International Circulation: We’d like to ask you a little bit about your experiences with medical ethical committees and how do you deal with medical ethics in general concerning clinical trials.  Can you give a little introduction?

Professor Weisz: So the ethics of conducting medical research or any research that involves human subjects， over the years has become an integral part of conducting research.  And this is based on history， unfortunately too many events that was really associated with misconduct and unethical behavior of researchers that were the basis for multiple international and different national documents and statements.  Starting with the Nuremberg Code and then going through the Helsinki Declaration which basically， internationally was one of the first things the United Nations did to really equalize the ethics of research around the world.  This is the basis for many of the ongoing documents.

International Circulation: And how about the status of this in China?  You’re obviously here speaking about it and as far as the standards in China and international cooperation， are they following those same standards and is it standardized here?

Professor Weisz: So I am not a big expert on China but I can tell you what I have seen here.  I can tell you there is much of a focus. And part of the opening of China to the western world is being in corporations that are being established between Chinese researchers and US researchers.  Actually this cooperation is also being integrated.  We need integration of the ethics of conduction of research because everybody has to speak the same language and one of the basics of ethic research is ethical conduct.  And beyond that， since industry is moving so much of our medical research， especially in the field of medical devices， it is very important for industry that different research pieces or protocols that are being done around the world – including China.  They have to comply with the western authorities because they sponsor the studies and they want to use the data for approval whether it is in Europe or the US， not just in China.

International Circulation: And how about quality control for single center clinical trials. What is the best way to go about that and what are some of the procedures?

Professor Weisz: Each institution has its own set of regulations and rules. And the easiest way for an institution that wants to make the first step of having some kind of standards of procedures， an SOP， for research ethics is of course to establish an IRB and to base their regulation of what is really being adopted by other countries. So it starts with the declaration of Helsinki， the Nuremberg Code， and in the US they have the Belmont Report， and all these documents they share those same principals of justice， of benefit for the patient， and the autonomy of the patient to his own life and able to make his own decisions.

International Circulation: When you talk about informed consent and some of those things about patient rights. Is it common or does it happen that patients are not really sometimes fully aware maybe not just some of the risks but some of the downsides to participating a trial. Do you think it can sometimes be under emphasized， is that common?

Professor Weisz: I guess it is more common than we would like it to be and it is all over， all over in every place but our duty as researchers is actually to make sure that the patient understands everything that is related to the study. It has to be presented to him in a very comprehensive way to include all the parts of the research and whether it is a new medication， it is a new device， it is a different strategy. Or even just collecting of data for a register or standard of care procedure， the patient has to know what is the plan， if there is any potential risk that are associated with being involved with the study， what is the potential benefit and in what capacity he is being protected by the investigator， by insurance company. If there is a sponsor who takes the responsibility if something goes wrong? All of these things need to be explained very comprehensively to the patient， and not just to make sure. It is our commitment to ask the patients not just “did you understand it” but “tell me what I told you” to be clear that they really do understand what was said to them not just “yes I understood”. And it has to be in a language that is appropriate for the patient. One of the rules in the US is that informed consent has to be written in a language level of 8th or 9th school grade student. So in simple language.

International Circulation: When we talk about conflict of interest for investigators in clinical trials， do you think that it affects the trial results?

Professor Weisz: This is a very hard topic now in the US and definitely conflict of interest should not affect it. And we have to make any effort and every effort that is possible to protect the study from conflict of interest of any of the investigators. There are many ways to do this and regulate it.  Anybody that is associated with the research has to be completely transparent and all these potential conflicts have to be completely transparent to the peer reviewers， to the other investigators， to the sponsors， to the public， and for the journals that are publishing the papers.  So that is the first step to being completely transparent. A set of regulations now that are being enforced in the US wants things to be open to the public， just to be open， so everybody knows. If somebody is a consultant to any industry， it does not mean that he cannot do anything honorable or do the right research without being conflicted， but people has to know because it is better than to be based on rumors if everything is open to the public.

International Circulation: So really a key is being open. If an investigator has certain involvements with a company， be open about it and transparent.

Professor Weisz: Transparency is the key.

International circulation: Moving on to training， can you talk about the status of training medical simulation and interventional cardiology?

Professor Weisz: I think the way we train interventional procedures is being changed while we speak. The old way of training was to watch many cases and then to work with a proctor.  Sometimes if it was simple it was even like see one， do one， teach one.  But this is not beneficial to our patients， it may be risky.  I’m talking about interventional cardiology. And maybe somebody is being trained on coronary cases. There are so many cases in which we do the procedures step by step and that is the way we all were trained. That is simple. But the case is different for more complex procedures like for carotid stenting. For new devices and new procedures that are being developed， people do not have much experience and simulators can really help and push you forward in the learning curve. If you get the cognitive understanding of the procedures and if you get a better understanding of the devices that are being associated on a simulator， then when you get to the patient level you already have some experience even if you have to deal with and train fellows how to deal with complications in the early stages.  Even a fellow who is in a very large and high volume institution may face some complications very early and does not have to deal with it by himself.  When he becomes an attending and has to face a perforation at 2am he panics and does not know what to do.  It is different when he was trained on a simulator and he has treated many different types