Statement in Support of Conflict-of-Interest Regulations at Federal Research Agencies

As an organization of physicians who care for desperately ill patients and scientists devoted to understanding the basic mechanisms of disease and discovering new therapies, the American Society of Hematology (ASH) supports the establishment of conflict-of-interest regulations at federal agencies that conduct and support research. This is to ensure that personal financial interests do not compromise the design of research, the safety and wellbeing of patients, the collection and interpretation of research data, or funding and contract decisions.

Background

On February 1, 2005, the National Institutes of Health (NIH) issued an interim final rule with stringent new restrictions for its 18,000 employees on all outside activities, financial holdings, and awards. The interim final rule prohibited all NIH employees from engaging in outside activities of any kind with pharmaceutical or biotechnology interests; health care providers; insurers; trade or professional associations; and supported educational institutions.

In addition, the draft rule barred nearly 40 percent of NIH employees and their spouses and children—including many who have no decision-making authority for grants or research—from holding financial equity in any “substantially affected organization.” The rule further banned other NIH employees from secretaries to lab technicians—who cannot be construed to have relevant conflict-of-interest issues—from holding more than $15,000 in such companies. Moreover, NIH changed the criteria and restricted the awards that NIH employees can accept from outside organizations for outstanding scientific, research, or leadership achievements.

When NIH announced its final conflict-of-interest regulations on August 25, 2005, many important changes were made to the interim policy. NIH removed professional associations and other science and health-related organizations from the list of entities with which NIH employees are prohibited from engaging in outside activities, allowing them to engage in important professional and scholarly activities with these organizations. The agency also formally recognized the differences between employees as to rank, duties, and level of responsibility for matters affecting public health and patients, including limiting the applicability of the prohibited financial interests provision to only senior Institute leaders. Finally, NIH modified the provision on accepting awards from outside organizations by applying the same conflict-of-interest criterion to awards and restricting senior NIH officials from receiving any monetary award component.

ASH Policy

Strong protections to prevent conflicts of interest are necessary to protect the integrity of science and ensure public trust in federal agencies that conduct and support research, such as NIH. ASH firmly believes that NIH’s final ethics rule strikes a reasonable balance between ensuring the integrity of NIH grant-making and allowing the appropriate level of interaction between institute employees and outside entities. The NIH ethics regulations should serve as a model for other federal agencies as they revise and update their conflict-of-interest rules.

The Society supports efforts at federal research agencies to craft and enforce regulations that prohibit significant financial conflicts of interest and that require full disclosure of all activities that could be perceived as representing a potential conflict of interest. ASH also supports regulations that more broadly define conflicts of interest for employees that have decision-making authority for scientific or research direction and funding, but are more focused for the vast majority of other scientists or researchers who are employed at these federal agencies.

Specifically at NIH, ASH suggests that the Institutes proceed cautiously in examining whether to extend or apply its new regulations to those not employed by NIH, but who serve NIH on peer review panels, Institute/Center Scientific Councils and Advisory Boards, or receive NIH grants and awards. Such a move would be of profound concern to ASH and many other professional biomedical research organizations.

Applying NIH’s new ethics rules to the extramural research community would threaten the recruitment and retention of the most qualified scientists for NIH study sections and Institute Scientific Councils and Advisory Boards. Moreover, extending the ethics rules to NIH grantees would limit the ability of investigators to collaborate with pharmaceutical and biotechnology interests, making it difficult for them to effectively and efficiently translate scientific discoveries into therapies to help patients. In the future, ASH believes that any revision or update by NIH to its conflict-of-interest rules must be done in consultation with NIH scientists, employees and their representatives, as well as the extramural research community.

Overall, the Society believes that any research entity’s ethics policy must strive to manage the real and potential conflicts of interest of its employees, incorporate the transparent disclosure of relationships, include restrictions on financial interests for those in decision-making positions, and institute clear and fair protective measures to ensure the integrity of science and research as well as public trust.

Founded in 1958, ASH represents over 14,000 clinicians and scientists committed to the study and treatment of blood and blood-related diseases. These diseases encompass malignant hematologic disorders such as leukemia, lymphoma, and myeloma; and non-malignant conditions including anemia and hemophilia; and congenital disorders such as sickle cell anemia and thalassemia. In addition, hematologists have been pioneers in the fields of bone marrow transplantation, gene therapy, and many drugs for the prevention and treatment of heart attacks and strokes.