Saving U.S. dietary advice from conflicts of interest.

A large and growing majority of people are dying from chronic diseases. To a large extent, however, whether this happens is up to us and the choices we make, since diet and lifestyle can prevent, slow, and even reverse these diseases. The government tries to inform the public about these healthy choices in the Dietary Guidelines for Americans. Unfortunately, the integrity of that advice has potentially been compromised by conflicts of interest among the people and organizations responsible for the Guidelines. As a result, as several studies show, the Guidelines are far less effective than other diets--especially the Mediterranean diet--at reducing the risk for chronic diseases. Improving the Guidelines would require eliminating these conflicts of interest, which would involve two statutory changes. First, Congress should give the authority to create dietary advice solely to an appropriate health agency, not the U.S. Department of Agriculture, which cannot give accurate and impartial dietary advice while also promoting agricultural interests. Second, Congress should find a way generally to prohibit individuals with ties to the food and drug industries from serving on the Dietary Guidelines Advisory Committee, as current ethical standards ignore the influence of past ties, and they are far too specific to address different forms of conflicts.

Working with the institutional review board.

PURPOSE: Working with an institutional review board (IRB) to ensure compliance and ethical conduct of research involving human subjects is discussed. SUMMARY: The Department of Health and Human Services (DHHS) and Food and Drug Administration regulations for the conduct of human research are grounded in the principles of the Belmont Report. By establishing the requirements for the function and operation of the IRB, the criteria needed for the review and approval of research, and the requirements for obtaining and documenting informed consent, the federal regulations help ensure the safety, rights and welfare of subjects. In developing research protocols and submissions to the IRB, the investigator should include clear, detailed information that addresses the regulatory requirements for the review and approval of research. Before starting a research study, review and approval by the IRB is required unless the study is determined to be minimal risk and fits one of the defined categories. Some research projects involving observation of public behavior, collection of anonymous surveys of nonvulnerable individuals in which the information is not considered sensitive, and evaluation of standard education practices may be exempt from DHHS regulations. Informed consent is central to the protection of human subjects and is required unless the IRB allows a waiver or alteration of informed consent. Once the study is approved, the investigator must conduct the study as approved by the IRB and continue to meet the regulatory requirements related to modifications, reporting unanticipated events, and continuing review. CONCLUSION: IRB review is integral to ensuring regulatory compliance and ethical conduct of research involving human subjects. Working closely with the IRB or colleagues who have had experience with the IRB will help junior investigators better understand the IRB submission and review process.

Protecting subjects without hampering research progress: guidance from the office for human research protections.

The Office for Human Research Protections (OHRP) within the US Department of Health and Human Services aims to protect human research subjects without hampering scientific progress. Institutions can foster safe and efficient research by guarding against conflicts of interest, making research subject safety a priority, having a well-staffed institutional review board, and continually training new investigators. The OHRP provides education on its Web site (www.hhs.gov/ohrp/) and is available to make site visits to offer guidance on federal regulations.

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.