Application for Initial Reviews

Applicationfor Initial Reviews Human Subject Protection Office UConn Health Center Judy Gaffney, BA Monika Haugstetter, MHA, RN, MSN http://resadm.uchc.edu/hspo/index.html

All applicationsmustbe typed. Point, click and type in the appropriate cell. Cells will expand to accommodate text. Tabbing out of the last cell on the right of a table will insert another row. Referencing the protocol is not acceptable since not all IRB members receive the complete protocol. The IRB reserves the right to return applications that do not provide sufficient responses. When submitting for continuing review the application must reflect the currently approved status of the study. For example, if inclusion / exclusion criteria were changed via a request for modification the application must reflect that approved change. For continuations the Addendum to the Application to Request Continuing Review must be appended to this form. Any modifications being proposed with the continuation are to be noted on that form in the proposed modification section. http://resadm.uchc.edu/hspo/index.html

NOTES: If you will be applying to the General Clinical Research Center to provide support for this study you must also submit this application and supporting documents electronically to Lisa Godin for review and approval by the GCRC. Investigators may apply to the GCRC prior to or concurrent with the IRB submission. For question related to GCRC submission contact Lisa Godin at 679-4145, or godin@uchc.edu. For complete direction for GCRC submission refer to the application instructions. If you are requesting approval for a Humanitarian Use Device, use the application specific to HUDs. If you are requesting approval for a registry/repository use the application specific to registry/repositories. If the study involves the use of Recombinant DNA or gene therapy you must first obtain approval from the Institutional Biosafety Committee. Refer to the complete and detailed instructions for specific questions to ensure that all elements are adequately addressed. You may print the document in color or in grayscale. http://resadm.uchc.edu/hspo/index.html

http://resadm.uchc.edu/hspo/index.html

3.2Indicate the expected percentage of enrollment at each applicable site, and place an X in the appropriate cell to indicate which institution, based on the preponderance of the expected enrollment, you are requesting serve as the IRB of record or that independent IRB approval will be sought from each applicable site.

4.0Provide the anticipated time frame during which the study will be conducted: 4.2 Place an X after the applicable study phase: 4.4Place an X after all characteristics that are applicable to the studydesign: http://resadm.uchc.edu/hspo/index.html

4.7Provide either a flow diagram or outline of the experimental design addressing the elements noted below. ( http://resadm.uchc.edu/hspo/index.html

5.6 http://resadm.uchc.edu/hspo/index.html

Pregnant Womenor Fetuses (B204 or B207) Children/Adolescents (D404, D405, D406 or D407) Prisoners (C ) Neonates of uncertain viability or non-viable (B205 or B207) Decisionally Impaired (S and (D404, D405, D406 or D407)) UCHC Inpatients- Including Prisoners (C ) Abortuses (B206 or B207) Viable Neonates (D404, D405, D406 or D407) UCHC Inpatients–No Prisoners UCHC Employees (S) Educationally Disadvantaged (S) Outpatients UCHC Students (S) Economically Disadvantaged (S) Terminally Ill (S) Other (describe) http://resadm.uchc.edu/hspo/index.html

Methods/Materials X to Select Description of Implementation Closed to enrollment Radio spots Newspapers Magazines Broadcast messages Purchased mailing lists Patient base Flyers Proband Phone Calls Web postings* Other methods, materials and strategies that will be used for subject recruitment(provide description): http://resadm.uchc.edu/hspo/index.html

Application for Initial Reviews