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1.1) Title of Study *

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Your Progress (77 fields)
Section 1: Study Title
1
1.1) Title of Study
2
1.2) Study Purposes and Objectives
3
1.3) Background and Introduction
4
1.4) Was this project previously ap...
Section 2: Research Team
5
2.1) Principal Investigator Name
6
Principal Investigator Email
7
Principal Investigator Department
8
2.2) Select the Position of the Pri...
9
2.3) Is this a student-led research...
10
Student's Name (if applicable)
11
2.4) Are two or more members of the...
Section 3: Funding
12
3.1) Is the research funded?
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3.2) Add any funding sources you ha...
Section 4: Subjects
14
4.1) Ages of Subjects
15
4.2) Specific age range of subjects
16
4.3) Indicate any vulnerable popula...
17
4.4) Has the participant selection ...
18
4.5.1) Total Subjects enrolled by U...
19
4.5.2) Total Subjects enrolled by a...
20
4.6) Participant Inclusion Criteria
21
4.7) Participant Exclusion Criteria
Section 5: Vulnerable Populations
22
5.1) How does the nature of the res...
23
5.2) Would it be possible to conduc...
24
5.3) Is this population being inclu...
25
5.4) Does the scientific merit of t...
Section 6: Study Information
26
6.1) Non-Experimental and/or Descri...
27
6.2) Experimental and/or Interventi...
28
6.3) This project is Community Base...
29
6.4) Study includes creating resear...
30
6.5) Study will include a research ...
31
6.6) Length of entire study from in...
32
6.7) Length of individual subject's...
33
6.8) How will subjects be recruited...
34
6.9) Describe the recruitment/parti...
35
6.10) How will consent be obtained?
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6.11) Describe all procedures chron...
37
6.12) Are all procedures for resear...
38
6.13) Provide a summary of the stat...
Section 7: Consent Process
39
7.1) Describe the location(s) where...
40
7.2) Describe whether there is a wa...
41
7.3) Describe what measures will be...
42
7.4) Describe the provisions that a...
43
7.5) Will a legally authorized repr...
44
7.7) Will a language other than Eng...
45
7.10) Are you requesting that docum...
Section 9: Data Monitoring
46
9.1) Privacy Protections – What pre...
47
9.2) Confidentiality Precautions – ...
48
9.3) Will photos, audio recording, ...
49
If yes, describe the recording/imag...
50
9.4) How will study data and docume...
51
9.5) Who will be the primary monito...
52
9.6) How often is study data and do...
53
9.7) Is there a SAFETY monitoring p...
Section 10: Risks and Benefits
54
10.1) Describe the reasonable fores...
55
10.2) Describe the potential direct...
56
10.3) Describe the potential benefi...
57
10.4) Using lay language, please de...
58
10.5) Are there any costs to the su...
59
10.6) Is there any compensation to ...
Section 12: Resources and Responsibilities
60
12.1) State and justify the qualifi...
61
12.2) Describe the training that st...
62
12.3) Describe the facilities where...
63
12.4) Describe the medical or psych...
Section 13: Additional Information
64
13.1) Does this study involve any o...
Section 16: Databases and Repositories
65
16.1) Select the items that will be...
66
16.2) What type(s) of future resear...
67
16.3) Who manages the repository an...
68
16.4) Indicate whether the data/sam...
69
16.6.1) Describe the process for de...
70
16.7) Describe the procedures for p...
71
16.8) Will future results or findin...
72
16.9) Describe the procedures for o...
Section 21: Devices
73
21.1) Name of device, algorithm, or...
74
Please describe the device, algorit...
75
Is this device generally considered...
76
What is the initial risk determinat...
77
Provide justification of why the me...
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