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IRB-HSBS Website Directory and Guidance
NOTICE
This page is intended for use by study teams on the Ann Arbor, Dearborn, and Flint campuses having research under review and oversight by IRB-HSBS.
Researchers having studies under review and oversight by IRBMED should refer to IRBMED website for specific information about their practices, procedures, application requirements, etc.
This page is regularly updated with information that might be helpful to study teams on various topics, including:
- IRB-HSBS practices
- Regulatory resources
- Tip sheets
- Decision trees
- Completing research applications and submitting reports in eResearch
- Document templates
Information is listed in alpha order. Use the shortcut bar to go to a section, then click the link for the topic of interest. If you don't immediately see the information you seek, consider thinking of a broader term or concept (e.g., if searching for "Child Assent", consider looking under "Assent").
A | B | C | D | E | F | G | H | I | L | M | N | O | P | R | S | T | U | V
TOPICS
45 CFR 46 - Non-FDA Federal Regulations
A
AE/ORIO: eResearch Instructions for Creating submission
Amendment process
Anonymous, confidential, and deidentified
Application sections
Application submission policy
Application tips
Application types
Assent
Authorization agreement flowchart
Authorization agreement guidance
B
Belmont report
Benign behavioral interventions
C
Children research federal guidance
Certificate of Confidentiality (CoC)
Class assignments: IRB review policy
Clinical Trials IRB-HSBS - Decision Tree
Clinical Trials IRB-HSBS - General Study Team Guidance
Clinical Trials NIH Social/Behavioral Sciences - Study Team Guidance
Collaborative research (see also single IRB review)
Community partners: Ethics and research training
Conflict of Interest (COI)
Continuing review guidance
Continuing review process
Criteria for IRB approval
Cultural Sensitivity and Surveys
D
Data classification levels
Data Management and Security Protocol Template
Data security guidelines
Deception and concealment
Department of Defense funded research: Additional requirements
E
Engagement of institutions in human subjects research
eResearch
eResearch training and reference materials
Exempt applications: Summary of recent changes
Exemption #1: Tips and examples
Exemption #2: Tips and examples
Exemption #3: Tips and examples
Exempt consent template
Exempt research guidance
Exempt research policy
Exempt studies: Brief protocol including data management and security questionnaire (download)
Expedited categories
Expedited review path
F
FAQ: Does my application have to go to the Full Board for review?
FAQ: Which IRB should review my application?
FAQ: Does my project require review?
Federal exemption categories
FERPA
fMRI behavioral component study guidelines and resources
fMRI behavioral component informed consent template
Full board meeting dates and submission schedule: Blue (2024)
Full board meeting dates and submission schedule: Maize (2024)
Full board review
Full board rosters
G
General data protection regulation (GDPR): Overview
General data protection regulation (GDPR) informed consent template
Genomic data sharing
H
HIPAA
HRPP education resources PEERRS
HRPP Operations manual- Part 4, Activities Subject to the HRPP
Human subjects research decision charts
Human Subjects Incentive Program
I
Incentive and compensation guidelines
Incident reporting: AE/ORIO UaP
Informed consent: Basic elements
Informed consent: Guidance and templates (includes assent and parent permission)
Informed consent: HRPP Operations manual
Informed consent: Making changes to documents
Informed consent: Using plain language
Informed consent: Waivers
International research
Internet research
IRB application process
IRB jurisdiction oversight
IRB organization authority
IRB review process
IRB review types
IRB-HSBS educational programming
IRB-HSBS SOPs
IRB-HSBS: Overview
L
M
N
NIH single IRB of record policy
O
OHRP education videos
OHRP FAQ index
Online surveys: Preventing fraudulent responses
P
Policy for reporting changes in approved research
Post approval remnders for study teams
Program evaluation
Prisoner research federal guidance
R
Recruitment flyer example (download)
Regulated/Not-Regulated research table
Repository application
Research Pause COVID-19 (03/13/2020)
Risk
S
Screening for eligibility
Secondary use applications: Summary of recent changes
Sensitive data guide
Sensitive identifiable human research data
Single IRB Review
Site approval/letter of cooperation example (download)
Student researcher guide (download)
T
Termination reports
Tips for faculty advisors
Tips for student researchers
Turn-Around times and Metrics IRB-HSBS
U
Umbrella applications
U-M demonstration projects
U-MIC educational recordings
Units served by IRB-HSBS