Science Research Conflicts Targeted

In 1993, California's Scripps Research Institute found itself in some hot water.

The institute had drawn national scrutiny--and a Congressional inquiry--for a 10-year, $300 million agreement that would have given Sandoz Pharmaceuticals, Inc. The right to examine all inventions from Scripps and to license almost half of them.

For many, the deal gave Sandoz, a private firm, too much control over the the scientists and technical publications of Scripps. Because the institutional conflicts of interest were too great, the partnership was eventually scaled back, and $100 million was cut from the agreement.

As these events unfolded, then-provost Jerry R. Green took a look at Harvard's practices and saw potential--too much potential--for similar institutional conflicts of interest.

With an eye toward Scripps' problems, he formed an ad hoc committee to make recommendations to bring Harvard's science policy into the 1990s.

And with the recent release of the committee's report, Green believes that will soon happen.

"This was one of my highest priorities, to make sure that Harvard was prepared for what I thought the future would bring," says Green, who resigned as provost in 1994 and is now Leverett professor of interfaculty teaching and research. "We just didn't have any [policies]. What we have was piece-by-piece, nothing at the University-wide level."

Green describes the report's recommendations as modest in nature. But he believes the report, now being circulated throughout the University, will help initiate an ongoing examination of the relationship between Harvard scientists and their sponsors.

"The report is intended to be kind of prospective in nature," says Green. "It's to set the tone and prepare the University for eventualities that haven't happened, to be prepared."

And the report also taps into an area untrodden by the University in the past, committee members say.

"Here Harvard's been going for hundreds of years and one never had a unified cross-University policy on a major issue of this sort," says Edgar Haber, a committee member who is Blout professor of biological sciences at the School of Public Health (SPH).

The Growing Partnership With Industry

The report is especially relevant, committee members say, as university science research becomes more heavily reliant on industrial funding.

A report issued recently by the National Science Foundation found that industrial sponsorship of research in U.S. universities grew from $236 million in 1980 to $1.2 billion in 1993.

This nearly six-fold increase made corporate sponsored research at universities the fastest growing component of all research expenditures in the nation.

At Harvard, the growth has been steady, but somewhat less dramatic than in the nation as a whole. Still, according to University figures, total non-federal sponsored research nearly doubled to $103.5 million between 1987 and 1993.

And with the federal government on a seven-year course to balance the budget, universities across the nation are fearing massive cuts in basic research funding by the government.

Those fears, coupled with the above national trends, may lead the University to become ever more reliant on industrially sponsored research.

The Recommendations

All of the above, plus changes in health care funding and evolving relationships among Harvard's teaching hospitals, motivated the committee to examine science policy problems from a University-wide perspective for the first time in its history.

"It was a vulnerability. We couldn't explain to people in Washington what exactly our procedures and policies were," says Green. "So I felt we should have a University-wide discussion even though the parts of Harvard are so different."

Green's committee reflected that University-wide approach, drawing members from four of the University's nine faculties: the Faculty of Arts and Sciences (FAS), the Medical School, the School of Public Health (SPH) and the Kennedy School of Government.

The committee met periodically while Green was still provost, but put its activities on hold when he resigned in April of 1994, according to committee member and Cabot Professor of Biology Richard M. Losick.

Green spent most of this past summer finishing up the report.

Ultimately, the committee came up with the following set of recommendations:

1) The report's first recommendation is to enhance both the scope and charge of the current Committee on Patents and Copyrights.

That would be done by expanding its duties to include oversight of all scientific-sponsored research at Harvard. The committee would be renamed the University Committee on Scientific Research to reflect that new mission.

Haber calls the proposed committee a "major advance."

"I'm sure that this kind of policy is going to evolve continuously, so this is one of our major recommendations," he says.

2) The committee recommends allowing scientists under research agreements a 30-day delay in the public release of their research. The delay would be useful in helping the firm and the scientist decide whether or not to seek a patent for innovative work done under the contract.

According to the report, the 30-day delay would "not materially impede the progress of science." Rather, it would keep sponsored research profitable and maintain the incentive for private firms to fund it.

But keeping the delay short was also important to the committee.

"Particularly if the delay isn't stated [in the contract],...one can have a piece of research that's dated and not really relevant," says Haber.

The slight delay also appears to be noncontroversial. In fact, a 1995 report prepared by the National Institutes of Health and cited in the science policy report, recommends a delay of between 30 and 60 days for this very purpose.

3) The committee recommends guaranteeing the rights of Harvard students to use technologies they have developed, even after they leave the University.

