Programmes of research standard conditions of approval

1. Further communications with the Committee

1.1 Further communications with the Committee are the personal responsibility of the applicant.

2. Duration of approval

2.1 Approval is given for a period of five years, which may be renewed on consideration of a new application by the Committee, taking account of developments in legislation, policy and guidance in the interim. New applications should include relevant changes of policy or practice relating to the programme of research, including any substantial amendments approved, since the original approval together with any proposed new developments.

2.2 The favourable ethical opinion provides legal authority to hold “relevant material” for approved sub studies on premises which are not licensed by the Human Tissue Authority (in England, Northern Ireland and Wales only – this requirement does not apply in Scotland). Where a favourable ethical opinion provides this legal authority, “relevant material” can be held under the terms of the ethical opinion until the programme of research ends.

3. Substantial amendments

3.1 Substantial amendments should be notified to the Committee and a favourable opinion obtained before implementing the amendment. A substantial amendment generally means any significant change to the programme master protocol and supporting documentation or the addition of a new sub study into the programme of research.

3.2 A substantial amendment to the programme should be generated by accessing the original application form on the Integrated Research Application System (IRAS).

3.3 The following changes should always be notified as substantial amendments:

3.3.1 A new sub study being added to the programme of research.

3.3.2 Any significant change to the research activities being undertaken within the programme of research.

3.3.3 Any significant change to the types of biological material to be collected and stored, or the circumstances of collection.

3.3.4 Any significant change to informed consent arrangements, including new/modified information sheets and consent forms.

3.3.5 Any significant change to the governance of the programme of research.

4. Progress reports

4.1 Research Ethics Committees can review a favourable opinion in the light of progress reports and any developments relevant to the programme of research. The Chief Investigator is responsible for ensuring the programme of research is undertaken in accordance with the favourable ethical opinion. The Chief Investigator should submit an annual progress report to the ethics committee, commencing 13 months after the favourable ethical opinion is issued.

4.2 Progress reports should be in the format prescribed by the HRA and published on the website.

5. Changes to sites

5.1 Confirmation of capacity and capability (for NHS/HSC sites in England, Wales and Northern Ireland or management permission (for NHS sites in Scotland and all non-NHS sites) should be obtained from the participating organisation where it is proposed to:

• include a new site in the research, not included in the list of proposed research sites in the original REC application
• appoint a new PI or Local Collaborator at a research site
• make any other significant change to the conduct or management of a research site

NHS sites

5.2 In the case of NHS/HSC sites, the REC’s favourable opinion for the programme of research will apply to any new sites and other changes at sites provided that confirmation of capacity and capability (for NHS/HSC sites in England, Wales or Northern Ireland) or NHS management permission (for NHS sites in Scotland). New NHS/HSC sites do not require a favourable ethical opinion.

Non-NHS sites

5.3 For clinical investigations of medical devices, changes at non-NHS/HSC sites require review by the REC which reviewed the application for the research. The non-NHS/HSC Site Assessment Form along with a substantial amendment and the relevant supporting documentation should be submitted to the Research Ethics Committee.

5.4 For other study types, there is no requirement to notify the Committee of the inclusion of new non-NHS/HSC sites or other changes at non-NHS/HSC sites.

Guidance on how to work with sites is provided in the IRAS help section.

6. Urgent safety measures

6.1 The sponsor or the Chief Investigator, or the local Principal Investigator at a research site, may take appropriate urgent safety measures in order to protect research participants against any immediate hazard to their health or safety.

6.2 The REC should be notified within three days that such measures have been taken, the reasons why and the plan for further action

7. Serious adverse events

7.1 A Serious Adverse Event (SAE) is an untoward occurrence that:

(a) results in death

(b) is life-threatening

(c) requires hospitalisation or prolongation of existing hospitalisation

(d) results in persistent or significant disability or incapacity

(e) consists of a congenital anomaly or birth defect

(f) is otherwise considered medically significant by the investigator.

7.2 A SAE occurring to a research participant should be reported to the Committee where in the opinion of the Chief Investigator the event was related to administration of any of the research procedures, and was an unexpected occurrence.

7.3 Reports of SAEs should be provided to the REC within 15 days of the Chief Investigator becoming aware of the event, in the format prescribed by the HRA and published on the website.

8. Conclusion or early termination of the programme

8.1 The Chief Investigator should notify the REC in writing that the programme of research has ended within 90 days of its conclusion.

8.2 If the programme or any research projects within the programme are terminated early, the Chief Investigator should notify the REC within 15 days of the date of termination. An explanation of the reasons for the early termination should be given.

8.3 Reports of conclusion or early termination should be submitted in the form prescribed by the HRA and published on the website.

9. Final report

9.1 A final report on the programme should be provided to the REC within 12 months of the conclusion of the programme.

10. Reporting results

10.1 Other than research for educational purposes, the findings of research projects, whether positive or negative, should be made accessible, with adequate consent and privacy safeguards, in a timely manner after they have finished.

10.2 Where appropriate, information about the findings of the research should be made available, in a suitable format and timely manner, to those who took part in it, unless otherwise justified.

11. Review of ethical opinion

11.1 The REC may review its opinion at any time in the light of any relevant information it receives.

11.2 The Chief Investigator may at any time request that the REC reviews its opinion, or seek advice from the REC on any ethical issue relating to the research.

12. Serious breaches of Good Clinical Practice or the protocol

12.1 To ensure that the REC is able to keep the favourable ethical opinion under review, the sponsor should report to the REC any serious breaches of the protocol or of the principles of Good Clinical Practice. A “serious breach” is defined as a breach of the protocol or, of the principles of Good Clinical Practice which is likely to affect to a significant degree the safety or physical or mental integrity of the research participants, or the scientific value of the programme or research. There is no requirement to notify minor breaches of GCP or the protocol.

12.2 Reports of serious breaches should give details of when the breach occurred, the location, who was involved, the outcome and any information given to participants. An explanation should be given and the REC informed what further action the sponsor plans to take.

13. Long-term studies

For long-term studies, Investigators are responsible for ensuring that the study procedures and documentation are updated in light of legislative or policy changes and also for reasons of good practice (e.g. standards for supporting documentation). This should be documented in the progress report to the REC (see above) and, where necessary, an amendment (see above) should be submitted to the REC. The REC may review its opinion in light of legislative changes or other relevant developments.