Social Care Research Ethics Committee - After ethical review

At the end of the review process the application will either be given a favourable opinion or unfavourable opinion.

Unfavourable Opinion

If the application receives an unfavourable opinion the investigator can either:

Submit a new application to the Social Care REC for ethical review, taking into account the Committee’s concerns.
Alternatively, having submitted the study to the Social Care REC as required by the Dept of Health, you may appeal against the decision of the Committee by seeking a second opinion on the application from another NRES Research Ethics Committee. The appeal would be based on the application form and supporting documentation reviewed by the Social Care REC, without amendment. If you wish to appeal, you should notify Joan Kirkbride, Director of Operations, Health Research Authority. (joan.kirkbride@nhs.net).

Favourable Opinion

The Social Care REC is required to monitor research which has received a favourable opinion. Investigators are therefore required to submit the following information:

Annual Progress Reports - You will need to provide a progress report to the Social Care REC each year of the study’s duration.
Notification of Substantial Amendments - When and how you should notify the Social Care REC of any changes to your study.
Safety reports - How to advise the Social Care REC that a significant adverse event has occurred.
End of study and final report - How to inform the Social Care REC that a study has finished.

Annual progress reports

A progress report should be submitted to the Social Care 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.

Please complete the Annual Progress Report Form (see Downloads) and send a copy, signed by the Chief Investigator, to the Co-ordinator within 30 days of the end of the reporting period.

The Social Care REC will acknowledge receipt of the progress report and the Chair and/or another REC member will normally review progress in correspondence. They will notify the full Committee at its next meeting that the report has been received.

The Chief Investigator may be invited to attend a meeting of the main REC or a sub-committee to discuss the progress of the research.

The Social Care REC does not need to re-confirm its favourable ethical opinion each time a progress report is received. It is generally assumed that the opinion applies for the duration of the research, although the Social Care REC may review its opinion at any time.

Following receipt of the first progress report, the Chair has the discretion to waive the requirement for further reports on receipt of a written request from the Chief Investigator. This might be appropriate where a study has completed recruitment and intervention but has a long period of follow-up with minimal participant involvement.

Notification of substantial amendments

If there are changes to the research after a favourable opinion has been given, these 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 research;
the scientific value of the research; or
the conduct or management of the research.

The Social Care REC has the discretion to decide whether or not a proposed amendment is substantial and requires ethical review. Chief Investigators and Sponsors should seek advice from the Social Care REC if in doubt.

Examples of substantial and non-substantial amendments

The following amendments should normally be regarded as substantial:

changes to the design or methodology of the study, or to background information affecting its scientific value;
changes to the procedures undertaken by participants;
any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study;
significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, information sheets for relatives or carers;
a change of sponsor(s) or sponsor’s legal representative;
appointment of a new Chief Investigator or key collaborator;
a change to the insurance or indemnity arrangements for the study;
temporary halt of a study to protect participants from harm, and the planned restart of a study following a temporary halt;
a change to the definition of the end of the study;
any other significant change to the protocol or the terms of the Social Care REC application.

Some changes, however, will have no significant implications for participants or for the conduct, management or scientific value of the study and can be regarded as ‘non-substantial’ or ‘minor’ amendments.

Examples of non-substantial amendments might be as follows:

minor changes to the protocol or other study documentation, e.g. correcting errors, updating contact points, minor clarifications;
updates of the investigator's brochure (unless there is a change to the risk/benefit assessment for the research);
changes to the chief investigator’s research team (other than appointment of key collaborators);
changes in funding arrangements;
changes in the documentation used by the research team for recording study data;
inclusion of new sites and investigators;
extension of the study beyond the period specified in the application form.

Changes to contact details for the Sponsor (or the Sponsor’s representative), Chief Investigator or other study staff are minor amendments but should be notified to the Social Care REC for information.

Requirement for favourable ethical opinion

Substantial amendments normally require a favourable opinion from the Social Care REC before they can be implemented.

The only exceptions to this are:

where urgent safety measures need to be taken;

Requirement for favourable ethical opinion

You can generate the amendment form in IRAS by opening your study, highlighting the REC application on the Navigate page and then selecting the Amendment tab.

Submitting notices of amendment

You should summarise the change(s) included in the amendment and briefly explain the reasons in each case on the notice of amendment. It is important that you complete the form using language comprehensible to a lay person.

