UNIVERSITY OF MICHIGAN MEDICAL SCHOOL

IRBMED Home Forms Informed Consent Templates Guidance Education About IRBMED Resources AE/ORIO/Unanticipated Problems IRBMED Members Research Participants

IRBMED
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Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603

Guidance

University of Michigan Human Research Protection Program Operations Manual (OM)--The OM is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.

All 'key personnell' must complete basic human subjects education in PEERRS prior to IRB approval of a study. Click here for details.

Click the Education link, left, for information about IRBMED workshops on IRB forms and policies.

To find guidance on particular topic search for the word on this page using the "Edit" "find" function in the browser toolbar, or use the search box above right, or click on the letter to jump to the alphabetically listings below:

A-B, C-D, E, F-H, I, N-P, R, S-T, U-Z

 

A-B

• Adverse Event Reporting
• Advertising (see Recruitment Advertising below)
• Belmont Report--Ethical Principles
• Billing (see Clinical Research Billing Unit)
• Blood Draw Guidelines

C

• Certificate of Confidentiality Kiosk (NIH website)
  • Certificate of Confidentiality Frequently Asked Questions (NIH)
• Children in Research (also see Neonates)
  • Assent (pediatric subject's agreement to participate in research)
    • HHS Office of Human Research Protections (OHRP) FAQ on child/parent disagreements on partcipation
    • National Cancer Institute Guidance (helpful information for all types of research)
  • Federal Regulations and Guidance for Children, HHS Office of Human Research Protections (OHRP)
  • Federal Regulations for research involving children, HHS Food and Drug Administration (FDA)
  • OHRP Frequently Asked Questions
  • Research involving greater risk than 'minor increase over minimal' without direct benefit for subjects --OHRP Guidance for 45 CFR 46.407
  • Food and Drug Administration 'Pediatric Drug Development' Guidance
  • Wards of the State as Research Subjects
• Clinical Research Billing Unit
• Clinical Trials Registration
• Complaints from Subject or Others about a Research Study

E

• Eligibility Screening
• Embryonic (human) Stem Cells
• Emergency Use of Test Articles
• Emergency Research with Exception from Informed Consent
• eResearch
  • Basic Step-by-Step Manuals:
    • PI and Study Coordinators
    • Core Staff
    • Committee Member/Reviewers
    • Ancillary Committee
    • Institutional Biosafety Committee (IBC)
  • Frequently As Questions
  • Glossary of eResearch Terms
  • Pre-submission Checklist--Things to have, information to gather before starting a submission
  • Quick Reference Card
  • Tips--Miscellaneous ways to optimize eResearch
• Exempt Research
• Expedited Review
• Expiration Date (see General Guidelines)

F-H

• FDA information about INDs or IDEs see Investigational New Drug Application or Investgational Device Excemption below
• Federal Regulations
  • 21 CFR 50 Regulations enforced by the Food and Drug Administration (FDA)-- Protection of Human Subjects
  • 21 CFR 56 FDA--Institutional Review Boards
  • 45 CFR 46 Regulations enforced by the Department of Health and Human Services Office of Human Research Protections (OHRP)
  • OHRP 45 CFR 46 FAQs
  • OHRP Federalwide Assurance FAQ
• Fees for IRBMED Review of Sponsored Projects
• Fetuses
• Foster children (see Wards of state)
• General Guidelines
  • University of Michigan Human Research Protection Program Operations Manual (OM)--The OM is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.
• Genetic and DNA Based Research
• HIPAA Guidance
  • HIPAA and Research - IRBMED Quick Guide
  • Helpful Links to Other Sites
    • Office of Civil Rights
    • UMHS HIPAA Information
    • Upcoming IRBMED Workshops and Presentations
    • HIPAA & Research Education Module
  • Privacy Board (forms and information)
  • Questions about HIPAA
    • General questions about mandatory education, education website, HIPAA processes or regulations
    • Questions about IRBMED HIPAA documents, applications, and processes click here

I

• IDE (see Investigational Device Exemption below)
• IND (see Investigational New Drug Application below)
• Informed Consent Guidance
  • Additional Required Elements under HIPAA
  • Children (see above, Children in Research, Assent)
  • Emergency Research with Exception from Informed Consent
  • Frequently Asked Questions (OHRP)
  • Non-English Speaking Subjects
  • Process
  • Simplification Guide to Medical Terms (Glossary)
  • Telephone (see Telephonic Consent)
  • Template-What's New
  • Tips on Preparing Understandable Informed Consent Documents
  • Waiver under OHRP, FDA & HIPAA Regulations
  • Who can Consent or Provide Permission for Participation in Research
• International Research
  • IRBMED Help Guide on International Research
  • International Compilation of Human Subject Research Protections (PDF document listing the laws, regulations, and guidelines that govern human subjects research in many countries around the world)
  • Miscellaneous International Resources at DHHS Office of Human Research Protections (OHRP)
• Investigational Device Exemption (IDE) Application
  • Decision tree to determine if an IDE is required
    • Continued Decision tree to determine if an IDE is needed for Custom or Diagnostic Devices
• Investigational New Drug (IND) Application
  • Decision tree to determine an IND is required
  • Bioavailability or Bioequivalence Studies--Decision tree to determine if an IND is required
• Investigator Responsibilities
  • FDA Guidance--Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
  • OHRP FAQs

N-P

• Neonates
• Other Reportable Events and Information (ORIO Reporting)
• Payment to Research Subjects
• Prisoners and Research
  • Federal Guidance (Office of Human Research Protections (OHRP))
  • OHRP FAQs
  • New study enrolling prisoners (OVPR webpage)
  • Subject becomes a prisoner / Study not previously approved to recruit prisoners seeks to enroll new subject who is a prisoner
• Privacy Board (forms and information)
• Protocol Deviations, Exceptions, Violations

R

• Radiation Exposure Guide
• Research Billing (see Clinical Research Billing Unit)
• Record Retention--How Long to Research Records
• Recruitment Advertising
  • Advertising--General Information
  • Guidelines for Non-Study-Specific Subject Recruitment Communication
• Removal of Blood
• Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g. DSMB, FDA)
• Risk--Guidelines For Using Magnitude Of Harm In Categorizing Risk Level 

S-T

• Signatures on Applications
• Standard Operating Procedures (IRBMED)
  • University of Michigan Human Research Participants Protection Program Operations Manual (Draft)
• Telephonic Consent
• Test Articles in Research
  • Biologics and Vaccines
    • General Information
    • Study Design
  • Charging for Investigational Products
  • Investigational Drugs
    • General Information
    • FDA IND Contact List (to determine if an IND is needed for off-label drug use in research or for a new drug, herb, or nutritional supplement)
    • Study Design
  • Investigational Devices
    • General Information
    • Significant Risk, Non-significant Risk Device Distinctions
  • Software Guidance (software may require an investigational device exemption from the FDA)

U-Z

• Unanticipated Problems involving research subjects or others
• Vulnerable Populations (links to HHS Office of Human Research Protections)
• Wards of the State as Research Subjects
• What's New on Applications
• What's New on the Consent Template

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