Amendments

Step by step instructions on how to submit your revised documents in eIRB as well as how to revise the eIRB application.

1. Go to eIRB.
2. To request an amendment, scroll to the top of your protocol in eIRB and look for a series of blue boxes and select the “New Amendment” box.
3. You now have the option of selecting a New Amendment or Continuing Review OR a New Amendment based on the type of study/expiration date.
4. Click “Request” to open the e-Amendment Form and you will complete the “Create New Amendment” sheet.
5. Select the “Type” of form you are filling out using the dropdown arrow. (Note you may ignore this step if the form type auto-filled correctly.)
6. Select the type of change you are requesting using the search or dropdown menu. (i.e. Research Team for this example). Note you may select multiple changes at one time.
7. Complete the rest of the fields as necessary. Make sure to indicate whether the current amendment changes the content of the consent form.
8. To continue click “Save” in the bottom right corner of the e-form.

    

   eIRB Instructional Walkthrough
   https://upenn.app.box.com/s/iy5xlgu3d7wwlhs0cifqt013or6e15dz/folder/365145935254

Step by step instructions on how to submit your revised documents in eIRB as well as how to revise the eIRB application.

1. Go to eIRB.
2. To request an amendment, scroll to the top of your protocol in eIRB and look for a series of blue boxes and select the “New Amendment” box.
3. You now have the option of selecting a New Amendment or Continuing Review OR a New Amendment based on the type of study/expiration date.
4. Click “Request” to open the e-Amendment Form and you will complete the “Create New Amendment” sheet.
5. Select the “Type” of form you are filling out using the dropdown arrow. (Note you may ignore this step if the form type auto-filled correctly.)
6. Select the type of change you are requesting using the search or dropdown menu. (i.e. Research Team for this example). Note you may select multiple changes at one time.
7. Complete the rest of the fields as necessary. Make sure to indicate whether the current amendment changes the content of the consent form.
8. To continue click “Save” in the bottom right corner of the e-form.

 

eIRB Instructional Walkthrough
https://upenn.app.box.com/s/iy5xlgu3d7wwlhs0cifqt013or6e15dz/folder/365145935254

Click below for guidance on how to submit personnel changes to the IRB, including Principal Investigator (PI) changes.

Guidance

Please see guidance online here: https://irb.upenn.edu/homepage/faqs/continuing-review-faqs

 

This section contains guidance on when modifications should be submitted for studies reviewed under exempt and limited review categories.

 

Federal regulations require modifications for studies that have undergone Limited Review. Please consult your initial approval letter to determine if your study underwent Limited Review. If you are still not sure, please reach out to the original reviewer or a senior analyst.

Modifications to exempt studies are typically not required. As the IRB has determined the study to meet criteria for exemption, the study team can make non-significant changes to their protocol and study documents without notifying the IRB or requesting formal approval.

Examples of changes that do not require IRB review:

• Editorial or administrative revisions to consent documents or other study documents.
• Adding non-sensitive questions to a survey or interview or revising current questions.
• Adding new recruitment strategies that follow IRB guidance.
• Increasing or decreasing the number of subjects without altering the target population.

Researchers may submit modifications to IRB exempt protocols that are not required. For example, researchers may want IRB reassurance that the changes are acceptable, or they may want to add new personnel to the protocol so that they can gain access to eIRB. IRB staff assigned exempt modifications are encouraged to process these items for acknowledgement in timely manner and to obtain necessary information via email in order to facilitate these requests.

Significant changes to the exempt protocol, changes that impact a limited IRB review determination, or changes that impact HIPAA-compliance status require assessment by the IRB through modification of the protocol in HS ERA. Changes that increase the risk of the study, enroll a vulnerable population, or otherwise require expedited or convened review should be submitted for IRB review under a new initial protocol submission.

Examples of changes that require IRB review:

• Removal of the consent process, or use of deception or incomplete disclosure.
• Adding sensitive questions to a survey or interview process (e.g. questions regarding illegal activities; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation).
• Collection of new elements of protected health information under a HIPAA Waiver.
• Changes to the data storage plan for studies that received a limited IRB review.
• Addition of new personnel who are not affiliated with the Penn health system, if the study involves the use of protected health information.
  
  

THE ABOVE LIST IS NON-EXHAUSTIVE. RESEARCHERS ARE ENCOURAGED TO CONSULT WITH A SENIOR ANALYST REGARDING PROPOSED CHANGES TO IRB EXEMPT STUDIES.