You should submit the documents that have been modified, showing both the previous and new wording, with the form. Where the modified documents (for example, the study protocol) are lengthy and the changes are not so widespread or significant as to justify a new version, you can provide extracts or list the changes in a separate document.

The Sponsor or Chief Investigator may also include other supporting information, such as a summary of research data, an updated safety analysis or a report from a research monitoring committee. Where the amendment could significantly affect the scientific value of the research, you should provide further evidence of scientific and/or statistical review.

Social Care REC procedures for reviewing substantial amendments

The Co-ordinator of the Social Care REC will write to you confirming whether or not the Notice of Amendment is valid for review, usually within five working days of receipt.

Amendments are normally reviewed by a Sub-Committee of the Social Care REC, either at a meeting or in correspondence. Exceptionally, amendments may be reviewed at a meeting of the full committee.

The Social Care REC will issue an ethical opinion on the amendment within a maximum of 35 days from the date of receipt of a valid notice of amendment.

Where an unfavourable opinion is given, you may submit a modified amendment. The Social Care REC will give an opinion on a modified amendment within 14 days of receipt.

Non-substantial amendments

You do not need to notify the Social Care REC of non-substantial amendments. Sponsors or Chief Investigators wishing to do so voluntarily should use a separate covering letter rather than the Notice of Substantial Amendment Form. The letter should make it clear that the amendment is not substantial and does not require an ethical opinion to be given. The Social Care REC will acknowledge receipt.

Adding new sites and investigators

If the study involves adults lacking capacity and has required a Site Specific Assessment (SSA) (which will only happen in very rare circumstances) you should submit the SSI Form for a new non-NHS site to the Social Care REC together with the supporting documents listed in the checklist for non-NHS site SSA in IRAS. The Social Care REC will acknowledge receipt of a valid application for SSA. It will undertake the SSA and then issue an opinion to the Chief Investigator within 35 days. A copy will be sent to the Sponsor.

If the study does not require SSA, the sponsor may add the new site or principal investigator as soon as the study has permission from the organisation responsible for the site. There is no need to notify the Social Care REC or apply for SSA. All sites and Principal Investigators are deemed to be approved within the terms of the favourable opinion from the Social Care REC.

Safety reports

If a research participant experiences a significant adverse event (SAE), this should be brought to the attention of the Social Care REC where in the opinion of the Chief Investigator the event was:

‘related’: that is, it resulted from administration of any of the research procedures; and

‘unexpected’: that is, the type of event is not listed in the protocol as an expected occurrence

Reports of significant adverse events should be submitted using the Significant Adverse Event Form (see Downloads) within 15 days of the Chief Investigator becoming aware of the event. The form should be completed in typescript and signed by the Chief Investigator.

End of study and final report

Declaring the end of the study

You should notify the Social Care REC in writing of the conclusion or early termination of a study using the Declaration of the End of a Study Form (see Downloads).

You should send the form within 90 days of the end of the study, or within 15 days if the study is terminated early. If the study has been terminated early you should provide reasons.

Temporary halt of a study

Where the sponsor halts a study temporarily for safety reasons, this should be notified to the Social Care REC by submitting a notice of substantial amendment. The form should clearly explain the reasons for the halt and the scope, e.g. stopping recruitment.

To restart the study, the sponsor should submit a further notice of substantial amendment for ethical review. Evidence should be provided that it is safe to restart the research. If the sponsor decides not to recommence the research after a temporary halt, the end of the study should be declared.

Defining the end of the study

The definition of the end of the study should be provided in the protocol and any change to this definition should be notified as a substantial amendment. In most cases, it will be the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol.

Final analysis of the data (following ‘lock’ of the study database) and report writing is normally considered to occur after formal declaration of the end of the study.

Final report on the research

You should send a summary of the final research report to the Social Care REC within 12 months of the end of the study. You may enclose this with the end of study declaration or send it to the Social Care REC subsequently.

There is no standard format for final reports. As a minimum, you should inform the Social Care REC whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research, including any feedback to participants.

Review by the Social Care REC

The Social Care REC office will acknowledge receipt of the end of study declaration and final report.

The Social Care REC Chair and/or another REC member will normally review reports in correspondence and will notify the full Committee at its next meeting.