UNIVERSITY SENATE HEARING OF

THE SUBCOMMITTEE ON CONFLICT OF INTEREST IN RESEARCH

Second Hearing

November 14, 2008

12:10-1:25 p.m.

104 Jerome Greene Hall, Columbia Law School

Approximately 20 people were in attendance. On the panel were: Sharyn O'Halloran, George Blumenthal Professor of International and Public Affairs; Naomi Schrag, Associate Vice President for Research Compliance; Samuel C. Silverstein, John C. Dalton Professor of Physiology and Cellular Biophysics; and Henry Spotnitz, George H. Humphreys, II Professor of Surgery.

 

SHARYN O’HALLORAN: This is a hearing on the conflict of interest policy regarding research funded by commercial outside interests. I’m Sharyn O’Halloran, and I chair the Senate Committee on External Relations and Research Policy. We have here Sam Silverstein from the medical school and Naomi Schrag from the Office of Research Compliance and Training, and Henry Spotnitz, also from the medical school. This is the second of our hearings. We had one last week up at the medical school at which David Hirsh, the executive vice president for research administration, was in attendance.

Now we’re here then to address the policies on financial conflict of interest and research in the Columbia University community. The goals of the policy are to standardize the rules and regulations across the campuses, especially in light of the growing importance of interdisciplinary work, and to balance the interests of researchers, the University, and the public in the conduct of commercially funded scientific inquiry. The new policy is designed to regulate or instruct research at Columbia without undermining the goals of the Bayh-Dole act, which requires universities to commercialize and share ownership of that commercialization. So this really is a balancing act. On the one hand, to understand that the role of universities to work with private enterprises and to commercialize, but on the other hand, it’s a need for us to disclose, to be clear, and to protect against any potential for bias.

Now over the last year, this process has been ongoing, and Naomi can attest to the numerous meetings and faculty input at many, many stages. We first had an interdisciplinary faculty committee that began developing an institution-wide policy that Henry Spotnitz chaired. The draft was reviewed and revised by the Senate ad hoc committee that Sam Silverstein chaired. And we are now in the process of disseminating the policy, holding public hearings as you see, and getting input from a variety of sources, at the deans’ level, the various schools and so on, before the next stage, which is to bring this policy for ratification by the University Senate.

So today Naomi Schrag will give an overview of the policy, the motivation for changing the current existing policy, and how the changes in the current policy are going to affect folks doing research on the Morningside campus. We’ll then have Sam Silverstein and Henry Spotnitz speak quickly to the importance of it, and then we’ll open this up for questions.

NAOMI SCHRAG: Thank you, Sharyn. Thank you all for coming. I’m going to start with just a little bit of background. What is a financial conflict of interest? It’s a situation where an individual’s private financial interest might interfere or might look as though it interferes with the conduct of research or professional obligations to Columbia. So what are the key concerns with respect to financial conflict of interest and research?

Well, we as a university have two priorities among many. One is preserving the academic mission. So unlike a commercial entity our primary mission is not to generate revenue, but to advance knowledge. And dedication to that mission is central to our identity. Number two: maintaining the public trust. An academic institution’s reputation and the reputation of our researchers is our currency. Based on reputation and credibility, we recruit faculty and students and we obtain the support that we need from the government, from companies, from the public. And I don’t mean just financial support, but moral support for the mission, and public willingness to participate in research.

So financial conflicts of interest can erode these priorities. They can divert the academic mission and degrade the public trust. And relationships between academic researchers and industry can give rise to real or perceived conflicts of interest.

But, on the other hand, our mission isn’t just the pursuit of knowledge in an ivory tower. Collaborations with industry can enhance academic research, and the public wants taxpayer dollars to benefit the public. They want research to benefit the public with new and useful products. And that’s why the federal government has created incentives and requirements that insure that academic institutions do collaborate with industry to benefit the public.

So as Sharyn mentioned, the Bayh-Dole Act is one great example of this. It was passed in 1980, and under the Bayh-Dole Act academic institutions are permitted to own the inventions that their researchers create with federal funding, to license the inventions, and to keep the royalties. The Bayh-Dole Act itself states that it’s the policy and objective of the patent system to promote collaboration between commercial concerns and non-profit organizations, including universities. And since the 1980s until today, collaboration with industry has continued to grow, as have individual relationships with industry at times as well.

So as researchers began to develop more individual ties with industry, concerns about conflict of interest also began to grow. And in the mid-1990s two federal agencies, the National Institute of Health and the National Science Foundation, issued regulations and policies that related to what they called objectivity in research. They agreed, in a perhaps unique instance of inter-agency collaboration, on some fundamental requirements for institutions and on some thresholds as to what would be considered a significant financial interest that might lead to a conflict.

Columbia’s current policies date back to that time. But we have separate policies for different campuses, and since that time, our process and our thinking about conflict of interest in research have evolved, as have the public dialogue and literature on conflict of interest.

So the new policy. With a number of events coming together, the increasing focus on interdisciplinary research collaborations, particularly from funders of research, a number of new recommendations and guidance documents from the American Association of Universities and the American Association of Medical Colleges, an overall charge to the executive vice president for research to standardize research policies across the University in light of the increasing collaborations, and a recognition that the institution as a whole has an interest in objectivity in research.

