How does lab permission generally work?

[DanTrentfield]

I have a general hypothesis on something in the field of medical research that I decline to share due to it's promise, but I must ask how does one gain access to a lab with a blood separation apparatus? It is needed for an experiment to test the feasibility of my hypothesis. While this has been said many times before by many prospective medicine researchers this has the potential to cure all diseases if my hypothesis is correct.

Also, would injecting test subjects with their own consent and full knowledge of the strep throat strain they are being injected with be legal? I would need to collect and separate a small portion of their blood and would need to inject it into a second test subject to test part of the hypothesis. 

[Strange]

You could try asking your local universities/colleges if they would allow you to do some experiments. You might have more luck contacting the lab technicians and getting them interested in a version(*) of your idea. Then you've got an expert in using the equipment and interpreting the results working with you.

(*) I say "version" because if you mention "cure all diseases" then they will say "Okaaay..." while edging slowly out of the door without taking their eyes off you

[Klaynos]

If you are concerned about IPR then it would be sensible to have an NDA in place. 

I've never done medical or human trials but my understanding is that your injection of humans would be unlikely to get past an ethics committee and may well be illegal. Some have even turned to testing on themselves... http://discovermagazine.com/2010/mar/07-dr-drank-broth-gave-ulcer-solved-medical-mystery (not recommended)

[DanTrentfield]

31 minutes ago, Klaynos said:

If you are concerned about IPR then it would be sensible to have an NDA in place. 

I've never done medical or human trials but my understanding is that your injection of humans would be unlikely to get past an ethics committee and may well be illegal. Some have even turned to testing on themselves... http://discovermagazine.com/2010/mar/07-dr-drank-broth-gave-ulcer-solved-medical-mystery (not recommended)

I don't so much care about an ethics committee so much as guarantee I cannot be legally punished for the experiment. Due to the nature of what I hope to accomplish we cannot use animals as the cells I hope to experiment with are different in animals, and the way in which they communicate is different. While it is a good introductory test to use lab rats or rabbits it would be much work and expense for small results. I have several potential candidates who stated they will consent and I will contact a lawyer for consulting on the issue and have him compose a legal document which the candidates can sign if he finds no law prohibiting introduction of non life altering/threatening diseases into consenting candidates with full knowledge of the experiment. 

 

After all it only strep and I would guarantee full disclosure and compensation for any damage or loss that would occur as a result of said introduction of disease. And it would not be painful beyond normal strep and a blood infusion after the strep has subsided. 

Edited January 17, 2018 by DanTrentfield

[Prometheus]

Their consent will not be considered informed if your trial has not been judged as reasonable by an ethics panel. They do not just assess the safety of participants, but also the scientific rigor of the study. For instance, a trial without a good statistical plan in place should be sent back to the drawing board.

If the substance is something not yet licensed for use in humans then you are looking at a first in man study, which has additional hurdles - such as ensuring access to a resuscitation team and an Intensive Care Unit on site. If it has been used in humans before, but you are looking at unlicensed uses/doses then you're looking at a phase 4 trial - usually still requires a healthcare professional to be around, but depends on the substance.

The fact you have identified volunteers before even thinking of gaining permissions would be considered very suspicious. Stating you don't care about the ethics also doesn't bode well.  Make sure your lawyer knows something about medical ethics and law and clinical trials regulation.

 

[CharonY]

If your experiments includes infecting humans I can tell you that you can pretty much forget that. Even someone with actual expertise in the area would have a very, very hard time to have anything on that level approved. Also note that on the cellular level mammalian cells (including humans) are very much alike. So if your basic idea does not work with any animals, it is very unlikely to work in humans.

Also, if your proposed interaction happens on the cell level, one would expect to be able to measure some effects in specific cell lines. I sense a huge knowledge gap when it comes to working with infection models, and I would spend some serious time addressing that before even thinking about infecting anything.

[dimreepr]

24 minutes ago, DanTrentfield said:

I don't so much care about an ethics committee so much as guarantee I cannot be legally punished for the experiment.

1

The ethics committee is the guarantee and rightly so unless you think Frankenstein got it right?

Crossposted...

Edited January 17, 2018 by dimreepr

[CharonY]

Note that the ethics committee does not guarantee any legal rights. It is there only for procedural purposes and it is an entity of the institution. I.e. an ethics committee of an university will not review projects from externals, unless there is an internal collaborator. Its presence is only there that if there is an investigation the institute can claim that they followed procedure and that a given project was reviewed. If something goes wrong people involved can still be punished if they did not follow all reasonable precautions, for example. But also even red flags were missed. 

But again, the requirement to infect humans pretty much renders all discussion moot. 

