Welcome back!
I hope these past few days have treated you well! This week, I've been working on completing a very lengthy Institutional Review Board (IRB) Application. First lesson I learned: When they say the IRB is not for people younger than graduate students, they're undoubtedly right. Although paperwork for the IRB was unlike any other set of forms I've seen, it was a remarkable learning experience for me.
The particular form that I needed to complete was the F200: Application for Human Research. When a study uses human subjects as a part of their research, the Institutional Review Board is required to approve the study to ensure the protection of each human subjects' health and privacy rights. It's fascinating to see that something as simple as conducting a survey comes with so much liability.
To better understand what the F200 entails, here's a quick run through of the application. The first section was the background, which mirrored my Introductory Post in this blog in explaining what narrative medicine is and its significance. Within the second section of purpose, I discussed the two direct purposes, two specific aims, two objectives, and the primary and secondary endpoints of the research. The following series of sections focused on compiling key words and adequate questions for the Likert scale survey. Once approved, I'll release my official survey questions on this blog!
Along with this survey, I was required to create two consent forms as well. One was a general consent form and the other was a consent to participate in research; both addressed potential concerns of the subjects (which, in this study are the medical students). Each consent form requires the human subject to read and then sign their rights to privacy and voluntary action, potential costs and risks, and potential benefits of the study.
After "briefly describing" (with a not-so-brief 650 word minimum!) the study population, subject recruitment process, research procedures, settings, costs and risks, benefits, and provisional protection and confidentiality of data, I was required to explain the research investigation in "lay summary". Funny thing is, this was by far the most difficult part of the entire application. According to research investigators, the guideline for being specified as "lay" is 10th grade reading level, but since this includes 10th graders of all backgrounds, it's surprising to see how much the writing style has to change to meet that. If I'm honest, I spent a solid 2.5 hours on making my lay summary from "15th grade" (I didn't even know that was a thing) to 10th grade level.
Although there were a lot of tedious applications and forms to fill out, I was personally fascinated by this process. I mean, who would've thought that a 2 minute survey would take over 15 hours of paperwork?! There are so many minute details that are often overlooked when it comes to dealing with human subjects, and as someone who plans on pursuing research at university and medicine in the future, this has been an amazing learning opportunity for me.
As always, thanks for reading and please check in next week!
Anivarya
The particular form that I needed to complete was the F200: Application for Human Research. When a study uses human subjects as a part of their research, the Institutional Review Board is required to approve the study to ensure the protection of each human subjects' health and privacy rights. It's fascinating to see that something as simple as conducting a survey comes with so much liability.
To better understand what the F200 entails, here's a quick run through of the application. The first section was the background, which mirrored my Introductory Post in this blog in explaining what narrative medicine is and its significance. Within the second section of purpose, I discussed the two direct purposes, two specific aims, two objectives, and the primary and secondary endpoints of the research. The following series of sections focused on compiling key words and adequate questions for the Likert scale survey. Once approved, I'll release my official survey questions on this blog!
Along with this survey, I was required to create two consent forms as well. One was a general consent form and the other was a consent to participate in research; both addressed potential concerns of the subjects (which, in this study are the medical students). Each consent form requires the human subject to read and then sign their rights to privacy and voluntary action, potential costs and risks, and potential benefits of the study.
After "briefly describing" (with a not-so-brief 650 word minimum!) the study population, subject recruitment process, research procedures, settings, costs and risks, benefits, and provisional protection and confidentiality of data, I was required to explain the research investigation in "lay summary". Funny thing is, this was by far the most difficult part of the entire application. According to research investigators, the guideline for being specified as "lay" is 10th grade reading level, but since this includes 10th graders of all backgrounds, it's surprising to see how much the writing style has to change to meet that. If I'm honest, I spent a solid 2.5 hours on making my lay summary from "15th grade" (I didn't even know that was a thing) to 10th grade level.
Although there were a lot of tedious applications and forms to fill out, I was personally fascinated by this process. I mean, who would've thought that a 2 minute survey would take over 15 hours of paperwork?! There are so many minute details that are often overlooked when it comes to dealing with human subjects, and as someone who plans on pursuing research at university and medicine in the future, this has been an amazing learning opportunity for me.
As always, thanks for reading and please check in next week!
Anivarya
This comment has been removed by the author.
ReplyDeleteHey Anivarya! Glad to hear you are taking all of the precautionary steps in order for you to have an extremely credible project. I'm sure by now that your feeling great about getting all of the tedious work out of the way, so that you can move onto the bulkier part of your project. I look forward to hearing more about your research as you make your transition onto your off-site campus locations. Best of wishes, and as always, have a wonderful time! -Eli
ReplyDeleteI admire your work-ethic (not that you had much of a choice). It's good though that you are taking your time to make sure that your subjects are protected and that your surveying goes smooth. With that paperwork finished, you should now be able to get into the best part of your project. I'm looking forward to hearing your future activities.
ReplyDeleteEven though the process may seem tedious now, you are on your way to some great results! Don't get too overwhelmed by the workload and as always, good luck! I look forward to reading your next blog post.
ReplyDeleteI never realized how much tedious paperwork came into surveying projects and congratulations completing them all. I look forward to seeing what discoveries you make in the following weeks now that you have finished all the necessary paperwork.
ReplyDeleteWow, Anivarya--this has to be some tremendous practice for the kinds of ethics training you'll receive as a medical student!
ReplyDeleteI admire your work-ethic (not that you had much of a choice). It's good though that you are taking your time to make sure that your subjects are protected and that your surveying goes smooth. With that paperwork finished,
ReplyDeletethai porn