More than eighteen months ago, Dr. David Hirsh, the executive vice president for research, appointed a faculty committee to begin drafting a new conflict of interest policy for research for the entire institution. That original drafting committee had about sixteen faculty members, including representatives from many different disciplines: at the Columbia University Medical Center, in the School of Engineering, in the Arts and Sciences. The committee met every two weeks for six months, and in the end developed a draft document, which was reviewed with faculty and deans of a number of other schools: the Law School, the Business School. We met with the vice dean for research at CUMC, the vice president for scientific affairs in the Arts and Sciences, the vice dean of the Engineering School, and the University Technology Policy Committee. Each of those meetings led to additional changes to the document.

The University Senate appointed an ad hoc committee, another interdisciplinary committee, including political scientists and business school faculty, as well as Medical Center faculty, led by Sam Silverstein and including Professor O’Halloran. And that committee worked through the draft document line by line during the summer and made further clarifications and refinements. Which brings us to the draft that you now have before you.

So how is it different from Columbia’s current policies? I’m going to highlight four principal changes. The first change is one of structure. We have a single policy, and we have a single institution-wide conflict of interest committee, but it’s composed of two subcommittees: one for the Medical Center and one for the non-health sciences disciplines. The concept is that each subcommittee has the flexibility to address the issues relevant to its community, but the two committees will come together at least once a year, and as institution-wide policy issues arise, the subcommittees will come together to address them. So that’s the first change.

The second change is that the current Columbia policies both include certain circumstances in which where there is a conflict of interest, participating in research is “not ordinarily allowable.” That means that there may be extraordinary circumstances where there should be an exception, and that is now codified in the new draft policy. So the concept of countervailing circumstances is built in for every case reviewed ­-- the committee looks at whether there are countervailing circumstances that would warrant making an exception to a general rule.

The third point is that the current policies do not really specify what process should be used or what factors should be considered in reviewing potential conflicts. The new draft policy does. It specifies a process of review and it outlines a number of factors in a risk-benefit kind of approach to determine whether there are countervailing circumstances that will provide much more guidance to the faculty serving on these committees, and still affording them flexibility. And also gives the community a sense of what factors are being considered when their particular disclosures may be reviewed.

The final point I want to highlight is the treatment of royalties. We’ve talked about the Bayh-Dole Act and how the it permits universities to license inventions. Another requirement in the Bayh-Dole Act is that universities share a portion of those royalties with the inventor. Now, this creates something of a double standard in the way royalties have been treated up until now. For inventors who invented something outside Columbia where they received royalties directly from their licenses, currently those royalties would be considered a potential financial interest that may need to be reviewed if the person is also doing related research. But royalties that are funneled through Columbia are excluded from the conflict of interest review process. Well, that creates something of an inconsistent standard for how royalties are handled, and that has troubled both the current conflict of interest review committees and the drafting committees, and that the AAMC and AAU have addressed in their recommendations. So the faculty committees determined that there should be a single standard, that all royalties should be treated the same way, but the policy also specifically acknowledges the importance of the Bayh-Dole Act public policy. And there’s a specific paragraph in the policy that addresses that, and that provides that that public policy in itself in some circumstances may be a sufficient countervailing circumstance.

In addition, in response and at the urging of many faculty, we included examples in an appendix to try to illustrate how the policy might apply. We’ve developed the frequently asked questions that you’ve seen, and we’ll continue to add to them and develop additional materials to make these policies easy to understand and as user-friendly as we can, and we welcome any suggestions or comments in that regard.

PROFESSOR O’HALLORAN: Thank you, Naomi, for that overview. So, Sam, did you or Henry want to say a few words?

PROFESSOR SPOTNITZ: Sure. Well, as always, Naomi summarized the situation beautifully. I have just a few additional comments. One, from the point of view of the Medical Center, we have concerns about protecting patient welfare, and that’s an important part of the policy.

In spite of recent publicity, conflict of interest is not a crime. Anyone who doesn’t want to get out of bed in the morning has a conflict of interest. We all have conflicts of interest. The key to this policy is to be sure that those conflicts are disclosed or managed when necessary.

Voluntary compliance with the policy is the critical part of this. To date, the conflict of interest policy is entirely dependent on voluntary disclosures by the faculty and responses by the committee. Those are my brief comments.

PROFESSOR SILVERSTEIN: Let me say a couple of things. First, the members of the subcommittee did a wonderful job, and I want to publicly acknowledge that. In the 1990s I served as president of the Federation of American Societies for Experimental Biology, which, you may know, is the largest organization of professional biological scientists in the United States, with about 70,000 members. I spent a great deal of time in Congress talking with Congressmen, advocating for appropriations in research and for many of the policies that protect our civil liberties and our rights. There was an occasion when the Office of Research Integrity wanted to make public, as an example, everyone who was under investigation for a supposed misconduct in science. We didn’t have to take them to court, but we negotiated with them and prevented them from doing so. Because, as you know, the accusation of misconduct in science for a scientist can be as damaging as the actual fact of a finding.

I use that here deliberately because the same thing can be true in conflict of interest. Nothing is more important than your reputation to your career in academics with students and as a representative of this university. And so all of us on this committee have taken this with extreme seriousness.

