Exemption Umbrella Protocols
What is an Exemption Umbrella Protocol?
An exempt study is one that adheres to principles of sound research design and ethics to protect the rights and welfare of participants, while also fitting into at least one of the Exempt Categories of Research. Investigators must adhere to all requirements and responsibilities described in Investigator Guidance Series: Exempt Research.
Studies that receive an exemption from the IRB
- Do not expire and are not required to obtain continuing review from the IRB; thus, continuing review applications are not required
- Require amendment applications for substantive changes to the protocol to ensure the study still qualifies for exempt status in light of the changes
- Must adhere to the University of Utah IRB reporting requirements for unanticipated problems and deviations
- Must be closed with the IRB once the research activities are complete
An Exemption Umbrella Protocol allows for multiple, similar research projects to be conducted under one IRB application. This group of projects should be similar in purpose and fit within the same individual exemption category or combination of categories.
In addition to all of the requirements described in Investigator Guidance Series: Exempt Research, you must also adhere to the following requirements:
- You must notify Lacy Clegg, IRB Administrator, via email of your intent to create an Exemption Umbrella Protocol. Discussion regarding your
protocol may be required prior to submission in ERICA.
For umbrella protocols under exemption category 7, you are highly encouraged to attend the following RATS classes:
- You must submit a full application in the ERICA system. Use the Help Sheet for Exemption Umbrella Protocol Applications and the example protocols below as a guide for completing the IRB application in ERICA.
- For studies that require consent processes: Because the IRB will not be approving individual consent documents and consent processes
for each specific project under the umbrella, the PI is required to ensure that any
consent documents or verbal consent discussions used include at a minimum the following
- A description that the project is for research purposes.
- A description of the procedures that will be conducted.
- A statement that participation is voluntary.
- The name and contact information for the investigator.
Remember, you must be able to account for consent for all participants in the study. The IRB requires this documentation to be maintained in the study records.
- You must maintain a record of all specific projects and analyses that are conducted
under this protocol, including documentation that each is conducted in accordance
with the procedures and provisions described in this umbrella application. You must
maintain all regulatory and study-specific documentation (i.e., consent documentation,
case report forms, questionnaires, etc.) as you would for any IRB-approved protocol.
- You must submit annual reports while the Exemption Umbrella Protocol is open, using
the Exemption Umbrella Annual Report Template (this template may also be used as the official record described in #3 above). The
annual report must be submitted to the IRB as a Report of Information, which will
be acknowledged by the IRB. This annual report must include:
- The title of each individual project initiated under the umbrella protocol
- The names of the investigators who conducted each individual project
- A short description of the specific aims and procedures for each individual project
- The actual or estimated number of participants who were or will be enrolled or included in each individual project
- The date each individual project began
- The date each individual project ended, if it was completed before submission of the
- You must submit 3 types of amendments:
- Keep your IRB application up-to-date with the investigators who will be performing research under the Exemption Umbrella Protocol. This allows for potential conflicts of interest to be considered.
- Keep your IRB application up-to-date with any and all sponsors providing funding or oversight for the projects conducted under the Exemption Umbrella Protocol.
- Submit any changes that would change the exemption category determination of the Exemption
Umbrella Protocol. The exemption category determination can be found in your exemption
letter from the IRB. The full list of exemption categories can be found in Investigator Guidance Series: Exempt Research.
- You must submit a Report Form in ERICA for any reportable unanticipated problems or
instances of non-compliance related to any individual projects under the umbrella
protocol, according to the standard IRB reporting policies.
