actually be a marketing point for your organization over others. You would need to balance the headache of implementing these regulations against the real and perceived benefits, but I think folks would be much more confident in the process from an investigator or potential investor perspective if you implemented a transparent but rigorous system.