Now, let me say something about the philosophy that guided us. The philosophy was an entrepreneurial philosophy. You should not be precluded by any of the rules that we write from doing anything legitimate that you want to do. On the other hand, there should be nothing that cannot be disclosed. If you want to take money from the tobacco companies to do research, that’s your business. But if you want to take the money from the tobacco companies to do research and are not willing to disclose it, that’s my business because you’re part of Columbia as am I, and if you’re going to taint me, then I need to know that. If I’m going to collaborate with you as a co-investigator and you have grants from a pharmaceutical company that support the drug we’re working on, or you are paid as a consultant by that pharmaceutical company for one thing or another, I have a right to know that because my name and your name are inextricably linked on these papers. And I am adamant that you have no right to jeopardize my reputation.

 I don’t think anyone in this room would take me on seriously about that. All the rest of it may be a slippery slope, and we need to deal with the slippery slope as colleagues and friends in as open, transparent, and generous a way as possible. We recognize that there are many cultures in research. And so there are two committees: one dealing with mostly with medical issues and one dealing with the others. Heaven knows, there may be a need for more committees and more cultures. The object is not to get in the way of the particular culture in which you operate. But let me say that transparency needs to be the rule. And so long as we have transparency, I don’t think we will have a problem.

We’re here today to hear you out, and I’ll stay here as long as necessary. And we will go back to the drawing board if we’ve made mistakes or not taken into account the issues that concern you. Each of you undoubtedly represents a different constituency and a different discipline, and we’d like to hear as much as you can tell us about the ways in which you perceive this policy to be beneficial or detrimental to your work and that of your colleagues. There’s nothing here that I will take as ad hominem even if you mean it to be. [Laughter.] This is core business for all of us because we’re all in this together. And when I say all, I mean the University, the faculty, the students, we’re all in this. Each one of us has a piece in either creating a really ethical and comfortable environment in which to work, or creating an environment that fosters distrust. And it’s the latter which is the real danger.

So let me close by saying that a number of years ago, many of you may recall Eugene Brownwald was involved with a guy by the name of Darcy at Harvard. And Darcy was found to be making up the experiments. Brownwald had published many papers with Darcy and all of them had to be retracted. And he then published a paper in Nature explaining his involvement, and I don’t mean to drag Eugene Brownwald particularly into this, but I do want to comment on what he said in the paper in Nature. He said the value of good collaborators is the value of being able to trust their work. So I brought it down to my lab, and I pinned it up on the board, and I got everybody together, and I said this is a hundred percent wrong. The value of good collaborators is that every one of them dissects your work and makes sure it’s as good as theirs.

I want us to be in the position where no faculty member, no student, and no post-doc, and no administrator here ever has the feeling that they can’t dissect everything that you and they have done together and feel perfectly comfortable that they knew everything you were involved with, and you knew everything they were involved with that potentially could cause someone to say this person has a bias and we need to understand it. So let me stop talking and ask Sharyn to ask you to tell us what we need to hear.

PROFESSOR O’HALLORAN: Thank you very much, Sam. We’ll now open the floor for questions or comments. And if you’d like to, you can or not, depending on how you feel, state your name and your affiliation.

PROFESSOR SILVERSTEIN: And I hope you point to chapter and verse in the policy if you can because we’re in the business now of trying to finish something. If we’re going to modify it, we ought to get to the verbiage that you see as problematic, and the issues specifically that you see that need to be corrected. And I’ll put them up on the board as we go.

PROFESSOR O’HALLORAN: Okay. Go ahead.

PROFESSOR ANDREAS HIELSCHER: My name is Andreas Hielscher. I’m with the biomedical engineering department. Biomedical engineering and radiology. So I’m all for transparency. I think that really has to be there. On the other hand, just reading through it, I find it very restrictive. It states right at the beginning, conflict of interest is not allowed. So it seems like I have to stop doing whatever I’m doing because everything I’m doing is somewhere a conflict of interest. And obviously I’m an expert in a certain area, I’m working with companies. So I just found the spirit not at all balanced. That is has to balance the Bayh-Dole Act with anti-conflict of interest, but it comes down very hard on the conflict of interest. But it may just be a perception.

PROFESSOR SILVERSTEIN: We’d be very grateful if you would take the paragraphs that you find negative. I don’t mean to give you more work. But tell me where you’re uncomfortable.

PROFESSOR O’HALLORAN: It may be most constructive if he could come back with us on that point by point.

PROFESSOR SILVERSTEIN: So let me put it up here.

PROFESSOR HIELSCHER: It’s not ordinarily allowable for a financially interested individual to conduct research. I think it comes down to how the committee handles each case, and that you don’t know. But it seems to me that only in extraordinary circumstances can you have a conflict of interest. Otherwise, basically you have to decide that either you’re a professor or you work with the company or you go to industry. It seems like either or. You have the choice.

MS. SCHRAG: I think the thing about a document like this is that in some ways it’s legalistic so there are a lot of defined terms that are used that are not necessarily intuitive. So what that paragraph means is not that it’s not permissible for someone to do research and also consult for industry. You can do both. Where there may be a concern is if the company you’re consulting with is funding your research or is also providing you technology that is the subject of your research, or has another kind of direct relationship with the research that you’re doing.

