IRB/IACUC Ethical Approval
Institutional Review Boards and Institutional Animal Care and Use Committees
JDRF follows U.S. National Institutes of Health (NIH) Guidelines for the humane care and use of animals in research and for the use of human subjects in research. According to U.S. Federal law, institutions that use laboratory animals for research or instructional purposes must establish an Institutional Animal Care and Use Committee (IACUC) to oversee and evaluate all aspects of the institution’s animal care and use programs, facilities, and procedures. Institutions that utilize human subjects in research as defined by the federal government must establish an Institutional Review Board (IRB). See NIH’s federal guidelines for more information.
JDRF Requirements for IRB/IACUC Approvals
All projects with human subjects and/or animal research must have up-to-date ethical approval documentation at all times. It is the responsibility of the institution/organization’s project program staff to ensure that JDRF receives required, up-to-date documentation throughout the duration of the project.
If applicable, current human and/or animal ethical approval forms must be electronically submitted with activation/renewal materials and as they expire. Grantees are required to provide additional verification if their ethical approval forms do not explicitly state (by inclusion of a JDRF grant number or title) that the ethical approval covers the JDRF award in question. A form for this purpose is provided to grantees on the JDRF Grant Management Portal (GMP). Grantees must also check the “certification” checkbox in GMP to assert to the fact.
Ethical approval forms submitted in a language other English require a cover letter signed by the awardee’s department head (in English) verifying the content of the form, which must also be submitted via GMP.
As of 08/27/2009: For all projects that require IRB/EC review, the investigator is also required to upload in GMP: 1) the most recently approved Study Protocol submitted to the institutional IRB/ED for review and 2) the approved informed consent documents associated with a given protocol (if applicable). Any changes to these documents should be uploaded to GMP as approved.
For all Multi Project Grants an IRB/IACUC approval must be submitted, if applicable, for each project and core. If the approval is not specific to that particular project/core, grantees must electronically submit the additional IRB/IACUC form, signed by an administrative official, stating that the particular project/core is covered by the approved protocol.
International institutions are required to follow the JDRF guidelines above.