Categories of Review for Research Studies

The CPHS office uses specific regulatory definitions and refers to the human subjects protections regulations in determining the appropriate level of review. Examples provided below are intended only to guide an investigator's determination of the level of review needed.  Please contact the CPHS office with any questions.

1. Exempt from further CPHS review

Determinations that a research project is exempt from review are made in the CPHS office.  Exemption from review is only available to certain categories of research, as defined by federal regulation.  

• Anonymous survey and interview procedures or observation (without intervention) of public behavior.
• Survey and interviews to which the identity of the participant can be linked but the information obtained is innocuous. Disclosure of this information would NOT reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation.
• If information is recorded without any identifiers, study of existing data or pathological specimens.

Application Procedure

Exemption Review Form (Go to: Forms).

CPHS Response

Upon receipt of an application for an exempt determination, the CPHS office will review the application and respond with questions, clarification requests,  and notify the investigator by letter of the exemption.

Please note: Do not use the "Exemption Review Form" to apply for CPHS review of activities that do not involve human subjects research, such as quality improvement, program evaluation, and public health activities without a research component. The CPHS only reviews human subjects research. "Exemption from further review" is the level of CPHS review applied to certain categories of research activities involving human subjects that satisfy specific regulatory criteria. The use of the word "exempt" does not mean the project does not need CPHS review or that participant permission for research participation is not needed. The CPHS will review the project and, if applicable, grant the designation "Exempt from further review".

2. Expedited Review

This level of review only applies to research involving no more than minimal risk. Minimal risk is defined as a risk level similar to what is encountered in daily life or during performance of routine physical or psychological exams or tests.  Only certain categories of research activities, as defined by federal regulation, are eligible for expedited review.  NOTE: The standards of review for expedited studies are the same as for studies that receive Full Committee review.  

Examples of research eligible for expedited review:

• Surveys, interviews, and focus groups which can be linked to individual participants and request some types of "sensitive" information.
• Blood draws.
• Study of data collected for non-research purposes, for example study of clinical data or pathological specimens.
• Collection of data or specimens using non-invasive procedures including audio, video, EEG, and ECG recordings, and ultrasound and MRI imaging.

Application Procedure

Expedited Review materials (Go to: Forms)

Review Procedure

Upon receipt of completed application and associated materials, designated CPHS members will review materials. CPHS office will notify the Principal Investigator in writing of approval.

Please note: Continuing review (renewal) is required for studies receiving expedited review.

3. Full Committee Review

• Criteria for exempt or expedited review are not met.
• Invasive medical treatments.
• Physical, psychological, economic, reputational, or social risk involved.
• Special populations (minors, prisoners, participants lacking decision making capacity).

Application Procedure

Full Committee Review materials (Go to: Forms)

Review Procedure

CPHS office will notify the Principal Investigator in writing of the results of the review by the full committee.

Please note: Continuing review (renewal) is required for studies receiving full committee review.