Applying for IRB Review





1. Determine if your project requires IRB approval.

Anyone conducting ‘research’ with ‘human subjects’ as defined in 45 CFR 46.102 must submit a research application for review. All forms are available on the IRB website. The IRB meets once per month to review applications. When in doubt, contact an IRB member for clarification. IRB approval is never retroactive.

 

2. Complete the Mandatory Certification for Researchers.

Before approval can be given for the use of human subjects, applicants (faculty and/or students) must complete the training course by PHRP (or an alternate approved source) “Human Subjects Research”, and complete and pass the Quiz. Attach a copy of your Certificate of Completion to your application. https://phrotraining.com/#!/

 

3. Complete the IRB Application.

This form must be completed with extensive detail and include all necessary accompanying forms. A sample copy of the application and informed consent are available on the IRB website.

 

Informed Consent:

Projects involving human participants require informed consent. Participant under the age of 18 require unique forms — parental consent and assent. All informed consent forms should include the following information:

  • The form should describe the purpose of the research
  • It should describe what participants will be asked to do and the duration of the research
  • It should a “concise and focused presentation of the key information” to help individuals decide whether they wish to participate or not
  • It should include any known risks and/or benefits
  • It must clearly state that participation is voluntary
  • It must clearly state that participants may withdraw at any time, and that refusal to participate or withdrawal will not result in penalty
  • Statements that participant identity will be protected, confidentiality or anonymity, must include a description of how that protection will be If data is gathered in such a way that linking the data to a specific person is impossible, then you can promise anonymity. If data records can be used to identify a participant, then all you can promise is confidentiality and the form should describe how that data will be protected, to the extent allowed by law.
  • It should describe the conditions under which any compensation will be made to
  • Names and contact information of individuals to contact if participants have questions: the principal investigator, and faculty advisor if appropriate, and the IRB chair
  • The form should contain no ‘exculpatory language’. Participants must not be asked to waive any legal rights, nor may they be asked to release the investigator or college from liability for

 

4. Submit the Application to the IRB.

  • Email completed proposal with labeled attachments (consent forms, researcher certifications) as a pdf to the IRB Chair (edu)
  • Mail to: Cloud County Community College IRB, Dr. Gwen Cannes, Chair 2221 Campus Drive

Concordia, KS 66901

5.  Approval Process.

Applications are logged, and given a protocol number, when received by the IRB Chair who then performs an administrative review. If the proposal has insufficient information for review, the PI will be notified and the proposal will remain pending for 30 days. If necessary information for review has not been received within the allotted time, the proposal will be terminated and the PI notified. If needed information is received within the allotted time, the proposal will be reviewed as follows:

 

Exempt: If the proposal is exempt, only the chair needs to review, although other members (partial board) may be asked to review. Exempt status indicates the research presents minimal risk and does not require continuous monitoring.

 

Expedited or needing Full Board review: The proposal will be considered by the full board at the next regularly scheduled meeting. The board meets monthly.

 

The proposal is denied, approved, or pending. PIs will be notified within 5 business days of the review. Pending applications, those needing minor or major revisions, will be given specific information for revisions and 30 days to complete the revisions.

 

A full board review is required before the denial of an application. When denied, the PI will be sent that determination with details of the decision. Any PI receiving a denied proposal may appeal the decision, within 30 days of notification, by requesting a hearing before the board to present extending evidence, or evidence contrary to the details of the board decision. The board will hear any appeal within 30 days of notification. Determination of the board is final.

 

6. Protocol Modification.

Any changes to the approved research protocol, except when necessary to eliminate an immediate threat to human subjects, must receive IRB approval. A modification request (or extension) must be submitted before any changes can be made to the approved protocol.

 

  1. All research except that considered ‘exempt’ will be on a continuous review process as determined by the IRB.

 

8. Final Report

A final report is due to the IRB upon the completion of each research project (within 60 days of completion).