PROFESSOR HIELSCHER: The company would only come to me for my expertise in an area. I mean, I could not consult on cancer genetics because I’m not in that area. The company would come to me because I build instruments. So I’ll build an instrument, I get a patent, I license that to the company, they pay royalties to me. So what other relationship exists?

PROFESSOR O’HALLORAN: You could have a pure consultancy relationship, and that would fall within your time commitment. So a pure consultancy relationship where a firm does not pay money to you to conduct research would be okay. And that could be done based on your expertise. The question, and this is where this conflict of interest policy would come into play, is when that firm has a financial relationship with your research. You’re absolutely correct though, there’s a fine line. I’m going to have Naomi speak to that.

MS. SCHRAG: With respect to the royalties question, that’s where I think it’s so important that there is this particular paragraph on page 8, paragraph 4, that says special considerations arise when the significant financial interest in question is royalty payments paid pursuant to a university license agreement. So that’s exactly the Bayh-Dole context. You invent something in your lab, it’s patented, it’s then licensed out to a company, and then that company wants you to do more work. Well, we don’t want to stop that. But it’s something that would need to be disclosed, something that would be looked at. But paragraph 4 calls it out as it’s not going to be treated in the same way that anything else would be treated because there are special considerations there, and certainly the person who invented the technology has the greatest expertise. Nobody wants to prevent that person from continuing to work with the technology. But that’s not to say that conflicts can’t come into play in some circumstances. So it is really a case by case analysis, and there are a lot of different factors. And certainly the investigator should feel free to make that information available as things are being reviewed. Usually the investigator is contacted at some point so that in case the committee misses something, that’s clear.

PROFESSOR SPOTNITZ: Do you have a specific situation in mind that you’d like to raise?

PROFESSOR SILVERSTEIN: I take your point, which I think is that the policy begins with a prohibition, and what we really mean, and that we should hear you out on, is that the University wishes to balance the financial interests of individuals in whatever research they are doing with the prejudicial effects those interests could have on the research. So why don’t we take a look at that?

MS. SCHRAG: Could we also look at the bottom of page 1? Because that first paragraph there under governing principles, which is unfortunately placed on the page so it’s easy to miss, was where we tried to capture this. The interests of the University, its researchers, and the public are served by responsible interactions between industry and the University, with a view to stimulating and nurturing research, the development of technology, and the pursuit of other scholarly activities. The University is also committed to protecting against the risks for research integrity, human subjects, and public confidence in the research enterprise that may arise from real or apparent conflicts of interest. And maybe we need to highlight that more.

PROFESSOR SILVERSTEIN: So let us take your point about the prohibition. Do you have other points? Okay, let me ask you one question before we leave you. Paul Duby alerted us to the fact that there were concerns at the Engineering School that some of the practices in engineering might be different than those we included in this policy. Does anyone else want to speak to that specific issue since we’ve already heard from the engineering school here? Okay. Next.

PROFESSOR JAMES APPLEGATE: My name is Jim Applegate. I’m a theoretical astrophysicist in the Arts and Sciences. So in a sense I don’t have a horse in this race since the industrial or medical applications of black holes is an emerging field that hasn’t emerged yet.

PROFESSOR SILVERSTEIN: I thought nothing ever emerged from a black hole.

PROFESSOR APPLEGATE: That’s true. Although we may have some real estate applications if you look at the front page of the New York Times. [Laughter.] My first question is really one of clarification, and that is to the degree to which, number one, Columbia’s current policies on conflict of interest are or are not in compliance with federal law. So if we are in fact currently in compliance with federal law, and I assume the revisions here are Columbia policy, and we can comment on them as we wish. There’s no point in us suggesting that we do things that would put us in violation of federal law. So my question is really, are we in compliance now and how much of what is in here is mandated by federal law, and how much of it is Columbia policy beyond federal law?

MS. SCHRAG: You never ask a compliance officer whether the institution is in compliance, especially when there’s a reporter in the room. So the current policy and process at Columbia are in compliance with the federal regulations. The new policy codifies some of our process and aligns with best practices recommended by many of the professional associations, the AAU, AAMC, etc. I would say that since the eighties and nineties when our current policies were first created, the public climate and attention to these issues has evolved.

PROFESSOR SILVERSTEIN: I think, Jim, there are a couple of other things that can be said here. The current policy I believe is silent on royalties.

MS. SCHRAG: It depends on which policy you’re talking about.

PROFESSOR SILVERSTEIN: The policy that’s currently in effect does not deal with royalties that one receives that may in fact add to the dollar amounts that –

MS. SCHRAG: The CUMC policy excludes them explicitly. The Appendix K, which is the University-wide statement on conflict of interest from the mid-1980s, may not address the royalties specifically, but I would need to check that.

PROFESSOR SILVERSTEIN: And the current policy doesn’t deal with material transfer agreements, which can amount to very substantial amounts of materials and dollar amounts which may have to be disclosed. So it is silent in certain areas that I think one is better served by knowing about in advance than getting surprised later. Go ahead.

