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- Title: IRB Application Fall 07
- Type: Notes
- School: Winthrop
- Course: SOCL 516
- Term: Fall
09/21/2007 IRB 1 of 6 IRB # TO BE COMPLETED BY SPAR Winthrop University REQUEST FOR REVIEW OF RESEARCH INVOLVING HUMAN SUBJECTS Institutional Review Board Complete form on-line, print one copy and obtain necessary approvals. Submit the approved request along with related survey documents, informed consent agreement, parental/guardian permission forms, and assent forms to the Director, Sponsored Programs and Research (Rm. 149 McLaurin Bldg). Also submit all documents electronically as an email attachment to the Director, Sponsored Programs and Research [justicet@winthrop.edu]. RESEARCHER of RECORD:Jeannie Haubert Weil COLLEGE/DEPARMENT:Sociology PHONE NUMBER: HOME:524-1599 WORK: 323-4293 EMAIL:weiljh@winthrop.edu CELL PHONE: ADDRESS:326 Kinard- Sociology, Rock Hill SC 29733 STATUS: $ Faculty or Staff (If a student, complete faculty advisor section) Graduate Student Undergraduate Student CO-RESEARCHERS: Blackwell, Brandon Derek Boyce, Emma Marie Davis, Nicholas Brett Frazier, Patricia DeAnne Gillespie, Samantha Marie Grubb, Ashley Danielle Hawkins, Jessica Nicole James, Brittany Arne' Pixley, Brittany Caprice Puhl, Rebecca Ann Romero, Katie Marie Story, Jennifer Lynn Twyman, Shardal Laytea Brown, Jason Theodore Deal, Brianna Elizabeth Dollard, Rhonda Eugenia Few, Ashley Ann Gibson, Ankia Chamari Gray, Korinne Marie Palm, Kathryn Elizabeth Roper, Paige Anita Shadbolt, Chad Charles Spencer, Kristian Michael FACULTY ADVISOR:Jeannie Haubert Weil ADVISOR PHONE: HOME:524-1599 WORK: 323-4293 EMAIL:weiljh@winthrop.edu CELL PHONE: ADDRESS:326 Kinard- Sociology, Rock Hill, SC 29733 TITLE OF RESEARCH: College Life: Views on Friendship, Diversity, and Campus Involvement DATES OF THE RESEARCH PROJECT: Approval Requested for Start Date: 11/16/2007 (The requested start date should be at least IRB 09/21/2007 2 of 6 2 weeks after the next scheduled meeting of the IRB) End Date: 12/16/2007 (Maximum of one year; must be renewed annually) IS THIS RESEARCH BEING FUNDED BY RESEARCH GRANT? YES; Sponsor: Funding Applied for; Sponsor: $ NO $ Yes No Is this activity being carried out by student as a classroom assignment to be reviewed by the faculty member. $ Yes No Will the information gathered or developed in this activity be used in a presentation or publication outside of the classroom? 1. If you checked yes to both questions above, please explain how the information will be used outside of the classroom: This is a survey constructed by students under my supervision for a Social Research Methods class (SOCL 516). If the findings are worthwhile, my hope is that some of the students will present their findings at our regional meetings next April. INDICATE THE TYPES OF MEMBERS OF THE RESEARCH TEAM WHO WILL HAVE DIRECT CONTACT WITH HUMAN SUBJECTS: 2. $ FACULTY MEMBER STAFF MEMBER $ UNDERGRADUATE STUDENT GRADUATE STUDENT OTHER; SPECIFY: 3. A. BRIEFLY DESCRIBE THE PURPOSE OF THE RESEARCH IN NON-TECHNICAL LANGUAGE: The purpose of this research is to study college life. Within college life, we are specifically interested in four things. First, the extent to which college life provides a caring community for students, membership and involvement on campus, standards of respectability amongst students, and transcending stereotypes. While this is a broad range of interest, the topics are based on subsections of an ethnography we read for class that studied community life amongst men at a diner in Chigago. We are applying many of the theoretical ideas raised in that text to university life. B. DESCRIBE RESEARCH PROTOCOL OR METHODOLOGY TO BE USED: The participants will take part in an online survey. 4. EXPLAIN BRIEFLY BUT COMPLETELY WHAT TASKS OR ACTIVITIES THE SUBJECTS IN THIS RESEARCH WILL BE DOING [If a survey/questionnaire is to be used, state how many questions will be asked and the expected time to complete the survey]: IRB 09/21/2007 3 of 6 DESCRIBE SUBJECTS FOR THIS RESEARCH, INCLUDING A STATEMENT OF WHO WILL BE RECRUITED AND THE ANTICIPATED POPULATION SIZE: AllWinthrop University students taking classes this semester are eligible for recruitment. We estimate our sample size to be around 400 students. 5. DO YOUR SUBJECTS INCLUDE ANY OF THE FOLLOWING: Yes $ No Infants and children younger than 7 years? Yes $ No Institutionalized mentally impaired people? Yes $ No Students enrolled in your own classes? Yes $ No Students enrolled at Winthrop University? Yes $ No Prisoners? Yes $ No Other special populations? Specify - 6. DESCRIBE HOW SUBJECTS WILL BE RECRUITED FOR THIS RESEARCH: We will use probability samply to randomly select courses from the Fall course catalogue. We will contact the instructors of the selected courses and request permission to come to their class to invite their students to participate in the study. If granted permission, two students will go to the class with the following script: "Thank you professor ____ for allowing us to come into your class for a few minutes today. Our names are ____ and ____. We are sociology majors and are here to ask for your help with a research project we are conducting for class. You are part of a select group of students that we