General Protocol Submission Guidance
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| All submissions must be complete prior to review and approval. (Note: incomplete submissions cannot be processed and may result in significant delays for the researcher). If possible, please submit applications at least three – four (3-4) weeks prior to the date you need approval. The IRB Full Board meets on the first Wednesday of the month. Protocols requiring Full Board review must be received by the IRB office at least two (2) weeks prior to the next meeting to get on the agenda. |
| The following items are necessary for a complete submission: |
- An application that is fully completed and signed (either electronically per the instructions on the form or by hand);
- Informed Consent (when applicable);
- All recruiting materials;
- All questionnaires or surveys (when applicable);
- If the Principal Investigator (PI) is a student, a Faculty Assurance Form completed by the student’s Faculty Advisor;
- Some studies may require other items such as documentation of permission to work in a school, IRB approval from a collaborating institution, etc.
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All applications and forms may be submitted electronically to irb-review@andrew.cmu.edu. Incomplete applications will result in a delay of approval.
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New Protocols
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Several forms are available for submission of new protocols. These forms are tailored to specific types of research. Please read the descriptions of these to determine which form is appropriate for your particular protocol. The Decision Tree provides some guidance.
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Exempt Review
- Protocols that are conducted in established educational settings and involve normal educational practices. Use Exempt Form (b)(1) .
- Protocols that only involve tests, surveys, interviews or observation of public behavior. Use Exempt Form (b)(2).
- Protocols that only involve the collection or study of existing data, documents or records if these are publically available or recorded in such a way that research participants cannot be identified. Use Exempt Form (b)(4).
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Expedited Review
Protocols that do not meet the criteria for exemption may qualify for Expedited Review. These are minimal risk studies that that fall into one of eight categories set forth in federal regulations (45 CFR 46.110). Use the CMU IRB Application and the CMU Consent Form Template or the Online Consent Template.
Full-Board Review
Protocols that are greater than minimal risk research or do meet the exemption or expedited criteria discussed above must go to the Full Board. Use the CMU IRB Application and the CMU Consent Form Template or the Online Consent Template.
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Informed Consent
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| When submitting a new protocol, please use the current CMU Consent Form Template or the Online Consent Template as a guide for your document. See this guidance for instructions on customizing the template to your study. If your study involves fMRI, please use the fMRI Consent Form Template. |
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If you are requesting a Waiver of Informed Consent or a Waiver of Documentation of Informed Consent, indicate this in the application and fully complete those sections.
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Information for Students and Faculty Advisors
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When a student is the Principal Investigator for a study s/he is responsible for completing the application and indicating student status and identifying the Faculty Advisor for the study. For all student lead studies, a Faculty Assurance Form must be completed and submitted.
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Modifications to an Approved Protocol
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| The IRB should be notified before a change is made to a protocol. Some changes require IRB review and approval, others do not. All requests for modification should be made using the Request for Modification Form. If you have a question about the need to submit a modification, contact the IRB office. |
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Things that require IRB review and approval:
- Change in study design – ex. adding a new type of study activity
- New location for conduct of the study
- A change in investigators.
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Things that may require IRB notification only:
- Changes to questionnaires that are consistent with the approved questionnaire
- Change to recruiting materials that are consistent with the approved materials
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Items that need to be submitted for a modification:
- Request for Modification Form
- Updated application highlighting the changes made
- Any supporting materials that are changed such as:
- Updated consent form
- Updated and/or new questionnaires, surveys
- Updated and/or new recruiting materials
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Continuing Review / Annual Renewal
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| Federal regulations require that IRB approved protocols be reviewed and approved no less than once every twelve months. The CMU IRB office typically sends reminder notices that a protocol is due for renewal 6 weeks prior to the first of the month in which it expires. |
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Items that need to be submitted for an annual renewal:
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International Research
In the event research is being conducted outside of the USA, please contact the IRB office for guidance. The human subject protection requirements for each country must be considered. Typically local review is required.
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Education Requirements - updated January 2010
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All personnel involved in Human Subjects Research that is under the purview of the CMU IRB must demonstrate completion of an education program on the use of human participants in research. In recent years, CMU used an NIH on-line course for education. In the fall of 2009 we began using an on-line education program through the Collaborative Institutional Training Initiative (CITI). One advantage of this program is that it includes material for both social and behavioral researchers and biomedical researchers.
As of February 1, 2010, anyone from CMU who has not completed human subjects education and will be involved in human subjects research must complete a CITI course rather than the NIH course. People who have previously completed the NIH education do not need to complete the CITI education.
To complete the required education go to CITI's website.
- Select Carnegie Mellon University as your "participating institution" and create an account.
- When you have created an account you will be directed to a page titled "Select Curriculum" which displays a list of courses on Human Subjects Research: Biomedical Research Investigators; Social & Behavioral Investigators, and IRB Members. Choose the human subject research module most appropriate to the type of research you conduct.
- The course may take a few hours to complete but can be done over a period of time.When you complete the course, CITI will e-mail your completion record to the CMU IRB.
If you have done CITI education for another organization, add CMU to your profile. You will be given credit for your previous courses to the extent they overlap with CMU's requirements.
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The CMU IRB will also accept the human subjects research education done via the University of Pittsburgh.
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Documents and Forms - NEW as of January 2009 and updated April 2010 and July 2011
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| CMU IRB Application Updated July 2011 |
| CMU IRB Application Exempt (b)(1) |
| CMU IRB Application Exempt (b)(2) |
| CMU IRB Application Exempt (b)(4) |
| CMU IRB Request for Modification |
| CMU IRB Request for Continuing Review |
| CMU IRB Faculty Advisor Assurance Form |
| CMU IRB Consent Form Template |
| CMU IRB Consent Form Template for fMRI studies |
| CMU IRB Instructions for Customizing Consent |
| CMU IRB Online Consent Template |
| CMU IRB Reporting of Adverse or Unanticipated Events |
| Exempt Status Decision Tree |
| FAQs |
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All applications and forms may be submitted electronically to irb-review@andrew.cmu.edu.
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Reference Information and Links
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