Social, Behavioral & Educational Research IRB
Submitting to the SBER IRB
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.
Note: If you are collaborating with another institution, you might need a IRB Authorization/Reliance Agreement.
Tips for a Successful Submission to the IRB
- USE THE SBER STUDY SUBMISSION CHECKLIST: This will help to ensure that you have prepared all of the needed documents that are relevant to your research. Complete submissions without missing documentation, such as recruitment materials or surveys, have a significantly faster turnaround time than submissions that are missing required documents.
- DOWNLOAD TEMPLATES & FORMS FROM THE SBER WEBSITE: Always visit the Tufts SBER IRB’s Forms & Templates page to download the current versions of our documents (Protocol, Consent, etc.) as these documents may be updated periodically. Using the current versions, rather than locally saved versions, will help to ensure that the necessary information is provided to the IRB and the consent forms include all required elements of consent, thereby reducing the time for review.
- SUBMIT DOCUMENTS IN WORD: This helps to facilitate communication with your reviewer(s) and reduces the likelihood of errors within the eIRB system.
- COMPLETE THE PROTOCOL THOROUGHLY: Respond to all prompts within the Protocol Template with clear and thorough explanations to provide an accurate description of the participant experience. Avoid using jargon. The Protocol should be written in plain language accessible to individuals without expertise in your specific field as the IRB reviewers come from a variety of experiential backgrounds.
- ASSESS THE READABILITY OF CONSENTS: Use the Editor function in Word to assess the readability of the consent form on the Flesch-Kincaid readability scale. Consents should be accessible to the youngest potential participant and should be written at an 8th grade reading level if participants are being recruited from the general population.
- IDENTIFY YOUR FACULTY ADVISOR: If you are a student PI, your Faculty Advisor must be identified on the “Basic Study Information” page in eIRB AND on the “Local Study Team Members” page. Failure to do so will leave the submission stuck in the Faculty Advisor Review phase, as the Faculty Advisor will not have access to the submission.
- SUBMIT EARLY: We encourage all researchers to submit their applications as early as possible, because the review process does take time. This is especially important for researchers traveling internationally or with strict funding deadlines.
- CONSULT EIRB RESOURCES: Available eIRB Tip Sheets and eIRB Video Tutorials can assist with navigating the eIRB submission platform.
- CLICK “SUBMIT”: All submissions in eIRB only enter the IRB review queue once the “Submit” button is clicked. When this button is not clicked, the project remains in the “Pre-Submission” state and does not reach the IRB Office.
Familiarize yourself with the following:
- Researcher Responsibilities
- Eligibility to be a Principal Investigator
- Required Training
- CITI Online Training. Approval will not be granted until all study team members have completed the training.
- Responsibilities for International Researchers
- General guidelines for turnaround time from submission to approval
Effective January 21st, 2019, the updates to the Common Rule include changes to exemption categories.
An Exempt determination 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.
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:
- Not Research/Not Human Subjects Research: your study was found to either not meet the definition of regulated research or the definition of human subjects research.
- Exempt review: an IRB staff member will work with you until your protocol meets institutional requirements and regulatory eligibility criteria for exemption.
- 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.
- Full Review: your application will be reviewed by the convened IRB on the next eligible meeting date.
Determinations as follows:
- Not Research/Not Human Subjects Research: You will receive a notice of Not Research or Not Human Research determination via email. No further action is required.
- 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.
- Expedited applications:
- Approved: you will receive an approval letter and stamped study documents via email.
- 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.
- 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.
- Full review applications:
- Approved: you will receive an approval letter and stamped study documents and stamped study documents via email.
- 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.
- 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.
- 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.
- 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.
- Only currently approved and stamped study documents may be used for research.
- 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.
- 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).
- 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.
- Closing a study: If you have completed data collection and analysis, submit a Request for Study Closure.
- Report issues, adverse events, or other developments that occur in the course of your research. Submit a Report of New Information (RNI) to the IRB via eIRB within 5 business days of becoming aware of the information.
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, if the study requires Expedited or Full IRB Review. If the IRB determined that your research is Exempt, you are not required to submit translated documents for IRB review and approval.
The IRB Approval Process for Translated Documents:
- Obtain approval for English-language versions of the study documents (consent forms, recruitment letters, flyers, surveys, etc.)
- Translate study documents into each language that will be used.
- Complete a Certificate of Translation for each language being used.
- Have the Certificate(s) signed by a person qualified to attest that the translation is accurate and matches the approved English version.
- The person who signs the Certificate may NOT be a member of the study team.
- A qualified person is any person who has fluency in both English and the language of translation.
- Submit translated document(s) and Certificate(s) to the IRB for review and approval.
Please note the following:
- Translated documents and translation certificates should not be submitted until the English versions have been approved.
- Translated documents must match the approved English versions throughout the conduct of the study, as long as non-English Speaking participants will be enrolled.
- 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).