PROFESSOR APPLEGATE: My second comment is to agree with my colleague from the Engineering School in that the statement on the bottom of page 1 for general principles sounds fine, but then God is in the details, and when I start reading the details, the first detail that I read says it is ordinarily not allowable for a financially interested individual to conduct research. This document seems to be written suffused with the presumption of guilt in the sense that commercialization of the research enterprise is a bad thing. It is likely to soil the purity of the research enterprise. I think this one’s very, very much counter to the lengthy public debate that preceded the Bayh-Dole Act and certainly runs counter to the general interest of the American taxpayers who support science and engineering research and medical research because they think it is going to make their lives better, not because it’s going to end up in a scholarly journal someplace that very few people read. So I would think that the general sense of what Columbia stands for is that the commercialization of our research activity is a good thing and it is part of our role in American society and in the world. Not that it’s something that’s radioactive and we should touch it only very, very carefully.

PROFESSOR SILVERSTEIN: Well said, and we will go back and look at the document with that in mind.

MS. SCHRAG: Can I make a comment? I think we agree completely, and I want to remind you that what we’re looking at here is an individual who has an outside financial interest. It’s not someone who’s working on research that’s funded by industry or working on research at Columbia that gets licensed out. That’s not the focus here. The focus here is an individual who’s doing that and has a consulting agreement, owns equity, has some kind of outside financial relationship, is receiving honoraria directly to them, check payable to that individual. And that’s where the issue arises. The issue doesn’t arise if those two elements aren’t in place.

PROFESSOR APPLEGATE: But that’s the whole point. The whole debate leading up to the Bayh-Dole Act was that potentially commercially viable and valuable products that were being produced in American laboratories were not ending up being commercialized by American industry. And they were, however, being commercialized by foreign industries, and the Bayh-Dole Act was an explicit response to that problem. And so the idea that somebody involved in biotechnology might be a university professor and also own an equity share in a biotech startup was viewed as a good thing, not a dangerous thing.

PROFESSOR SILVERSTEIN: And we’re not disagreeing with that, right? We want to make the verbiage here as friendly as possible. So we take that as a given. Let’s move on, because there may be many more specific things here. Yes, go ahead.

DR. DANIEL SAVIN: I’m Daniel Savin, senior research scientist in the astrophysics laboratory, just to keep the astrophysics theme going because we have so many conflicts of interest. I’m also a Senator representing the research officers. My concern here is that this is a University-wide policy which, as it states in the third paragraph of section A, includes officers of instruction, research, libraries, students and staff members. And yet the committee in section 3, paragraph 2A, the financial conflict of interest committee, consists solely of officers of instruction and research, and my concern is for people such as the librarians, students, and staff who are not represented on this committee. And if a subcommittee is convened in order to investigate a conflict of interest, I would urge that that subcommittee have a peer member of whoever is being investigated. This would also bring it in line with the misconduct in research policy which was passed by the Senate a couple of years ago. So that’s my suggestion for the policy.

PROFESSOR SILVERSTEIN: Thank you.

PROFESSOR HIELSCHER: There’s a point he brings up -- there is a policy on misconduct in research. Is that not governing here?

MS. SCHRAG: It’s a different issue.

PROFESSOR SILVERSTEIN: The answer is no. Misconduct in research is formally defined as fabrication, falsification or plagiarism.

PROFESSOR HIELSCHER: But isn’t this what you say here?

PROFESSOR O’HALLORAN: So it’s the bias concern.

PROFESSOR SILVERSTEIN: No, excuse me. There is a clear distinction. You can have a conflict of interest where you own the drug, you are paid by the drug company, and you are doing research on the drug, but that does not mean you are doing anything wrong. And the conflict of interest committee here will have to make a decision whether your financial interest in that has the potential to either create a bias in your research or make the public see that conflict of financial interest as potentially biasing your research. But no one has the right to say that anything you’ve done is misconduct in science. Misconduct in science is very clearly defined, and so long as you report all the data from that study, it is appropriately dealt with statistically and every other way and there’s real transparency. There cannot possibly be any evidence or any allegation of misconduct of science. So please understand that these are two totally separate things.

PROFESSOR O’HALLORAN: The other one would be that a particular person skewed, mismanaged data and so forth, which would be a misconduct of research. So it takes up two different points within the process, and I think that would be the way to think about it.

PROFESSOR SILVERSTEIN: And one of the important things you all should understand about the scientist’s stand on misconduct in research was that there was formerly a clause which said, “and other activities which are not usual in the conduct of science.” I haven’t said it perfectly, but that’s what it said.  And we objected to that strenuously and got that out of the misconduct in science regulations because, of course, anything that you and your mother think is irregular could then be misconduct in science, and that is not good law.

PROFESSOR APPLEGATE: Excuse me. The example given here seems to be an excellent argument for removing the first sentence, number one on page 2. Because that says you can’t do research on the drug in the normal course or circumstances.

PROFESSOR SILVERSTEIN: I’ve heard you, Jim, and I think both of you have made the same point, and we will go and revisit that. I promise you.

PROFESSOR O’HALLORAN: Other questions?

