IRB Update - Due October 31

My university's IRB application went to online-only submission and review this fall and it was startling how easy it was. When I was at Georgia Tech, an IRB Level I approval took almost all semester, involved three reviews, and I seem to recall them asking for various oaths and body parts. Since I was, in essence, asking for retroactive approval I thought I was going to have a long go of it.

I had approval (Level I exemption) the next day, and the signed approval was in my campus mailbox the day after that.

I came to realize that student focus group qualitative data would be a great compliment to the quantative data for the Environmental Psychology course that I team taught. I therefore went through the online IRB approval process which was recently developed at my institution, Cabrini College. After IRB approval, which required student consent forms, the Director of our Center for Teaching and Learning conducted two student focus groups from students enrolled in the class of last spring. The discussion was audiotaped and transribed by an outside professional organization. We received a word document of the transcription last week and we are currently analyzing the results.

I did IRB last year for another SoTL project and SoTL type of project was categorized as “exempt research”. There were two forms but they weren’t very involved. This month I used the same forms and submitted my project to the new chair only to be told that now this type of research needs “expedited reviews.” I need to use other forms and answer more questions. I read the 45-page IRB guidebook of our university and everything I am doing fits the descriptions “exempt research” perfectly. Our Teaching and Learning Center consultant told me that SoTL type of research should be categorized as exempt reseach and that is what he has been doing. Over the years I have learned that it will probably take me more time to rebut so I spend another weekend working on the application of expedited reviews. And it is very likely that I miss something in the guidebook and the current chair is absolutely right. This is two weeks ago and I haven’t heard anything from the chair. However, I have to admit that, with new university calendar and new campus-wide curriculum and new departmental curriculum and new science building and two brand new courses going on, needing to apply for expedited reviews makes me not want to do any SoTL type of research right now.

I met with our IRB committee chairperson to discuss whether my SoTL project was exempt or needed expedited review. While we concluded that it was likely exempt, I applied with an expedited review form so that I would have no problem later publishing the results. I applied in September and was granted approval for the project. I had applied for previous expedited reviews, so the forms were not too bad. The worst part was creating the surveys and pre/post-tests. Within a few days I had my approval notice. edited 12:36, 29 Oct 2008

Once, I figured out who is in charge of looking through IRB application and what the required forms are, the process ended up being pretty straightforward for me. However, this was mainly because after talking to several people, I decided that the best route for me was to seek for IRB exemption. At least for my institution and my project, this only required me to rephrase some parts of my project and what kinds of data collection I would do to make sure that I confirmed I was NOT adding any additional means of collecting new information (just for this project) that I would normally not have collected as a part of my already existing course design. For me at this stage of my project, that worked ok and a few things I really did want to add, I added anyway and did them as a part of the course development I had anyway intended to do. Once I filed the paperwork this way, I was granted the exemption in a week. I was still told that it would be nice for me to get some consent forms from the students, just to be on the safe side. However, I haven't done this yet and am still debating whether or not to do it at the end of the semester or when would be a better time to do it. The subset of Wellesley students I have in my particular classes are really very unique in their own ways and due to them being almost all premeds they have a tendency to overinterpret many things esp. during the course of the semester. So I am leaning towards asking them to sign off something once the semester is over and they have received their grades and filled out their course evaluations. Then I am pretty sure everyone will be very cooperative.
On a side note though, from all the "unofficial" talks I had with different people on campus, I have come to realize how much of a tiptoeing will be required if one really wants to collect data and publish these unless there is a better collective understanding of educational research (back to our discussion on the value given to Scholarship in Teaching and Learning)

I am lucky, since I am associated with the campus Science Education Initiative, my work falls under several IRB approvals already in place, and most of what I collect falls under exempt status. However, to be on the safe side, I had a very general consent form approved that they signed on the first day that allows me to use any of the data I collect for research and publication. Out of 67 students, 63 agreed to let me use their data. For interviews, I have a separate approved form (again, a general form that allows any of us associated with the SEI to use it). So, for me, it has been almost completely painless.

My college also has moved to an on-line submission for IRB approval. That end went pretty smoothly. The part that I struggled with the most was the "Risk to Students". As my project mainly involves surveys and a reflective paper to assess student attitudes towards genetics, I found it difficult to answer the question of what risk the study posed to my students. My naive answer (that I wanted to put) would have been "None", however I knew that was not going to satisfy the committee. So I discussed the time that it would take and said that otherwise there was little risk. In the end I got a "Requires Modification" reply for the committee. The issue that they had was that my identification of risk in the IRB proposal did not exactly match what I said was the risk in the consent form. At this point I returned to my proposal and looked again at what I was having the students do. Because I had added in a reflective paper regarding the lab experience to mine for qualitative data, I looked at the potential for risk there. I turned it into an anonymous paper and modified my risk statement to this:

“Both tools used in this study will be anonymous. Questions in the survey will address students’ attitudes towards the subject, but there will be no identifying information that could connect the students with their responses. The reflective assignment will ask students to reflect on the impact of the lab experience on the course and overall student learning, in an anonymous survey. In both cases, the identity of respondents cannot be connected to the content of responses, be used to determine a student’s grade, or in any way be held against the respondents. Therefore, the risk to the students is confined to potential anxiety involved in revealing their attitudes and confidence regarding genetics in a survey.”

