1. University of Maine ENG 317: Business & Technical Writing © 2012 Charlsye Smith Diaz, Ph.D.

2. Make notes on the Informed Consent Handout as you go through these slides.

3. Well, that’s a mouthful. Let’s just call it the IRB

4.  The IRB oversees research on campus.  The goal of the IRB is to make sure humans are safe.  The federal government requires UMaine to have an IRB and to follow specific laws related to research. What is the IRB? If we do not follow the rules, the university risks losing federal funding. This class was designed in part with federal funds, so losing funding could mean losing resources to offer courses online.

5. Because of experiments Americans conducted in the using black males with syphilis from 1930s-to early 1970s and before that… Nazi researchers conducted involuntary experiments on humans, as depicted here. Source: http://weimarinflation.wordpress.com/sources/ Source: http://humanitiesandhealth.wordpress.com/2010/10/05/clinton- delivers-formal-apology-for-a-newly-discovered-tuskegee-like-study/

6. 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? If you answer YES to any of these, then the IRB protects you.

7. The IRB wants to make sure researchers and their human subjects are safe. You are a researcher in ENG 317 so these rules apply to your work.

8. All surveys are governed by the IRB, so following the rules is required.

9.  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…

10.  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.) Application Form for Approval of Research with Human Subjects:  Continuing Review Instructions: For currently approved (non-exempt) studies. Continuing Review Instructions:  Deadlines: The deadline for submitting applications for approval is the first Friday of the month. Deadlines:  Exemption Categories: Listing of research activities that may be exempt from further review. Exemption Categories:  Expedited Review Categories: Categories of research that may be reviewed by the IRB through an expedited review procedure. Expedited Review Categories:  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.Human Subjects Approval (PDF)  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). Guidelines for Class Projects: flow chartcourse syllabus  Information about Oral History Activities: Information to assist individuals in determining when/if oral history activities require human subjects review. Information about Oral History Activities:  Informed Consent Information and Sample Document: Information about the informed consent process, requirements, and a sample document. (Last update 11/2009) Informed Consent Information and Sample Document:  Internal Institutional Data Collection Guidelines: Internal Institutional Data Collection Guidelines  Membership: Current membership listing. Membership  Policy Concerning the Protection of Human Subjects of Research: All persons involved with human subjects research should read this Policy. (Last update 10/2009.) Policy Concerning the Protection of Human Subjects of Research:  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. Request for Student Data for Use in Research Project  Required Training: All personnel named in an existing or new “Application for Approval of Research with Human Subjects” must complete a web- based tutorial on the protection of human subjects. The training is valid for four years from the date of completion. Required Training  Useful websites: Links to federal policy, guidelines, resources, etc. Useful websites  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). What is 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…

11.  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

12.  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

13. The IRB considers these vulnerable populations and require IRB oversight. This means you cannot survey the 17-year-old first- year student in your biology class.

14.  an individual’s psychological well being or mental health  sexual attitudes, preferences, or practices  the use of alcohol or drugs  illegal behavior  Information that if released could reasonably place the individual at risk of criminal or civil liability or be damaging to the individual’s financial standing, employability, or reputation  Information that would normally be recorded in a patient’s medical record and the disclosure could reasonably lead to discrimination, stigmatization, etc. Sure, researchers ask questions about these things all the time, but the researchers take time to gain IRB approval for their research and the IRB oversees these projects.

