Appendix 6: Template for IRB Protocol Language
Note: The NRMN Coordination Center used this template to communicate with individual studies.
Two components that need to be addressed in the [study name] IRB protocols include:
- Data sharing with the [coordination center name] at the [name of institution where coordination center is housed]
- Ability to share and use collected data in future studies
Data sharing with [name of institution where coordination center is housed]
[Study name], is a major national initiative funded by the [funder]. [Institution name] serves as the coordination center for this national effort. Identifiable data needs to be shared with the [coordination center name] at [institution name] so that we can, at a minimum, report on the hallmarks across the research community. IRB protocols must be set up to include the following so that this sharing is possible.
- IRB protocols must state that the collected data (identifiable) will be shared with [coordination center name] at [institution name]. Data will be transferred through a secure mechanism (each site may decide how this will be done).
- The [coordination center name] at [institution name] will have an approved IRB protocol which will cover the ‘storage’ of the data (we will distribute this protocol number soon for each study to include in their IRB).
- The [coordination center name] at [institution name] will only report aggregate results with the agreement of each site. No data (identifiable or not) will be shared for research without an approved IRB protocol and the permission of each site. Only the data for which the participants consented will be shared (see section below).
Ability to share and use collected data in future studies
IRB protocols typically cover the research which will be conducted in the current study. However, we want to allow for this data to be used beyond the specific research studies and by the larger [research community name]. In order to share data AND allow for the data to be used in future studies we need all participants to agree to these terms when they consent into the current study.
Since we do not know the exact nature of these future studies, several elements need to be included in each IRB protocol.
- Consent statements
- Participants must agree to allow for their data to be used for ongoing and future research
- Participants must also agree to allow for their name and email to be shared with collaborators (including those outside of their university) for future longitudinal studies
- IRBs for future studies
- In the IRB protocol, researchers must agree to create new protocols for any future research studies which will use this data (i.e. the use of the data will be covered under the new IRB)
We recognize that each IRB operates differently and are happy to discuss any questions or concerns.
Checking if your IRB protocol covers everything
Since all IRBs are a bit different, one good way to ensure your IRB has everything that you need is to ask the reviewer if the protocol allows for the following:
- Share all collected data with the [coordination center name] at [institution name]
- Share identifiable data with the [coordination center name] at [institution name]
- Allow the collected data to be used in future research studies at your university (for those who consented in and with an approved IRB)
- Allow the collected data to be used in future research studies at other universities/with other partners (for those who consented in and with an approved IRB)
- Share participant names and email addresses with the [coordination center name] at [institution name] (if the participants have consented)
If the answer is no to any of these, please work with your IRB office to make any necessary changes to allow for all of the above to take place.
