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1 \APPLICATION FOR INITIAL REVIEW APPROVAL OF A PROJECT INVOLVING HUMAN SUBJECTS Biomedical, Health Sciences Institutional Review Board (BIRB) Social Science, Behavioral, Education Institutional Review Board (SIRB) 207 Olds Hall, Michigan State University East Lansing, MI Phone: (517) Fax: (517) irb@msu.edu Office Hours: M-F (8:00 A.M.-5:00 P.M.) IRB#: X ID# i a. Responsible Project Investigator: Name: Natasha Speer ID#: XXX-XX-1070 Department: DIVISION OF SCIENCE AND MATH EDUCATION College: NAT SCIENCE Academic Rank: Assistant Professor Mailing Address: 211 N. Kedzie Hall Phone: Fax: nmspeer@msu.edu 1b. Secondary Investigator: Name: ID#: Department: College: Academic Rank: Mailing Address: Phone: Fax: 1c. Additional Investigators: 1/8

2 Kimberly Rogers Aaron Brakoniecki 1d. Other Personnel: 1e. Person Preparing Document: 2. Study Coordinator: Name: ID#: Department: College: Academic Rank: Mailing Address: Phone: Fax: 3. Title of Project: A study of students understanding of lines in Euclidean and non-euclidean spaces 4. Have you ever received preliminary approval or a 45 CFR designation for this project? 5. Category of Review EXEMPT 1. Clinical studies of drugs and medical devices when neither an IND or IDE is required. 2. Collection of blood samples from healthy, non-pregnant adults or other adults. 3. Prospective collection of biological specimens for research purposes by noninvasive means. 4. Collection of data through noninvasive procedures routinely employed in clinical practice. 5. Research involving materials that have been collected, or will be collected for nonresearch purposes. 6. Collection of data from voice, video, digital, or image recordings made for research purposes. 7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, or quality assurance methodologies Is this project being conducted to fulfill the requirements of an education/training Other In- 2/8

3 program? (a) Please describe. Training Research Project The project will initially be used for coursework in SME 997: Topics in Math Ed. It may subsequently be used for other courses, conference presentations or papers. 7a. Funding: 7b. The protection of human subjects often requires resources be dedicated for things such as the consent process (space, personnel), the performance of the research (trained personnel interacting with subjects, time, access to subjects, access to facilities) care of subject issues or injuries (counseling, medical care), confidentiality of data (space, equipment) and other monetary and non-monetary resources. Describe the resources that are available for this project for the protection of human subjects. The consent process will be done by the secondary investigators as part of their work in SME 997. A consent form will have to be signed by the subjects before the data is collected to make the student eligible for participation. The data collected will be kept confidential. The data collected will not identify the student from which it was collected, other than to members of the research team. The audiotapes will be stored in the office of the secondary investigator. Electronic data will be stored on a computer accessible by password. 8a. List all sites where this research will be conducted. Offices or classrooms on MSU campus. 8b. Do any of these sites have their own IRB? 8c. Will employees or agents of non-msu organizations (e.g. schools, companies, hospitals) be involved in the research? 8d. Will MSU units (e.g. Department of Radiology, Biomedical Research Informatics Core (BRIC), Department of Psychology) outside the control or supervision of the investigator be involved in the conduct of the research? 8e. Are any of these sites international? 9. Do you have any related project that were approved by an MSU IRB? 10. Have you or will you submit this to any non-msu IRBs? 11. Is another institution(s) relying on MSU's IRB as the IRB of record? 12. Are you using an FDA approved drug/device/diagnostic test? 13. Does this project involve the use of biological products, color additives, food additives, human drugs, medical devices, foods, infant formulas, dietary supplements, or nutritional supplements? 14. Has this protocol been submitted to the FDA or are there plans to submit it to the FDA? 3/8

