N.I.H. to Scrutinize Private Donations to Scientific Research Projects

Six months after halting a study of moderate drinking that was underwritten by donations from the alcohol industry, the National Institutes of Health outlined a series of steps to prevent similar conflicts of interest and to safeguard the integrity of its research and its reputation.

In a report issued on Thursday, N.I.H. officials said its 27 institutes must evaluate all current research projects that receive private donor support for conflicts of interest of the kind that compromised the alcohol trial. The institute directors are to report their findings to Dr. Francis Collins, director of N.I.H., early next year.

“We have to do everything we can to ensure the integrity of the N.I.H. grants process and the quality of our research is above reproach, which means worrying about conflicts,” Dr. Collins said.

The Times reported in March that the principal investigator of the alcohol study, along with an official from the N.I.H., had approached the alcohol industry on several occasions to solicit corporate support for a study of moderate drinking.

The investigator shared details of the design of the trial and had suggested the results would reflect well on moderate drinking, possibly leading to official advice endorsing a daily drink to prevent heart disease.

The report also called for N.I.H. officials to examine the motives of private donors offering gifts, determining whether donations are given unconditionally or with the expectation of desired results from scientific research.

The recommendations also included ensuring that the N.I.H., and not private donors, make final decisions about trial design and data analysis.

Dr. Lawrence A. Tabak, the principal deputy director of the N.I.H. who presented the new policy recommendations, said they will buttress the agency’s standards and provide uniform enforcement across the institutes.

“We want to make sure we’re doing it completely consistently across the agency,” Dr. Tabak said.

Critics worried that the reforms did not go far enough.

“What, you mean the N.I.H. isn’t doing this already?” said Marion Nestle, a professor emerita at New York University who has studied how food industry funding influences nutritional science.

There is ample evidence that corporate-funded research yields results that are favorable to the sponsor “whether or not the donor explicitly expects a quid pro quo,” she said.

The Foundation for the N.I.H., a nongovernmental entity, raises private money and funnels these donations to the institutes. Since 1996, it has raised nearly $1 billion in private money for research, officials said. The foundation currently funds dozens of research projects at the N.I.H.

The foundation should only accept unrestricted private gifts not earmarked for specific research and directed to the agency’s top priorities, Dr. Nestle said.

”Anything short of that risks bias and loss of research integrity and trust,” she added. “N.I.H. sets a world-class standard for research integrity and also must maintain the highest possible standards for protecting that integrity.”

The report does not recommend a halt to public-private partnerships for scientific research or demand changes in the operations of the foundation, which served as the conduit for alcohol company donations toward the alcohol trial.

“These recommendations are weak and will not prevent industry influence,” said Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University and director of Pharmed Out, a group that advocates evidence-based drug prescribing.

Instead, N.I.H. research should be exclusively funded by Congress, without contributions from private sources, she said.

The new report also does not address gaps in the scientific review processes used to vet N.I.H. studies, which failed in the case of the alcohol study to identify and modify serious design flaws that could have led to false conclusions.

Dr. Collins said public-private partnerships are critical to carrying out N.I.H. research on important diseases like diabetes, Parkinson’s, Alzheimer’s and others.

Dr. Tabak and other N.I.H. officials absolved the Foundation for the N.I.H. of any culpability in the alcohol trial debacle, saying the foundation was deceived by officials at the National Institute on Alcohol Abuse and Alcoholism, which initiated that study.

The new policy recommendations, delivered by Dr. Tabak at a meeting of the advisory committee to Dr. Collins, noted that the alcohol study had cast a shadow over the government agency’s reputation for sound, impartial research.

The report said the problems that came to light in the alcohol trial “threaten public trust,” and that public-private partnerships must be reviewed with an eye to “assessment of reputational risk to the agency.”

“There were many things that had gone wrong” in the alcohol trial, which resulted in a flawed trial design and a selection process for a principal investigator that was “wired” for a certain outcome, Dr. Collins said. It is now important to “ascertain whether this could be going on in other places.”

“It’s one of these moments you hope will not happen,” he added. “You’ve got to learn from them and put in place appropriate steps so it does not happen again.”

Many of the new recommendations underscore guidelines that were presumed to be in effect, he said. “Had we had all these things in place and insisted on certain things and the institute had followed through, it wouldn’t have happened the way it did,” Dr. Tabak said of the alcohol study.

“We’re saying to the world, ‘We’ve got to start looking at this to make absolutely certain, because of what happened,’” he added.

The report calls for more rigorous disclosure of conflicts of interest, and for written disclosure of all interactions between scientists, N.I.H. officials and private donors.

The report urges greater transparency about N.I.H. funding opportunities, so as to ensure fair competition among outside researchers vying for grants. And the new measures limit the ability of N.I.H. employees to favor certain investigators or direct grants to those with whom they have close relationships.

That the N.I.H. should make all final determinations about trial design and data analysis should be an inviolable principal, Dr. Tabak said, “but you know, we did detect some heterogeneity among institutes in how they did things.”

“I think we have got to be doubly sure that the final analytical plan and trial design is the N.I.H.’s,” he added.

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