are inviting to give us their opinions on various aspects of life here at Winthrop. We are visiting today just make you aware that you will be getting an email from us in the next few days inviting you to complete a survey online. The email will have a link to the survey. This survey is created by students for students and should take you less than 10 minutes to complete, so we hope that you will consider participating. When you go online, there will be a consent document that will explain to you that your answers will be kept strictly confidential and will give you further details about the project before you decide whether to take the survey. You should not feel obligated in to take the survey, but we would very much appreciate it if you would take the time to go online to look over the consent document for more information. We know you are busy people, so in an ideal world we'd give you $10 or something for your time, but unfortunately we are broke students so we are just going to have to rely on our charm and your generosity! Again you don't have to complete the survey, but please take 1 minute to click on the link when you get it and read over the consent form, because we've put a lot of work into it and we think that this information will really go a long way in helping us understand the views and activities of the average Winthrop student. Are there any questions we can answer for you? Ok, please be on the lookout for an email titled "college life" and know that we really appreciate your and your professor's help with our project" At the end of the informed consent document, they will have the option to continue with the survey or exit the survey. We will ask professors if they'd be willing to give a small extra credit incentive for the printing out of the informed consent document, but participants would not have to complete the survey to get the extra credit. HOW WILL YOU ASSURE THAT PARTICIPATION OF THE SUBJECTS IS VOLUNTARY? CAN THE HUMAN SUBJECT BE DIRECTLY IDENTIFIED BY: (For any responses of yes indicate in the space provided how the subject s privacy will be protected.) Yes Yes $ No $ No $ No $ No $ No $ No 7. Name on Response form; Photograph: Television/VCR/DVD tapes: Audiotape: Coded Research Forms: Detailed Biographical Data: Informed Consent, Assent or Parental Permission forms: Other: 8a. Yes Yes Yes Yes Yes Yes $ No $ No IRB 09/21/2007 4 of 6 8b. If you checked yes to any item in 8a; then: Yes $ No Will personally identifiable data be shared with others outside of this research team? If you checked yes, please explain. THE RESEARCHER SHALL MAKE EVERY POSSIBLE ATTEMPT TO MAINTAIN CONFIDENTIALITY OF THE RESEARCH AND THE HUMAN SUBJECTS. IF FOR SOME REASON, THE RESPONSES, INFORMATION, OR OBSERVATIONS OF THE SUBJECT BECAME KNOWN TO PERSONS OTHER THAN THE RESEARCHERS, COULD THIS INFORMATION POTENTIALLY PLACE THE SUBJECT AT RISK OF: Yes Yes Yes $ Yes $ No $ No $ No 9. DAMAGE TO HIS/HER FINANCIAL STANDING? DAMAGE TO HIS/HER PRESENT OR FUTURE EMPLOYABILITY? CRIMINAL OR CIVIL LIABILITY? PSYCHOLOGICAL/EMOTIONAL PROBLEMS? No EXPLAIN ANY YES ANSWERS AND STEPS THAT HAVE BEEN TAKE TO MINIMIZE RISK: As with any study, there is always some risk of psychological or emotional reprecussions; however we have made every effort to minimize this risk through the wording of our questions. Nonetheless, we will provide contact information for on campus counselors should a participant experience emotional or psychological difficulties after taking the survey. ARE ANY OF THE TECHNIQUES LISTED BELOW INVOLVED IN THE RESEARCH? Yes $ No $ No $ No $ No MEDICAL INVASIVE PROCEDURES? NON-INVASIVE MEDICAL PROCEDURES? STRENUOUS EXERCISE? OTHER PHYSICAL TESTING 10. Yes Yes Yes EXPLAIN ANY YES ANSWERS AND STEPS THAT HAVE BEEN TAKE TO MINIMIZE RISK: 11a DESCRIBE HOW LEGALLY EFFECTIVE INFORMED CONSENT WILL BE OBTAINED AND ATTACH A COPY OF THE CONSENT FORM. IF MINORS ARE TO BE USED AS RESEARCH SUBJECTS, DESCRIBE PROCEDURES USED TO GAIN CONSENT OF THEIR PARENT(S, GUARDIAN(S), OR LEGAL REPRESENTATIVE(S). The consent form will be on the first page of the online survey. After reading the consent form, they will have the option to continue to the survey questions or exit the survey. 11b WAIVER OF SIGNED INFORMED CONSENT REQUIREMENT TO REQUEST A WAIVER OF A SIGNED INFORMED CONSENT, COMPLETE THE FOLLOWING: $ The only record linking the subject and the research would be the consent document, and the principal risk will be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject s wishes will govern; OR The research presents no more than minimal risk of harm to the subjects, and involves no procedures, for which written consent is normally required outside of the research context. In cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. STORAGE AND DISPOSAL OF DATA AND OTHER RESEARCH MATERIALS: 12. A. How and where will the data and other research material be stored until no longer needed? The data will be stored on a password protected website (surveymonkey.com). The website has been IRB 09/21/2007 5 of 6 encrypted so that all information is secure. We will download the files to be converted into SPSS readable files for data analysis; however it will not be possible to identify any individual participants from these data. Additionally, the list of courses selected in the sampling design will be kept in the primary researchers office (Dr. Weil) in a locked file cabinet. B. When will the disposal of data and research materials take place? 