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Setting a 'Higher Standard'
'Sweeping' Ban on Outside Activities Announced, Affects All Employees

By Carla Garnett

Photos by Janet Stephens

On the Front Page...

NIH director Dr. Elias Zerhouni announced on Feb. 1 a "sweeping" ban on consulting and other activities employees may engage in outside of their federal jobs. The new ethics regulations — which apply not only to NIH's approximately 5,000 intramural scientists, but also to every federal employee at the agency — took effect on Feb. 3, the day they were published in the Federal Register.

Continued...

"We believe we need to hold ourselves to a higher standard," said Zerhouni at a 45-minute news conference called in Bldg. 1 to announce the new policies. Accompanied by NIH deputy director Dr. Raynard Kington, who has served as the agency's point man on conflict-of-interest issues, and Holli Beckerman Jaffe, director of the NIH Ethics Office, Zerhouni told the room of reporters, "The guiding principle for these regulations is that we will do whatever is necessary to ensure that the advice of the NIH receives the highest level of trust."

Strict Limits Set

In general, the new rules prohibit all NIH'ers from engaging in three kinds of activities for four types of organizations: Banned are paid and unpaid employment; paid teaching, speaking, writing and editing; and self-employment for "substantially affected organizations" such as pharmaceutical and biotechnology companies; supported research institutions, including NIH grant recipients; health care providers and insurers; and related trade, professional or similar associations.

In addition, financial interests in organizations substantially affected by NIH, such as the biotechnology and pharmaceutical industries, are also banned for those employees who are required to file financial disclosure reports, and are restricted to $15,000 for all other staff. The prohibited holding rule applies also to spouses and minor children of NIH'ers.

Scientific awards, too, are now subject to stricter limits. Generally, senior employees may "accept the honor" of any award, but must reject any associated prize money or other tangibles valued at more than $200. There is an exception for awards that confer extremely high honors in the fields of medicine or scientific research such as the Nobel Prize or Lasker Award. [The full text of the new regulations can be found online at http://www.archives.gov/federal_register/index.html.]

NIH director Dr. Elias Zerhouni (r) and NIH deputy director Dr. Raynard Kington discuss ethics rules.

Stressing that his goal is to draw a "bright line so clear" and unambiguous that crossing it would be obvious and not permitted, Zerhouni briefly recounted events over the last 18 months that led to what he termed "drastic measures." With a majority of institute and center directors and deputies looking on from the audience, he said, "What has happened is that we needed to absolutely achieve the number one goal: Nothing is more important for NIH than preserving the public's trust in our advice, our science, in our ability to provide public health advice with no taint of conflict of interest or the appearance of conflict of interest. I have always felt that people look to us for the most accurate health information and to fund the most outstanding medical research without any other considerations in mind. I feel that that's why we are here and that's why people trust us with their tax dollars. And that trust cannot be compromised in any way — even by the perception that something might taint our ability to carry out our public health mission."

Putting Events in Context

In Masur Auditorium on the day after the rules were announced, Zerhouni again faced a room filled with expectancy. This time the large majority of attendees were NIH employees — many of them intramural scientists — called to a quickly arranged town hall meeting to discuss implications of the new policies.

"Between yesterday and today I've had mixed feedback," Zerhouni said. "A good portion of the NIH community, some intramural scientists included, feel that this may be a bright day. We are solving and closing an embarrassing chapter. We couldn't sustain the loss of integrity and the fact that NIH fell from its pedestal. At the other end of the spectrum I have a group that says, 'This is the darkest day. You're taking away the ability of our scientists to be equal to those in the private sector, to have the same opportunities and rights.'"

To put the ethics decisions in context, Zerhouni recalled the July 2003 congressional query about cash awards that prompted an internal review of ethics policies and regulations. The self-exam pointed out areas of "major vulnerability," he said. Instead of the balanced, uniform NIH-wide standard he had expected, Zerhouni said he and other NIH officials found differing interpretations and uneven enforcement of rules among the ICs. In response, Zerhouni established in November 2003 a trans-NIH ethics advisory committee (the NEAC) to "reorganize our thoughts" and give consistent review to requests for approval of outside activities and awards.

