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Eastfield College Operating Procedures

DCCCD IRB Standard Operating Procedures contain Eastfield College's written guidelines that operationalize federal IRB requirements.

Research Review
The Eastfield College Grants Team will help EFC's principal investigators decide which type of review to request from the IRB. There are four categories of review:

• Exempt research review - for projects involving with less than minimal risk and no vulnerable subjects
• Expedited review - for projects involving less than minimal
• Full Committee review - for project involving significant risk
• Continuing review - for annual oversight of projects
  

IRB Training
Federal regulations require IRB committee member training at the time of their appointments. IRB members must then submit a training verification form to the IRB chair indicating they have completed human subjects training.

Other sources of IRB training and information:

• Office for Human Research Protections, Department of Health and Human Services training
• National Institute of Health training and information
• National Cancer Institute training and information

Get help making decisions
The Office for Human Research Protections of the Department of Health and Human Services provides a decision tree to help you decide: Does my research activity have to be reviewed by the IRB? Can the review go through the expedited process? Can informed consent be waived?

Exempt - review determines whether or not the proposed research meets the requirements or exempt status, or whether the project should be submitted for review under another category.
Expedited - applicable in instances of renewal, minor changes in previously reviewed research, and in special cases of limited human involvement with minimal risk.
Full - required for all new research proposals that do not meet the requirements for Exempt status or Expedited review (99% of all of our projects will be either exempt or expedited).

Important Links
The online version of the Code of Federal Regulations, (45 CFR Part 46) is user-friendly and allows you to search for particular topics.

Another indispensable online resource is the comprehensive Guidebook of the Department of Health and Human Services Office for Human Research Protections. It is called the Institutional Review Board Guide Book.

The National Science Foundation, and 16 other federal agencies, adhere to federal regulations called the Common Rule for the Protection of Human Subjects is 45 CFR Part 690.