I don’t think I need Beacon Hospital Ethics approval because:-
I am student and have approval for my research from my University’s REC:
Your proposed participants are patients or staff of Beacon Hospital means YES you need approval from Beacon REC.
I am just looking at patient charts:
Your review of healthcare records , electronic or hard copy records means YES you need approval from Beacon REC.
I am only interviewing / surveying staff members:
You are interviewing or surveying Beacon Hospital staff means YES you need approval from Beacon REC.
I really want to get started doing the research as soon as possible. How long does the ethics process take?
You cannot begin any research or data collection until you have Full Approval from the REC. Allow yourself 3 months from first downloading the application form to receiving your notification of ethics approval. These timelines factor in the time it takes to make the ethics submission itself, wait for the next ethics committee meeting and then make any amendments the committee requests.
I was granted full ethical approval and I am in the middle of my study but:
I have recruited 10 participants, but have just discovered that I will need to take an extra blood sample from patients? What do I do?
This is classed as an Amendment to your original application. You need to get ethics approval for every amendment to all documents you wish to alter. In this example it is an amendment to both the methodology (e.g. an extra blood sample) and to the documentation (e.g. a revised consent form).
Submit a cover letter to the administrator entitled ‘Amendment Number ___ dated _______’ stating what amendments you wish to make to which documents and outlining the reasons. Send a revised and tracked altered document and a clean document.
Your amendment request will be reviewed by a sub-group of the committee, and (if approved) updated approval documentation will be sent back to you. Certain amendments may need to be reviewed at a committee meeting. Substantial amendments to clinical drugs trials under S.I. 190 can be submitted using the relevant Department of Health and Children Amendment Form.
My original ethics application involved issuing a questionnaire to patients however, now I want to add one question to the questionnaire. Do I have to submit this as an amendment?
Yes this is an amendment to the original application and the initial approval that was given by the REC.
Submit an amendment and attach the revised and re-versioned questionnaire outlining the changes you wish to make in a tracked document.
My study has ethics approval and is on-going. One of the participants fainted during one of the study procedures. What should I do?
It is important to inform the REC of any adverse reactions or events which occur during the course of your study. Your approval is conditional upon your agreement to do this. S.I. 190 of 2004 has very specific timelines and definitions for adverse events. However, as stated before, S.I. 190 applies to clinical drugs trials only. If your study is a clinical drugs trial, it is the SPONSOR’S responsibility to comply with the reporting regulations in S.I. 190 of 2004. Researchers involved in any other type of research approved by this committee are obliged to inform the committee of any serious adverse events.
I am a Principal Investigator and I believe the pharmaceutical sponsor company for the clinical drugs trial sends event reports for Sudden Unexpected Serious Adverse Reactions (SUSARs), and annual reports to the Ethics Committee. Is that correct?
Yes, that is correct. The most common question sponsor companies ask is do they need to send individual SUSAR reports for every SUSAR which occurs internationally. The answer is ‘no.’ The Committee has adopted the Department of Health guidelines with regard to reporting of SUSARs.
Annual Reports to the Committee should list international events, but individual reports should refer to SUSARs which occur at any site in the Republic of Ireland only. It is the committee’s remit to protect the safety and welfare of patients in Ireland. Although, we only require individual reports for events occurring in Ireland, it remains essential to contact the committee if anything occurs, which impacts on the safety of participants. Reports from Data Safety Monitoring Committees are of interest to the Committee in this regard.