FDA Expected To Approve Technique To Create “Three-Parent Babies”

[brinny]

They would use embryos that are considered "irreversibly arrested":

"The group isolated thirteen surplus embryos acquired via in vitro fertilization that were deemed to have “arrested irreversibly,” meaning the blastomeres had not undergone any cleavage division for at least 24 to 48 hours after conception."
https://www.ocf.berkeley.edu/~issues/articles/14.2_Shaikh_A_Dead_Embryos_1.html

These are embryos that have stopped dividing into new cells on their own, and would not grow any further if implanted. The initial research into this possible treatment for mitochondrial disease would start in these non-viable embryos to hone the process of introducing the mitochondria without doing harm to the embryo. Reading the press release from the National Academies of Science, the next step would move to viable male embryos since men do not pass on mitochondria to their children, if approved by the FDA.

Thank you for your generous information and providing some clarity.

Something i'm wondering about is what exactly gives the FDA authority to approve of or disapprove of something like this.

This is confusing.

It's the "Food and Drug Administration". Did something change, or have i just been in the dark about what they've always done?

 

[Dave-W]

To be pedantic, that doesn't require fertilization between two people.

True - but the thought is that all procreation has to involve sex.

 

[Super Hotdog Salesman]

It's the "Food and Drug Administration". Did something change, or have i just been in the dark about what they've always done?

The FDA has been in charge of regulating research involving human subjects since the 70's: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

The FDA has this authority given to it via federal legislation:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm

 

[Loudmouth]

Thank you for your generous information and providing some clarity.

Something i'm wondering about is what exactly gives the FDA authority to approve of or disapprove of something like this.

Laws passed by Congress.

It's the "Food and Drug Administration". Did something change, or have i just been in the dark about what they've always done?

I would think that the vast majority of the US population is probably unaware of what the FDA regulates, so you shouldn't feel alone in your surprise. Nothing has changed that drastically since the FDA was established by the 1906 Pure Food and Drug Act. If a drug is going to be used by doctors, it first needs FDA approval. In order to get FDA approval, you have to follow their rules and regulations. This includes procedures like mitochondrial implantation.

Basic science research outside of human trials is governed by a whole slew of governmental and non-governmental agencies, including local institutional review boards and federal safety regulators like the EPA and OSHA.

 

[brinny]

The FDA has been in charge of regulating research involving human subjects since the 70's: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

The FDA has this authority given to it via federal legislation:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm

i had no idea. Thank you.

 

[brinny]

Laws passed by Congress.



I would think that the vast majority of the US population is probably unaware of what the FDA regulates, so you shouldn't feel alone in your surprise. Nothing has changed that drastically since the FDA was established by the 1906 Pure Food and Drug Act. If a drug is going to be used by doctors, it first needs FDA approval. In order to get FDA approval, you have to follow their rules and regulations. This includes procedures like mitochondrial implantation.

Basic science research outside of human trials is governed by a whole slew of governmental and non-governmental agencies, including local institutional review boards and federal safety regulators like the EPA and OSHA.

Again, thank you. I was obviously in the dark about all of this.

Your generous responses are appreciated.

 

[Loudmouth]

Again, thank you. I was obviously in the dark about all of this.

Your generous responses are appreciated.

As far as I am aware, all scientific research in the US is overseen by Institutional Review Boards, or IRBs. If you are interested, you could be on an IRB since IRBs are strongly encouraged to include community members on their board. I found this interesting article written by a non-scientist community member that sits on an IRB board (read pg. iv if nothing else).

https://oprs.usc.edu/files/2013/05/Community-Member-Booklet-5.1.13.pdf

As a member of the IRB, you would be in charge of voicing your approval, concern, or outright rejection of research proposals as they relate to your own ethical and moral beliefs, and as a general member of the community at large. The proposals are required to be written so that non-scientists can understand what the research will entail.

Oversight is something that scientists have been sensitive to over the last 40 years as bad scientists have given science a bad name. Not only that, but much of research is funded by tax dollars, including yours. It makes sense to have the community engaged with the science that they fund.

 

[brinny]

As far as I am aware, all scientific research in the US is overseen by Institutional Review Boards, or IRBs. If you are interested, you could be on an IRB since IRBs are strongly encouraged to include community members on their board. I found this interesting article written by a non-scientist community member that sits on an IRB board (read pg. iv if nothing else).

https://oprs.usc.edu/files/2013/05/Community-Member-Booklet-5.1.13.pdf

As a member of the IRB, you would be in charge of voicing your approval, concern, or outright rejection of research proposals as they relate to your own ethical and moral beliefs, and as a general member of the community at large. The proposals are required to be written so that non-scientists can understand what the research will entail.

Oversight is something that scientists have been sensitive to over the last 40 years as bad scientists have given science a bad name. Not only that, but much of research is funded by tax dollars, including yours. It makes sense to have the community engaged with the science that they fund.

Thank you! I had never heard of them. I will read the information on the link.