Protecting Human Subjects in Student Inquiry Projects

Draft symposium documents and participant assignments

Symposium participant homework assignment (Microsoft Word 2007 (.docx) 21kB Feb13 12)
Each symposium participant was asked to contribute an example of the consequences of failure to protect some aspect of subject rights or well-being; the examples will be consolidated into an instructional handout for students

Case study: Question Inspires Student to Pursue 'Life-Changing' Initiative
An ACM article describing a student's field-based investigation of cognitive impairment among the elderly in Florencia, Costa Rica, using diagnostic testing and extensive interviewing, and his use of the results to help develop and fund a new community-based senior educational program. We will be referring to this case study several times throughout the symposium.

Protecting Participants in Research Projects: What Do I Have to Do and Why? (Microsoft Word 53kB Feb29 12)
A draft instructional handout explaining the basics of human subjects protection for students who are conducting inquiries that do not require IRB review

Determining Whether IRB Review is Required – Policy – Draft 02-15-12 (Microsoft Word 2007 (.docx) 47kB Feb16 12)
A draft policy document that explains the policy considerations involved in determining whether a proposed investigation requires IRB review. The document draws extensively on the regulations and policy guidance available on the OHRP website. It also reflects advice from OHRP staff on an earlier draft of the policy; however, this draft has not yet been reviewed by OHRP.

Determining Whether IRB Review is Required – Form – Draft 02-15-12 (Microsoft Word 2007 (.docx) 18kB Feb16 12)
A draft form to accompany the above policy document which can be used to record an institution's analysis of project characteristics in relation to federal regulations.

Student plan for protecting research participants (Microsoft Word 2007 (.docx) 33kB Feb23 12)
A form students can complete that will describe how they will minimize risks, respect privacy, carry out agreements regarding the identifiability of data, keep data secure, and provide for informed consent. The form is primarily closed-ended, so it doubles as an instructional document.

Student plan for protecting research participants (Microsoft Word 2007 (.docx) 33kB Feb23 12)
A template students can use to prepare written project information to inform consent

Instructor informed consent checklist.docx (Microsoft Word 2007 (.docx) 20kB Feb29 12)
A checklist instructors can use to determine whether an Information for Participants document includes all the required elements

Working drafts (private access only) [new as of 2-29-12]
A private workspace for documents under construction by symposium participants

Symposium follow-up information and activities (Microsoft Word 2007 (.docx) 732kB Mar1 12)
A memo that outlines plans to complete work together after the symposium.