University of Minnesota
Institutional Review Board
http://www.research.umn.edu/irb
612-626-5654

Institutional Review Board home

Guidance & FAQs

Guidance for Human Subjects' Protection in Research

The links on this page are meant to assist researchers in preparing their application for review of research involving human subjects in accordance with the guidelines set forth by the University. Human Research Protection Program staff also developed a downloadable guide to provide more information. Download the Protecting Human Subject Guide.

Consent Process & Forms

Guidance on consent forms, recruitment, obtaining consent, and details on what must be included on these forms and how to avoid problems when creating them. This section also contains some assistance regarding consent form language, best pratices, and a few templates are provided.

Click here to learn more.

Regulations and Ethics

Vulnerable Populations

Federal regulations 45 CFR 46 and 21 CFR 56 identify the following populations as potentially vulnerable and requiring certain protections:

In addition to these three categories, the IRB has also identified the following subject groups who may be vulnerable to coercion because of their situation or issues pertaining to autonomy. Additional protections may be required for these groups:

Other considerations regarding the status of potential subjects that are reviewed in the specific context of the research include:

  • Economic disadvantage
  • Educational disadvantage
  • Language barriers or cultural values
  • Involvement in potentially emotional or otherwise sensitive current events or incidents
  • Health status and/or chemical use
  • Terminal illness

Research may also involve otherwise healthy, normal subjects but propose to address sensitive topics, including:

  • Sexual practices
  • Substance use/abuse
  • Illegal behavior
  • Religion
  • Immigration status
  • Race/Ethnicity
  • Physical emergency conditions in a community or geographic area
  • Economic status of the subject or subject’s family
  • Perceived sanctions for participation/non-participation

Data & Privacy

HIPAA & Research

  • Learn how to perform HIPAA compliant research
  • What to do for existing studies?

Electronic Data Storage & Security

  • How to keep Research Data Protected and Secure

Biological Specimen & Tissue Storage

  • Guidance on Coded Data⁄Human Specimens
  • IRB Recommendations for Storage
  • Suggestions for Informed Consent and Consent Forms

Data Safety Monitoring

  • Data Safety Monitoring requirements of the IRB
  • Data Safety Monitoring Boards and Plans

Certificates of Confidentiality

  • Protect identifiable research information from forced disclosure
  • NIH Statement on Certificates of Confidentiality
  • NIH Guidelines on the use of Certificates of Confidentiality

What Every Researcher Needs to Know

  • Getting Started
  • Points of Emphasis
  • Responsibilities

Regulations & Ethics

  • Federal Regulations
  • Federal Guidelines
  • Board of Regents Policies and Procedures
More Information

Other Topics

Social Research

  • Advice for Advisors
  • Tips from Students
  • Resources Specific to Social Research

Exempt Research

  • Common Errors
  • Useful Definitions
  • Resources Specific to Social Research

International & Cross-Cultural Research

  • IRB Review of International Research
  • BioEthics around the World

Class Protocols for Research Methods Courses

  • How to request approval for a Class Protocol
  • Guidelines for Class Protocols

Drugs & Devices

  • IND/IDE
  • HDEs

Emergency Waivers of IRB Approval

Granted in "Emergency Use" cases for drugs or devices, typically life-threatening, situations.

Essential Documents for the Conduct of Clinical Trials

Outlines Specific Documents Which Demonstrate Compliance For Sponsors and Regulatory Agencies

 

For guidance on the consent forms, recruitment, and obtaining consent, see: Consent Process & Forms

Frequently Asked Questions

Feel free to contact our office with any questions or suggestions.