So, how does the committee work?

There are 21 members of the committee. They are all recognised by the Department of Health and Children. They come from all disciplines, specialities, backgrounds and interests, and give up their time voluntarily to read, review and assess the applications for research, and to attend a committee meeting, in compliance with S.I. 190 of 2004, to discuss these applications. In addition to their own professional roles, the workload is considerable.

Beaumont Hospital is extremely lucky to have a high-calibre and committed committee. Among the group include a solicitor, ethicist, physicist, pathologist, psychiatrist, respiratory consultant, clinical pharmacologist, cardiologist, radiologist, palliative care consultant, renal consultant, retired teacher and records management consultant.

In addition, the committee can co-opt up to two members per meeting, and if the committee does not possess the expertise to review a study in a particular area, it will invite a consultant in the field to attend and to externally review the study.

How often does the committee meet?

Roughly every six weeks. Meetings can be five to ten weeks apart. There is no meeting in July of each year to facilitate annual leave of members. There is no meeting in October of each year to facilitate committee training.

I want to do some research. What do I do next?

Look at the meeting dates and meeting deadlines on this website. Then contact the committee administrator to book an agenda slot at a meeting. Once you have a confirmed agenda slot, begin to complete the relevant application form and draft or compile the relevant documents for review. If you are a first time applicant, the key is to get as much help as possible with your submission.

It is important to put a lot of thought, time and effort into your ethics application. A lot of busy professionals are giving up their time and energy to review it. You should get as much help as possible to complete it, from as many experts in the area of research as possible. Beaumont is a centre of excellence for research in Ireland; the calibre of applications and research is generally very high, and there are many consultants in the hospital who are experienced both in research and in applying for ethical approval who can help you with your application. It is important to meet with your hospital supervisor and your academic supervisor frequently and extensively to ensure all your documents are of a high standard of excellence. Ensure that you enlist the help of a statistician when designing any research study.

I have filled in my application form. My hospital supervisor and academic supervisor agree it is of a high standard. What other documents will I need to submit?

Most likely, if your research involves adult patients (over 16 - although there is some debate in this area), they will need to give informed consent to be involved in the research. This involves drafting a Patient Information Leaflet and Consent Form. (Templates which have been awarded a Plain English Mark are available this website.

If your research participants are under 16, they need an Information Leaflet and Assent Form, which is written in a language children and young people can understand. In addition, you will need an Information Leaflet for Parents and Guardians and a Consent Form for parents and guardians to consent to their ward/child to be involved in research.

If your patients are unconscious, e.g. in ITU, they obviously cannot consent to research. Legally however, their next of kin cannot give consent either. Therefore you should submit an Information Leaflet and Assent Form for Next of Kin and Significant Others to assent their relative to be involved in research. You should also think of preparing an Information Leaflet and Consent Form, should the unconscious patients regain consciousnesss and capacity to consent.

S.I. 190 of 2004, which is only specific to clinical drugs trials, allows a Legal Representative to give consent on behalf of an incompetent adult to be involved in a clinical drugs trial.

Other documents you should include in your application might be a letter to the patient's General Practitioner, letting him/her know that their patient is involved in research, or a letter writing to patients at home asking them if they would like to take part in the study. Some studies require an advertisement poster by which potential participants are first informed of the study, or a copy of a questionnaire, if it is proposed to administer a questionnaire to the participants.

If your participants are staff as opposed to patients, the Information Leaflet you draft will be a Participant Information Leaflet, as opposed to a Patient Information Leaflet. Other types of Information Leaflets which can be relevant are Control Information Leaflets, Sibling Information Leaflets, Information Leaflets for Next of Kin & Significant Others etc.

Remember at all times however, there are 100s of pieces of research currently ongoing in the hospital. All of these applicants had to fill in an Application Form and draft an Information Leaflet and Consent Form. It is likely that there is someone else in the hospital who has done or is doing something similar and can help you.

I have heard that the agenda for the ethics committee meeting books out very quickly. Is that true?

Yes. As soon as you know which meeting you are aiming to submit an application to, contact the administrator in order to book an agenda slot at this meeting. The main committee along with its standing sub-committee, the Nursing Research Access Committe, aim to review no more than 19 applications per meeting. The agenda for some meetings can also be reduced to facilitate training for members or any other business. In addition, there are internal maximums in place for certain types of studies e.g. eight low-risk studies involving interviews, questionnaires or surveys of staff, patients or relatives.

Do I really need to go to the Beaumont Hospital Ethics (Medical Research) Committee? I am student and have approval from my university's Research Ethics Committee already for my research.

Send the administrator a brief summary of your study, along with a copy of the approval from your University Ethics Committee. Your summary will be reviewed by the Committee, and you will be informed whether a full application to Beaumont Hospital is required. A full application will generally be required if your study involves patients or relatives of patients.

I don't think I need ethics approval. I am just looking at patient charts.

Please note that the Beaumont Hospital Ethics (Medical Research) Committee has a remit when access to healthcare records (hard copy and electronic) is required for the purposes of research. This is particularly the case when identifiable data is being 'processed.' Patient consent is required for the 'processing' of identifiable personal data under the Data Protection Legislation. However, should access to medical charts be required for the purpose of undertaking a clinical audit or audit, then the appropriate department to contact for advice, support and permission to proceed is the Beaumont Hospital Clinical Governance Department.

I don't think I need ethics approval. I am interviewing staff members.