In the eIRB electronic modification application request you will identify the level of IRB review required for your modification submission so that it can be properly assigned. If a change may represent more than minimal risk to participants, it must be reviewed and approved by the IRB at a convened meeting. This applies to both minimal risk and greater than minimal risk studies. The IRB must review and approve proposed changes before the change can be implemented, unless the change is necessary to eliminate an immediate hazard to the research participants. In the case of a change implemented to eliminate an immediate hazard to participants, please review the separate guidance for how to submit Exception requests. Click below for examples.

What level of IRB review is required?

In the eIRB electronic modification application request you will identify the level of IRB review required for your modification submission so that it can be properly assigned.

If a change may represent more than minimal risk to participants, it must be reviewed and approved by the IRB at a convened meeting. This applies to both minimal risk and greater than minimal risk studies. The IRB must review and approve proposed changes before the change can be implemented, unless the change is necessary to eliminate an immediate hazard to the research participants. In the case of a change implemented to eliminate an immediate hazard to participants, please review the separate guidance for how to submit Exception requests.

Examples of changes that may require convened board review:

• Increase in target enrollment for early phase (first in human, Phase 1-2) research
• Significant increase in target enrollment for an investigator-initiated greater than minimal risk protocol
• Revised acute or long-term risk information that may change the risk/benefit ratio or affect a particpant’s willingness to participate
• Significant changes to the protocol design that may affect the risk/benefit ratio or criteria for IRB approval, including changes to the selection criteria
• Introduction of new procedures that do not qualify for expedited review under the designated expedited review categories (e.g., biopsy, CT scan, X ray, MRI with contrast, etc.)
• Adding a non-significant risk medical device used in an investigational manner to a protocol (these determinations must be made at the convened level)
• Changes to the following section of an IB: Summary of Data and Guidance for the Investigators

Examples of changes that may be eligible for expedited review:

• Increase in target enrollment at Penn where overall enrollment target is not exceeded
• Administrative changes: changes in personnel, editorial edits to study documents
• Expanding inclusion or removing exclusion that improves the safety of the protocol or where a new population has the same expected risk as the previous, based on similarities of condition
• Revised acute risk information where all participants have completed the study or are in long-term follow-up (in essence, the risk information doesn’t apply to these subjects)
• Minor risk revisions that do not affect the risk/benefit ratio, and no participants are enrolled to date
• Non-substantive changes to the protocol design that do not affect the risk/benefit ratio or criteria for IRB approval
• Introduction of new procedures that qualify for expedited review under the designated expedited review categories (e.g., non-sensitive questionnaires, venipuncture within the limits outlined in expedited category 2, collection of saliva, non-contrast MRI, etc.)
• Non-substantive changes to an IB (e.g., changes to clinical and non-clinical study summaries that do not affect the Summary of Data and Guidance for the Investigators)

Guidance on timelines for submitting “New Information” that identifies new risks or that may affect a subject’s willingness to take part in the study (e.g., action letter, revised IB with impact on the protocol and/or consent, revised procedures, etc.).

When a change of protocol is planned it should be submitted to the IRB for review in a timely manner, especially if the changes include revisions that

1. affect the risk/benefit ratio of the study (e.g., result in a change to the protocol);
2. affect alternatives to study participation for subjects;
3. represent new information that should be provided to subjects; or
4. affect the local conduct of the study.

Some modification submissions may not technically be changing any aspect of the study but are still required. Such as providing DSMB reports, notes to file, memos from the sponsor, letters from the FDA or other oversight organization. Submitting these things in real time throughout the year will help to reduce the number of documents you need to coordinate and include at the time of Continuing Review and will improve regulatory compliance.

Changes Resulting from New Information
Changes that are the result of new information that identifies new risks or that may affect a subject’s willingness to take part in the study (e.g., action letter, revised IB with impact on the protocol and/or consent, revised procedures, etc.) should be submitted to the IRB by the study team as soon as possible. Submission to the IRB of such new information is expected to occur no later than 90 days from either 1) receipt from a sponsor, lead PI, etc. or 2) identification of the new information when there is not an external sponsor or lead site. This timeframe should allow the research team sufficient time to prepare the change of protocol application materials and obtain approval by a scientific review committee, when required, prior to review by the IRB.

Please note that some new information may require immediate notification to participants. Principal Investigators should consider this and (when applicable) consult with the sponsor / lead PI or the IRB as necessary.

Exceptions to the 90 day submission timeline may be appropriate in certain circumstances (e.g., when no one has been enrolled on the study and enrollment will be held until the new information is approved by the IRB; when no one is actively participating in the study and the new information doesn’t apply to subjects on study, etc.). Principal Investigators should consider the impact on participants in these cases and consult with the sponsor / lead PI or the IRB as necessary.

As necessary, if version dates on documents appear significantly delayed, please clarify for the IRB date of receipt from the sponsor. The IRB may ask for this clarity if this is not provided.