The consideration of ethical implications of our research goes beyond the snapshot information provided to ethics reviewers just before the project starts. It needs to be an ongoing process that takes place throughout the lifetime of the research and into the dissemination of its findings. In doing so, we can truly achieve the principal aim of the ethics review - to protect all involved in research (participants, researchers, institutions and funders).
As projects evolve, new situations may arise which will require changes to be made to the project. Changes to projects for which a favourable opinion has been confirmed are called amendments.
Changes to any documentation under review, or before a favourable opinion has been issued are treated as revisions to the paperwork and do not require the process below to be followed. For help with making changes to documentation currently under review please contact email@example.com.
|The principlies in this guide apply to all research projects including those which were reviewed by PREC, SSREC and REACH or considered for Sponsorship before Ethics@Bath was launched. For detailed step by step instructions on how to process an amendment for these 'legacy projects' please visit our Ethics@Bath portal.
Definition of amendments
Examples of amendments that should be submitted for review, via the Ethics@Bath system, include (not an exhaustive list):
- Changes to the end date of the project, principal/lead/chief investigator or named researchers
- Changes to participant facing materials, number of participants, population types or to recruitment strategy
- Changes to protocol or procedures undertaken by participants which do not affect the potential to do harm
- Adding or removing research locations which do not affect the level of risk for the researcher or the participants
At this University, amendments are defined and processed as summarised in the table below:
|Other Type of Amendment
|The proposed change(s) does/do not affect research design or protocol
|Affects research design and/or protocol
|Anyone in the Research Governance and Compliance Team
|Requires review as advised by the Chair of the relevant Committee. Depending on the level of revision, this type of amendment can be approved by Chair's Action, be sent to the original reviewer, or other member of the committee without the need to go to a meeting, or be referred for discussion at the next available meeting
|In most cases will not require consultation with the Chair and can be approved at Office level
|As agreed with the Chair
It is at the discretion of the Research Governance and Compliance Team to categorise whether an amendment is minor or ‘other’.
What is not an amendment
For instances where the changes to the project are considered to be too substantial and affect the overall potential to do harm, or a new funding application is being submitted, then a whole new project will need to be created in Ethics@Bath.
Examples of changes to projects which will require a new application to be raised via the Ethics@Bath system include (not an exhaustive list):
- New applications for funding requiring a new PAM costing
- Changes which may introduce the need for additional approvals and that fundamentally and substantially change the level of vulnerability (e.g., consenting adults to no-consenting adults, adults to children, introducing participants who lack the capacity to consent... etc.)
- A major redesign of the project and particularly the intended methods of data collection
|In situations where a new PAM costing is required (e.g. follow-on funding), please duplicate the previously reviewed project, enter the new PAM reference and submit the ethics form. Once the award is confirmed, complete the full ethics form and note under the ‘other section’ that this new project is linked to a previous record.
For projects which have been designed in phases (i.e. where different components of a single project are being carried out sequentially), a new application should be raised for each phase. Examples of these projects are those where the following phase is determined by the results of the preceding phase and it is not possible to define which methods of data will be adopted at the onset of the study.
Amendments only apply to changes to projects that have already been wholly reviewed and a favourable opinion has been issued.
Examples: Amendment vs. New application
|Review end date
|Follow-on funding requiring a new PAM record
|Change research team (excluding principal / lead / chief investigator)
|Add to research team
|Change principal / lead / chief investigator
|Minor changes to recruitment materials (typos, contact details, correcting errors, etc)
|Minor changes to protocol (correcting typos, updating contact details, minor clarifications etc)
|Significant changes to participant facing materials, consent forms, invitation letters, messages to carers/relatives, etc.
|Small changes to procedure/data collection method, inclusion and exclusion criteria
|Significant changes to procedure/data collection method, inclusion and exclusion criteria etc that fundamentally change the level of potential to do harm of the project
|Adding new sites/collaborators in the UK
|Adding new sites/ collaborators outside of the UK
|Temporary halt of the study
How are amendments submitted?
Researchers wishing to amend a previously reviewed project will need to submit an amendment request via Ethics@Bath. For step by step guidance on how to submit an amendment via Ethics@Bath, please see here.
For projects under Sponsorship please see more detailed guidance on our webpage.
Review process for amendments
Once the form is submitted via the Ethics@Bath system by the researcher (staff or student), a member of the Research Governance and Compliance Team will carry out the necessary administrative checks and will process the amendment in line with the criteria detailed above.
Minor amendments will be processed by a member of the Research Governance and Compliance Team. All other amendments will be sent for review. The Chair can either approve the amendment via Chair’s action, or request that it is reviewed by one of the relevant Committee members. Should the Chair consider that a Committee-level discussion is required to consider the ethical implications of the proposed changes, the application will be allocated to a meeting of the relevant Committee and the researcher informed accordingly. If the Chair or Reviewer raise any comments/queries in Ethics@Bath during their review, the Research Governance and Compliance Team can return the amendment request back to the researcher for clarification and/or revision at any point during the review process.
The amendment can be implemented as soon as a favourable opinion is confirmed via the Research Governance and Compliance Team and all other regulatory approvals, where applicable (e.g. HRA) are in place. For instances where the amendment is required due to urgent safety measures, the necessary changes can be implemented with immediate effect.
If you have any questions about the type of amendment, please contact firstname.lastname@example.org.
Researchers will be kept informed of the status of their application via e-mail as the review progresses through different statuses.
Timelines for review and approval
We will endeavour to process minor amendments between 3-5 working days.
For other types of amendments consideration of the following cumulative timeline will apply:
- up to 3 working days, plus 1 week to allow for consideration by the Chair and a further week to allow, where applicable, committee member review outside of the committee meeting timetable; or
- 1 month should Committee level discussion be required