Irb compliance

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Irb compliance

  1. 1. Writing Program IRB Compliance Information for faculty about student-conducted research involving human participants March, 2009
  2. 2. Introduction <ul><li>The Institutional Review Board (IRB) at the University of Denver (DU) is responsible for protecting the rights and safety of individuals participating in research projects that involve human participants. </li></ul><ul><li>The following PowerPoint is divided into three sections: </li></ul><ul><ul><li>Writing Program IRB Compliance </li></ul></ul><ul><ul><li>IRB oversight: what’s covered/what’s not </li></ul></ul><ul><ul><li>Resources for faculty </li></ul></ul>
  3. 3. WRIT IRB COMPLIANCE
  4. 4. WRIT IRB Compliance <ul><li>In 2009, the IRB approved the Writing Program’s proposal that student-conducted research projects in WRIT classes involving human subjects be classified exempt. </li></ul><ul><li>This compliance means that as long as student-conducted research abides by certain guidelines the following applies: </li></ul><ul><ul><li>Students conducting fieldwork research, including observation, interviews, and surveys in 1122, 1133, 1622, 1633, and 1733, do not have to get separate IRB approval to conduct that research. </li></ul></ul><ul><ul><li>You, as instructor, do not have to complete an IRB application nor have your students complete a Class Project Form for each class project involving fieldwork research. </li></ul></ul>
  5. 5. WRIT IRB Guidelines 3 Parts <ul><li>Part 1: Student-conducted research is limited to confidential interviews and observations, and anonymous surveys of 100 or fewer participants. </li></ul><ul><li>Part 2: Student-conducted research cannot specifically target or ask questions about certain participant behaviors or traits. </li></ul><ul><li>Part 3: Students should be given the IRB Introduction and Research Limitation handout. Surveys must include the pre-approved statement about a participant’s right to refuse to respond to the survey and of his/her right of anonymity. Interviewed participants must sign a pre-approved statement about a participant’s right to refuse to respond and his/her right of confidentiality. </li></ul>The IRB Introduction and Research Limitations along with anonymity and confidentiality statements can be found at the Writing Program’s Portfolio at http://portfolio.du.edu/writng
  6. 6. WRIT IRB Guidelines Part 1 <ul><li>Student-conducted research is limited to confidential interviews and observations, and anonymous surveys of 100 or fewer participants. </li></ul><ul><li>Thus, students cannot do experimental/quasi-experimental research that involves the following: </li></ul><ul><ul><li>Deception of participants </li></ul></ul><ul><ul><li>Shock or other forms of punishment </li></ul></ul><ul><ul><li>Handling of money or other valuable commodities </li></ul></ul><ul><ul><li>Extraction of blood or other bodily fluids </li></ul></ul><ul><ul><li>Purposeful creation of anxiety </li></ul></ul><ul><ul><li>Physical exercise or stress </li></ul></ul><ul><ul><li>Administration of substances to participants </li></ul></ul><ul><ul><li>Compensation to participants </li></ul></ul><ul><ul><li>Any procedure that might place subjects at risk </li></ul></ul>
  7. 7. WRIT IRB Guidelines Part 2 <ul><li>Student-conducted research cannot specifically target or ask questions about certain participant behaviors or traits. </li></ul><ul><li>Students cannot do field research specifically targeting any of the following: </li></ul><ul><ul><li>Participants under 18 years of age </li></ul></ul><ul><ul><li>Physically or mentally disabled participants </li></ul></ul><ul><ul><li>Participants unable to provide their own legal informed consent </li></ul></ul><ul><ul><li>Pregnant females </li></ul></ul><ul><ul><li>Subjects in institutions (e.g., prisons, nursing homes, halfway house) </li></ul></ul><ul><ul><li>Sexually explicit materials or questions </li></ul></ul><ul><ul><li>Questions about drug use </li></ul></ul><ul><ul><li>Questions about illegal behavior </li></ul></ul><ul><ul><li>Questions about suicidal thoughts or ideas </li></ul></ul><ul><ul><li>Questions about sexual orientation, sexual experience, or sexual abuse </li></ul></ul>
  8. 8. WRIT IRB Guidelines Part 3 <ul><li>Surveys must include the pre-approved statement about a participant’s right to refuse to respond to the survey and of his/her right of anonymity. Interviewed participants must sign a pre-approved statement about the participant’s right to refuse to respond and his/her right of confidentiality: </li></ul>By completing the following questions, you are also granting consent for this information to be used as part of a research exercise that I am completing for my WRIT class at the University of Denver.  Your participation is completely voluntary.  The information you provide may be used in a class project.  While profile information may be included in my writing project (i.e. your age, gender, class standing, etc.), your name will NOT be used. If at any time you do not want to answer a question, you do not have to. By signing on line &quot;a&quot;, you are granting consent for this information to be used as part of a research exercise that I am completing for my WRIT class at the University of Denver. Your participation is completely voluntary. The information you provide may be used in a class project. By signing on line &quot;a&quot;, you acknowledge that your identity and the identity of the organization will remain confidential and will be known only by me and my professor.    a. _____________________________________ ______________ (signature) (date)   _____________________________________ (phone / email)
