IRB Protocol Life Cycle

New Project

Any research involving human subjects, bio specimens and/or tissue samples from humans, and/or private identifiable data must be reviewed by an Institutional Review Board (IRB). Submissions for review must be done using IRBNet and all new project application packages must include the protocol form properly filled out and, when applicable, the informed consent document(s), and any other relevant materials (e.g., advertisements, research instruments, surveys, questionnaires, etc.). Forms and templates are available in IRBNet under the “Forms and Templates’ tab in the left-hand side menu options.

Once submitted the IRB office will determine the type of review needed. If the project is deemed to be exempt or suitable for an expedited review the process will be done on an ongoing basis as projects are received. Processing times will vary depending on the total workload of the IRB at a given time. When a new project is determined to require full board review it will be assigned to the next available IRB meeting agenda. The IRB at UD meets once a month and deadlines for submissions to be considered for review are posted in the research calendar. After review the IRB office will communicate with the principal investigator and request for any clarifications or edits needed to be completed before approval can be issued.

Once a review has been completed, decision letters are uploaded in IRBNet and always accessible to the investigator(s). Informed consent documents from projects approved via an expedited or full board reviewed will be stamped with the IRB approval and expiration date and also uploaded in IRBNet. Informed consent must be obtained using the stamped version of the approved documents, (i.e., participants signatures need to be collected in a copy of the stamped informed consent.) No IRB stamp is added to informed consent documents associated to projects deemed exempt.

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For questions, send email to: hsrb-research@udel.edu

Ammendments

If ANY changes need to be made to an IRB approved protocol, investigators must seek IRB approval of those changes prior to their implementation. Examples of changes that would require the submission of an approval are: changes to the research team members, modifications in the recruitment strategies and/or advertisement materials, any changes to the research instruments already approved, elimination of previously approved procedures and/or data collection measures, new approaches to data processing or storage, edits to the approved informed consent language, etc. Amendments are reviewed as they are submitted and may take on average up to 2 weeks to be completed.

Amendment submission packages must contain the amendment form properly filled out, and the tracked changes version of any documents affected by the change (e.g., the previously approved protocol form and informed consent document, advertisement materials, etc.). In addition if the amendment does affect the informed consent document, a clean version (changes accepted) needs to be submitted so a newly IRB-stamped informed consent can be issued upon approval. The approval of an amendment has no effect on the previously set expiration date but will change the approval date.

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For questions, send email to: hsrb-research@udel.edu

Continuing Review

Protocols approved by the IRB, whether under expedited or full board review, are required to undergo continuing review at least annually on or before the expiration date set at the time of approval for as long as recruitment and data collection is to take place, and/or private identifiable data is kept. In some cases, the IRB may require more frequent continuing reviews. Expiration reminders are automatically sent from IRBNet to the Principal Investigator (PI) and all others with whom the project has been shared with, and granted full access to, in IRBNet. Reminders are sent 60 and 30 days before the project is set to expire. In addition an expiration alert is sent on the expiration day if no approval has been secured before that day. Applications for continuing review must be submitted with enough time to allow for IRB review prior to the expiration date. In order to maintain the expiration anniversary date continuing reviews applications are reviewed no earlier than 30 days before the expiration date (because of it, a 30 day expiration notice will always be received even when the application for review has been submitted early). Once a continuing review is approved a new one year approval period starts and informed consent documents are stamped with the new approval and expiration dates.

Unless eligible for expedited continuing review, protocols originally reviewed and approved by the convened IRB meeting (full board) must undergo a full board continuing review. IRB meeting dates and deadlines must be considered when submitting a continuing application to be reviewed at a full board as to avoid lapses in IRB approval. Continuing review submissions must contain the continuing review form properly filled in and all other current documents relevant to the project (at a minimum the most current previously approved protocol form and a clean version of the informed consent). If any changes are added at the time of continuing review the tracked changes version of the protocol form and informed consent document(s) need to be added to the continuing review application.

Lapses in IRB Approval: It is the responsibility of the investigators to provide in a timely manner the information needed by the IRB to perform its continuing review functions. When continuing review of a research project is not completed prior to the end of the approval period specified, the IRB approval will expire. All research activities involving human subjects (i.e., participant recruitment and/or data collection), must stop after IRB approval expires. Expired projects for which the IRB office has not been notified, shortly after the expiration date, of the intent for continuation will be closed. Once closed, a project cannot be re-opened and will have to be resubmitted as ‘new’ for review and approval before any research related activities can be re-initiated.

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For questions, send email to: hsrb-research@udel.edu

Problems

Investigators must report to the IRB any instances of unanticipated problems and adverse events related to the research within 3 days of the incident. Unanticipated problems, in general, include any incident, experience, or outcome that meets the following criteria:

• unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;


• related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research);


• suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.

Unanticipated problems and adverse events must be reported to the IRB by submitting the appropriate form via IRBNet. If researchers propose to implement any corrective measures based on the incident that would need modification of the previously approved protocol and/or informed consent documents, the tracked changes version of those documents needs to also be uploaded along with the UP/AE form. Depending on the nature and of the event reported the IRB Office and Chair will decide if a full board review of the submission is needed.

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For questions, send email to: hsrb-research@udel.edu

Closure

Protocols approved by the IRB under an expedited or full board review must receive continuing review at least annually until closed. A project can be closed when all the following conditions are true:

• Enrollment and all data collection for the study have been completed. If future contact with participants or follow up is planned or needed the study cannot be closed
• Private identifiable data is no longer being stored, accessed, or worked on
• Link (access code) if any between the research data and the identifiers has been destroyed

A closure submission should be done as soon as the conditions above are met by creating a new submission package and including the closure form in IRBNet. If no closure request is submitted by the investigators projects will be closed by the IRB Office upon expiration. Once a study has been closed it cannot be re-opened. Any future work related to the study (e.g., long- term follow up with participants, etc.) will require for a new project to be reviewed and approved by the IRB before the work can start.

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For questions, send email to: hsrb-research@udel.edu