- As of 9/1/2013 and until further notice, all accepted Exemption Umbrella Protocols will be audited by the IRB within the first two years of activation. The audit worksheets used by the IRB are available on the Self Assessment page. It is highly advised that investigators use these worksheets to (a) establish appropriate methods of maintaining research records prior to beginning the study, and (b) prepare for scheduled IRB audits.
|Short Description||Types of study procedures conducted||Exemption
|Education policies and practice evaluation||Interviews
Analysis of secondary data
Example consent form
|Analysis of congressional behavior||Interviews
Analysis of secondary data
Secondary biomedical data and tissue analyses -
|Analysis of secondary data
Analysis of banked tissues
|Secondary biomedical data and tissue analyses -
using identifiable data and tissues
|Analysis of secondary data
Analysis of banked tissues
|Secondary biomedical data analyses - using identifiable data||Analysis of secondary data||7|
Exempt studies require less regulatory oversight than other studies that require full IRB approval. The IRB also has to make fewer determinations for exempt studies. Because of this, it is acceptable for the activities conducted under an IRB-issued exemption to receive less detailed consideration, so long as the activities fit into an exemption category and the rights and welfare of participants are continually protected.
Tips and Notes about Exemption Umbrella Protocols
Exemption umbrella protocols must not be used for partial coverage of a project.
Consider the following examples:
- A retrospective chart review is needed to identify potentially eligible patients for a clinical trial. The retrospective chart review must not be conducted under an existing exemption umbrella protocol for secondary data analysis, but should be conducted under the IRB approved application for the clinical trial. Because the purpose of the retrospective chart review is fundamentally tied to the purposes of the clinical trial, it is not appropriate to separate these components under two different IRB applications.
- A retrospective analysis is conducted under an existing exemption umbrella protocol for secondary data analyses. Through this retrospective analysis, new findings are derived and prompt new hypotheses that need to be tested using a prospective study. The prospective study is subsequently designed. In this case, it is appropriate for the retrospective analysis and the prospective study to be conducted under separate IRB applications, as the need for the prospective study was not determined until the retrospective analysis was complete. These would be considered two separate projects.
Exemption umbrella protocols are not appropriate for the creation and maintenance of research registries, databases, or tissue banks.
This includes databases of people who have agreed to be contacted for future research. Consult the IRB to determine if the creation and maintenance of a registry, database, or tissue banking meets the definition of human subject research and requires IRB approval.
Information About Exemption Umbrella Protocol Audits
Tip 1: Study teams have developed a variety of documents to help keep track of individual projects conducted under their Exemption Umbrella Protocols. These documents also help to inform investigators of the rules for conducting research under the umbrellas. The IRB highly recommends the use of such documents, as it helps to ensure compliance with Exemption Umbrella Protocol policies. Two examples are provided for reference in the case that such examples are useful to other study teams.
Tip 2: A common audit finding was that new investigators and study staff working on individual projects under the umbrella had not been added to the Exemption Umbrella Protocol application via an amendment. Please ensure that amendments are submitted promptly to add new investigators and study staff who are working on projects under the umbrella. An amendment for new personnel must be approved before an individual project begins.
Bulk Personnel Amendments:
If you anticipate times of year when a new group of individuals may want to work on projects under your umbrella (i.e. when a new semester begins with a new class of students, when new medical residents begin, etc.), it is recommended that you make provisions for submitting a single amendment with a full list of possible umbrella users. This will allow you to submit fewer amendments to change personnel. You will need a process for informing this group of individuals to (1) create an account in ERICA, (2) complete CITI training, (3) complete a COI disclosure in an efficient and timely manner. Many study teams that work with students and residents require steps 1-3 as part of course work or orientation processes to ensure the students and residents are ready to be added via an amendment.
Tip 3: Create and maintain a Study Site Signature/Delegation log to include all study team members managing the Exemption Umbrella Protocol. The Umbrella log should include all activities that have been delegated by the PI to other study team members as well as the signatures/initials of all study team members. Study teams for individual projects under the umbrella are not required to be included on the Umbrella log. However, if the individual project investigator delegates some of the individual project procedures to other staff members, the project investigator should maintain his/her own signature/delegation log for the project.
Tip 4: Research records may be printed or electronic format. If electronic records are used,
they should be organized in such a way that the IRB auditor can easily locate all
of the necessary documents in one place. The records must meet the standards set
forth in the Self-Assessment Worksheet for Exemption Umbrella Applications.
Tip 5: Ensure that you have access to copies of CVs for all investigators working under the umbrella. CVs or resumes for non-investigator study team members are not required.