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This commentary makes the case for a re-examination of certain existing guidelines of the Department of Health and Human Services (DHHS) and the National Institutes of Health (NIH) regarding reimbursement of salary costs under NIH grants. The settlement earlier this year involving salary costs and effort reporting at Northwestern University has focused attention on arrangements under which grantee faculty and other personnel receive compensation from two or more legal entities (dual compensation), or from a legal entity other than the grantee (separate compensation). Existing NIH and DHHS guidelines define reimbursable salary narrowly, to include in general only compensation that is paid by the grantee itself. The commentary identifies certain problems that these guidelines cause for some grantees, researchers, and the Government itself, and argues for a more flexible approach that accommodates the many different compensation arrangements that exist today in the field of biomedical research. The commentary concludes that a dual or separate compensation arrangement should be permitted if it (a) results in salary levels that are reasonable and accurately allocated to grants by a workable effort reporting system, and (b) provides a reasonable assurance that the grantee's performance and compliance obligations will be fully satisfied.

Abstract: Background: Black and premenopausal patients have been shown to have poorer stage for stage survival than the overall population. The purpose of this study was to define the effects of age and race on axillary lymph node involvement at a Midwestern safety-net hospital. The hypothesis was that black patients under the age of 50 would be found to have increased rates of axillary involvement in breast cancer. Methods: A retrospective case review was performed of 184 breast cancer patients from 2000 to 2005. Statistical analysis was performed by race and age. Patients under 50 years of age were defined as premenopausal. Results: The overall rate of axillary involvement was 47.8%. Black patients had an overall rate of axillary involvement of 52.9%. However, premenopausal black patients had a 70.8% rate of axillary involvement (P < .05). Premenopausal white patients had a 46.3% rate of axillary involvement. Logistic regression analysis was performed, and premenopausal age and tumor size were found to be independent predictors of positive lymph node status in black patients. Conclusion: In our study, premenopausal black patients had a much higher rate of axillary lymph node involvement than any other group. This finding was consistent even when tumor size was taken into account. More research needs to be done to better define this difference and to detect this disease at an earlier stage. [Copyright &y& Elsevier]