Guidance

Resources

Operations Manual — The University of Michigan Human Research Protection Program Operations Manual (OM) is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and other members of the research community. Expect updated version in early 2018 due to regulatory and policy changes.

Standard Operating Procedures — The Institutional Review Boards of the University of Michigan Medical School Standard Operating Procedures (SOPs) serve as the overarching guidelines for IRBMED practices and procedures. Expect updated version in early 2018 due to regulatory and policy changes.

Glossary — The IRBMED Glossary is a compilation of regulations, terms, and acronyms related to human subjects research. The contents of this glossary have been collected from a variety of authoritative sources. 

Plain Language Medical Dictionary — This is a project of the University of Michigan Taubman Health Sciences Library as part of the Michigan Health Literacy Awareness project.

Electronic Records and Electronic Signatures (21 CFR Part 11) — Part 11 provides criteria under which FDA will consider electronic records to be equivalent to paper records and electronic signatures to be equivalent to traditional handwritten signatures.

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Guidance

To find guidance on a particular topic, you may either click on one of the following letters or scroll down through the alphabetical listing.

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

A  
Accessing Medical Records   Advertising (see Recruitment Advertising)
Adverse Event Definitions   Amendments: Routine or Urgent
Adverse Event Reporting   Assent (see Children - Assent)
B  
 Belmont Report--Ethical Principles   Biorepository Informed Consent Template
 Blinded Studies    Blood Draw Guidelines
Blood or Specimen Informed Consent Template    
C  
Certification Preparatory to Research   Complaints from Subject or Others about a Research Study
Certificates of Confidentiality                                            Compliance Office
Children in Research   Concealment
Clinical Research Calendar Review & Analysis Office (CRAO)   ClinicalTrials.gov: Registration 
ClinicalTrials.gov: UM Policy   Consent (see Informed Consent)
Compassionate Use Informed Consent Template     Consent Templates
Covered Entity    Cross-Reference Table (eResearch)
D  
Data Safety Monitoring Boards: Agency for Healthcare Research and Quality (AHRQ) Mandatory Use   Deception
Decedents   De-Identified Data Sets
Department of Defense (DoD): Additional Requirements for Researchers    
E  
Eligibility Screening   Eligibility Screening Informed Consent Template
Emergency Research with Exception from Informed Consent: FDA Guidance   Emergency Use Informed Consent Template
Emergency Use: FDA Contact Information   Emergency Use of Test Articles                           
eResearch Regulatory Management (eRRM)    eResearch Cross-Reference Table
Emergency Research (planned and approved) with Exception from Informed Consent                              Exempt Research
     Expedited Review
F  
Federal Regulations   Fetuses
Fees for IRBMED Review   Foster children (see Wards of State)
G  
Genetic and DNA Based Research (currently under revision)   Genomic Data Sharing Policy (NIH) 
H  
HIPAA Guidance   Humanitarian Use Device (HUD) Guidance
Humanitarian Use Device (HUD) Informed Consent Template    
I  
iFeasible   Informed Consent
Informed Consent Templates   International Council for Harmonisation: Good Clinical Practice (ICH-GCP)
International Research    Investigator Responsibilities
J  
     
K  
     
L  
Legally Authorized Representatives (LARs)   Limited Data Sets
Lotteries    
M  
Medical Records Access   Minors in Research
N  
Neonates   NIH Genomic Data Sharing Policy
Non-English Speaking or Reading Subjects    
O  
One-Time Blood or Specimen Informed Consent Template   Operations Manual (OM)
Other Reportable Information or Occurrence (ORIO Reporting)    
P  
Payment to Research Subjects    Privacy Board
Plain Language Medical Dictionary   Protected Health Information
Prisoners in Research    Protocol Deviations, Exceptions, Violations
Q
 
     
R  
Radiation Exposure Guide   Removal of Blood (see Blood Draw Guidelines)
Reconsenting Study Subjects   Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g., DSMB, FDA)
Record Retention--How Long to Keep Research Records   Recruitment/Advertising
Repository Overview   Risk--Guidelines For Using Magnitude Of Harm In Categorizing Risk Level
Roster (IRBMED)    
S  
Screening Informed Consent Template    
Standard Informed Consent Template   Standard Operating Procedures (IRBMED) 
Survey Informed Consent Template    
T  
Telephonic Consent    Templates, Informed Consent
Test Articles in Research    
U  
Umclinicalstudies.org (formally Engage)   Urgent Amendments
Unanticipated Problems involving research subjects or others    
V  
Vulnerable Populations    
W  
Waiver of HIPAA Authorization Request   Wards of the State as Research Subjects
X  
     
Y  
     
Z  
     

 

Updated 1/9/2018