How to Complete a Replacement Application in ARROW
How to complete a replacement application
The purpose of this document is to provide guidance to study teams regarding replacement applications, which is outlined under the University of Wisconsin-Madison 5-Year Renewal Policy. This policy was put in place to ensure that applications approved by the IRB are updated to meet current IRB and regulatory standards. For additional information, please see Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW.
Replacement submissions should be submitted as a new initial review application in ARROW and at least 3 months (for non –VA studies) or 5 months (for VA studies) prior to expiration of the original application. Replacement applications should:
- Identify the activities that are ongoing
- Briefly summarize activities that have been completed
- Be able to stand on their own (i.e., IRB reviewers or external auditors should be able to obtain all the information they need to assess the study from the replacement application and not need to refer back to the application being replaced)
Generally, a replacement study is not required to undergo scientific review unless it has changed substantially from the study being replaced.
The text of the application should be clear in regard to which activities are still occurring versus those that are complete. Thus, simply copying and pasting from the previously approved application is not advised. Particular sections of the ARROW application to pay attention to that may differ from the original application include, but are not limited to:
Funding: These sections should reflect the current funding supporting the replacement application. Any expired funding sources, even if they previously supported the research, should not be included in the new application.
Study Team Members: Only those study teams members who will be conducting ongoing study activities should be listed as study team members. Those study team members no longer participating should not be listed in the replacement application.
Study Location Section: If the original study occurred at multiple sites and/or the UW served as IRB of record for other sites or personnel for this study, the study location section should be updated to include only those sites or personnel who will continue to participate in study activities. The study protocol also should be revised to reflect any changes to where or who will be involved in the conduct of ongoing study activities.
Question 1.1: The most recent version of the protocol, if one was required by the IRB previously, should be uploaded in 1.1 on this page of the ARROW application. The protocol should be revised to include a summary of the status of the application being replaced.
Changes not previously approved by the IRB that the study team wishes to make to the research study can be incorporated into the protocol within the replacement application. Any changes to the protocol from the last version approved by the IRB in the application that is being replaced should be tracked.
Question 1.3: The timeline of expected completion should be entered in 1.3 and may be different from the original estimate depending on how the study has progressed.
Research Design and Procedures:
Questions 1.1 and 1.2: These sections should generally include the same information regarding the overall purpose and aims of the project as was provided in the most recently approved IRB application being replaced. If changes are being incorporated into the application since the most recent IRB approval, a description of the previous purpose and aims should be briefly summarized followed by a description of the current purpose and aims and how they differ from them.
Question 1.3: This section should reflect the current state of the study. Please use this section to provide background information in support of the study or project and include in the description any new information that has arisen over the course of the project which would impact the rationale for it, such as any interim analyses or new supporting studies.
Question 1.4: Please describe the activities that will continue. Any activities that have been completed should be referred to in the past tense. If samples, images, data, records, or recordings collected or accessed for the project being replaced will continued to be used as part of the study (e.g., combined with data, images, or samples that will be collected under the replacement application or continued to be analyzed under the replacement application) indicate here what will be carried over into the new application.
Research Design and Procedures (continued):
Questions 2.1 and 2.2: Please complete these sections as they were with the application being replaced, unless treatment and alternatives have changed during the course of the study.
Question 2.3: This section should be clear about the activities that have been completed versus those still being performed.
Risks and Benefits: These sections should be updated to describe the risks or potential benefits of the research but also include any changes to this information (e.g., any risks originally anticipated that have not occurred or unexpected risks experienced since the project was initiated). In cases where the study status changed from when it was originally approved these sections should be clear on the current expected risks related to the activities that will be completed under the replacement application. For example, if the study closed to enrollment and subjects are still receiving active treatment, briefly describe the primary risks of the original study and then concentrate on any long-term risks to subjects that will be monitored.
Subject Population: Question 1.2 of the Subjects Population: General section of the ARROW application should describe the total number of subjects intended to be enrolled overall (meaning the number of subjects to be enrolled under the current replacement application as well as the number of subjects that were enrolled under the previous iteration(s) of the study). In general, this answer will be the same as was given under the original version(s) of this application (unless enrollment goals have increased/decreased with the replacement application).
A Study Status Summary that includes information about the number of subjects enrolled under the previous iteration(s) of the study should be uploaded in the Supplemental Information section of the replacement application.
