What We Don't Know Yet
UNDER CONSTRUCTION: BEAR WITH US

As you know, the new rules set deadlines. The time for compliance with some of the provisions draws near. However, some employees may be unable to fulfill their obligations under the regulations because there are implementation questions unanswered and necessary procedures yet to be established. Please continue to be patient. We are working as quickly as possible to get answers, to make the rules clear and understandable, and to make their implementation fair and efficient. Here are the most critical details we are working out as The NIH Catalyst goes to press:

The application of the rules to various members of the NIH community. Certain classes of NIHers may be exempt from the total prohibited holding ban or may be switched from the total ban to the de minimis rule.

When the stock divestiture period will begin. Right now, it’s set for April 5, but an extension of the filing date for the supplemental disclosure reports may be issued. If this happens, it will also push back the start of the divestiture period.

The breadth of the definition of "substantially affected organization (SAO)." The definition says that an SAO is an entity that is "significantly involved, directly or through subsidiaries, in the research, development, or manufacture of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, treatments, or products." But "significantly involved" still needs to be interpreted.

How employees should report the information required by the new rules. We are revising and developing some new forms and will distribute these shortly, along with instructions for their use.

Specific operating procedures. There are numerous procedural provisions in the regulations, several of which allow employees to ask for extensions, exemptions, exceptions, or waivers of the application of the rules. For now, employees should file any such requests with their IC ethics office.

As we get answers, procedures, or changes in the COI policies, we will send out NIH-Staff-list messages and post the updates through  a link on the NIH Ethics page.

—NIH Office of Intramural Research

WHERE TO SEND YOUR COMMENTS

The NIH community may be able to have an impact on whether and how the the rules are changed. Anyone interested in expressing their views can communicate with NIH leadership and federal regulators at the addresses below.

To respond to the federal regulators regarding the February 3 Federal Register regulation, comments must be submitted by April 4, 2005.

Write to: Office of the General Counsel, Ethics Division, DHHS, Room 700-E, Hubert H. Humphrey Bldg., 200 Independence Ave. SW, Washington, DC 20201, Attn. Linda L. Conte

Or send e-mail HERE. Important: The subject line should include: "Comments on Interim Final HHS Supplemental Ethics Rule."

To contact NIH leadership, send e-mail HERE.

Important: The subject line should begin with: "Question:" or "Comment:" Note that this address is accessible to individuals outside NIH.