Meanwhile a series of news articles was alluding to a far more serious problem — possible conflict of interest among some NIH scientists — and hinting that patients and NIH research could potentially be compromised because of financial ties with pharmaceutical companies. Congress asked Zerhouni to a special hearing about the articles. On Capitol Hill, he defended the customary and beneficial practice of scientific collaboration among peers, but also acknowledged that NIH needed to tighten its policies in the area. He testified that he could "find no evidence that any patient was harmed or that any decision...was corrupted" by NIH'ers' consulting. Next, Zerhouni enlisted the aid of outside advisors, establishing a blue-ribbon panel to study the ethics situation in depth and make expedited recommendations that he immediately implemented.

The Final Straw

Congress, however, was not satisfied and began gathering information independently. Not long afterwards, the NIH director was called to Capitol Hill on June 22, 2004, for another hearing.

"Everybody has their own emotions about that day," he said, candidly, "but I can tell you that I felt like I was out in front, fighting whoever was in front of me, and getting shot in the back by my own troops"...because some employees evidently had not disclosed what their activities were. "That was discovered by congressional inquiry to the pharmaceutical companies."

NIH deputy director for intramural research Dr. Michael Gottesman and NIH Ethics Office Chief Holli Beckerman Jaffe talk about the new rules.

After more fact-finding, NIH "found instances that were very disturbing...some were purely and simply product-endorsement activities" by employees, Zerhouni pointed out, showing a slide quoting Congress's FY 2005 appropriation for NIH that warned that the conflict issue could jeopardize budget support for the agency. "It's a shame that the actions of a few have tainted the great service that many thousands of scientists here render every day, selflessly, with no taint," he continued. "I have to protect the reputations of the 5,000 scientists who are doing their jobs...I am convinced that we owe nothing less to the American public than what we are doing today."

NIH ethics head Jaffe then gave an overview of the new "interim final" regulations, which are considered permanent unless the Department of Health and Human Services makes changes to them.

During Q & As, employees — many visibly upset — asked why spouses should have to divest themselves of certain financial assets and why NIH'ers were being held to stricter limits than grantees or advisory councilors, who often have equal or greater influence on research. How could NIH ask its employees to divest of personal assets during poor market conditions, and why did the rules apply to NIH'ers without grant-making authority? Who exactly is defined as an NIH employee, and how could longterm NIH'ers be required to accept new employment practices midstream?

"The department did not do this casually," stressed Kington, who worked with HHS to craft the regulation. "The fundamental explanation is that the world changed over time. The industry became more complex. It became more difficult to track our relationships with industry. Our influence on the market became greater."

'First, Do No Harm'

Emphasizing that "we do not want to put any obstacles in the way of normal scientific academic interchange," Zerhouni concluded: "You have to ask yourself, is it 'first, do no harm' or [is it] prove that no harm is being done to the integrity of science? I think the previous policy was, 'Let's just do and then worry about the consequences.' The attitude of these regs is, if we have to err on the side of uncertainty, then we will err on the side of protecting the agency's integrity in the public eye."

Over the next few months, NIH and HHS will be looking for unintended consequences of the rules — detrimental effects on recruitment and retention, for example — that may prompt changes. A 60-day comment period began with the Federal Register posting; NIH'ers who have comments are encouraged to submit them by Apr. 4, 2005. Comments may be emailed to ethics@hhs.gov. Use the subject line "Comments on Interim Final HHS Supplemental Ethics Rule."

A dedicated NIH email address was also created, ConflictofInterest@od.nih.gov. To help direct email quickly, use either "question" or "comment" in the subject line.

What You Can Still Do Officially

Official duties: Government ethics rules, including the new regulations, do not affect the agency's authority to conduct business with outside entities. Therefore, as assigned and approved through all appropriate channels, NIH employees may, as part of their official duties:

  • collaborate with a university researcher,
  • be involved in a cooperative research and development agreement (CRADA) with a pharmaceutical company,
  • be involved in a material transfer agreement (MTA) with a biotechnology company,
  • serve as an officer or board member of a professional or trade association,
  • peer review grant applications.
In addition, an offer of travel reimbursement from the outside organization may be accepted by the employee's institute or center with respect to these duties, as appropriate.

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