12/16/10 At a minimum, investigators must maintain research records for at least three (3) years after completion of the research. All records must be accessible for inspection and copying by authorized representatives of the IRB, any federal department or agency supporting the research, and sponsor, if any. (Source: 45CFR46.115) If the Principal Investigator is a student, then the faculty advisor will be responsible for the record retention. If you are a member of a professional association or society, you may be required by their practices to keep records longer than 3 years. C. How will data and research materials be disposed ? The electronic files will be erased and the list of courses selected will be shredded. 13. INDICATE ON THE CHECK LIST BELOW, ANY DOCUMENTS THAT APPLY TO YOUR RESEARCH AND ATTACH TO THIS PROTOCOL A COPY OF THE APPLICABLE DOCUMENT. $ SURVEY INSTRUMENT AND/OR INTERVIEW QUESTIONAIRE INFORMED CONSENT AGREEMENT PARENTAL OR GUARDIAN PERMISSION FOR A MINOR CHILD TO PARTICIPATE IN A RESEARCH STUDY ASSENT TO PARTICIPATE IN A RESEARCH STUDY (AGES 7-14 YEARS) ASSENT TO PARTICIPATE IN A RESEARCH STUDY (AGES 15 17 YEARS) COPIES OF ANY OTHER MAIL TO BE DELIVERED TO RESPONDENTS OR SUBJECTS (E.G. COVER LETTERS, SCRIPTS OF VERBAL INSTRUCTIONS, ETC. $ 14. a. Yes $ No DO YOU CONSIDER THIS RESEARCH EXEMPT FROM REVIEW BY THE HUMAN SUBJECTS COMMITTEE? IF YES, Please check the reason for exemption from the list below: b. c. d. e. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies; or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods [45CFR46(b)(1)] Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior, unless a research subject will be under 18 years of age or (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; or (b) any disclosure of the human subjects responses outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects financial standing , employability or reputation. [45CFR46(b)(2)] Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior if (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statute(s) without exemption that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. [45CFR46(b)(3)] Research involving the collection study of existing data, documents, records, pathological specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. [45CFR46(b)(4)] Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine; (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in methods or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs. [45CFR46(b)(5)] IRB 09/21/2007 6 of 6 Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed; or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. [45CFR46(b)(6)] f. Certifications By my signature below, I certify that each of the named co-researchers has accepted his/her role in this study. I agree to not begin any research activity on this study until written approval by the IRB has been received. I agree to a continuing exchange of information with the Institutional Review Board (IRB). I agree to obtain IRB approval before making any changes or additions to the project. I will provide progress reports at least annually, or as requested. I agree to report promptly to the IRB all unanticipated problems or serious adverse events involving risk to human subjects. A copy of the informed consent will be given to each subject and the signed original will be retained in my files, unless a waiver of a signed informed consent has been granted. I further certify that I have successfully completed the following Human Subjects Training Course: CITI Biomedical Research Investigator $ CITI Social and Behavioral Research Investigator CITI Undergraduate Researcher CITI IRB Member ____________________________________________________________ Signature of Researcher _______________________ Date By my signature below, I certify that I have reviewed this research study and agree to counsel the student researcher in all aspects of the research study. I further certify that I have successfully completed the following Human Subjects Training Course: CITI Biomedical Research Investigator $ CITI Social and Behavioral Research Investigator CITI IRB Member ____________________________________________________________ If Student Researcher; Signature of Faculty Advisor _______________________ Date Approval by Department Chair of Researcher of Record (Dean, if Chair is the Researcher or if Chair is otherwise unable to review.) I have reviewed this research study. I believe the research is sound, that the study design and methods are adequate to achieve the study goals, and that there are appropriate resources (financial and otherwise) available to the researcher. I support the study, and hereby submit it for further review by the IRB. _____________________________________________________________ Signature of Department Head or Dean _______________________ Date Note: Do not use personal home addresses and phone numbers on Informed Consent, Assent, Parental Permission or Debriefing statements.
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