The following is an overview of what to expect before you submit your application, during the review process, after the IRB has made a determination, and responsibilities after approval.
Before You Submit Your Application
Familiarize yourself with the following:
Exemption from IRB Review
Effective January 21st, 2019, the updates to the Common Rule include changes to exemption categories.
Exemption from IRB review means that the study is not sent to the IRB Committee for expedited or convened meeting review. However, federal regulations and University policy require that the exempt determination is made by a person other than the research team. Tufts University has delegated responsibility for exempt determinations to the Tufts SBER IRB Office and Tufts Health Sciences IRB Office.
The University has also charged the IRB offices with the responsibility for reviewing exempt research to ensure compliance with IRB policy and University standards for human subjects research.
Exempt research may not begin until the Principal Investigator receives an official Exempt Determination Notice from their respective IRB office.
Exemption from IRB Review
During Review of Your Application
Within five business days of receipt of your application documents, you will be provided with feedback via email from an IRB staff member. Revisions are usually requested. IRB staff will advise you on best practices and guide you on how to revise your research plan according to federal, state, local and institutional regulations and guidelines. This process can involve several rounds of emails between you and the IRB office, so it is recommended that you submit your application several weeks in advance of your desired start date, and reply with revisions in a timely manner. Once your revisions are complete, your application will be placed in one of the following review categories:
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Excluded from review: your study was found to be not human subjects research.
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Exempt review: an IRB staff member will work with you until your protocol meets institutional requirements and regulatory eligibility criteria for exemption.
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Expedited review: once the staff requested revisions to your protocol have been satisfied, your application will be sent to an IRB member for review. The reviewer is given five business days in which to complete the review and make a determination.
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Full Review: your application will be reviewed by the convened IRB on the next eligible meeting date.
IRB Determinations
Determinations as follows:
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Excluded status: You will receive a notice of excluded status via email. No further action is required.
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Exempt applications: You will receive a notice of exempt status via email. Exempt applications do not receive stamped study documents but any changes to the protocol should be reported to the SBER IRB office.
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Expedited applications:
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Approved: you will receive an approval letter and stamped study documents via email and interdepartmental mail.
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Approved with Conditions: approval will be given as long as certain revisions are made. You will receive a letter via email outlining the necessary revisions. Once those revisions are received and approved, you will receive an approval letter and stamped study documents via email and interdepartmental mail.
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Referred to the convened IRB: the reviewer has determined that the application requires review by the full IRB. You will receive an email or phone call with next steps.
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Full review applications:
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Approved: you will receive an approval letter and stamped study documents and stamped study documents via email and interdepartmental mail.
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Approved with conditions: approval will be given as long as certain revisions are made. You will receive a letter via email outlining the necessary revisions. Once those revisions are received and approved, you will receive an approval letter and stamped study documents via email and interdepartmental mail.
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Tabled: the IRB cannot approve the research at a meeting for reasons unrelated to the research, such as a loss of quorum. You will receive a letter via email or phone call noting this determination and the date on which your application will be reviewed.
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Deferred: the IRB determines that it is unable to approve the research and suggests modifications that might make the research approvable. You will receive a letter via email or phone call outlining the necessary revisions, and you will have the opportunity to respond to the IRB in writing.
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Disapproval: Made when the IRB determines that it is unable to approve research and there are no modifications which might make the research approvable. You will receive a letter via email or phone call outlining the reasons for this decision, and you will have the opportunity to respond to the IRB in writing.
After Approval
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Only currently approved and stamped study documents may be used for research.
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If you have received approval to conduct your research in a language other than English, you must submit the translated documents/texts for approval, along with a Certificate of Translation. Do not submit translated documents until after you receive approval of the finalized English versions.
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Modifications: If you wish to modify your approved study protocol, you must submit a Request for Protocol Modification and receive approval prior to implementing the modification(s).
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Continuing review: Approval must be renewed every 364 days. Several weeks in advance of your study expiration date, as noted on your approval letter(s), plan to submit a Request for Continuing Review. If your approval expires before continuation has been approved, all study activities must be suspended until approval is received.
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Closing a study: If you have completed data collection and analysis, submit a Request for Study Closure.
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Report issues, adverse events or other developments that occur in the course of your research. Download the Reportable New Information Form and refer to page 3 to see if this information should be reported to the SBER IRB. Reportable information should be sent to the IRB within 5 business days.
Translations
Do you plan to enroll Non-English speaking participants in your research?
If YES: The IRB must review and approve translated study documents before you can use them in your study.
The IRB Approval Process for Translated Documents:
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Obtain approval for English-language versions of the study documents (consent forms, recruitment letters, flyers, surveys, etc.)
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Translate study documents into each language that will be used.
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Complete a Certificate of Translation for each language being used.
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Have the Certificate(s) signed by a person qualified to attest that the translation is accurate and matches the approved English version.
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The person who signs the Certificate may NOT be a member of the study team.
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A qualified person is any person who has fluency in both English and the language of translation.
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Have the Certificate(s) signed by the Principal Investigator and Faculty Advisor (if the PI is a student).
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Submit translated document(s) and Certificate(s) to the IRB for review and approval.
Please note the following:
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Translated documents must match the approved English versions throughout the conduct of the study, as long as non-English Speaking participants will be enrolled.
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If English versions of study documents are modified, modifications are required for the corresponding translated study documents (unless otherwise approved for population-specific study documents).
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Modifications to translated documents must be submitted with corresponding tracked and clean English versions of the document.
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If the IRB determined that your research is Exempt, you are not required to submit translated documents for IRB review and approval.