This recommendation would apply only to students who use the fruits of their research in a not-for-profit setting.

The committee would not guarantee similar rights to faculty members, though it recommends strongly that they be included in sponsored research contracts.

In an interview, Green says that the University's commitment is in some ways more permanent to its students than to its faculty.

"We have a responsibility to nurture and look after the educational development of our students," he says.

4) The committee recommends establishing internal peer review for large-scale, long-term sponsored grants.

The report says the committee was particularly concerned that "excessive reliance on continuing support from the same sponsor [would] have an undue effect on the research effort conducted under University auspices."

5) The report proposes allowing the University to accept shares of a firm's stock in lieu of licensing fees if the payment of such fees would be impractical.

This would normally be the case for a small start-up firm that did not have enough cash to make a payment.

The report notes that the University has a tradition of refusing equity in those cases. It quotes a 1981 report written by former president Derek C. Bok warning against the University "going into business with its faculty."

Critics have warned that holding stock in a firm would tie the University's financial prospects to the success of a faculty member's research. This could potentially result in favoritism toward that particular faculty member and damage the University's academic integrity.

But as long as the University takes certain precautions, the committee wrote that there is no reason why such stock ties should be forbidden.

These precautions would include forbidding the Harvard Management Company (HMC) to sell that equity before a certain time. The committee would also prohibit the University from making direct investments in those firms, which are frequently cash-starved early in their history.

It would also require HMC to hold the shares in an account separate from all of its other investments.

According to Joyce Brinton, director of the Office for Technology and Trademark Licensing, offers of equity instead of cash for licenses are only made to the University about five times each year.

Brinton says that this particular recommendation of the committee has already been approved by the Corporation, the University's highest governing board.

Reaction

Most University scientists interviewed say they have yet to read the report, which was only completed about a month ago and is currently in the process of being distributed.

Even Dean of the Faculty of Arts and Sciences Jeremy R. Knowles, who is also Houghton professor of chemistry, says in a written statement that he has "read but not yet studied" the report, and declines to comment on its recommendations.

But those who have scrutinized the report say they're pleased by the results of the committee's work.

President Neil L. Rudenstine, who says he's read a draft of the report, hails it as "exactly on target."

"Unless the position is really very, very clear in terms of the integrity of the institution,...you could sign a lot of agreements, it would get you a lot more dollars for research, but it would not be the kind of fundamental research that we would feel happy training our students on," he says.

Green says the initial feedback he's received from members of the Corporation has been positive.

He says Geyser University Professor Henry Rosovsky in particular responded quite favorably to the report. Rosovsky did not return repeated phone calls seeking comment for this story over the last two weeks.

"It's a good report and I think it was important work," says committee member Patricia Tucker, director of awards management and resource information in the Office of Sponsored Research. "You do need clear guidelines in those areas, and some of the things are fairly new issues."Crimson File PhotoNEIL L. RUDENSTINE

"The report is intended to be kind of prospective in nature," says Green. "It's to set the tone and prepare the University for eventualities that haven't happened, to be prepared."

And the report also taps into an area untrodden by the University in the past, committee members say.

"Here Harvard's been going for hundreds of years and one never had a unified cross-University policy on a major issue of this sort," says Edgar Haber, a committee member who is Blout professor of biological sciences at the School of Public Health (SPH).

The Growing Partnership With Industry

The report is especially relevant, committee members say, as university science research becomes more heavily reliant on industrial funding.

A report issued recently by the National Science Foundation found that industrial sponsorship of research in U.S. universities grew from $236 million in 1980 to $1.2 billion in 1993.

This nearly six-fold increase made corporate sponsored research at universities the fastest growing component of all research expenditures in the nation.

At Harvard, the growth has been steady, but somewhat less dramatic than in the nation as a whole. Still, according to University figures, total non-federal sponsored research nearly doubled to $103.5 million between 1987 and 1993.

And with the federal government on a seven-year course to balance the budget, universities across the nation are fearing massive cuts in basic research funding by the government.

Those fears, coupled with the above national trends, may lead the University to become ever more reliant on industrially sponsored research.

The Recommendations

All of the above, plus changes in health care funding and evolving relationships among Harvard's teaching hospitals, motivated the committee to examine science policy problems from a University-wide perspective for the first time in its history.

"It was a vulnerability. We couldn't explain to people in Washington what exactly our procedures and policies were," says Green. "So I felt we should have a University-wide discussion even though the parts of Harvard are so different."

