+Q: What did you do with the other embryos? Were they implanted?

+A: There are seven couples but the clinical trial is on hold due to the current situation.

+

+Q: What did you to get feedback on the clinical trial design? What was the scope of the team and where did you go to get approvals?

+

+A: I first talked with a couple of scientists and a doctor to find out whether CCR5 was the one recommended. Once we had some data, I presented at Cold Spring Harbor in 2017 and also at the Berkeley genome editing conference. Some of the others in that conference too. I received positive feedback and also some criticism and also some constructive advice. I continued to talk with not just scientists but also the top ethicists in the United States such as at Stanford and Harvard. I also showed my data to visiting scientists. When I started a clinical trial for the informed consent, we.. as a reference.. and drafted a consent form. The letter was reviewed by a US professor. ... Subsequent... follow-on plan.

+

+Q: How many people reviewed the informed consent and felt it was appropriate?

+

+A: About four people. ...

+

+Q: On the informed consent issue, was that an independent person talking to the patient, or was your team involved in that process directly?

+

+A: ... team member went to talk to the volunteer first for 2 hours, and then after 1 month, the volunteers came to Shenzhen and I personally took them to another professor and gave them informed consent.

+

+Q: So you were directly involved?

+

+A: I was involved. Also, I brought them the information about off-targets and so on.

+

+Q: How did you recruit these couples into your study? Was it done by personal connections? Did your institution put out a release? How was recruitment done of these particular couples?

+

+A: It was by an HIV/AIDS volunteer group.

+

+Q: I think what we should do now is... start answering questions from the floor. David Baltimore would like to say a quick word first, if possible.

+

+When it comes to taking questions, I will take questions from the general participants who are lined up. I will also... I have questions from the media. I have a lot of questions. Many of them are the same. I'm not going to say who asked the questions, because they are the same questions. But quite a few of them have already been answered during Dr. He's talk. I will be quite selective. First, David.

+

+# David Baltimore

+

+I want to thank Dr. He for coming and being responsive to the questions that have been asked. I still think that the statement that we made at the end of the last meeting, was that it would be irresponsible to proceed with any clinical use of germline editing unless and until the safety issues have been dealt with and there is universal societal consensus, that this has not happened, and it would still be considered irresponsible. I don't think it has been a transparent process. We only found out about it after it happened, so we feel left out. After the children were even born. I personally don't think it was medically necessary. The choice of disease we heard discussion about earlier today are much more pressing than providing to one person some protection against HIV infection. I think there has been a failure of self-regulation by the scientific community because of the lack of transparency. I am speaking here entirely for myself. The committee that organized this meeting will be meeting and issuing a statement, but that will not be until tomorrow. Tomorrow? Tommorow. And why don't we continue?

+

+# Questions

+

+Q: I'd like to echo David Baltimore's comments thanking you for coming here under some unusual circumstances. First, I don't see the unmet medical need for these girls. The father is HIV positive and the mother is HIV negative. You already did sperm washing, and thus you already could generate uninfected embryos that could give rise to uninfected babies. Could you describe what is the unmet medical need, not of HIV in general which I think we all appreciate, but what is the unmet medical need for these patients in particular? Second, you justified the critical decision of implanting these embryos to create a human pregnancy with the decisions made by the patients rather than made by the scientists, doctors and ethicists. Can you comment on what is our responsibility as scientists and doctors and independent communities to make that decision for the patients rather than allowing them to make that decision seemingly on their own? Thank you very much.

+

+A: The first question was whether CCR5 is an unmet medical need. I actually believe that this is not just for this case, but for millions of children. They need this protection. HIV vaccine is not available. I personally experience with some people in AIDS where 30% of a village people are infected. They even have to give their children to relatives and uncles to raise just to prevent potential transmission. For this specific case, I feel proud. I feel proudest, because they had lost hope for life. But with this protection, he sent a message saying he will work hard, earn money, and take care of his two daughters and his wife for this life.

+

+Q: Before we get to the second question, you said there has been no other implantations. Just to be clear, are there any other pregnancies with genome editing as part of your clinical trials?

+

+A: There is another one, another potential pregnancy.

+

+Q: You said early stage? So chemical pregnancy?

+

+A: Yes.

+

+Q: I have a two-part ethical question. Could you slow down a little bit and talk about the institutional ethics process that you said you went through. Looking to the past. The second part is looking to the future- how do you understand your responsibility to these children? Your last slide indicated that you would be doing follow-up treatment. What is your responsibility towards the future as well?

+

+A: Do you see your friends, your relatives who may have-- a genetic disease-- the way I see it, those people need help. There are millions of families with inherited diseases or or exposure to infectious disease. If we have the technology and can make it available, then this will help people. When we talk about the future, first it's a transparent open and share what knowledge I accumulate to society and to the world. It is up to society to decide what to do next.

+

+Q: What about the actual children? It was not an abstract question. Going forward with these born children, how do you understand your responsibility to them?

+

+Q: It relates to questions from the media. Will you publish the identity of Lulu and Nana in the future? Will it effect things if the individuals remain secret? You really have to protect patient identity in this case. The world wants to know, they will want to know whether they are healthy, whether the method had any negative or positive consequences. How will you deal with this?

+

+A: It is against Chinese law to disclose the identity of HIV positive people in public. Second, for this couple, it's under careful monitoring. I will propose that the data should be open and avaliable to experts.