Application Process

Protocol materials are submitted through email to hrpp@carasresearch.org

Materials to Submit

The following is a general list of items required by CARAS to begin the review process for a research study. These include:

  • New Research Application Form - Download here

  • Research protocol

  • Supporting documents, such as data collection instruments used, including survey and interview questions

  • All information intended to be seen or heard by subjects, including:

    • Consent documents (in Microsoft Word compatible format)

    • Information sheets (in Microsoft Word compatible format)

    • Advertisements and recruitment scripts and materials

  • Current curriculum vitae for the Principal Investigator and study staff that interact with subjects or have access to human subjects data

  • Research ethics training certificate of completion for the Principal Investigator and study staff that interact with subjects or have access to human subjects data (must be completed within the past 12 months).

  • If applicable, professional license(s), for the study investigators showing the expiration date, if a current one is not already on file with CARAS HRPP

HRPP Review and Regulatory Determinations

Upon receipt of the application packet, a staff member from the CARAS HRPP will review the submission for completion. We will coordinate with the principal investigator to address any questions or missing information.  Once complete, the HRPP Director, or designated CARAS person, will evaluate the regulatory status and appropriate review pathway.

Only the IRB is legally authorized to review and approve non-exempt human subjects research. Expedited review of non-exempt human subjects research is performed by the IRB Chair or an IRB member designated by the Chairperson, and the results are reported to the full IRB.  Exempt and limited IRB reviews are generally conducted by the IRB Chairperson or an IRB member designated by the IRB Chairperson.

Regarding Not-Research and Not-Human Subjects Research Determination (or not subject to IRB requirements)

Many activities that involve collection and analysis of information are not classified as human subjects research under the regulations and do not require IRB review.  In some cases, an activity may technically meet regulatory criteria for human subjects research but not require IRB review because the activity is not under federal or other legal jurisdiction that requires such review. It may be helpful for a researcher to have a formal determination made by an independent authority that their research or scholarship does not require review by an IRB.  CARAS can assess the activity and, if appropriate, can provide a determination letter documenting such regulatory status. If the project does require IRB review, CARAS can clarify the regulatory status for the investigator and assist with obtaining necessary review and approvals.

If you have questions about the regulatory status of your research, please contact the CARAS HRPP at hrpp@carasresearch.org.


Protocol Closure

Unless subject to annual continuing review, all exempt and non-exempt human subjects research protocols reviewed by the CARAS IRB or HRPP will be administratively closed three years from the date of initial approval or determination. A new review including a report of the project’s status will be required for continuation. The HRPP Office will assist Principal Investigators who wish continue a research project beyond a three year period following the initial approval or determination by the CARAS IRB or HRPP.