NOGUCHI MEMORIAL INSTITUTE FOR MEDICAL RESEARCH INSTITUTIONAL REVIEW BOARD RESEARCHER’S CHECK LIST

Title of Study Proposal: Back ground Information Yes No N/A Has the application letter been signed by the PI who is directly responsible for the ethical and scientific conduct of the research? Are there collaborating institutions on the study? If YES, are all the collaborating letters attached? Are the study investigators NMIMR staff? If YES, has the protocol been reviewed by the NMIMR Scientific. [...] been described under ethical considerations? Is the statistical basis for the study design appropriate and is the plan for analysis of the data appropriate? Are the dates on the work plan current? Has the budget been justified? Are the procedures for participant recruitment, admission, follow up and completion appropriate? Has the references been cited properly? Has the signatory page been signed?. [...] Phase 1 & Phase II studies been stated? Is the investigational product brochure for the study attached? If No, why not? Are the Data Safety Monitoring Board (DSMB) membership,Charter of Work and current CV of members attached? If No, why not? Will insurance cover be provided for study participants? If No, why not? Is the Food and Drugs Authority approval letter for use of the Investigational Produ. [...] If No, why not? Consent Forms Yes No N/A Have all the technical terms been simplified or written in laypersons’ language? Is the consent form easily understandable? Are the research participants below 18 years? If YES, has a parental consent form been attached? NMIMR-IRB RESEARCHER’S CHECKLIST 2 Version Date: February 2018 Has the parental consent form been written with reference to the child? E.g. [...] Please note that you are required to pay for the ethics review at the NMIMR Accounts Office and the receipt should be submitted to the NMIMR-IRB Office before the protocol would be reviewed.