4 15a. Does this project involve the use of materials of human origin (e.g. human blood, tissue, or cell lines)? 15b. Will there be any use of radioactive materials and/or use of radiation producing machines? 15c. Will this project involve human embryos? 15d. Have you or will you be registering this project with 15e. Have you or will you be committed to complying with ICH-GCP? 16. Research Category Education Research Yes Gene Transfer Research Yes Clinical Trial Type Survey/Interview Surgical Yes Fetal Research Yes Therapeutic Audio/Video Recording Yes Medical Records Yes Prevention Oral History Internet-based Yes Yes Stem Cell Research Medical Imaging Yes Yes Other Investigator Initiated Analysis of Existing Data Yes Oncology Yes International Research Yes Clinical Research Yes Other Yes Clinical Trial Phase Phase I Phase II Phase III Phase IV 17. Project Description (Abstract) The mathematical concept of straight is a fundamental concept in geometry that is frequently addressed inadequately by textbooks and teachers because it is assumed to be obvious. However, when addressing geometries in non-euclidean spaces, understanding the mathematical concept of straight can present challenges unless the concept has been well-defined by students in their studies of Euclidean spaces. Discussions with past teachers of geometry have indicated that a thorough understanding of the mathematical concept of straight is important for successful understanding of non-euclidean topics. The questions the project will attempt to answer through the data derived are: i) How do students think about straight lines in the plane? ii) How do students think about straight lines on a sphere? iii) How does thinking about the symmetries of straight lines affect students ability to understand and define straight lines? iv) How do students definitions of the mathematical concept of straight in the Euclidean space impact their definition of straight on the sphere? 18. Procedures The secondary investigators will conduct interviews with participants. The interviews will be audio recorded and all written work will be collected. Participants will be recruited from TE 802 Section 19 and the graduate students in the MSU Mathematics Department.. Participants will be asked to discuss their thinking while working on some tasks that will elicit their understanding and definitions of the mathematical concept of straight. All audio recording will be transcribed for analysis. Written work and transcriptions will be analyzed for degrees of understanding of both Euclidean and non-euclidean concepts of straight. They will also be analyzed for their breadth and depth of different ways of understanding the mathematical concept of straight. 19. Does your investigation involve incomplete disclosure of the research purpose or 4/8

5 deception of the subjects? 20a. Subject Population Undergraduate students of TE 802 Section 19 and graduate students who are in the Mathematics Department at Michigan State University. 20b. Age range of subjects 18 to 80 20c1. The following study populations will be purposely included in the research: Minors Pregnant Women Women of Childbearing Age Institutionalized Persons Students Low Income Persons Minorities Prisoners HIV/AIDS Individuals Psychiatric Patients Incompetent Persons Wards None of These 20c2. Will some or all of the subjects likely be vulnerable to coercion or undue influence? 20c3. Will some or all of the subjects be prisoners (i.e. involuntarily confined or detained in a penal institution)? 20c4. Will the research be conducted in the Federal Bureau of Prisons (i.e. Federal Prison System)? 20d. Total expected number of subjects (including controls) for the entire project period 10 20e. Provide the rationale for your sample size. In this exploratory research, we will be studying as many participants as possible from our subject population. The small number is sufficient to pilot the instruments and begin to analyze notation and student understanding. 20f. Describe the criteria for the inclusion of subjects. Students enrolled in TE 802 Section 19. Also graduate students who are in the Mathematics Department. The secondary investigators will approach in person graduate students in the Mathematics Department and will make an announcement in the classroom of TE 802 Section 19 to seek participants for the study. 20g. Describe the criteria for the exclusion of subjects. Any participants who are minors will not be included in the research. 20h(1). How will the subjects be identified, recruited and enrolled? Include who will make initial contact with the subjects, who will recruit the subjects, and who will enroll the subjects. The secondary investigators will invite TE 802 section 19 students to participate in the study during a class meeting or via . The secondary investigators will also invite Mathematics Department graduate 5/8

6 students to participate via or in person. 20h(2). Will an advertisement be used? 20i. Are you associated with the subjects? 20j. Will someone receive payment for recruiting the subjects? 20k. Will the research subjects be compensated? 20l. Will the subjects incur additional financial costs as a result of their participation in this study? 20m. Will this research be conducted with subjects in another country? 20n. Will this research be conducted with subjects in the U.S. from an ethnic group of subgroup or other non-mainstream minorities (including non-english speakers)? 20o. Will student education records that directly relate to a student be accessed? 20p. Will any subjects be recruited from MSU Health Team clinics? 20q. Will any subjects insurance be billed as part of this project? 21a. Risks and Benefits for subjects: Describe and assess any potential risks (physical, psychological, social, legal, economic) and assess the likelihood and seriousness of such risks. The known risks are very low. A participant might feel psychological stress or anxiety by not knowing how to answer a math question or by recognizing their own words in publication. There are no other known risks. 21b. Describe procedures for protecting against or minimizing potential risks and provide an assessment of their likely effectiveness. During the interview, the secondary investigators will reassure participants that they are not looking for a right answer, just how they think about the mathematical concept of straight lines. 21c. Assess the potential benefits (if any) to be gained by the subjects in this study, as well as benefits which may accrue to society in general as a result of the planned work. The subjects may gain some additional understanding of what it means for a line to be straight in the plane and on a sphere. Society in general may benefit by the improvements made to the education of future teachers, which will enhance future geometry courses. 22a. How will the subject's privacy be protected? Include a description of who will be interacting with the subjects or accessing and abstracting data from the subject's records (academic, medical, etc.) and where the study will take place. For example, will individuals not associated with the research study be present during the consent process and the conduct of the study? All identifying information from student s scratch-work during the interview will be stripped before analysis takes place. All work will be given an ID code so that work (written and transcriptions) of individuals can be matched together. All names will be changed for publication. Only the investigators will be interacting with subjects, accessing and analyzing the data. The study will take place in classrooms and offices on the Michigan State University campus. The instructor of TE 802 Section 19 will be present during the announcement inviting participants but the consent process (where students decide whether or not to participate) will take place without the instructor being present. The instructors will not know which students are participating and which are not. 22b. Where will the data be stored and for how long? 6/8

