What if I want to make an amendment/change to my approved research?
A modification is defined as any change to a protocol from what was previously approved during the period for which approval has already been given. Changes of any kind in research procedures, the recruitment process, the recruitment instruments, the informed consent/assent process, and/or to the consent/assent document cannot be initiated by the investigator prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to human participants.
To request amendments/changes to your currently authorized and/or approved protocol, you must submit an Amendment Request Form and receive IRB approval prior to implementation.
Amendments/Changes to my currently authorized Exempt study:
There are no deadline dates for the submission of exempt amendment requests. They can be submitted electronically as an attachment to an email (orip@syr.edu), via campus mail (IRB-214 Lyman Hall), via U.S. mail (IRB-Syracuse University, 214 Lyman Hall, Syracuse, NY 13244) or by hand delivery to our office located in Room 214 of Lyman Hall during regular business hours (Academic Year-8:30 am-5pm; Summer Hours-8am-4:30 pm).
Turn-around time following initial review is generally 5-7 business days. Should modifications and/or clarifications be requested, additional review time will be required.
Amendments/Changes to my currently approved Expedited study:
There are no deadlines for the submission of expedited amendment requests. They can be submitted electronically as an attachment to an email (orip@syr.edu), via campus mail (IRB-214 Lyman Hall), via U.S. mail (IRB-Syracuse University, 214 Lyman Hall, Syracuse, NY 13244) or by hand delivery to our office located in Room 214 of Lyman Hall during regular business hours (Academic Year-8:30 am-5pm; Summer Hours-8am-4:30 pm).
Turn-around time for review is approximately 7-10 business days. Should modifications and/or clarifications be requested, additional review time will be required.
Amendments/Changes to my currently approved Full Board study:
Modifications/changes to your approved full board research may or may not require review at a convened meeting of the IRB.
- Changes related to methods, procedures, addition of research instruments, privacy of participants, confidentiality of data, and or risks, generally require review at a convened meeting of the IRB (Link to meeting schedule: ). One original plus 14 copies of the signed amendment request form, including any supplemental documentation is required.
- Changes related to addition/removal of a research staff member, minor consent/assent form revisions, and/or minor changes to the recruitment process/materials, can be reviewed via the expedited review process. Only one copy of the signed amendment request form, including any supplemental documentation is required. Allow 7-10 business days for initial review for these types of modifications/changes.
For guidance as whether your modification/change requires full board review or can be reviewed via the expedited review process, contact the Office of Research Integrity and Protections at 315.443.3013 or send an email to orip@syr.edu describing your proposed modification/change.
Do I need to notify the IRB every time I make an amendment/change to my authorized and/or approved IRB study?
Yes, any changes to the currently authorized and/or approved IRB protocol must be approved by the IRB.
Continuing Renewal
When do I need to renew my study?
Currently, federal regulations dictate that previously approved Expedited and Full Board studies must be re-reviewed annually at least once a year. Federal regulations do not permit the IRB to waive this requirement or grant an extension. If the protocol is not reviewed and approved by the expiration date, you must stop all aspects of your human participants’ research until your continuing renewal application is submitted, reviewed and approved by the IRB.
Exempt research studies do not require annual review/renewal.
Notice of Expedited Continuing Renewal
Approximately 60 days before the approval period expires, the Principal Investigator and members of the research team listed in Section 1 of the protocol application, will receive an email reminder notice of the expiration of the approved protocol. Until the project is submitted or expires, two additional reminders will be sent; one 30 days prior to expiration and the final notice two weeks prior to expiration.
If the protocol is not reviewed and approved prior to the expiration date, all research activities including advertisement, recruitment, enrollment, consent, data collection, data analysis, and interventions and interactions on current participants must cease until a continuing renewal application is submitted, reviewed and approved by the IRB.
A lapse may occur even if the investigator has provided the continuing renewal application prior to the expiration date, if the IRB was not allowed sufficient time for the review process.
Expedited Continuing Renewal Review Process
In conducting its continuing review, the IRB must engage in a process of substantive and meaningful review that allows it to make necessary determinations regarding risks, potential benefits, informed consent, and safeguards for human participants. The information requested in the application for the renewal approval process is intended to provide sufficient information to allow the IRB to make a reasoned determination. Specifically, the IRB must ensure that the currently approved or proposed consent document is accurate and complete; and that any significant new findings that may relate to the participant’s willingness to continue to participate in the study are provided to them.
All approved expedited research must be re-reviewed annually at least once a year and are renewable for up to seven years; after which a new application must be submitted for review and approval.
The expedited continuing renewal process is dependent upon the status of your study. It is important to note that the Continuing Renewal Application also serves as a request for Study Closure. Whether you wish to renew your application you must complete the entire application as instructed in the options outlined below.
Option 1: If your expedited study is active and remains open to the enrollment of new participants, a continuing renewal application including copies of the currently IRB date stamped consent and assent forms (if appropriate) along with clean copies of the identical documents that do not include the IRB date stamp, should be submitted for IRB review and approval at least 30 days prior to the expiration date to allow time for the IRB review process.
Option 2: If your expedited study is closed to enrollment but the participants are still engaged in the research or if follow-up with participants continues, a continuing renewal application should be submitted for IRB review and renewal approval. When your study is closed to enrollment, you no longer need to submit consent/assent forms for IRB review and IRB date stamping.
Option 3: If your study is closed to enrollment but data analysis* continues on data that have not been de-identified, a continuing renewal application should be submitted for IRB review and renewal approval. When your study is closed to enrollment, you no longer need to submit consent/assent forms for IRB review and date stamping.
