IRB FAQ

University of Denver Writing Program

IRB FAQ

The following are questions from writing program faculty and students collected over the following year about the writing programs exempt research compliance for student-conducted research. As a reminder, this only applies to the programs current agreement with IRB; if you would like your students to conduct research that beyond the scope of the exempt status agreement, you are free to submit a class project application to the IRB office for approval.

Q: The interview permission includes the statement that the subject is giving their consent for the interview. However, in neither the Survey/Questionnaire/Poll statement nor the Interview Permission form do we ask the subject to verify that they are legally able to give their, e.g., that they are at least 18 years old.

A: Student researchers cannot target people who cannot provide their consent.The Writing Program Informed Consent form doesn't have the check-box because it was understood that our students were not going to be doing research on subjects who couldnt provide their consentit includes as much on the information sheet. Students arent allowed to target subjects who cannot provide consent, but should assume subjects in a particular setting can provide consent.In other words, assuming DU students are 18+, are not pregnant, don't have mental illness, are not disabled, and thus able to provide consent. We are in the process of adding a statement on the confidentiality statement for next year. Q: Why are physically disabled folks not allowed to give consent?

A: Students cannot target individuals for the obvious reason they have to disclose a medical condition that they have a right not to disclose (HIPAA), and students, at this level, dont have the training to work with those populations.From an IRB standpoint, those with diminished capacity might be placed into a situation in which they cannot fulfill part or all of an experiment, interview or survey; even non-obvious issues like vision or hearing impairment can prevent participants from fulfilling even the shortest of surveys or being informed about that survey.

That being said, IRB is only concerned with research of disabled subjects. In fact, students dont have to avoid certain populations (e.g. paralympic athletes). They also can perform anonymous observations (e.g. observing how many students will open a door for somebody physically disabled) as long as they maintain confidentiality of those observed and dont place participants or researchers into potentially harmful (physically or mentally) situations.Q: Does every IRB form that someone signed need to be attached to the final draft? I ask because I misplaced a few and I may need to ask these people to sign it again.

A: Misplacing a signed consent form is a breach of trust. Remember, you have agreed to protect the informant/participant from being identified, and a stray form floating around campus, although not immediately connected to your study, is still a violation of trust that he/she placed in you. Please keep track of any informed consent that you collect.Q: One of my students wants to interview frat boys about why they wanted to join a fraternity. I suspect, as does he, that drinking will emerge as a big reason. If the participants are under 18, is this an unacceptable project?

A: Given that we are using a confidential model of interviews, if it comes up, it comes up (as might alcohol use in the dorms, illegal file-downloading, or cheating on a test). He/she can even report on it. What he/she cannot do is "target" those behaviorshe/she cannot specifically ask questions about those behaviors. You also might tell this student that he/she could be subpoenaed if charges are ever brought against the informant for the illegal activity that he/she collects information about. Research is not protected under Media Shield laws. If you wanted your student to be fully protected, he/she can state at the beginning of the interview that the participant/interviewee should not reveal any illegal activity. Q: This year several of my students have scored amazing interviews with authors, politicians, business owners, etc., who are pleased to be interviewed and *want* to be associated with the student's project. Is there any way to give an option to waive anonymity? I understand why it is essential in many cases ("I'm interviewing my friend who had anorexia."), but it's frustrating and disappointing to my students, when they get a great interview but can't brag about it or use it to bolster support for their argument in the policy brief.

A: This depends on the writing being done. A policy brief is not a systematic and generalizable study of a participant or group of participants. A feature or profile article is not research. The research definition is as follows: "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."For IRB, interviewing a politician, or even interviewing a few politicians is not really research given what your students are probably asking about. I say "probably" because if they were asking politicians how often, if ever, they cheated on their spouses for a "generalizable report" about personal behaviors of politicians, then it would have to follow the IRB guidelines.Q: I have two students, working together, who want to conduct a simple test using bottled water and tap water, determining consumers' perceptions of taste and quality. Can they do this on campus?

A: This shouldnt be a problem. Your students should follow the informed consent guidelines set out on the handout; you could use the anonymous survey response and include it on a printed statement. U.S. Code Title 45 46.101 (the part of federal code that establishes protection of research participants) specifically states that taste and food quality evaluation and consumer acceptance studies are exempt.Q: A student has proposed the following: I plan to investigate whether or not the use of illegal or illicit drugs (including marijuana) has an effect on an individual's view of contemporary art. In other words: do people who participate in drug related activity have a higher or lower appreciation for contemporary art? Can a student do this with the Writing Programs IRB exempt status?

A: This would require separate IRB approval. Given the fact that it would take the IRB a few weeks to review this proposal, your student should pursue a different line of research. The only solution might be if she rephrased the question, something like, "Other people's use of marijuana troubles me: strongly agree, agree, etc."

IRB information, April 2014 pg 2