3. Procedures: What precisely will be done to the participants? Explain in detail your methods and procedures in terms of what will be done to participants. If you are using a questionnaire or handout, please include a copy with each copied set of application documents. 4. Risks and Benefits: What are the potential risks to the participants? How do you propose to minimize these risks? What potential benefits will accrue to justify taking such risks? 5. Confidentiality: Adequate provisions must be made to protect the privacy of participants and to maintain confidentiality of identifiable information. Explain how your procedures accomplish this objective, such as means of data storage, data location and duration, description of persons with access to the data, and method of destroying the data when completed. Also, explain in this section that the data will be kept for 3 years or for as long as required by external agencies or funding sources. At the conclusion of that time period, all data must be destroyed. 6. Obtaining Consent: FSU faculty, staff, and students must obtain the informed consent of any potential human participant before involving that person in research. Typically, you do this by providing the participants with an informed consent document written in simple, lay language. State how the participants’ informed consent will be obtained. 7. Consent Forms and Information to Include: Submit a final copy of the Consent Form in a separate document, as it will be provided to participants. When using children or minors in research, the Consent Form should be addressed to and signed exclusively by the parent/guardian to gain their consent for their child to participate. A separate
Review Board (IRB) of Frostburg State University. For research-related problems or questions regarding participants' rights, contact the IRB through the Director of the Office of Research and Sponsored Programs at 301-687-3101." Final Statement: The following should be the final statements of the informed consent form verbatim: "I have read and understand the explanation provided to me and have been given a copy of this consent form. I have had all my questions answered to my satisfaction, and I voluntarily agree to participate in this study." Signatures: The informed consent must be signed and by both the participant and the principal investigator or authorized representative. Page Numbering: Consent forms with more than one page should be initialed and dated by the participant on each page and the pages should be numbered like this: "page 2 of 3" Please see http://www.frostburg.edu/admin/orsp/irb-informedconsent/ for other important required elements that pertain to specific situations. 8. Supporting Documents: Include all relevant supporting documents, interview questions, surveys, letters sent to recruit participants, questionnaires completed by participants, and any other material germane to human subjects review in separate documents. SIGNATURE ASSURANCE SHEET Principal Investigator/Student Assurance Statement I understand Frostburg State University’s policy concerning research involving human participants and I agree: To obtain prior approval from the Institutional Review Board before beginning this research study; To accept responsibility for the scientific and ethical conduct of this research study: To obtain prior approval from the Institutional Review Board before amending or altering the research protocol or implementing changes in the approved consent form: To immediately report to the IRB any adverse reactions and/or unanticipated effects on participants which may occur as a result of this study; To complete, on request by the IRB, the Review Forms. SIGNATURE: ___________________________DATE: ___________________ TYPED NAME: ___________________________________________________ Faculty/Research Advisor’s Assurance Statement: