Transcript Slide 1
University of Maine ENG 317: Business & Technical Writing © 2012 Charlsye Smith Diaz, Ph.D. Well, Let’s just that’s a call it the mouthful. IRB The IRB oversees research on campus. The goal of the IRB is to make sure humans are safe. The federal government requires UMaine to If we do not follow the rules, the university risks losing federal funding. have an IRB and to specific laws This class was designed in part withfollow federal funds, so losing funding could mean losing resources related to to offer courses online. research. The IRB is a government response to research handled very Nazi researchers conducted involuntary experiments on unethically. For example, the U.S. conducted research on black humans, as depicted here. males with syphilis from the 1930s to the early 1970s. and before that… Source: http://humanitiesandhealth.wordpress.com/2010/10/05/clintondelivers-formal-apology-for-a-newly-discovered-tuskegee-like-study/ Source: http://weimarinflation.wordpress.com/sources/ Have you ever: Participated in a PSY 101 project? Gone to a “potato tasting” on campus? Taken a survey for someone doing research for class? Filled out a course evaluation? You are a researcher in ENG 317 so these rules apply to you. All surveys are governed by the IRB, so following the rules is required. Students, employees, and agents of the University who conduct research involving human subjects must comply with the University Policy and Procedures for the Protection of Human Subjects of Research. These procedures exist for the rights and welfare of the people who participate in UMaine research. No systematic investigation of information obtained by observing or interacting with people, or by collecting and examining any form of identifiable private information about people, may be conducted until the Protection of Human Subjects Review Board has approved the research protocol. Application Form for Approval of Research with Human Subjects: The application form for requesting approval from the IRB for research with human subjects. (Last update 10/2009.) Continuing Review Instructions: For currently approved (non-exempt) studies. Deadlines: The deadline for submitting applications for approval is the first Friday of the month. Exemption Categories: Listing of research activities that may be exempt from further review. Expedited Review Categories: Categories of research that may be reviewed by the IRB through an expedited review procedure. Graduate School Policy: Graduate students and faculty advisors, please read section 10.2.3 (page 38) Human Subjects Approval (PDF), from the Graduate School’s Policies and Regulations. Guidelines for Class Projects: These guidelines are intended to assist instructors in determining when class projects meet the definition of research with human subjects and require review by the University of Maine’s Institutional Review Board for the Protection of Human Subjects (i.e., IRB). Please see flow chart to assist with the decision-making process. (Last update 11/2009.) Sample of a course syllabus addressing class projects (used with permission). Information about Oral History Activities: Information to assist individuals in determining when/if oral history activities require human subjects review. Informed Consent Information and Sample Document: Information about the informed consent process, requirements, and a sample document. (Last update 11/2009) Internal Institutional Data Collection Guidelines: Membership: Current membership listing. Policy Concerning the Protection of Human Subjects of Research: All persons involved with human subjects research should read this Policy. (Last update 10/2009.) Request for Student Data for Use in Research Project: If a researcher proposes a project using student records (non-directory information, e.g., email addresses, SAT scores, grades, majors, etc.) approval for use of such data must be obtained from the Office of Student Records. This form must be completed and submitted to the Office of Student Records. Required Training: All personnel named in an existing or new “Application for Approval of Research with Human Subjects” must complete a webbased tutorial on the protection of human subjects. The training is valid for four years from the date of completion. Useful websites: Links to federal policy, guidelines, resources, etc. What is HIPAA?: HIPAA is the Health Insurance Portability and Accountability Act. If investigators gather, generate, access, or share subjects’ personal health information, the research may be subject to the Privacy Rule (a Federal regulation under HIPAA). Ummmm…..are you thinking that’s too much to read and the font is too small and you just want to click to the next screen? Then go for it…click on… The IRB has given us special permission to do research without approval if we stay within certain guidelines. If your ENG 317 survey might become part of an honors thesis or your senior capstone research, talk to your instructor. You may need to go through the entire process. For the guidelines we must follow… The guidelines are on the IRB handout and focus on three areas: Who Can Be Surveyed Subjects that are Off-Limits Informed Consent Requirements Children/Minors (under the age of 18) Prisoners (now includes non-publicly available secondary data) Pregnant women People with diminished capacity to give consent Mentally or physically challenged individuals Fetuses and products of labor and delivery The IRBmeans considers This you these vulnerable cannot survey the populations 17-year-old and firstrequire IRB in year student oversight. your biology class. You approach people over the age of 18 only You identify the project to participants as a class assignment, not as university research You inform participants that data will be destroyed after their assignment or class project is completed The data does not contain any personal, identifying information an individual’s psychological well being or mental health sexual attitudes, preferences, or practices Sure, researchers ask questions the use of alcohol or drugs about these things all the time, but illegal behavior the researchers take time IRB could approval forplace the Information to thatgain if released reasonably individual at risk of criminal or civil liability or be damaging their research and employability, the IRB or to the individual’s financial standing, reputation oversees these projects. Information that would normally be recorded in a patient’s medical record and the disclosure could reasonably lead to discrimination, stigmatization, etc. Decide whether the following situations would be permitted or not permitted under IRB guidelines. Click anywhere to begin. No, having in residence halls is Skipping class is the legal, so at a first Have you pets heard of cyberbullying? Yes, this survey is fair. You aare asking No, this survey will with not provide fair against the rules. Asking people to talk is Yes. This survey starts the bias that happiness YES – you can ask this question. glance, this survey seems fair, how No. Questions often a student about alcohol skips class. are off assessment of UMaine students’ plans, unless related their to goingbehavior to church,might which could me in construed about result objective, and within IRB policies. Have you ever athe victim ofpurposes limits. you limit your to your fraternity rather in very specific orstudy verybeen general ways. For the I heard want to study how often I think people are much I a lot of people students being evicted from their rooms. My team is studying But the questions lead to potential of thisseniors study, would synagogueIdea or mosque be the cyberbullying? Project than in general. people skip class. I plan to happier ifI want they go to church to have a have pets in the residence ENG 317 surveys do not ask about illegal cyberbullying. I am curious Canabout we ask equivalent to church? answers from the categories of NO – This question asks about illegal You might Project read the Idea “FRESHMAN survey students to people find out Ihalls. want to know why once a week. I’msurvey going to campus-wide party with Imany plan to all behavior. these how questions seniors in our plan information we shouldIdea not askother about: behavior. Project ATTITUDES Lookwill oninterpret Uwire.com ABOUT GREEK and LIFE” how often they skip class skip class. I’m going to do a do a survey to find out if Survey takers the questions differently. alcohol. I plan to the people in my building survey: to leave MaineUse when your IRB Handout to help medical issues, psychological wellAHave great idea forto this survey project would be you ever been a cyberbully? websites SURVEY find information here: about Always pay attention to the bias wording can cause. and which days and times survey that asks for reasons students who go to church conduct a campus-wide to ask them if they have a Project Idea 1. Have theyyou graduate. heardyou ofI’m make sure being, alcohol use, sexual preferences, to find another survey about seniors planning NOyour – This question also asks build about skipping http://bit.ly/greeklifesurvey. class. Can you aillegal survey topic is they skip most. why people skip class. once a week are happier survey about students’ pet, what kind, and how You could survey students about whether Also, this question asks about psychological well being, cyberbullying? going to survey my to leave their states after graduation and then etc. behavior. based Consider on the repeating background a tiny information piece of thanlong those who don’t go to opinions of this idea. which is off limits to ENG 317. permitted under the UMaine they’ve they thinkstudents pets should be permitted inYou the 2. Have you fraternity. ever had beenit.a ask UMaine the same questions. Project Idea the survey, that and you compare find? UMaine Is this fair? Can you ask students church atsurvey all. why residence halls, and their on could compare surveys inopinions your report. victim of cyberbullying? IRB guidelines. Cyberbullying isthe a Project hot topic. To study thiswhat Idea freshmen’s attitudes to the attitudes skipCan class? yousurvey ask these of pets be what permitted. You can 3. Have Is this you ever been fair?a Akinds great idea for a should survey would be to find out topic, you could find project out people know Project Idea reported here. Does thisquestions? survey idea have nationally many seniors plan to leave their states find information about various university Here iscyberbullying. a how report about college cyberbully? about You could ask whether The Pew Internet &Michigan American Life any problems? to work andplans thenpet survey UMaine students to compare. students’ to leave the state policies here: people think certain situations areafter Project studies issues relevant to graduation: http://www.residentassistant.com/reslifepr cyberbullying. YouMichigan must work carefully college students Here is a report about college students: http://www.fsutorch.com/2011/09/28/opinio o/pets/listserves.htm when conducting surveys about this kind of http://www.fsutorch.com/2011/09/28/opinions/will(http://www.pewinternet.org/). Look ns/will-you-stay-after-graduation/ you-stay-after-graduation/ topic. for prior surveys you could repeat at UMaine and then compare the results. The IRB requires that we include an Informed Consent Statement when we write a survey. An informed consent statement “informs” the participant about the project and the participant “consents” to participating. Copy and revise the Informed Consent Statement on your IRB handout to fit your needs. Do not try to rewrite it or be creative. We will talk more about this requirement in 7.3. Read the Homework 7: Find a Topic worksheet/ assignment and continue to think about your topic. Move on to Slide Presentation 7.3