  9. 9. IRB OVERSIGHT: WHAT’S COVERED
  10. 10. Definitions <ul><li>Research is defined as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” ( 45CFR46.102(d) ) </li></ul><ul><li>A human subject is defined as &quot;a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.&quot; ( 45CFR46.102(f) ) </li></ul>
  11. 11. What “research” means for WRIT student-conducted research <ul><li>Research leading to “generalizable knowledge” </li></ul><ul><li>At DU, “generalizable knowledge” constitutes all research of human subjects by students that extends beyond the classroom including pilot studies, focus groups, questionnaires, observations, interviews and oral histories, whether in class or published outside the class. </li></ul><ul><li>This is subject to interpretation by each university IRB. Some universities interpret this to mean only research published outside the classroom; thus, why DU’s interpretation of §46.102 may be different than another institution’s interpretation. DU’s interpretation is why the writing program applied for the WRIT exempt research compliance. </li></ul>
  12. 12. What “human-subjects” means for WRIT student-conducted research <ul><li>“ a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” </li></ul><ul><li>The key phrase in this definition is “ about whom ”; it means that “human subjects” specifically applies only to research that asks about participants’ attitudes, beliefs, traits, behaviors, or values. </li></ul><ul><li>According to the Collaborative Institutional Training Initiative [IRB training course for students and faculty], “Information-gathering interviews where questions focus on things, products, or policies rather than about people or their thoughts regarding themselves are not human subjects research. Example: canvassing librarians about inter-library loan policies or rising journal costs” (Cho and Rose). </li></ul><ul><li>Thus, for formal or informal interviews that students conduct in which they are not asking about or revealing personal information, they are not subject to IRB (although, they should abide by general research ethics). </li></ul>
  13. 13. What this means for WRIT courses <ul><li>Journalistic assignments such as features or reporting that might involve interviews by named or unnamed sources about things, phenomena or occurrences are not considered research of human subjects. </li></ul><ul><li>Observations of public behavior that do not name individuals are not considered research of human subjects. </li></ul><ul><li>Research activities or lessons (e.g. interviews, observations, surveys) that you or your students conduct in-class and are not reported or conducted outside of the classroom are not considered research of human subjects. </li></ul><ul><li>All other research consisting of organized study of human participants’ observable or reported attitudes, beliefs, behaviors, values, traits is subject to IRB oversight. Because each university IRB interprets the federal guidelines differently, only refer to resources from DU’s IRB/ORSP website or the DU’s Writing Program’s IRB Compliance. </li></ul>
  14. 14. Further Options <ul><li>If you or your students have a project that would not work under the Writing Program’s IRB compliance, there are three options available: </li></ul><ul><li>Option 1: If all students are following the same protocol (e.g. interview questions, questionnaire/survey), you can apply for Class Project IRB Approval by completing IRB training and a submitting an IRB application for the assignment. This should be completed before the term begins. </li></ul><ul><li>Option 2: If students are following different protocols for the same assignment , you can apply for Class Project IRB Approval and each student conducting the research will complete the Class Project Approval Form . Your application should be completed before the term begins; the students can fill the form out before they conduct the project. </li></ul><ul><li>Option 3: If students are doing independent projects that do not meet the writing program’s IRB compliance guidelines, the student can submit their own application to IRB—the student will have to complete IRB Basic/Refresher course training via CITI , apply for eprotocol access , complete an eprotocol application for the research project, and wait to conduct research until the application has been reviewed by IRB. </li></ul>
  15. 15. RESOURCES
  16. 16. Resources <ul><ul><li>DU IRB (OSRP) – DU IRB website (part of the Office of Research and Sponsored Programs) </li></ul></ul><ul><ul><ul><li>History of the IRB – This DU, web-accessible Flash animation provides a history of IRB and research ethics and can be a helpful introduction for students. </li></ul></ul></ul><ul><ul><ul><li>Classroom research – The process and requirements for student-conducted research at DU outside the WRIT IRB Compliance guidelines. </li></ul></ul></ul><ul><ul><li>OSRP (Mary Reed 222) </li></ul></ul><ul><ul><ul><li>Sylk Sotto-Santiago , research compliance manager, IRB (OSRP) </li></ul></ul></ul><ul><ul><ul><li>Susan Sadler , Chair, IRB (OSRP) </li></ul></ul></ul><ul><ul><li>Writing Program (Penrose 202) </li></ul></ul><ul><ul><ul><li>Richard Colby , Writing Program IRB liaison </li></ul></ul></ul><ul><ul><ul><li>Douglas Hesse , Director, Writing Program </li></ul></ul></ul>

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