PROFESSOR SILVERSTEIN: May I ask is there anyone? You’re from the Business School, but there are others here from the Business School. The one that I want to ask you about that we discussed in the executive committee this morning that concerns me the most in other groups is the prohibition that deals with or that indicates a significant financial interest is service as officer, manager, member of a board of directors and any other fiduciary or managerial role for an interested business whether or not remunerated. I just want to be sure that other parts of the University have looked at this. Is there anything in that which changes the way you do business within your school or profession? Because that says that if you are a director of an interested business and are doing research or receive research monies from that interested business, then you have a conflict of interest to report. That doesn’t say you can’t do it. But I want to be sure that that falls within the usual practice of communities other than the medical community, or doesn’t fall within the concerns.

DR. SAVIN: I have a question regarding the point you’ve raised. Have you put this policy to the deans of the respective schools and met with them? And have you also met with the chairs of the various departments?

PROFESSOR O’HALLORAN: We have brought this to the deans. The provost has a deans’ council. We have asked the provost to circulate that to them. And we’ve asked each of the deans to bring it to the appropriate chairs. We think the internal conversation should happen among the deans. And we are happy to meet with anyone and everyone, and Naomi has indeed met with many of the deans or at least representatives of the deans to discuss the policy at this stage. So we are indeed trying to be inclusive, and this is part of the conversation, to make sure that everyone understands how it will be implemented within their school and with the appropriate discipline.

DR. SAVIN: Then if I may follow it up, I’m somewhat surprised by the questions that have been raised by our colleague from the Engineering School and by Jim behind me. I’m surprised that the deans and the chairs of the respective schools and departments didn’t raise this beforehand. So I would question whether they actually found the time to read the policy.

MS. SCHRAG: There were, let me just say, a number of engineers on the original drafting committee who participated actively in this process. There are three who come to mind immediately, and I met with Mort Friedman and talked it through with him. But we are, as Sharyn said, more than happy to meet with anyone and everyone. I’ve also done presentations to the basic science chairs meetings, both uptown and downtown. You know, there is a lot to read that comes across one’s e-mail, but we’ve certainly made a lot of efforts and we’re happy to continue and look forward to meeting with anyone else.

PROFESSOR O’HALLORAN: Additional questions?

PROFESSOR SPOTNITZ: I’d just like to comment that I think that without actually discussing real world situations, it’s impossible to understand what this policy means. And the verbiage is something that we have to agree on in order to let this policy do what it needs to do, which is to protect us in an environment that’s out to judge us appropriately or inappropriately as being biased scientists or biased faculty members. So your point about the Bayh-Dole Act is a good point, but I’m sure you also read the newspapers. I’m sure you’re aware that there’s a Congressional investigation of our institution. So we all have to live with those issues, and we don’t have a policy that protects us against that kind of situation, we can lose our funding, we can lose our reputation, and we can lose the ability to do research whether the policy allows us to do it or not.

PROFESSOR HIELSCHER: I have another question for the committee. Was there a sense that conflict of interest is something bad? I know people in our department and other schools where professors open their own companies. Or the companies are spun off from the research. Even with the old policy I have somewhat stayed away from that because I didn’t know how to maneuver the waters with the Columbia policy. It seems I would have a huge conflict of interest if I have a company or try to spin off some of my ideas, and so I’ve worked with other companies, but without any ownership in them. But what is the sense at the University level? Is that something to be encouraged, that professors also become entrepreneurs, or is to be discouraged?

PROFESSOR SILVERSTEIN: Absolutely. I think I said that at the beginning, but I’ll say it again. We live in a very entrepreneurial world, and this university is certainly a testament to that. Every department, every school has various faculty who are raising huge sums of money privately from industry, from government, to do the research and education that we do. There is no sense that an involvement with industry is anything other than on the up and up and a good thing to do. If you want to develop a drug and you came to me and said, Sam, I had the choice of working in your lab and developing this drug or going to Merck and developing the drug, I would say to you straight away to go to Merck because their business is drug development and mine is basic research. If you want to start a biotech company because you have figured out a better process or compound, you should be encouraged to do that within the confines of your twenty percent consulting time. But the one thing you may not do is run a biotech company, and use a University lab as the research space for that biotech company. I think we agree on that. And so this is not meant to prohibit you from doing that. It’s meant to be sure that there’s transparency so that everyone knows what the facts are, including the folks in your lab: your students, the post-docs, the research scientists, everyone in your lab, and the folks you collaborate with. Because as I said at the beginning, that’s only fair.

But this is not to prohibit any activity that is within the bounds of reason. And there are many cases where you may develop a process, a compound, or a device where you are the best person in the world to make sure that that gets expanded. In which case, there is a committee of your colleagues that will look at that conflict and decide how best to manage that within the multiple needs that are being served: the opportunity to create something that is enormously beneficial to the public, the possibility for you to realize real profits, and the possibility of the University to be derelict in its supervision of what’s going on or derelict in its duty to see that we encourage the very activity at which you are best.

PROFESSOR O’HALLORAN: So the general upshot is, no, this is not to discourage entrepreneurship. In fact it’s to facilitate you to be able to manage those conflicts clearly and transparently and to give you the opportunity to do so. So that’s the spirit in which this was discussed, and that’s the spirit in which those tradeoffs are taking place. I think, one, that language should be clearer from I’m hearing, the objectives laid out more clearly. Two, understanding how this fits in with the other issues that you’ve just raised, such as the conflict misconduct in research policy. And then I think moving forward on that will be helpful.

