irb process

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redesign CMU IRB form process book

Suzanne Choi Typography 2 School of Design Carnegie Mellon University


PART 1: get to know IRB form project description

inspiration and research

For this project, we were assigned to redesign CMU IRB (Internal Review Board) main application form and approximately had 3 weeks to complete the project. We had five project objectives : 1. Identify communication problems and propose solutions 2. Organize information conceptually 3. Organize information visually 4. Create work that is highly legible, readable, and functional 5. Tell a story a clear and compelling story Limitation or restriction of this project were: 1. The size of the form must be 8.5” x “ 11” 2. The form must be done in black and white (+ shades of gray) 3. The final deliverable should be interactive pdf.

intent and purpose For this IRB form redesign project, I wanted to show : 1. Sensible flow of reading through re-organizing sections and questions 2. Sense of time in completing the form in order to lessen the burden people who needs to complete the form gets 3. Distinguished questions that all person need to fill out and only some person need to fill out 4. Easy reading and understanding through

a. revise wording of questions

b. change size, leading, line length of questions.

When I am first introduced to CMU IRB (Institutional Review Board) Application form, I did research on various types of forms that are existing today. I primarily used Google to find some examples of forms and also used Fafsa, CollegeBoard, and random online hospital websites. While scanning the form examples, I found out that most of the “working“ forms has aligned check boxes and distinctive graphics that distinguish sections of information. I also found out that the working forms have 2-3 levels of heirarchy, which I think is appropriate number of heirarchy in order to hence the reading while not confuses understanding.

In order to find out pros and cons of current CMU IRB form, I asked three friends (+ me) to fill out the form. While they were filling out the form, I observed them carefully to see where they stumble, and made note of the confusing areas. From my observation, I found that problems in current IRB form are : order of information, wording of question, not distinguished audience ( between questions that all people need to fill out and only some people need to fill out), and no sense of time presented while completing the form ( which eventually gives more burden to people who has to fill out the form.) Pros of the current forms are : numbered question and divided section.

After finding out pros and cons of the current IRB form, I started my redesign. Before moving into layout of the form, I started with type studies ( selecting typeface, type size, leading, thickness, etc.) I was looking for typeface that tastes concise, clean and simple, modern, condensed ( so that many information could fit in), and feels formal but not too intimidating. As a result of my type study, I chose Avenir Next Condensed Regular 10/12 for my body texts and Avenir Next Condensed Demi Bold 10pt for sub heading.

c. arrange information in set system (aligned questions/check boxes)

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PART 2 : early exercise re-organizing content While reading through the entire form, I realized that many of the similar contents are not grouped together. Because of that, I felt I was answering same question over and over again. Some of the questions had potential to be combined, and some other questions were not belong to the section they are in.

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In order to solve this problem, I first print out the original IRB form and cut each sections and moved the sections around so that flow of reading makes sense. For example, I made all the questions that are related to Participant next to each other, while before it was separated. Then, I re-ordered questions within the section, so that questions that are related to each other is physically next to each other. And I pulled out some questions that are not belong to the section they were in, and moved to section that covers similar topic. In addition to re-organizing, I made some notes where I should revise wording of questions, and indented sub sections that not all people need to fill out. Also I brainstormed how I can make systematic grid for this form.

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PART 3 : developing a system iteration 1, portrait studies

iteration 2, landscape studies < At first, I tried portrait styled form ( like many others). In this system, all check boxes are aligned in their own space, and answer boxes are aligned with the questions. First, I only used indentation to differenciate sub sections and main sections. But then, I wanted to give users a visual guide for tasks they have to do and don’t have to do, so I created a system where sub sections are connected to the answer ( for example, if the question says “if yes then complete 8b,” question 8b is connected to “if yes then ...” statement with dotted line), and questions that all people need to answer is nested in solid line. With the chosen typesize, leading, and column width, portrait sytled form felt too empty, so I decided to explore more on landscape styled forms (two pages of question on one page).

> (Read from left top to bottom/ then right top to bottom) So, I tried landscape sytled forms while also progressing on the portrait style. In landscape styled forms, “yes“ and “no“ checkboxes are also aligned in seperate space, and answer boxes are aligned with questions. I kept the system where sub sections are connected with answer with dotted line, and that sub section lives in dotted lined box, so that users can ignore the block of questions if they don’t need to answer. Then, I tested my system with Aya, a friend, and she told me that it was hard to keep referencing back to “if yes then ...“ kinds of statement to see what she has to do after answering “yes, no“ question on right side. And, I realized the dotted line box doesn’t set enough seperation between the “all“ questions and “some questions.” So I tried light gray color block to seperate sub section, but it was too overwhelming; And, decided to eliminate the seperate space “yes and no“ question have, and merge the “yes, no” question with other questions.

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PART 4 : iterations refining system for draft 1

draft 1

<

< I wanted to find out where I should put instruction. I tried several iteration which instruction is on the same page with questions, but it got really busy. So I decided to make separate instruction page.