Edited January 17, 2018 by CharonY

[Arete]

Hi, 

So I run a lab and have been involved in a phase I clinical trial. 

1) Lab access. My lab is in a university and I have had visiting scholars work in there before. They generally have their own funding and I have been fully briefed on the work they are doing. I've signed NDA on patent sensitive work before. There's no way I would let someone in the lab without evidence of proper training, liability coverage and a good idea of exactly what they are doing in there. 

If all you wanted to do was fractionate blood, all you really need is a centrifuge and fractionation tubes. 

2) Human subject experiments would need coverage by an institutional review board (IRB) to be permitted in any lab in any university. Title 45 of the Code of Federal Regulations dictates that any human subject research in the US must legally be overseen by an IRB. IOW - to legally do any research on humans in the US you need IRB approval. To get an IRB approval, you need to be an affiliate of an institution with an IRB. 

Deliberate infection of human subjects with live Streptococcus would be a non starter. You would need to conduct an animal trial to prove efficacy before anyone would let you near human subjects. Animal trials in the US would similarly need Institutional Animal Care and Use Committee (IACUC) approval.  

[DanTrentfield]

16 minutes ago, Arete said:

Hi, 

So I run a lab and have been involved in a phase I clinical trial. 

1) Lab access. My lab is in a university and I have had visiting scholars work in there before. They generally have their own funding and I have been fully briefed on the work they are doing. I've signed NDA on patent sensitive work before. There's no way I would let someone in the lab without evidence of proper training, liability coverage and a good idea of exactly what they are doing in there. 

If all you wanted to do was fractionate blood, all you really need is a centrifuge and fractionation tubes. 

2) Human subject experiments would need coverage by an institutional review board (IRB) to be permitted in any lab in any university. Title 45 of the Code of Federal Regulations dictates that any human subject research in the US must legally be overseen by an IRB. IOW - to legally do any research on humans in the US you need IRB approval. To get an IRB approval, you need to be an affiliate of an institution with an IRB. 

Deliberate infection of human subjects with live Streptococcus would be a non starter. You would need to conduct an animal trial to prove efficacy before anyone would let you near human subjects. Animal trials in the US would similarly need Institutional Animal Care and Use Committee (IACUC) approval.  

Sounds reasonable. I can begin with animals that have a disease similar to Streptococcus, and prove or disprove the key "given" in my hypothesis. Upon it being explained to me that proper training is required I am sure that I can pay technicians with said training to perform experiments according to my hypothesis if the animal experiment proves the hypothesis. Then if everything goes according to plan I can then jump through the safety/regulation hoops and move on to the meat of the process. 

I will also detail what I hope to do to you in a PM if you are interested if you can guarantee that you will not share the information or claim any work I perform as your own. 

[Arete]

To legally do an animal experiment, you'll still need an IACUC approval from an institution with an animal ethics board, which would also require an institutional affiliation. 

In reality, if you don't have any scientific training to perform the work yourself, you wouldn't have the knowledge to oversee the project either. Also, clinical trials cost a lot of money - hundreds of thousands to millions of dollars. If you honestly have that kind of money to spend on testing a scientific hypothesis but no expertise in the field you want to investigate, you'd be best off pursuing it as a philanthropist. I worked as a postdoc on a project funded by a philanthropist in that kind of fashion.

If you're putting up the cash, you can specify conditions of your funding (i.e. specify the hypothesis you want to investigate) and solicit applications from interested labs - or simply approach a scientist you would like to give the money to. Similar to how agencies like the Gates Foundation, Wellcome Trust, Howard Hughes Medical Institute, Ford Foundation etc operate. 

[DanTrentfield]

5 minutes ago, Arete said:

To legally do an animal experiment, you'll still need an IACUC approval from an institution with an animal ethics board, which would also require an institutional affiliation. 

In reality, if you don't have any scientific training to perform the work yourself, you wouldn't have the knowledge to oversee the project either. Also, clinical trials cost a lot of money - hundreds of thousands to millions of dollars. If you honestly have that kind of money to spend on testing a scientific hypothesis but no expertise in the field you want to investigate, you'd be best off pursuing it as a philanthropist. I worked as a postdoc on a project funded by a philanthropist in that kind of fashion.

If you're putting up the cash, you can specify conditions of your funding (i.e. specify the hypothesis you want to investigate) and solicit applications from interested labs - or simply approach a scientist you would like to give the money to. Similar to how agencies like the Gates Foundation, Wellcome Trust, Howard Hughes Medical Institute, Ford Foundation etc operate. 

I have no background in medicine, I am a chemist, but I can attack this from a different avenue as well. I have a method of getting people interested that only needs my basic knowledge of medicine and my knowledge in chemistry. 

