[MUSIC] Finally we're going to talk about the Governance of SynBio-based Medical Applications. Again, this is not an exhaustive review of governance in this area. As noted before, this is a very diverse set of applications of the science. But I'm going to focus here on the human subject aspects, because that's sort of what distinguishes this week from others. And it's also the area of governance that's likely to be least familiar to basic bench scientists. So as I noted in the ethics lecture, the Belmont Report led to or was the foundation for the Common Rule. The Common Rule is the human subjects governance in the United States as noted for it focuses heavily on the informed consent process. The Common Rule governs human subjects research. Now what does that mean? Human subjects research involves both, or rather, involves either an intervention or interaction with an individual that wouldn't occur but for the research. So we're not talking about clinical care, or the use of identifiable private data or information in a form that's associable with a living individual. So this goes to the tissue samples, right, or medical information. It is not human subjects research according, again, to the US Common Rule. If the material, in its entirety, was collected for purposes other than research, and the material is deindentified. So if you're going through a clinical exam, tissue is taken, a blood sample is taken, for example, tests are done. Once the test is done, there is additional blood left over. If that blood is deidentified, so that it's not associable with a living person, it can be used in research and doesn't count as human subjects research. In the Havasupai case, those blood samples were taken specifically for the purposes of research. That blood would not have been taken but for the research. So clearly human subjects research. Now the Common Rule was enacted in 1991. Science has advanced considerably and revisions are needed, and they are underway. So in 2011, the US federal government issued the advanced notice of proposed rule making. Which was our government saying that they were thinking about, thinking about revising the Common Rule. Then in 2015, the next step in this process happened, the Notice of Proposal Rule making which was the government saying, okay we're thinking about revising the Common Rule and here's what we're thinking about having it look like. At each of these stages there was a public comment period wherein people were able to write in and give their reactions to what the government had produced. So importantly for our purposes, and again, going back to the question of tissue samples as opposed to intervention directly with living people in front of you. One of the main changes that's being considered in this Common Rule revision is bringing those tissue samples, those de-identified tissue samples under the umbrella of human subjects research, such that human tissue samples, regardless of whether they are discarded from clinical interventions or are de-identified, might in fact become human subjects research. And therefore governed under the same rules. However, in the final rule issued in January of 2016 by the Obama administration, this change was not included. The status of the final rule remains unclear given the change in administration. With regard to gene transfer, somatic gene transfer, you've heard about the oversight mechanism there before, the RAC. There were committee DNA advisory established in 1974. We talked about this in week one and the RAC now as we discussed before reviews gene transfer trial proposal. So they don't review all of the proposal anymore. They review a subset that, for example, use a novel technique, such as. The European Commission has the Committee for Advanced Therapies that serves a similar role of having oversight responsibility for gene transfer trials of this sort. With regard to germline genetic modification, which we aren't doing yet, in the US, the oversight would come from [COUGH] the RAC and the Food and Drug Administration, the FDA. However, the RAC currently has language, and for years has had language, that it will not entertain proposals for germline alteration. This any intervention that changed germline DNA would also require an investigational new drug application to the FDA. And currently the FDA is not considering such applications. Internationally, there are 40 countries, about 40 countries, that have relevant policies. Again, germline genetic modification, and all of them ban it. It is under very active discussion and debate in many, many countries. There is an important distinction to be made between germline and mitochrondial DNA. This is a distinction that some jurisdictions make and some don't when talking about what counts as germline genetic modification. So germline modification includes modification of nuclear DNA but not necessarily modification or movement of mitochondrial DNA. So here I am talking about mitochondrial transfer technologies that we won't be discussing but there is a distinction that some are trying to make there in governance of germ line genetic modification going forward.