15. Decide whether the following situations would be permitted or not permitted under IRB guidelines. Click anywhere to begin. I think people are much happier if they go to church once a week. I’m going to do a survey to find out if students who go to church once a week are happier than those who don’t go to church at all. Does this survey idea have any problems? I am curious about how many seniors plan to leave Maine when they graduate. I’m going to survey my fraternity. Is this survey fair? I want to have a campus-wide party with alcohol. I plan to conduct a campus-wide survey about students’ opinions of this idea. I want to know why people skip class. I’m going to do a survey that asks for reasons why people skip class. Can you ask why students skip class? My team is studying cyberbullying. Can we ask these questions in our survey: 1.Have you heard of cyberbullying? 2.Have you ever been a victim of cyberbullying? 3.Have you ever been a cyberbully? I want to study how often people skip class. I plan to survey students to find out how often they skip class and which days and times they skip most. Is this survey fair? Have you heard of cyberbullying? YES – you can ask this question. Have you ever been a victim of cyberbullying? NO – This question asks about illegal behavior. Have you ever been a cyberbully? NO – This question also asks about illegal behavior. Project Idea Cyberbullying is a hot topic. To study this topic, you could find out what people know about cyberbullying. You could ask whether people think certain situations are cyberbullying. You must work carefully when conducting surveys about this kind of topic. Have you heard of cyberbullying? YES – you can ask this question. Have you ever been a victim of cyberbullying? NO – This question asks about illegal behavior. Have you ever been a cyberbully? NO – This question also asks about illegal behavior. Project Idea Cyberbullying is a hot topic. To study this topic, you could find out what people know about cyberbullying. You could ask whether people think certain situations are cyberbullying. You must work carefully when conducting surveys about this kind of topic. No, this survey will not provide a fair assessment of UMaine students’ plans, unless you limit your study to your fraternity rather than seniors in general. Project Idea A great idea for this survey project would be to find another survey about seniors planning to leave their states after graduation and then ask UMaine students the same questions. You could compare the surveys in your report. Here is a report about Michigan college students’ plans to leave the state after graduation: http://www.fsutorch.com/2011/09/28/opinio ns/will-you-stay-after-graduation/ http://www.fsutorch.com/2011/09/28/opinio ns/will-you-stay-after-graduation/ No, this survey will not provide a fair assessment of UMaine students’ plans, unless you limit your study to your fraternity rather than seniors in general. Project Idea A great idea for this survey project would be to find another survey about seniors planning to leave their states after graduation and then ask UMaine students the same questions. You could compare the surveys in your report. Here is a report about Michigan college students’ plans to leave the state after graduation: http://www.fsutorch.com/2011/09/28/opinio ns/will-you-stay-after-graduation/ http://www.fsutorch.com/2011/09/28/opinio ns/will-you-stay-after-graduation/ Yes, this survey is fair. You are asking how often a student skips class. Project Idea You might read the “FRESHMAN ATTITUDES ABOUT GREEK LIFE” SURVEY here: http://bit.ly/greeklifesurvey. Consider repeating a tiny piece of the survey, and compare UMaine freshmen’s attitudes to the attitudes reported here. http://bit.ly/greeklifesurvey Yes, this survey is fair. You are asking how often a student skips class. Project Idea You might read the “FRESHMAN ATTITUDES ABOUT GREEK LIFE” SURVEY here: http://bit.ly/greeklifesurvey. Consider repeating a tiny piece of the survey, and compare UMaine freshmen’s attitudes to the attitudes reported here. http://bit.ly/greeklifesurvey No, having pets in the residence halls is against the rules. Asking people to talk about their behavior might result in students being evicted from their rooms. ENG 317 surveys do not ask about illegal behavior. Project Idea You could survey students about whether they think pets should be permitted in the residence halls, and their opinions on what kinds of pets should be permitted. You can find information about various university pet policies here: http://www.residentassistant.com/reslifepr o/pets/listserves.htm No, having pets in the residence halls is against the rules. Asking people to talk about their behavior might result in students being evicted from their rooms. ENG 317 surveys do not ask about illegal behavior. Project Idea You could survey students about whether they think pets should be permitted in the residence halls, and their opinions on what kinds of pets should be permitted. You can find information about various university pet policies here: http://www.residentassistant.com/reslifepr o/pets/listserves.htm I heard a lot of people have pets in the residence halls. I plan to survey all the people in my building to ask them if they have a pet, what kind, and how long they’ve had it. Can you ask these questions? No. Questions about alcohol are off limits. Project Idea Look on Uwire.com and other websites to find information about skipping class. Can you build a survey based on the background information that you find? No. Questions about alcohol are off limits. Project Idea Look on Uwire.com and other websites to find information about skipping class. Can you build a survey based on the background information that you find? Yes. This survey starts with the bias that happiness is related to going to church, which could me construed in very specific or very general ways. For the purposes of this study, would synagogue or mosque be the equivalent to church? Survey takers will interpret the questions differently. Always pay attention to the bias wording can cause. Also, this question asks about psychological well being, which is off limits to ENG 317. Project Idea A great idea for a survey project would be to find out nationally how many seniors plan to leave their states to work and then survey UMaine students to compare. Here is a report about Michigan college students: http://www.fsutorch.com/2011/09/28/opinions/will- you-stay-after-graduation/ http://www.fsutorch.com/2011/09/28/opinions/will- you-stay-after-graduation/ Yes. This survey starts with the bias that happiness is related to going to church, which could me construed in very specific or very general ways. For the purposes of this study, would synagogue or mosque be the equivalent to church? Survey takers will interpret the questions differently. Always pay attention to the bias wording can cause. Also, this question asks about psychological well being, which is off limits to ENG 317. Project Idea A great idea for a survey project would be to find out nationally how many seniors plan to leave their states to work and then survey UMaine students to compare. Here is a report about Michigan college students: http://www.fsutorch.com/2011/09/28/opinions/will- you-stay-after-graduation/ http://www.fsutorch.com/2011/09/28/opinions/will- you-stay-after-graduation/ Skipping class is legal, so at a first glance, this survey seems fair, objective, and within the IRB policies. But the questions lead to potential answers from the categories of information we should not ask about: medical issues, psychological well- being, alcohol use, sexual preferences, etc. Project Idea The Pew Internet & American Life Project studies issues relevant to college students (http://www.pewinternet.org/). Look for prior surveys you could repeat at UMaine and then compare the results.http://www.pewinternet.org/ Skipping class is legal, so at a first glance, this survey seems fair, objective, and within the IRB policies. But the questions lead to potential answers from the categories of information we should not ask about: medical issues, psychological well- being, alcohol use, sexual preferences, etc. Project Idea The Pew Internet & American Life Project studies issues relevant to college students (http://www.pewinternet.org/). Look for prior surveys you could repeat at UMaine and then compare the results.http://www.pewinternet.org/ Use your IRB Handout to help you make sure your topic is permitted under the UMaine IRB guidelines.

16. The IRB requires that we include an Informed Consent Statement when we write a survey. Copy and revise the Informed Consent Statement on your IRB handout to fit your needs. We will talk more about this requirement in 7.3.

17.  Take the 7.2 Quiz  Continue thinking about your topic  Move on to Slide Presentation 7.3 Next Steps