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ED Form 424, Human Subjects Itee2, Pitfalls to Avoid .< Page 1 of 2 <br /> Pitfalls to Avoid in Responding to Item 12 of the ED 424 <br /> (Human Subjects Item on Application for Federal Education Assistance) <br /> In 1998, the U.S. Department of Education (ED) began using in all grant application packages a <br /> revised version of the Application for Federal Education Assistance (ED 424). The ED 424 contains a <br /> new item, item 12, which requests information about the protection of human research subjects in <br /> projects funded by ED. To minimize the need for ED- requested revisions to item 12 responses, we <br /> have prepared a list of pitfalls to avoid. We have also tightened up the instructions for item 12 to <br /> specify where in the application, if necessary, the applicant should insert 1) the information we need <br /> to determine if designated exemptions to the Regulations for the Protection of Human Subjects are <br /> appropriate or 2) the six -point narrative required when nonexempt research activities involving <br /> human subjects are planned. <br /> The following are the most common responses that result in ED- requested revisions <br /> to item 12 of the ED 424. <br /> 1. The applicant did not check the "Yes" or the "No" box. One of the boxes must be checked. <br /> 2. The applicant checked "No," but the proposal suggests that research activities involving human <br /> subjects are planned. If research activities involving human subjects are planned, whether or not those <br /> activities are exempt under the ED regulations, "Yes" must be checked. <br /> 3. The applicant checked "No" but also responded to other parts of item 12. If "No" is checked, do not <br /> respond to the remaining parts of item 12. <br /> 4. The applicant checked "Yes" and designated one or more exemption(s) in 12a., indicating that all <br /> the research activities involving human subjects are exempt, but also provided information in 12b. or <br /> 12c. <br /> • a. If all the research activities are exempt, do not respond to the remaining parts of item 12, <br /> even if the applicant submits the proposal to the Institutional Review Board for review. <br /> • b. If some or all of the research activities are covered (nonexempt), skip 12a. and go directly to <br /> 12b. <br /> 5. The applicant checked "Yes" and entered one or more exemption number(s) in 12a. but overlooked <br /> the requirement to provide the information we need to determine if the designated exemptions are <br /> appropriate. The narrative information about the designated exemptions should be provided in an <br /> "Item 12/Protection of Human Subjects Attachment" and be inserted immediately following the ED <br /> 424 face page. The narrative must be succinct. <br /> 6. The applicant checked "Yes" and did not designate exemption(s), but failed to provide the six - <br /> point research activities narrative outlined in "Instructions to Applicants about the Narrative <br /> Information that Must Be Provided if Research Activities Involving Human Subjects are Planned" in <br /> Protection of Human Subjects in Research (Attachment to ED 424). The narrative is required when <br /> covered (nonexempt) research activities involving human subjects are planned. The six -point <br /> narrative should be provided in an "Item 12/Protection of Human Subjects Attachment" and be <br /> http:// ocfo .ed.gov /humansub /pitfalls.htm 8/31 /2000 <br />