Green's committee reflected that University-wide approach, drawing members from four of the University's nine faculties: the Faculty of Arts and Sciences (FAS), the Medical School, the School of Public Health (SPH) and the Kennedy School of Government.

The committee met periodically while Green was still provost, but put its activities on hold when he resigned in April of 1994, according to committee member and Cabot Professor of Biology Richard M. Losick.

Green spent most of this past summer finishing up the report.

Ultimately, the committee came up with the following set of recommendations:

1) The report's first recommendation is to enhance both the scope and charge of the current Committee on Patents and Copyrights.

That would be done by expanding its duties to include oversight of all scientific-sponsored research at Harvard. The committee would be renamed the University Committee on Scientific Research to reflect that new mission.

Haber calls the proposed committee a "major advance."

"I'm sure that this kind of policy is going to evolve continuously, so this is one of our major recommendations," he says.

2) The committee recommends allowing scientists under research agreements a 30-day delay in the public release of their research. The delay would be useful in helping the firm and the scientist decide whether or not to seek a patent for innovative work done under the contract.

According to the report, the 30-day delay would "not materially impede the progress of science." Rather, it would keep sponsored research profitable and maintain the incentive for private firms to fund it.

But keeping the delay short was also important to the committee.

"Particularly if the delay isn't stated [in the contract],...one can have a piece of research that's dated and not really relevant," says Haber.

The slight delay also appears to be noncontroversial. In fact, a 1995 report prepared by the National Institutes of Health and cited in the science policy report, recommends a delay of between 30 and 60 days for this very purpose.

3) The committee recommends guaranteeing the rights of Harvard students to use technologies they have developed, even after they leave the University.

This recommendation would apply only to students who use the fruits of their research in a not-for-profit setting.

The committee would not guarantee similar rights to faculty members, though it recommends strongly that they be included in sponsored research contracts.

In an interview, Green says that the University's commitment is in some ways more permanent to its students than to its faculty.

"We have a responsibility to nurture and look after the educational development of our students," he says.

4) The committee recommends establishing internal peer review for large-scale, long-term sponsored grants.

The report says the committee was particularly concerned that "excessive reliance on continuing support from the same sponsor [would] have an undue effect on the research effort conducted under University auspices."

5) The report proposes allowing the University to accept shares of a firm's stock in lieu of licensing fees if the payment of such fees would be impractical.

This would normally be the case for a small start-up firm that did not have enough cash to make a payment.

The report notes that the University has a tradition of refusing equity in those cases. It quotes a 1981 report written by former president Derek C. Bok warning against the University "going into business with its faculty."

Critics have warned that holding stock in a firm would tie the University's financial prospects to the success of a faculty member's research. This could potentially result in favoritism toward that particular faculty member and damage the University's academic integrity.

But as long as the University takes certain precautions, the committee wrote that there is no reason why such stock ties should be forbidden.

These precautions would include forbidding the Harvard Management Company (HMC) to sell that equity before a certain time. The committee would also prohibit the University from making direct investments in those firms, which are frequently cash-starved early in their history.

It would also require HMC to hold the shares in an account separate from all of its other investments.

According to Joyce Brinton, director of the Office for Technology and Trademark Licensing, offers of equity instead of cash for licenses are only made to the University about five times each year.

Brinton says that this particular recommendation of the committee has already been approved by the Corporation, the University's highest governing board.

Reaction

Most University scientists interviewed say they have yet to read the report, which was only completed about a month ago and is currently in the process of being distributed.

Even Dean of the Faculty of Arts and Sciences Jeremy R. Knowles, who is also Houghton professor of chemistry, says in a written statement that he has "read but not yet studied" the report, and declines to comment on its recommendations.

But those who have scrutinized the report say they're pleased by the results of the committee's work.

President Neil L. Rudenstine, who says he's read a draft of the report, hails it as "exactly on target."

"Unless the position is really very, very clear in terms of the integrity of the institution,...you could sign a lot of agreements, it would get you a lot more dollars for research, but it would not be the kind of fundamental research that we would feel happy training our students on," he says.

Green says the initial feedback he's received from members of the Corporation has been positive.

He says Geyser University Professor Henry Rosovsky in particular responded quite favorably to the report. Rosovsky did not return repeated phone calls seeking comment for this story over the last two weeks.

"It's a good report and I think it was important work," says committee member Patricia Tucker, director of awards management and resource information in the Office of Sponsored Research. "You do need clear guidelines in those areas, and some of the things are fairly new issues."Crimson File PhotoNEIL L. RUDENSTINE