 

Frankly, I do kind of have the knowledge to oversee the project based on a couple points which I will explain in a PM. 

[CharonY]

If your project can be conducted using animal or in vitro models, the question boils down to a) how complex  the proposed experiments are and b) whether you are going to pay for it. If it involves fairly standard analyses there may beUniversity groups (typically core facilities) and a number of commercial labs who can do that, though it may cost quite a bit. If it requires the development of experimental approaches (something that my lab has quite some experience in) the cost skyrockets (mostly personnel costs).

If you actually have that level of money, it makes most sense to do as Arete has mentioned: solicit applications. What you basically put up is a rough description of the work you want to do, including e.g. whether you need cell lines or animal models, which level of analysis you need (e.g. what type of analytes are to be measured, targeted or global measure, etc.) as well as budget, while omitting proprietary information. Most universities have a research office where you can send out this level of information and they distribute it to researchers. Folks like me then can look at it and figure out whether we got the capacity to do it. Note that if it involves an NDA the money has to offset the fact that we cannot publish to some degree.

If you cannot pay for all that, the interest will be very low at best. The best case scenario here is that you have an idea that is good and detailed enough so that a lab will invest some money  for preliminary results. These can could then be used to submit a full application based on these to some granting agency. However, it is extremely unlikely to find someone to go through that trouble without a significant level of evidence that it may actually be successful. Moreover, if the work is not actually funded by you, the IP will usually have to be shared.

[Arete]

23 hours ago, DanTrentfield said:

Frankly, I do kind of have the knowledge to oversee the project based on a couple points which I will explain in a PM. 

While I am certainly not trying to disparage you or question your scientific knowledge, someone unaware that IRB approval is required for human subject research is not qualified to run a clinical trial. FWIW, if you've never been involved in a clinical trial before as a researcher, you're unlikely to be qualified to run one yourself. 

Therefore, you'd need someone else to operate as the Principle Investigator both formally and practically - which means you will need convince an established scientist to invest time and energy (and money) into your idea. If you're fronting the cash, it will be easier to convince someone, but ultimately, the reality is that ideas are often the easiest part of the job. My lab does work on alternative antibiotic therapies, and me and my lab can up with 20 odd proposals in 30 minutes, but the reality is that we only have the capacity to actually pursue 2-3 at any given time - we have more ideas than we will ever be able to actually investigate 

Having actually worked on a project arranged like this before, I personally would only consider it if:

a) It fit well with my current research interests  

b) Came with enough $$$ to cover a postdoc and data collection

c) Had the freedom to design, conduct and publish research without interference. 

Given your brief description in this thread unusual level of concern over IP, I already know I personally would not take this on, but best of luck with your project. 

[DanTrentfield]

23 hours ago, Arete said:

While I am certainly not trying to disparage you or question your scientific knowledge, someone unaware that IRB approval is required for human subject research is not qualified to run a clinical trial. FWIW, if you've never been involved in a clinical trial before as a researcher, you're unlikely to be qualified to run one yourself. 

Therefore, you'd need someone else to operate as the Principle Investigator both formally and practically - which means you will need convince an established scientist to invest time and energy (and money) into your idea. If you're fronting the cash, it will be easier to convince someone, but ultimately, the reality is that ideas are often the easiest part of the job. My lab does work on alternative antibiotic therapies, and me and my lab can up with 20 odd proposals in 30 minutes, but the reality is that we only have the capacity to actually pursue 2-3 at any given time - we have more ideas than we will ever be able to actually investigate 

Having actually worked on a project arranged like this before, I personally would only consider it if:

a) It fit well with my current research interests  

b) Came with enough $$$ to cover a postdoc and data collection

c) Had the freedom to design, conduct and publish research without interference. 

Given your brief description in this thread unusual level of concern over IP, I already know I personally would not take this on, but best of luck with your project. 

It is nothing illegal or immoral. It is merely a well backed hypothesis that I am surprised has not been proposed before. This is why I have been concerned over privacy, because people have stolen my ideas before, for example, https://www.google.com/search?q=Interlocking+pool+noodle&oq=Interlocking+pool+noodle&aqs=chrome..69i57.12591j0j1&sourceid=chrome&ie=UTF-8

I had an idea that was essentially the same when I was about 13 and I spoke with an engineer about making interlocking pool noodles that you could create rafts with and he turned me down then went on to make these. 

So, yes, I have good reason to be private with my ideas.

[CharonY]

a) Just having an idea without evidence of feasibility is pretty much worthless in the biomedical arena. 

b) anything that has potential to harm individuals, even when it may have benefits is an ethical dilemma.  Stating that one wants to have a limited human trial without realizing that is troublesome.