DR. SAVIN: I want to follow up a comment that Dr. Spotnitz made to help put this in context. You had mentioned that the University’s currently being investigated for a conflict of interest. I personally have not heard anything about it. That investigation has probably affected this document and how it was formed. So could you say something about what the investigation is just to bring us up to speed to within what you can say?

PROFESSOR SILVERSTEIN: Yes. The document antecedes the Grassley Committee’s investigation of faculty who are involved in imaging and transvascular surgery, a group at Presbyterian Hospital also appointed to the faculty at Columbia. I’m not conversant with all the facts of their conflict of interest disclosures or anything else, but I assure you this policy was not at all influenced by any particular case. It was written and vetted repeatedly by folks such as Henry and me and many others who wanted to create transparency, with no prohibitions that were unseemly or that could not be dealt with by a sensible committee. So I think I’ve said enough about the Presbyterian Hospital.

PROFESSOR SPOTNITZ: I want to make a comment about this. I said before that conflict of interest is not a crime, and it’s not. But the way you get in trouble is if you don’t comply with the University policies or you hide facts or you commit fraud. Those can become legal issues. In this particular situation, if the faculty complied with the conflict of interest rules of Columbia University, as far as we’re concerned, they should be okay, and the policy will have protected them.

I think it’s important to understand that the reason you have a policy is to protect the faculty. It’s to protect you from doing things that because of lack of information or an honest mistake get you in hot water. The purpose of a committee like this is to understand what people are doing, to tell them if what they’re doing is okay or not, and if it’s not okay, to tell them what they have to do to make it okay for them to continue to either do research or to pursue their financial interest, their commercial interest, or in some cases both.

PROFESSOR APPLEGATE: Exactly on that point: if I report to the committee on the conflicts of financial interest, and Columbia certifies that I am in fact in compliance, and I later get in hot water somehow, does Columbia stand behind me legally? What are my protections in this case?

MS. SCHRAG: I think we may have an FAQ on that.

PROFESSOR SILVERSTEIN: We do.

PROFESSOR SPOTNITZ: It was a topic of some discussion in our committee.

MS. SCHRAG: Yes.

PROFESSOR SILVERSTEIN: It’s toward the end of the FAQs.

MS. SCHRAG:  I have seen a lot of articles about government investigations into conflict of interest and research. This is number 20. What happens if the government investigates possible conflicts of interest in my research? Answer: the University would initially take the lead in responding to any such investigation. The University supports personnel who are subject to external investigations provided that the personnel have complied with University policy and were acting within the scope of their employment. Ultimately, however, it is the responsibility of each individual to avoid conflicts of interest with respect to his or her research.

PROFESSOR APPLEGATE: I’m not terribly sure I know what that means. [Laughter.] Definite maybe.

PROFESSOR SILVERSTEIN: Well, since I’ve been through this. It says the University will support you in general, but if push comes to shove, you may need your own counsel. Right? We have been through a lot of negotiations on this one. Suffice it to say that the same situation does apply in misconduct in science. That is, up to a point you can rely on the University to have a very evenhanded stance, and in fact, under some circumstances, support you. But in the long run, you may need your independent counsel to look out for your best interests.

And let me just add one other example of that. If you remember, a few months ago, Peter Pronovost at Johns Hopkins was accused by the Office of Protection of Human Subjects of doing research in Michigan which was hugely effective in the emergency room on comatose patients where the Office of Protection of Human Subjects said that he didn’t get informed consent. And Johns Hopkins University backed him up, and the Office of Protection of Human Subjects backed down. So there are lots of examples where universities have behaved honorably in this regard.

Okay, so you’ve told us two things, if I can take this home. One is that the document could have some much friendlier verbiage and begin more positively than it does. And second, that there’s a need for additional representation of students, post-docs and research scientists in section E on the committees.

DR. SAVIN: There’s a need of librarians, students and staff.

PROFESSOR SILVERSTEIN: Librarians, students and staff.

DR. SAVIN: Yes.  Research scientists are already included.

PROFESSOR SILVERSTEIN: How do librarians differ?

DR. SAVIN: Officers of the libraries are a different constituency than officers of research.

PROFESSOR SILVERSTEIN: I didn’t actually know that. I chair the Senate Libraries Committee, but I didn’t know that.

DR. SAVIN: And they have two Senator representatives on the Senate.

PROFESSOR O’HALLORAN: I also heard that in addition, you’d like to hear how this addresses the other conflict of interest policies such as time and conflict, misconduct of research, and the difference between the uptown and the Morningside campus.

PROFESSOR APPLEGATE: Yeah, I was supposed to bring that up.

PROFESSOR SILVERSTEIN: There’s one more question back here.

POONAM PAI: My name is Poonam Pai, and I’m with the Center on Medicine as a Profession at the Medical Center. I’m just curious as to when this will go into effect.

PROFESSOR SILVERSTEIN: It won’t go into effect until the Senate ratifies it. So you all get another bite at the apple.

MS. PAI: And I assume there’s another compliance set of regulations and subcommittees regarding vendor relationships with health practitioners.

PROFESSOR SILVERSTEIN: The Medical Center is writing a set of regulations of conflict of interest in education and clinical care, and the dean intends to hold a meeting on that on December 5.