<

< I wanted to include something that shows time frame within the form and also serve as navigation bar. But separate circles that are filled or not filled didn’t really show sense of time, so I decided to change it to reflect sense of time more.

< This was the conclusion.

For draft 1, I had :

For draft 1, people responded that problems I had are:

Separate cover page, so that instruction doesn’t merge with other questions.

There are too many lines - so confusing, and solid line that should be served as nesting line( complete “a” to “d”) looks like connecting line from question “a” to “d”.

Heirarchy between left side (navigation bar and reference info.) and right side (questions) are not visible. And those two sections are fighting each other.

Navigation bar that shows how much you’ve done to complete the form & which section you are in( black bar on the left side filled up as you go on - black bar stops in the middle of two section means you will complete the entire section in this page, and in the middle of one section means you will complete about half of the section in this page).

IRB contact number and some referencing information on left bottom side to aid users if they need help.

Distinguished “all need to answer” questions and “some need to answer question by solid line and dotted line.

Check boxes (circles) aligned with questions.

Re-arranged order of section and questions.

Distinguished sections by bolded type and black bar.

Numbered and lettered questions so that it is easy to point out.

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PART 4 : iterations revising from draft 1

draft 2 < Revisions that I made to find balanced heirarchy between left side( navigation bar and reference information) and right side (questions). I also got rid of the solid line that was nested the “all people need to answer“ questions to reduce confusion & kept dotted line that distinguishes sub section from main section.

< Notes that I took on Rivision #4. Issues include spacing between questions, dominance of answer box ( as a result of brainstorming, I reduce the answer box line to .25 pt and 60% gray), wording of questions, and navigation bar ( as a result of brainstorming, I kept black bar extending as sections go on, but bolded typeface for current page section)

For draft 2, I had :

For draft 2, I thought problem I had is:

Revised navigation bar that shows how much you’ve done to com plete the form through black bar, and which section you are in through bolded type.

Revised heirarchy within the page (left side < right side).

Footnotes on left side.

Consistent spacing between questions/ yes, no boxes/ question to answer box or check box.

No line that indicates “ all people need to answer” questions, but kept dotted line that acts as visual guide to find out where to go/ what to do based on the answer the audience chose.

Got rid of the dotted lined box that bounded sub section.

Cover page( can be seen on next page first image ) : because I couldn’t see enough heirarchy between heading and in struction/ it looked boring/ and I want the cover page to be more useful than just instruction ( so I decided to make the instruction final check boxes that audience can see first but can also come back at the end to make sure they attached everything needed.)

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PART 4 : iterations draft 3 < ( Read from top right to left - bottom right to left ) Some examples of Cover Studies.

For draft 3, I had :

Revised cover page

Revised navigation bar that shows how much you’ve done to com plete the form through black bar, and which section you are in through bolded type.

Revised heirarchy within the page (left side < right side).

Footnotes on left side.

Consistent spacing between questions/ yes, no boxes/ question to answer box or check box.

No line that indicates “ all people need to answer” questions, but kept dotted line that acts as visual guide to find out where to go/ what to do based on the answer the audience chose.

Got rid of the dotted lined box that bounded sub section.

For draft 3, people responded that problem I had are: Spacing between questions and yes/no circles to spacing between question to question is same. ( what is together and what is separate?)

Some of the wording of questions & need different numbering system

Heading of the navigation bar ( may not needed).

Need Assurance Statement in navigation bar too.

For draft 3, I realized:

Order of sections would work better if flows from:

Personal Info Co-investigator Protocol Info Funding Info Cooperating Institution Conflict of Interest Participant Info Recruitment Method Benefit/Compensation/Cost Risk Consent Form Confidentiality/ Data Security Assurance Statement <

revising from draft 2

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PART 5 : final before

final resolution ( print , it is also done in interactive pdf ) For Final, I have:

Revised navigation bar with assurance statement section that shows how much you’ve done to complete the form through black bar, and which section you are in through bolded type.

Revised spacing between questions/ yes, no boxes/ question to answer box or check box.

Revised numbering system ( main question A, B, C, D .../ sub question a, b, c, d, .../ sub questions for sub question small 1,2,3,4 ...)

Re- ordering of the sections.

Revised Assurance Statement section.

Rewording confusing and complex questions.

self reflection From this project, I learned how designers can influence easyness of completing complex tasks through systematic grid and visual guides. Also, I learned how order of content could lessen or increase burden the users could get while completing the task given. While doing this project, I realized importance of visual heirarchy because it might cause misunderstanding to the user in completing the task if done incorrectly. I also realized how voice of content could be affected by typeface, graphics, leading, and column width choices. For future, I am planning to be always careful with my choices on type, grids, visual heirarchy, graphic elements, wording, and order of content because I realized how powerful those are in communication.

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