Option 4: If your study is closed to enrollment but data analysis* continues on data that have been de-identified, a continuing renewal application should be submitted as a request to close and archive the study.
Option 5: When all research activities are completed, a continuing renewal application should be submitted as a request to close and archive the study.
*Data analysis. The Office for Human Research Protections (OHRP) has determined that no analysis of identifiable private information may be conducted without IRB review. As a result, researchers may only close studies that have completed enrollment and study interventions and are doing data analysis on de-identified/anonymous data. If data analysis continues on identified data then the investigator must continue to obtain IRB approval for the research.
Notice of Full Board Continuing Renewal
Approximately 60 days before the approval period expires, the Principal Investigator and members of the research team listed in Section 1 of the protocol application, will receive an email reminder notice. The notice will include the submission deadline date for the IRB meeting at which the protocol must be reviewed to avoid the expiration of the approved protocol. Until the project is submitted, two additional reminders will be sent; one 30 days prior to expiration and the final notice two weeks prior to the submission deadline date for the IRB meeting at which the protocol must be reviewed.
If the protocol is not reviewed at a convened meeting of the IRB with a majority of members prior to the expiration date, all research activities including advertisement, recruitment, enrollment, consent, data collection, data analysis, and interventions and interactions on current participants must cease until a continuing renewal application is submitted, reviewed and approved at a convened meeting of the IRB.
Because it is imperative that all full board continuing renewal applications are reviewed at a convened meeting of the IRB with a majority of members present, if the investigator fails to submit the full board continuing renewal for review prior to expiration, a new protocol application will need to be submitted for full board review and approval.
Full Board Continuing Renewal Review Process
In conducting its continuing review, the IRB must engage in a process of substantive and meaningful review that allows it to make necessary determinations regarding risks, potential benefits, informed consent, and safeguards for human participants. The information requested in the application for the renewal approval process is intended to provide sufficient information to allow the IRB to make a reasoned determination. Specifically, the IRB must ensure that the currently approved or proposed consent document is accurate and complete; and that any significant new findings that may relate to the participant’s willingness to continue to participate in the study are provided to them.
All approved full board research must be re-reviewed 365 days from the date it was reviewed at a convened meeting of the IRB with a majority of members present. Full board studies are renewable for up to seven years after which a new protocol application must be submitted for review and approval.
The full board continuing renewal process is dependent upon the status of your study. It is important to note that the Continuing Renewal Application also serves as a request for Study Closure. Whether you wish to renew your application you must complete the entire application as instructed in the options outlined below.
Option 1: If your full board study is active and remains open to the enrollment of new participants, a continuing renewal application including copies of the currently IRB date stamped consent and assent forms (if appropriate) along with clean copies of the identical documents that do not include the IRB date stamp, should be submitted for IRB review and approval at least 30 days prior to the expiration date to allow time for the IRB review process. One original and 12 copies of the IRB continuing renewal application and consent/assent forms must be submitted. Consult the IRB meeting schedule for submission deadline dates.
Option 2: If your full board study is closed to enrollment but the participants are still engaged in the research or if follow-up with participants continues, a continuing renewal application should be submitted for IRB review and renewal approval. When your study is closed to enrollment, you no longer need to submit consent/assent forms for IRB review and date stamping. One original and 12 copies of the IRB continuing renewal application must be submitted. Consult the IRB meeting schedule for submission deadline dates.
Option 3: If your study is closed to enrollment but data analysis* continues on data that have not been de-identified, a continuing renewal application should be submitted for IRB review and renewal approval. When your study is closed to enrollment, you no longer need to submit consent/assent forms for IRB review and date stamping. When research activities are limited to data analysis, the protocol may be re-categorized as expedited research and the request for renewal may reviewed via the expedited review process. Therefore, only a single copy of the continuing renewal application should be submitted for review.
Option 4: If your study is closed to enrollment but data analysis* continues on data that have been de-identified, a single copy of the continuing renewal application should be submitted as a request to close and archive the study.
Option 5: When all research activities are completed, a single copy of the continuing renewal application should be submitted as a request to close and archive the study.
*Data analysis. The Office for Human Research Protections (OHRP) has determined that no analysis of identifiable private information may be conducted without IRB review. As a result, researchers may only close studies that have completed enrollment and study interventions and are doing data analysis on de-identified/anonymous data. If data analysis continues on identified data then the investigator must continue to obtain IRB approval for the research. For full board studies: When research activities are limited to data analysis the protocol may be renewed through the expedited review process.
Unanticipated Events
During the course of the research, investigators or others may encounter events which are unexpected in nature, potentially adverse, and/or can affect the potential risks or conduct of the research. Such information must be reported to the IRB on the Report of Unanticipated Problems form. However, not everything needs to be reported.
Criteria for Reporting to the IRB
- Information that indicates a new or increased risk, or a new safety issue
- Harm experienced by a subject or other individuals, which in the opinion of the investigator are UNEXPECTED and PROBABLY RELATED to the research procedures
- Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance
- Audit, inspection, or inquiry by a federal agency and any resulting reports
- Written reports of study monitors
- Failure to follow the protocol due to the action or inaction of the investigator or research staff
- Breach of confidentiality
- Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject
- Incarceration of a subject in a study not approved by the IRB to involve prisoners
- Compliant of a subject that CANNOT be resolved by the research team
- Premature suspension or termination of the protocol by the sponsor, investigator, or institution