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If the specified target is substantially exceeded, or it emerges that representation from different groups is required, data collection must be paused or disrupted pending further approvals of protocol amendments by the REC and NHS research and development departments.
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Thirty-five clinically stable Veterans with diabetic nephropathy were recruited from the Renal Clinic of the Roudebush VA Medical Center, Indianapolis, IN after review and approval of protocol by the Institutional Review Board of Indiana University and VA Research and Development Committee.
The activities in the UCRC allow the students to be introduced to issues related to Institutional Review Board approval of protocols and consenting subjects for research.
Institutional review board approval of protocols and informed consent of patients for this study were obtained.
Ethical approval of protocols was obtained from the Ministry of Health and Uganda National Council of Science and Technology UNCSTT), Uganda, and the ethics committee of University of Heidelberg, Germany.
Approvals of the protocol and informed consent forms were obtained from the DSMB and the NHLBI prior to enrolling the first study participant.
Revision of study design and protocol: All authors Drafting and approval of final protocol and manuscript.
After the approval of the protocol by the Quality committee, training in the protocol was conducted in the hospital.
Article VII specifies that the protocol shall enter into force after the exchange of ratification instruments, which shall take place after approval of the protocol by the procedure called for by the constitution of each party.
Mr. Hoffman convinced the Reagan administration of the threat and played an influential role when the United States eventually helped shape and secure approval of the protocol, which was expanded in later years.
The National Ethics Committee of Luxembourg gave overall approval of the protocol.
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