If enrollment under the replacement application is closed, question 1.2 in the Subjects Population: General page of the ARROW application should be the same number as was provided in 1.2 of the previous iteration of the application.
Subject Identification and Recruitment: If recruitment is ongoing, describe the procedures that will be used. If a recruitment method previously used will no longer be employed it does not need to be described unless it will help the IRB in contextualizing the replacement application. Recruitment materials previously approved by the IRB that will no longer be used in ongoing recruitment activities do NOT need to be uploaded in the replacement application. If the study accrual has been met, this should be clear in this section.
Informed Consent: General: If the IRB originally approved a waiver or alteration of informed consent or a waiver of documentation of consent to conduct all or certain components of the study, the replacement application should reflect this if the activities for which the waivers were granted are still being conducted. For example, study teams who accessed medical records to identify potential subjects or for telephone screening would need to include the waiver of informed consent request in the replacement application. However, if the study team is no longer accessing medical records to identify potential subjects or telephone screening is complete (e.g., enrollment has been completed), the study team does not need to include a request for a waiver or alteration of informed consent for this activity in the replacement application.
Informed Consent: Overview:
Questions 6.1 through 6.3: This section should describe the consent process that was followed in cases where enrollment is closed. If enrollment is ongoing, this section should describe the consent process that will be followed. If any re-consenting needs to occur, this should be described in this section as well.
Question 6.5: If consent forms and information sheets were required for the study by the IRB and will still be used for the replacement project, the most recently IRB-approved version of the consent documents should be uploaded in this section. This includes studies that are closed to enrollment for which the most recently approved consent documents should be uploaded for future reference and if re-consenting will be needed or enrollment re-opens.
Changes not previously approved by the IRB that the study team wishes to make to the consent documents can be incorporated into the replacement application. Any changes to the consent documents from the last version approved by the IRB in the application that is being replaced should be tracked.
Consent documents that will no longer be used will not be stamped for approval.
HIPAA: Continued: How to complete this section depends on whether the study team was previously required to obtain written authorization from participants for some or all components of the project and which activities will continue under the replacement application.
Question 3.1: Select how the HIPAA Privacy Rule was satisfied in the application being replaced as well as how it will continue to be addressed.
Question 3.2: Select only the identifiers that will continue to be used in the replacement study.
For subsequent sections, please complete as follows:
- If the study team previously used a HIPAA authorization separate from the consent form to obtain authorization from participants, the HIPAA authorization form that was used to enroll subjects should be included in the HIPAA: Authorization section even if the study is closed to enrollment. If the HIPAA authorization was combined with the consent form, it should be uploaded as described above.
- If the study team obtained access to protected health information under a complete waiver of authorization, the replacement application should include the waiver of authorization request.
- If the study team received a waiver of authorization for a component of the study, also called a partial waiver of authorization, and will continue to use the protected health information accessed or collected under that partial waiver for the replacement application, the replacement application include the partial waiver of authorization request.
Question 1.1: Please answer “yes” and in 1.1.1 explain that the application is being replaced due to the campus 5-year replacement policy. In 1.1.2 provide the UW IRB number for the application being replaced.
Question 2.1: Upload a Study Status Summary. The Study Status Summary includes a description of the following information to help the IRB contextualize the replacement application:
- Proposed Changes – Any changes being made to the protocol, consent documents, or other study documents not previously approved as part of the application being replaced.
- Completed Activities – Any activities completed under the IRB application being replaced that will not continue under the replacement application.
- Enrollment Information – The total number of subjects enrolled or number of samples, images, and/or recordings already collected for the research study under the application being replaced and how many additional will be enrolled or collected. If subjects were enrolled and enrollment will not continue under the replacement application (e.g., for studies with subjects still on active treatment), the procedures that had been used to identify and recruit subjects should be provided.
- Significant Events in the Study History: Any events that affected study progress (e.g., prematurely closed to enrollment).
- Reportable Events, Subject Withdrawals, and Subject Complaints: Any reportable events (unanticipated problems, noncompliance, and adverse events), subject withdrawals, and subject complaints that since the last continuing review for the study being replaced should be described.
In addition to the Study Status Summary described above, please also upload in 2.1 any studywide reports (e.g., Data Safety Monitoring Board or Data Monitoring Committee reports) and updated Investigator’s Drug Brochures (IDBs) received since the last continuing review.
Question 2.2: Please describe any documents uploaded in 2.1.