7 The audiotapes and videotapes will be stored in locked cabinets in the office of the secondary investigator. The electronic files from digital audio recorders and student work will be kept on the researchers computers and/or the course Angel site under passwords known only to the investigators. Data will be stored until all analyses are complete and any presentations or publications of the findings are complete (approximately two years). 22c. Who will have access to the research data? Only project investigators. 22d. How will you ensure the confidentiality and/or anonymity of the research data? Include a description of the procedures and safeguards you will use, including if identifying information will be stored with the data. All identifiers (i.e., names, random comments that could make it possible for someone to figure out who they are, etc.) on written work and transcripts will be stripped before analysis takes place. The participants will be given pseudonyms in the reporting of the study. Each participant will be assigned an ID code so that their names are not being used in the analysis of the data. Participant names will be removed from files and only the ID number will be used during the analysis of the data. 22e. Is it appropriate for your research to have a monitoring plan to periodically assess the data to ensure the safety of subjects or to ensure negative outcomes do not occur (e.g., ongoing study of domestic abuse, clinical trial, full board projects)? 23. Does this project involve protected health information as defined by HIPAA? 24. (a) Select appropriate consent option. Approval of a consent form and process (b) Consent Procedures: During the recruitment phase, the secondary investigators will inform potential participants that the study is investigating how students understand the mathematical concept of straight. They will also be informed that participation is voluntary and that they will be asked to answer questions about their definition of a straight line in Euclidean and non-euclidean Geometry while being audio taped. It will be emphasized that participation or non-participation will have no effect on their grade in their respective courses. During the consent process, the recruitment phase comments will be repeated and the attached consent form will be read to them. Any questions participants have will also be addressed. (b)(2)will the subject or legally authorized representative sign a consent document(s)? 25a. Does any person responsible for the design, conduct, or reporting of findings of this protocol have a Significant Financial Interest (as defined for the MSU Faculty Conflict of Interest Policy) or other opportunity for tangible personal benefit related to the conduct of the research that might compromise, or reasonably appear to compromise, the independence of judgment with which their responsibilities would be completed under this research protocol? A reportable financial interest includes, but is not limited to, a financial interest in the sponsor, product, or service being tested, or in a competitor of the sponsor or product or service being tested. 25b. Has any financial arrangement, including compensation, ownership interest, stock options, or other ownership interest, (e.g., compensation that is: explicitly greater for 7/8

8 a favorable result; in the form of an equity interest in the sponsor of a covered study; or in the form of compensation tied to sales of the product, such as a royalty interest) been established whereby the value of compensation or ownership interest to investigators conducting the study could be influenced by the outcome of the study? 25c. Is this a clinical study where the results may be used to support marketing applications for new human drugs and biological products and marketing applications and reclassification petitions for medical devices to the FDA, as required by law? 25d. Have you or will you submit an FDA form 3454 or 3455 (Conflict of Interest)? 25e. Are you aware of any individual who has a financial interest which may create an organizational conflict of interest? 26a. When would you prefer to begin this project? 11/5/ b. Estimated duration of project (including identifiable data analysis): 2 years ADDITIONAL DOCUMENTS/ATTACHMENTS /26/2007 Consent Form (i028984_ _consent_form_2nd_draft.pdf) Protocol (i _ _Interview_Protocol_2nd_Draft.pdf) COMMENTS COMMENT AFTER REVIEW / EDIT BY IRB STAFF (Viewable by PI) PI RESPONSE 8/8

IRB#: x ID# i036148

IRB#: x ID# i036148 SU IRB - Application - Initial of 9 10/3/2014 10:41 AM \APPLICATION FOR INITIAL REVIEW APPROVAL OF A PROJECT INVOLVING HUMAN SUBJECTS Biomedical, Health Sciences Institutional Review Board (BIRB) Social

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