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.

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.

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.

_________________________________________________________

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 7/26/2017