Force Protection: Improving Safeguards for Administration of Investigational New Drugs to Members of the Armed Forces : Hearing Before the Subcommittee on National Security, Veterans Affairs, and International Relations of the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, First Session, November 9, 1999U.S. Government Printing Office, 2000 - 86 páginas |
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adverse events anthrax BAILEY best interests biological warfare biological weapons Caplan certify and document Chairman chemical and biological chemical or biological Christopher Shays circumstances clinical Commissioner Defense Authorization Act Department of Defense DOD's drugs or biologics DSMB ensure Executive Order 13139 FDA regulations FDA rule FDA's feasible Food and Drug force health protection going health risk communication human subjects informed consent requirements informed consent waiver Institutional Review Board interim final rule interim rule investigational drug investigational new drug investigational products involved issue McCarthy military member military personnel monitoring national security obtaining informed consent off-label oversight particular military operation Persian Gulf War potential President prior pyridostigmine bromide rare RAUB response safeguards safety Secretary of Defense SHAYS SPOTILA standards and criteria Thank threat tracking training and health troops unapproved waive informed consent waiver of informed waiver request
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Página 28 - ... or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings...
Página 35 - ... assess whether there are beneficial or adverse health consequences that result from the use of the investigational product. (xii) DOD is pursuing drug development, including a time line, and marketing approval with due diligence. (xiii) FDA has concluded that the investigational new drug protocol may proceed subject to a decision by the President on the informed consent waiver request. (xiv...
Página 21 - Under 10 USC 1107(f) the President may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation. The statute specifies that only the President may waive informed consent in this connection and the President may grant such a waiver only if the President determines in writing that obtaining consent: Is not feasible; is contrary to the best interests of the...
Página 12 - ... chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening injury or illness. (iii) There is no available satisfactory alternative therapeutic or preventive treatment in relation to the intended use of the investigational new drug. (iv) Conditioning use of the investigational new drug on the voluntary participation of each member could significantly risk the safety and health of any individual member who would decline its use, the safety of other military...
Página 12 - President that the following standards and criteria contained in paragraphs (d)(l) through (d)(4) of this section have been met. (i) The extent and strength of evidence of the safety and effectiveness of the investigational new drug in relation to the medical risk that could be encountered during the military operation supports the drug's administration under an IND. (ii) The military operation presents a substantial risk that military personnel may be subject to a chemical, biological, nuclear,...
Página 12 - ... through (d)(4) of this section have been met. (i) The extent and strength of evidence of the safety and effectiveness of the investigational new drug in relation to the medical risk that could be encountered during the military operation supports the drug's administration under an IND. (ii) The military operation presents a substantial risk that military personnel may be subject to a chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening injury...
Página 33 - ... interests of the military member; or is not in the interests of national security. The statute further provides that in making a determination to waive prior informed consent on the ground that it is not feasible or the ground that it is contrary to the best interests of the military members involved, the President shall apply the standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior informed consent requirements of section 505(i)(4) of the Federal...
Página 12 - DOD's request is to include the documentation required by §56.115(a)(2) of this chapter. (vi) DOD has explained: (A) The context in which the investigational drug will be administered, eg, the setting or whether it will be self-administered or it will be administered by a health professional; (B) The nature of the disease or condition for which the preventive or therapeutic treatment is intended; and (C) To the extent there are existing data or information available, information on conditions that...
Página 13 - DOD's recordkeeping system is capable of tracking and will be used to track the proposed treatment from supplier to the individual recipient. (viii) Each member involved in the military operation will be given, prior to the administration of the investigational new drug, a specific written information sheet (including information required by 10 USC...