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New PolicyAs of October 2006, researchers are to sign the "Translated Consent Statement" located on the Accuracy of Translated Document policy when translating consent forms and other materials (i.e. recruitment scripts, instruments, etc) into a foreign language. Education RequirementsAll IU Northwest researchers must document that they have been trained to involve humans in research by passing the IU test for using humans in research, before their study will be approved. Test certification will expire after a five (5) year period.
Proof of having passed the test (available by return email at the above site) must accompany the application at the time of submission. Failure to provide proof with the application will delay the review until documentation is provided. This applies to all submissions (new, continuation and/or amendment) regardless of funding or rank of the PI, sponsor and co-investigators. Those individuals specifically listed in the application as PI, sponsor, and/or co-investigators must provide proof of having passed the test. Health and Human Services RequirementsEffective 7/30/99 all studies that are being submitted to any Health and Human Services (HHS) agency for funding must submit the identical information to the Human Subjects Committee (HSC) as was submitted in the grant application. And, a copy of the grant application must be provided with the HSC application. If you are unsure as to whether an agency is part of HHS, please contact the office of the at (219) 981-5646. Electronic SubmissionsTo help speed up the review process researchers are asked to submit the initial application electronically to the Human Subjects Office for a preliminary review. The purpose of this pre-review is to ensure that the application contains all the information that is required by the regulations and needed by the committee for its official review. The administrator will highlight suggestions for any alterations that may be needed. They will return the application to the researcher for approval of the changes. After this pre-review process has been completed and authorized by the researcher, a hard copy of the application with original signatures is to be submitted to the office, Lindenwood, 326. |
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