Submit a full application to the committee. The Committee's remit is to protect the safety and welfare of research participants, including Beaumont Hospital staff members.
Most common types of applications involving staff are MSc Nursing students who wish to interview or issue questionnaires to nursing staff in the hospital. However, the requirement for ethical approval is the same whatever discipline the staff member (research participant) is from. (If your participants are nurses the Beaumont Hospital Ethics (Medical Research) Committee will involve the Nursing Research Access Committee in the review of your application.) IF YOU ARE INTERVIEWING NURSES AND HAVE PRIOR ETHICAL APPROVAL FROM A UNIVERSITY OR HOSPITAL COMMITTEE BASED IN THE REPUBLIC OF IRELAND, CONTACT THE ADMINISTRATOR.

I really want to get started doing the research. How long does this whole ethics business take?

Allow yourself 4 months from first downloading the application form, to receiving (if all goes well) your notification of ethics approval.

Another way to look at this is to allow 3 months from the day you drop your application into the ethics office. (These timelines are given in order to make academic researchers factor in the time it takes to make an ethics submission, wait for the next meeting, and make any amendments the committee requests. MSc students in particular often need to write a thesis in the second year of their course, and should prepare in advance for this, and make their ethics submission in the first half of second year.) (These timelines should not be taken to mean that it takes four months to get ethics approval. The average time from application receipt to application approval is two months.)

Within 10 working days of the ethics meeting, the Principal Investigator will be sent a letter outlining the committee's comments in relation to your application. You will need to respond to these comments and make any changes or amendments requested. Once your responses and amendments have been addressed to the committee's satisfaction, an approval letter will be issued.

I have already done the research. I didn't realise I needed ethical approval?

THE ETHICS (MEDICAL RESEARCH) COMMITTEE CANNOT GRANT RETROSPECTIVE ETHICAL APPROVAL. Consequences of undertaking a research study without prior ethical approval being in place include inability to publish, inability to graduate and lack of insurance cover for any harm caused to participants.

What does an approval letter look like?

The approval letter lists every document the committee has approved for use in your study. It will list the document specifically. The version number and date of all the approved documents are on the approval letter. Keep the original approval letter safe. You may require it to make a grant application, or in order for a recognised journal to publish your final research.

I got ethics approval two months ago. 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 methodology (e.g. an extra blood sample), and to documentation (e.g. a revised consent form).
Submit a cover letter to the administrator entitled 'Amendment Number ___ dated _______' stating what amendment you wish to make to the study, and outlining reasons for same. It is also important to submit either a revised application form or a revised study protocol with any changes which are as a result of this amendment highlighted. If your amendment requires patients to be reconsented, also submit revised and reversioned Information Leaflets and Consent Forms. Your amendment request will be reviewed by one committee member, and (if approved) updated approval documentation will be sent to the Principal Investigator. 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 Form.

My original ethics application involved issuing a questionnaire to patients? I want to add one question to the questionnaire. Do I have to submit this as an amendment?

Yes. Submit an amendment, and attach the revised and reversioned questionnaire.

My study has ethics approval and is ongoing. One of the participants fainted during one of the study procedures. What should I do?

It is important to inform the Ethics Committee 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, you must 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 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), six monthly reports and annual reports to the Ethics Committee. Is that correct?

Yes, that is normally the case. Please ensure that the sponsor company is doing this. 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. Six monthly and 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.

If Beaumont Hospital is the only Irish site, it is quite common for the Principal Investigator to send a report on each event at the hospital directly to the Committee.

If the trial is multi-centred, and there are a number of Irish sites, the sponsor company tends to contact the committee whenever an event occurs in Ireland.

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.

My study was approved a year ago. Does the committee need a Progress Report?

Yes. Progress Report Forms are available from the administrator and on this website. Part of your original ethics approval was conditional upon you submitting annual progress reports to the committee. Again, clinical drugs trials have specific reports which must be submitted to the Committee under S.I. 190 of 2004.

My study is now over. Do I need to do anything?

Yes. Inform the committee. The committee is interested to know if your research was published. Or if your research resulted in a change in clinical practice of some sort. An End of Study Progress Report is required in order to close your study file. Your file will then be placed into off-site storage.

I am a consultant in Beaumont Hospital and am unsure if my research proposal is a clinical trial of a medicinal product under S.I. 190 of 2004.

E-mail or write to the Irish Medicines Board and they will be able to confirm if your research proposal is a clinical trial of a medicine. If your study involves giving a medicine (licensed or unlicensed) or medicinal product (licensed or unlicensed) to a patient, it is important to check if the study can be classed as a clinical trial of a medicinal product.

The Irish Medicine Board states that my study is a clinical trial of a medicine. What do I need to do?

Step 1:
Get a EudraCT number.

Step 2:
Apply for Ethical Approval + Apply for Irish Medicines Board Approval

Step 3:
Send your Ethics Committee Approval and IMB Approval to the Hospital CEO.

Step 4:
With the CEO's permission, begin the trial

You should note that the decision to run a clinical trial of a medicinal product without a pharmaceutical sponsor is onorous and expensive. In addition to the fees associated with making an ethics application and IMB application, you will very likely need to hire a research nurse or administrator or to dedicate a research doctor to the management and monitoring of your clinical trial. Your trial site and documentation can be inspected at any time by the Irish Medicines Board, and the reporting requirements of the legislation are significant, for example, strict timelines for reporting of adverse events, six monthly and annual safety reports etc. An external Data Safety Monitoring Committee will most likely also have to be organised to review safety information on a regular basis.

There are a number of clinical trials of medicines ongoing in Beaumont Hospital which are investigator-led. Please contact the administrator, and she can direct you to the relevant consultants for advice and assistance.