§1580.80. Requirements for Submitting Research Proposals


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  • a)         The person or entity requesting the research involving human subjects must submit to the general counsel of the Authority a research application that includes the following written documentation:

     

    1)         A formal research proposal including the names and vitae of the researchers; an abstract of the project; a full description of the project purpose, methodology, protocol, and duration; the number of subjects, the amount of time required for each subject, and a detailed description of the interaction with the subjects; the procedures for obtaining informed consent; the testing or measurement instruments; and Authority resources to be utilized;

     

    2)         Identification of funding sources for the research proposal;

     

    3)         Any certifications and assurances regarding the protection of human research subjects, privacy and confidentiality, that are required by applicable law or regulations; and

     

    4)         Any other information necessary to the IRB review procedure.

     

    b)         The general counsel of the Authority will review the application, in accordance with Section 1580.40(a).