MS. PAI: Wonderful. Thanks.

PROFESSOR SILVERSTEIN: And I urge you to come to the meeting, and I’d be very interested to hear what you have to say about it.

PROFESSOR O’HALLORAN: But that is distinct from this policy.

PROFESSOR SILVERSTEIN: But nothing in that policy can supervene what’s here.

PROFESSOR SPOTNITZ: But there is a policy on conflict of interest in research in effect now.

DR. SAVIN: Once the Senate passes this, the Trustees I believe still have an opportunity to determine it. So it, does it become policy after two Trustees meetings have passed?

PROFESSOR O’HALLORAN: Yes. Usually we would know if there’s a concern that’s being raised. It’s usually articulated at various points. So we’re working collaboratively with all levels of the administration. I don’t believe that’ll be a problem in this particular case.

PROFESSOR SPOTNITZ: Sharyn, have you said anything about your two-year trial?

PROFESSOR O’HALLORAN: No, I haven’t. What we’ll be doing is, when this policy goes into effect, collecting information about the policy. So we are working on some language looking at that. It would be the policy impact if any on the administration research grants. We’re looking at the impact of including royalties among faculty, financial ties that are covered by the policy, adequacy of University support for the implementation of the policy, the researchers’ experiences with the policy themselves, and the effects of any changes in applications of external regulations. We’ll be looking within a two-year period after this goes to effect to assess the efficacy of this policy, and whether in fact we’ve seen the perverse impact that we are concerned about raising right now. So when we hash out all the particulars we’re speaking about here, once it does get enacted by the University Senate, it becomes policy with the understanding that we will be working with the Office of Research and Compliance to actually look at these indicators and then revisit the policy within that two-year period. And I think that will help us refine and tune this to meet the concerns being raised.

PROFESSOR APPLEGATE: Sharyn, I have just one thing. I heard a lot about the desire to have a single unified policy for Columbia University. And that sounds like a fine idea, but this is a very large and diverse enterprise when it comes to research, and the potentials for financial conflict of interest or misconduct are many and varied. And so it seems to me to be inevitable as this policy moves forward and develops a set of – I hate to use the term – case law in that it defines what it is through precedent, it seems to me almost inevitable that it will bifurcate into a series of policies for the Medical School, for the Engineering School, and the Business School, and so on and so forth simply because the situation of one engineering professor is likely to be similar to the situations of a second engineering professor and not terribly like the situation for a medical professor. I think we need to keep that in mind as we go forward on this.

PROFESSOR O’HALLORAN: So there is in some ways almost a de facto bifurcation that we have two distinct committees looking at, but it may turn out, and we’ll have to see this in practice, into a difference between human subject research and other types of research.

PROFESSOR SILVERSTEIN: One of the things we have put into the policy is that there should be some exchange of faculty between the two committees, and the reason for that is that one learns a great deal by looking at other communities and how they handle their affairs. Frequently you find out that they’ve figured out a better way to do it than you have, and by going back and forth we may enrich and enliven the way all of us do our business.

Let me say as we’re coming to a close here that one of the things in the frequently asked questions, but that is not part of the policy, is that at any point when you have a potential conflict of interest, one that you’re not sure is even real, certainly with people with whom you’re collaborating it makes sense to share that information. And I would recommend that you share it in written form so they never have the opportunity to say to you, well, you didn’t tell me that, or I don’t remember you telling me that. Those are real, honest to goodness protections that each of us needs to have, just as we need to have the signatures of all the people who are on the paper before the paper goes to the journal. You never want to send something off for publication that your co-authors haven’t read. You want to be sure that your collaborators know for sure what you think is the potential for any downside. Whether they think it’s of concern or not, it’s a protection for you.

Thank you all for coming. We will do our best to address the many things that you’ve thoughtfully raised. Thank you.

SHANE FERRO: I just have one question.

PROFESSOR SILVERSTEIN: Sure.

MS. FERRO: My name is Shane Ferro. I’m an undergraduate student from the Spectator, and I was wondering if, in the current conflict of interest policy, there have been any violations of it in the recent past, other than what has been investigated by the U.S. Senate currently? Just in the last few years, have you found any conflict of interest policy violations?

PROFESSOR SPOTNITZ: There aren’t any violations. We deal with any issues and resolve them.

MS. FERRO: Okay. That was just a clarification point. Thank you.

PROFESSOR SILVERSTEIN: I think, however, the same principle would prevail that I spoke of earlier about misconduct in science in terms of conflict of interest. That is that the allegation of either one of them is particularly harmful to a person who is so accused or so alleged. And therefore I think in the interests of fairness, the University has a responsibility to look into that and to make sure that that never rises to the point of public disclosure unless there is real substance in the allegation. And therefore there are protections in here, including the University’s Counsel’s office, for assuring that that information is not publicly disclosed, and you I think would feel strongly that that’s an appropriate way to handle this. We’re dealing with sensitive issues, people’s reputations and livelihoods, and we take it very seriously.

PROFESSOR O’HALLORAN: Well, thank you very much, and any additional questions or concerns that you have, please either submit them by e-mail or to any of us personally, and we’ll be happy to take those up. So thank you.

END OF SESSION