Closing a Project

Principle Investigators (PI) are responsible for filing a Closing Report within the ARISE system, when ethics certification is no longer required for a project.

Filing a Closing Report, rather than just letting your approval lapse, is important as it a llows the University to ensure that research is only being undertaken with active ethics approval in place. Note that some funding agencies and sponsors require a notice of closure from the ACUC/REB which can only be generated after the Closing Report has been filed.

Additionally, when a Closing Report is filed for a funded project, a notice is automatically forwarded to RSO, allowing them to update the project file without the need to follow up with REO or the researcher.

When to close your study

Human Participant Research

An active REB approval may no longer be needed when the human participant research outlined in your ethics application is completed. Depending on your research, this may be when:

  1. you have collected all of your human participant data in accordance with the study protocol and there will be no further contact between the researcher and participants. Examples:
    1. You will not conduct member-checking (going back to participants to check that the data you collected is correct);
    2. You will not be reporting results back to participants.
  2. you will no longer need to access any participant records or original data sources being used for the research. Examples:
    1. Student records;
    2. Medical/health records;
    3. Administrative data;
    4. Data source collected by another researcher but being used by you in your research (ie. secondary analysis).
  3. you do not need to maintain active ethics approval in case the data may be used by others in the future (ie. secondary use by others of your data).
  4. you do not need to maintain active ethics approval to access funding held by UA Research Services. When human ethics certification to access funding is no longer required as above, a Closing Report can be submitted to the REB to close the file. The closure approval letter can be provided to Research Services as documentation to allow the fund to continue to be accessed without active ethics certification. NOTE: precluding funder requirements for active ethics approval being maintained for the life of the grant.

REB Termination of Research Activities

The REB may also terminate approval if after 4 years no participants have been recruited. This is in consideration of the administrative burden that such reporting creates on the REB. As well, scientific standards and research ethics standards continually evolve. A dormant certification may not keep pace with such changes and participant safety might be best served by new applications. In cases where the research has not been initiated and no participants have been recruited, the REB will consider:

  • the rationale provided by the researcher
  • changes in research ethics oversight standards
  • sponsor requirements

Animal Research

An active ACUC approval may no longer be needed when the animal research/teaching or testing outlined in your Animal Use Protocol is completed. Submitting a Closing Report means ethics approval is no longer required because the study team will no longer be working with live animals.

The following table contains helpful examples to assist in determining when you should renew versus close an AUP.

RENEW STUDY CLOSE STUDY
Animal work as outlined in the AUP is ongoing. Live animal work is completed and there is no plan to renew or continue the research outlined in the AUP (ex vivo/post-mortem tissue work and data analysis are ongoing).
Scientific articles are submitted for review and publication - sponsors/reviewers may require the PI to repeat or perform experiments to gather more data.

The PI is leaving the institution (ie. no longer employed) and there is no local PI who will take over the study. NOTE: All animals remaining in the facility must be transferred to another active AUP. Animals cannot be housed under a closed protocol.

If PI is planning to continue the research at another institution, they must check animal ethics requirements at that Institution (ie. you cannot leave your U of A AUP open as evidence of valid ethics approval at another Institution).
Wildlife specific studies: Animal monitoring/study-related activities are completed but tracking devices are employed on animals. No live animal research or teaching has been conducted in the past 2 years; the ACUC may recommend closure of the AUP.  Contact the ACUC specialist for more details in these cases. Please note: AUPs are able to be copied in ARISE even if you close a study (ie. you don’t have to start building your AUP from scratch).

You do NOT need to maintain active ethics approval to access funding held by UA Research Services. When animal ethics certification to access funding is no longer required as above, a Closing Report should be submitted to the ACUC to close the file. The closure approval letter can be provided to Research Services as documentation to allow the fund to continue to be accessed without active ethics certification.  Note: precluding funder requirements for active ethics approval being maintained for the life of the grant.