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IRB-HSBS Website Directory and Guidance

NOTICE

This page is intended for use by study teams having research under review and oversight by IRB-HSBS.

Researchers having studies under review and oversight by IRBMED, or the Flint or Dearborn IRBs, should refer to those websites 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.  Click on 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").

TOPICS

45 CFR 46 - Non-FDA Federal Regulations
 
A
AE/ORIO: Creating submission
Amendment process
Amendment tip sheet
Amendment: Creating submission
Amendments: Submission guidelines
Anonymous, confidential, and deidentified
Application sections
Application submission policy
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 Social/Behavioral Sciences - Decision Tree
Clinical Trials Social/Behavioral Sciences - Study Team Guidance
Collaborative research
Common rule changes
Common rule changes: Continuing review
Common rule changes: Exemptions
Common rule changes: Informed consent
Community partners: Ethics and research training
Conflict of Interest (COI)
Continuing review guidance
Continuing review process
Criteria for IRB approval
 
D
Data classification levels
Data security guidelines
Deception and concealment
Department of Defense funded research: Additional requirements
 
E
Education research
Engagement of institutions in human subjects research
eResearch
eResearch training and reference materials
eResearch: Uploading, editing, and deleting documents 
Exempt #2A
Exempt research guidance
Exempt research policy
Exempt studies: Brief protocol 
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
fMRI master protocol
Full board meeting dates and submission schedule: Blue
Full board meeting dates and submission schedule: Maize
Full board review
Full board rosters
 
G
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
Informed consent: HRPP Operations manual 
Informed consent: IRB-HSBS general consent template
Informed consent: Making changes to documents
Informed consent: Exempt study template
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
 
J-K
 
L
Limited data sets
 
M
Mandatory reporters/reporting
mTurk
 
N
NIH single IRB of record policy
 
O
OHRP education videos
OHRP FAQ index
 
P
Pilot and test activities
Policy for reporting changes in approved research
Program evaluation
Prisoner research federal guidance
 
Q
 
R
Recruitment flyer example
Regulated/Not-Regulated research table
Repository application
Risk
 
S
Screening for eligibility
Secondary use
Sensitive data guide
Sensitive identifiable human subjects research data
Site approval/letter of cooperation example
Student researcher guide
 
T
Termination reports
Tips for faculty advisors 
Tips for student researchers 
Turn-Around times and Metrics IRB-HSBS 2017
 
U
Umbrella applications
U-M demonstration projects
U-MIC educational recordings
Units served by IRB-HSBS
 
V
Vulnerable subject populations