Guidance for Analysis Centers
Version Date: August 24, 2010
A significant number of research groups at the University of Wisconsin-Madison serve as analysis centers for multi-site studies. Analysis centers are defined as providing core or central image reading or analysis, specimen analysis, or statistical data analysis for multi-site studies but are otherwise not involved in the conduct of the research. Research groups that provide such support for multi-site research studies are considered to be engaged in human subjects research and thus IRB oversight of their activities by a University of Wisconsin-Madison IRB is required.
This document describes how the Health Sciences IRBs review research studies involving human subjects when the University of Wisconsin-Madison’s role for that study is limited to serving as an analysis center and what documents these research teams must submit for IRB review. The Health Sciences IRBs review analysis center protocols primarily to ensure local activities meet institutional and federal criteria for IRB approval and to determine whether the study for which the UW-Madison will serve as an analysis center presents any ethical concerns that would prevent the institution from supporting the protocol. The Health Sciences IRBs rely on the IRBs reviewing the study to ensure that the other components meet the criteria for IRB approval under the Common Rule and/or FDA regulations.
When preparing an initial review application for an analysis center, study teams ensure the following issues are addressed in the application:
- Describe the role of the UW-Madison researchers related to the study, the purpose of the overarching study, and the subject population (including whether the study includes vulnerable subjects)
- Identify the coordinating center
- Identify the status of the overarching study (e.g., completed vs. ongoing)
- What UW-Madison receives for this study (data, images, specimens, other) and what information is associated with what the UW-Madison receives
- How UW-Madison receives the data, images, or specimens, included whether they are coded or directly identifiable
The study team should provide the following supporting documents with the initial review application:
- Documentation of IRB approval for the coordinating center
- A copy of the study-wide protocol
- Template or model consent form for the study
teams generally are not required to submit investigational drug brochures
Changes of Protocol
Only changes that affect procedures at UW-Madison require review and approval by a Health Sciences IRB. Examples of changes that affect local procedures include:
- Revisions to data transmission procedures
- Change in information associated with data, images, or samples provided to the UW-Madison or the type or source of data, images, or samples the UW-Madison will review
- Local personnel changes.
Changes that do not directly affect the analysis center activities can be described at the time of continuing review. Research teams do not need to provide the revised documents (e.g., updated study-wide protocols or IDBs).
Analysis center protocols must continue to undergo IRB review until all activities involving human subjects that involve the UW-Madison are complete. Copies of revised documents (e.g., study-wide protocol, IDBs) that do not affect the analysis center activities do NOT need to be submitted with the continuing review application. Changes to these documents should instead be described in the continuing review application.
Note on Data Retention or Research Outside of the Scope of the Analysis Center Protocol
If UW-Madison researchers retain identifiable data, specimens, after the study supported was completed or conducts research on images or conduct research on data, specimens, or images they receive that are beyond the scope of the activities the IRB approved for the protocol, a new research protocol is needed to cover these activities.