NIH Grants Research Integrity Amendments of 1991

Summary

NIH Grants Research Integrity Amendments of 1991 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, with regard to any entity receiving assistance for research to evaluate the safety or effectiveness of a drug, medical device, treatment, or other product or substance, to establish criteria for preventing or responding to any financial interests which will or may create a conflict of interest. Requires the criteria to be uniformly applicable to each entity. Allows individual variation in implementation. Prohibits allowing each entity to develop individual criteria. Allows the Secretary, where such a conflict of interest exists, to take certain actions, including disapproving an application, terminating assistance, and recovering assistance obligated while the conflict exists. Directs the Secretary to require the entity to disclose the conflict in each public presentation of the research results. Prohibits the Secretary, in fiscal years after regulations establishing the criteria are issued, from making a grant, cooperative agreement, or contract for biomedical or behavioral research unless the entity seeking assistance agrees to be subject to the regulations. Requires biomedical or behavioral research entities receiving financial assistance from the Secretary to make available to other researchers all data and other materials relevant to the results of the project that have been created or gathered in the course of the project, subject to exceptions for confidentiality and practicality, for five years after publication or eight years after the period of financial assistance ends, or longer if the materials continue to be in the possession of the entity. Limits charges for providing the materials to the costs incurred. Allows the Secretary to recover any or all of the assistance provided to an entity that fails to comply with these requirements. Directs the Secretary to establish recommendations regarding the timely dissemination of the results of biomedical or behavioral research that have any clinical application to a disease or disorder that poses a significant threat to the public health.

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2 official files

• Introduced in House (text)

  Introduced in House · EN

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• Introduced in House

  summary · EN · 16 April 1991

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