Investigator Resources

Human Subject Research Determination

The responsibility for initial determination as to whether an activity constitutes human subjects research rests with the investigator. This determination should be made based on the definitions of "human subject" and “research" in the HRPP Standard Operating Procedures. Final determination rests with Connecticut Children's HRPP. A confirmation that an activity does not constitute human subjects research should be requested from the HRPP Director, Medical Director or IRB Chair. This request may be made verbally, by phone, by email, or through formal written communication. All requests must include sufficient documentation of the activity to support the determination. If you have questions or need additional information regarding the human subjects research determination process, please contact the HRPP Director at 860.837.5517.

IRB Review 

All human subjects research conducted under the auspices of Connecticut Children's must meet the criteria for one of the following levels of review: 

  • Exempt
  • Expedited review
  • Full board review

Detailed policies and procedures for IRB review are included in the HRPP Standard Operating Procedures. 

If you have questions or need clarification regarding the IRB review process, please call the IRB Office at 860.837.5516.