- Research in Progress
The Health Research Authority (HRA) along with NHS Research Ethics Committees (RECs) are required to monitor research that has received a favourable opinion. A progress report should be submitted to the REC which gave the favourable opinion (the ‘main REC’) 12 months after the date on which the favourable opinion was given. Annual progress reports should be submitted thereafter until the end of the study.
- Notification of Amendments
Amendments are changes made to the research study after favourable NHS approval has been given. They can be 'substantial' or 'non-substantial'.
A substantial amendment is defined as an amendment to the terms of the application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree:
- the safety or physical or mental integrity of the subjects of the trial;
- the scientific value of the trial;
- the conduct or management of the trial; or
- the quality or safety of any investigational medicinal product used in the trial.
The review bodies that originally provided a favourable opinion of the research must authorise any substantial amendments to the study. For further information about what constitutes an amendment, please look at the HRA website (http://www.hra.nhs.uk/research-community/during-your-research-project/amendments/).
If the study is a Clinical Trial of an Investigational Medicinal Product, the MHRA as the competent authority under the Clinical Trials Regulations, must authorise the amendment.
For hosted studies, our team of research nurses manage study amendments. If the Trust is acting as the sponsor for the study, please contact kina.bennett@lthtr.nhs.uk as the Sponsor representative now needs to submit the amendment on your behalf.
- Research and Innovation Requirements
If there is any proposed changes to a study protocol that will have an impact on Trust resources, R&I acknowledgement is required for the proposed changed. The Sponsor is responsible for sending us the amendment pack. If we accept the amendment, an email is sent to the research team and Sponsor acknowledging the amendment. If we are unable to accept the amendment, dialogue with the Sponsor will be started.
- Changes to the Research Team
If the Chief Investigator (CI) or local Principle Investigator (PI) is changed, please contact the HRA to establish their requirements for reporting a change to CI or PI. Changes to the research team other than the CI and PI are NOT considered substantial changes and do NOT need to be reported to the HRA. If the study is a Clinical Trial of an Investigational Medicinal Product, the MHRA as the competent authority under the Clinical Trials Regulations, requires notification of change of Chief Investigator as named on the Clinical Trial Authorisation. Please inform the Sponsor of changes to the Chief Investigator (CI) or local Principal Investigators (PIs). This will allow the Sponsor to ensure that appropriate agreements, allocating responsibilities for the study can be put in place with the new CI or PI. Where the Trust is the Sponsor, please contact your Sponsor represenative: kina.bennett@lthtr.nhs.uk Please notify the Research Access team of any changes to the local Research Team named on the original HRA / IRAS application forms. Please NOTE that honorary contracts / research passports may be required for new members of the research team.
Further details can be found in the document
