Human Subjects in Research

Does Your Research Project Require IRB Review? 

In order to determine whether an activity is research that requires review by the IRB the following questions should be answered:
 
A. Does the research meet the federal definition for involvement of human subjects?
 
  • Does this project involve working directly with people, i.e. collecting information through intervention such as interviews, procedures, or questionnaires? 

     

  • Does this project collect data indirectly through the review of records or non-detected observation e. g., through a one-way glass?

     

  • Can the data or information as collected be linked with an individual through a name, ID number, etc., or through deductive reasoning?

     

  • Will the data collected in this project be used at a later time as part of a research project? Example: data about an employer, age or gender.

     

  • Will this project involve children, prisoners, incompetent persons, pregnant women, University of  Toledo students, faculty or staff as subjects in the study?
 

B. Does the research meets the Federal Definition for "research"?

 
  • Is the purpose of the project to carry out a systematic investigation which is designed to develop or contribute to generalizable knowledge?

     

  • Is the project part of an internship, research practicum, independent study, independent research, honors project, thesis, dissertation or other formal research activity?

Ifthe answer to any of the questions posed in A is "Yes" and either of the questions in B is "Yes", the projects is subject to review  by the IRB and the investigator must submit the project on either a Protocol Application or Claim of Exempt Application as determined by the level of risk. 

A worksheet to assist in determining whether your protocol meets exempt category can be found on the first three pages of the Claim of Exempt Instructions and Form. If your protocol does meet an exempt category, complete the Claim of Exempt Form and submit it for IRB review.

 

Instructional Projects

 
A project may be considered “instructional” and not require IRB review if it satisfies the criterion listed below:
  • Is the purpose of the project strictly instructional in nature and is the aim the development of student knowledge and skills independent of the data collected?

Ifthe answer is 'Yes', the project does not meet the definition of human subjects research and does not require review by the IRB. 

 

All qualifying research projects involving human subjects not falling in the "instructional" category must be reviewed by the IRB Chair, Chair Designee or the full IRB in order to comply with federal regulations and University policies concerning the use of human subjects in research. An investigator should allow sufficient lead time for the review of any project submitted to the IRB as the committee meets on a monthly basis. 

Categories for review by the IRB are: full Convened, Expedited and Exempt. Following submission of the protocol application, projects will be pre-reviewed and assigned to either the convened or expedited category.  Expedited applications will not require the review of the entire committee but will be evaluated in detail by the Chair or Chair Designee to determine compliance with human subject research guidelines, 45 CFR 46 and the University's Federalwide Assurance.  Exempt applications will also be reviewed in the same manner.  Convened items will be reviewed by the entire board at the monthly meeting.  Please see IRB Meeting Schedules & Member Information for submission dates.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Last Updated: 3/23/15