I want to do some research. What do I do next?
Look at the meeting dates and deadlines on this website, then 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. Incomplete applications or those of a poor standard will not be reviewed at the meeting.
You should get as much help as possible to complete your application, from as many experts in the area of research as you can. 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?
As per S.I. 314 of 2018 all research requires explicit consent of the research subject. As a result if your research involves adult patients (over 16), they will need to give informed consent which needs to be documented to be involved in the research.
This involves drafting a Patient Information Leaflet and Consent Form. Please ensure to use the suggested templates for these on this site, however be careful to adapt them to your specific study and not to just copy and paste the template as this can lead to corrections being required if the template content contains items that do not apply in the case of your study.
If your research participants are under 16, then you will need a Patient 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. When the participant becomes of legal age, they will then need to be re-consented to continue participation using the Consent form.
All research requires explicit informed consent from participants, however if you are unable to get consent from the participant directly, for example if your patients are unconscious, e.g. in ICU, then you will need to obtain an exemption from the Consent Declaration Committee for your study. The process will be to apply for REC approval, then to the Consent Declaration Committee. Once approved by the Consent Declaration Committee, you must submit their approval to the REC to receive full approval before commencing your research.
You should also think of preparing an Information Leaflet and Consent Form, should the unconscious patients regain consciousness and have 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 them know that their patient is involved in research
an invitation letter to patients asking them if they would like to take part in the study
Advertisement poster by which potential participants are first informed of the study
Copy of any questionnaires, if it is proposed to administer a questionnaire
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.
There is a legislative requirement to ensure researchers respect the confidentiality of their participants’ data. You will be required to produce and submit a Data Privacy Impact Assessment (DPIA) which has been signed off by their organisation’s Data Protection Officer. In the case of hospital employees this will be the hospital DPO.
The key stages of completing the DPIA are:
1. Identify the need for the DPIA – determine the inherent risks associated with data processing for your project.
2. Describe the information flow – be able to describe how the information within the processing operation is collected, stored, used and deleted.
3. Identify privacy and related risks – catalogue the range of threats, and their related vulnerabilities, to the rights and freedoms of individuals whose data you collect and/or process.
4. Identify and evaluate solutions – for each identified risk make a decision whether to accept or reject the risk and why including how to take steps to reduce the impact or likelihood of any threats.
5. Sign off and record the DPIA outcomes – record the outcomes of the DPIA in a report that is signed off by the Data Protection Officer for your organization. Where a high risk has been identified, the organisation must submit the DPIA to the regulatory authority for consultation.
6. Integrate the DPIA outcomes into the project plan – you will need to continually refer to the DPIA in order to ensure that it is being followed and that its responses to the risks have been implemented effectively.
Remember at all times however, there are 100s of pieces of research currently on-going 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 that has done or is doing something similar and can help you.
Do I really need to go to Beacon Hospital Research & Ethics Committee? I am student and have approval from my university’s Research Ethics Committee already for my research.
Yes, unfortunately, you do need to apply to Beacon Hospital Research Ethics Committee if you wish to conduct an academic study, and your proposed participants are patients or staff of Beacon Hospital.
I don’t think I need ethics approval. I am just looking at patient charts.
Under the Health Research Regulations S.I. 314 of 2018 all research requires explicit consent including use of patient chart data. You do need to apply to Beacon Hospital Research Ethics Committee if you wish to conduct ANY RESEARCH STUDY which involves the review of healthcare records, be they electronic or hard copy records.
I don’t think I need ethics approval. I am interviewing / surveying staff members.
You DO require prior approval of the REC if you wish to conduct RESEARCH on STAFF. Most common types of applications received are from staff members who wish to interview or survey their colleagues.
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 time to allow data collection, analysis and write up)
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, each applicant is sent a letter outlining the committee’s comments in relation to their 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 Research Ethics 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.
Types of Approval
No conditions and the REC is satisfied with the application and documentation you have supplied. You can now commence your study, however are required to submit annual reports updating the REC on your project and a final report once completed.
You cannot commence your study until any issues/queries the REC have outlined are responded to and reviewed again by the REC. Once you have satisfied all queries satisfactorily you will receive full approval.
Your study does not meet the required ethical standards and therefore you cannot proceed with it.
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 re-consented, also submit revised and re-versioned Information Leaflets and Consent Forms. Your amendment request will be reviewed by a sub-group of the committee, 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 Amendment 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 re-versioned questionnaire.
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 Research 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, 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.
My study was approved a year ago. Does the committee need a Progress Report?
Yes. 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, for example, ‘development safety update reports’ as opposed to progress reports.
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. A Final Progress Report is required in order to close your study file. Your file will then be placed into off-site storage. [For clinical drugs trials submitted to the Committee under S.I. 190 of 2004, an ‘End of Trial Form’ is usually submitted.]