Research with Human Subjects Policy .docVIP

Instructions for Submitting a Protocol Application for the Involvement of Human Subjects in Research Background Information 1. ECSU adheres to U.S. federal regulations covering research on human subjects as described in the Code of Regulations, Title 45, Part 46 Protection of Human Subjects (aka 45CFR46, or “The Common Rule”): /ohrp/humansubjects/guidance/45cfr46.htm Additional information about federal policies covering research on human subjects can be found at the Office of Human Research Protections (OHRP), Dept of Health and Human Services, website: ?/ohrp 2. The ECSU Committee on the Use of Human Subjects in Research (CUHSR) is registered as an Institutional Review Board (IRB) with the OHRP. Our registration number and name are as follows: IORG Number: IORG0004941 IRB Number: IR IRB Name: Eastern Connecticut State U IRB#1. Federalwide Assurance Number: FWECSU Human Protections Administrator: Dr. Rhona Free, Vice President for Academic Affairs 3. Researchers (faculty, staff, and students) planning to conduct research on human subjects must submit a Protocol Application for the Involvement of Human Subjects in Research. This form may be obtained from the CUHSR Chair (contact information given below), or downloaded as a Word file from the ECSU Academic Affairs website: /academicaffairs Submitting a Protocol Application 1. On the Protocol Application form, you may enter text in the gray boxes, or skip the boxes and enter the text as you would in any Word document. Check-off boxes can be filled by double clicking to open a dialog box, and checking the appropriate item. You can save the completed form as a Word document. NOTE: Please do not reformat the Protocol Application form, or delete any sections that are not applicable to your research; any form that has been reformatted, or has sections missing, will be returned without review. 3. All investigators must provide documented evidence of having completed an NIH-approv