I made sure that the consent form and the application matched word for word, and resubmitted. I was concerned that since the initial process had taken 2 weeks (returned on a Friday afternoon) that it would take another week or two. Therefore I stressed in my cover letter that I really needed to start collecting data right away. Whether or not the cover letter had any bearing on the swift response, I did receive approval the next day, and then started the collection of data.
edited 03:46, 31 Oct 2008

Although I needed to submit a paper form, it was approved with exempt status at the beginning of the semester. I had no problems with the process.

IRB is new to me, and it’s been a long time since I’ve done research other than my every semester request for students to let me know what works and what doesn’t for class improvement.
Soon after the institute I contacted the dean of institutional research (our IRB officer), and we have been emailing and conversing back and forth since then. The ball is now in her court, I believe. I'll get there somehow. I hope.

Just completed the online training for IRB (I think this has to be done every 3 years or so). It was a good refresher for things I haven't thought about in a few years. I also just finished my paperwork for my studies on team based learning and will submit them next week. If approved, I'll be able to start working with the data by the end of this semester.

I just submitted my project to the MSU IRB for "Exempt" status. MSU's online IRB application system is actually very easy to use. I am awaiting approval (7-10 days), but anticipate no major problems.

My main hurdle was that my co-PI was a new investigator in the MSU system and had to go through the initial online IRB tutorial before I could hit the "submit" button. Once that was accomplished, we got the application submitted.

I submitted my project to the BU IRB for Exempt status. As my project became a rather large collaborative project there were four investigators and it took a while for everyone to have the time to do the ethics certification necessary. Seems like a common experience from the other comments above.

The paperwork was submitted on the second day of classes (busy time on any campus). I had one question the next day for clarification and request to change on line of the form the students filled out to participate in the program. The next day I had approval. Overall, for all of the potential for pitfalls in the process it was exceedingly smooth. We have approval for the project for several years so will not have to do this again soon which is also nice.

I have attempted to submit a continuation request via our online submission site, but there is a glitch I cannot figure out that is stopping me. Very aggravating. I am hoping it will all go through smoothly once I can get a response from the IRB person in charge about the problem.

UTas has a Human Research Ethics Committee (HREC) which works collaboratively with the state department of health to assess issues relevant to human research. The HREC is the body that issues permits to conduct human research under the auspices of UTas. As I collected most of my data in 2005, I applied for and received a minimal risk social sciences (as distinct from medical) authority to collect identifiable (to me) student opinions on the teaching and learning exercises that I carried out in one unit: Applied and Environmental Microbiology. I wanted to be able to relate student opinion to student achievement and intend to publish the findings with the student de-identified. Without publication I was advised that ethics approval would not be needed because such information would only be collected for quality control use. I needed the minimal risk authority in order to publish.

To gain the HREC authority my application described what I wanted to do and as well I supplied the information sheet that I would give out to all students in the class, the authority forms that the students would sign if they chose to participate (voluntarily) and the survey questions that I would use. I also guaranteed to keep the survey material safe in my office and organized a system for students to complete the survey in my absence, and then hand it to the secretary who kept it until I had completed grading all students. For any questions I had at the time, I called the executive officer of the HREC who could either advise me or who directed me to the HREC chair. My application was thus framed with their guidance and proceeded smoothly. This was good, because, while plenty of my colleagues had experience with animal ethics approval, none had experience in human research, which is not surprising given that I was in the School of Aquaculture!

Since this time the HREC have made the application and approval system even easier in that they have an online Scope Checker which enables researchers to answer questions about their intended research so that they can determine whether or not a full application is required. This looks neat. I include the url and hope that as you are outside the uni, that you will be able to access it if you want to have a look. Go to http://www.research.utas.edu.au/human_ethics/index.htm and hit the hotlinked scope checker.

I put through an IRB for the course I am studying last semester, so I will just have to make minor adjustments to that IRB to continue my study in the Spring semester. I am not teaching the class that I am using for my Biology Scholars project this fall, so I don't have to submit the IRB until the beginning of January. Fun!