IRB#: PI: Submitter: Date Submitted: Note: Numbers in parentheses indicate eIRB section and research summary section. [i.e. (06 & 10) referes to eIRB 06. Research Summary & Abstract and 10. Subject Population Groups and Enrollment.] Division CRU Submitter Y,N,N/A Required elements prior to submission for IRB review Is the funding source cited? (04) Is SPS# entered? (if applicable) (04) If funding is Federal, AHA or March of Dimes, are the entire grant & budget attached? (04) If funding is from private industry, is the sponsor’s protocol attached? (07) If funding is from private industry and involves an investigational drug/device, is the investigational brochure included? (08) Number of subjects in the study population (10) Age of study population (06) Are there exclusions in study population? (06 & 10) Are exclusions justified? If not, why? (06 & 10) Data Use/Transfer Agreement? Duke researchers wishing to transfer or use human subject data must contact ORC to initiate a discussion on the proposed data transfer or use. Material Transfer Agreement (MTA)? An agreement entered into by the parties to govern the provision or receipt of research material. The specific form of agreement depends upon the nature of the material, the intended use, whether the recipient is an academic or commercial organization, and the consideration of any intellectual property interests associated with the material. Potential subject identification & recruitment: --Will a review preparatory to research occur? If not, (13.1) --Is a waiver of HIPAA authorization for records review requested? (13.2) --How subjects will be identified? (06,5) --How subjects will be recruited? (06,6) --Is PHI to be collected justified? (13.1) Plan for protection of subject privacy? (12,06) Plan for protecting confidentiality of PHI &/or specimens? (12, 14) Is a consent form attached? (14) --If not, is a waiver of consent request attached? (13.2) --If a waiver is requested, is it justified? (13.1) If a consent form is attached, are the specific requirements for valid authorization listed below included in the document: --The information --Who may use or disclose the information
IRB#: PI: Submitter: Date Submitted: Note: Numbers in parentheses indicate eIRB section and research summary section. [i.e. (06 & 10) referes to eIRB 06. Research Summary & Abstract and 10. Subject Population Groups and Enrollment.] Division Submitter Y,N,N/A Required elements prior to submission for IRB review Is the funding source cited? (04) Is SPS# entered? (if applicable) (04) If funding is Federal, AHA or March of Dimes, are the entire grant & budget attached? (04) If funding is from private industry, is the sponsor’s protocol attached? (07) If funding is from private industry and involves an investigational drug/device, is the investigational brochure included? (08) Number of subjects in the study population (10) Age of study population (06) Are there exclusions in study population? (06 & 10) Are exclusions justified? If not, why? (06 & 10) Data Use/Transfer Agreement? Duke researchers wishing to transfer or use human subject data must contact ORC to initiate a discussion on the proposed data transfer or use. Material Transfer Agreement (MTA)? An agreement entered into by the parties to govern the provision or receipt of research material. The specific form of agreement depends upon the nature of the material, the intended use, whether the recipient is an academic or commercial organization, and the consideration of any intellectual property interests associated with the material. Potential subject identification & recruitment: --Will a review preparatory to research occur? If not, (13.1) --Is a waiver of HIPAA authorization for records review requested? (13.2) --How subjects will be identified? (06,5) --How subjects will be recruited? (06,6) --Is PHI to be collected justified? (13.1) Plan for protection of subject privacy? (12,06) Plan for protecting confidentiality of PHI &/or specimens? (12, 14) Is a consent form attached? (14) --If not, is a waiver of consent request attached? (13.2) --If a waiver is requested, is it justified? (13.1) If a consent form is attached, are the specific requirements for valid authorization listed below included in the document: --The information --Who may use or disclose the information CRU