TUH Research and Ethics

Research Finance – Research Funding

Contact Details: Finance Department, Ms Lydia Doyle – Lydia.Doyle@tuh.ie, 01-414 2044

Contact Details: Finance Department, Ms Eilish Martin – Eilish.Martin@tuh.ie, 01-414 2044

• Research taking place in TUH is often funded by a Sponsor company, a University, a Charity, a TUH related foundation, etc.
• Clinical Trials of IMPs, Medical Device Trials and some Observational Research Studies include this funding as a study budget. This is incorporated as part of the Clinical Trial/Study Agreement (CTA). The bank details for transferring these funds is specified in the CTA
• Other Research studies do not require a formal CTA but these studies are also funded
• The Finance Department in TUH requests all research funding for all research taking place in TUH to be deposited into the TUH bank account (LINK)
• Researchers must register their study using Registration Form page and declare where the funding for their Research will be lodged. Researchers who choose not to lodge funds into the TUH bank account must confirm on the registration page that they take full responsibility for the funds  from a personal taxation point of view.

The process for accessing funds lodged into TUH bank account:

- Funds are assigned to an internal order with a six-digit code provided to you
- To access the funds please contact Lydia Doyle
- Finance will provide instructions for accessing the funds
- Funds can be spent on Research related costs, such as salaries for research staff or consumables.

Research Office

The Research Office is managed by Dr Sadhbh O’Neill

• Contact Details: Sadhbh.Oneill@tuh.ie, researchethics@tuh.ie 

The Research Office is being launched to align TUH resources with the TUH Research Strategy and as a response to the needs of researchers within TUH.

The function of the research Office is laid out in the Organogram below:

1. Research Registration: All research, clinical or other should be registered with the Research Office through the Registration Form. Registering your research will include providing names and affiliations of all researchers involved in the study,  financial aspects of the study if applicable, and data protection considerations.
2. Research Ethics: All research involving the recruitment of staff or patients must receive ethical approval before beginning by applying through Research Ethics Application Form. Please see the Research Ethics Committee section for further details.
3. Data Protection: All research is subject to the Data Protection Legislation. Please see Research Data Protection page
4. Clinical Trial and Observational Study Agreement, Material Transfer Agreement and Data Sharing Agreement sign off: The DCEO is the designated signature for the above agreements in TUH. The Clinical Trials Officer, Ms Colette Hoare is responsible for the review of these agreements. Please see the Clinical Trial and Observational Study Agreement Sign Off
5. Staff Training, Development and Support: The Office will offer training such as ICH-GCP training to researchers, other training will also be offered. Resources such as SPSS and networked laptops with remote access will be provided through the Research Office.

SJH/TUH Joint Research Ethics Committee

The Research Ethics Committee is Managed by Dr Sadhbh O’Neill, Sadhbh.ONeill@tuh.ie

• Contact Details: ResearchEthics@tuh.ie
• Please contact Dr O’Neill directly and cc the ResearchEthics@tuh.ie

- The Chair of the JREC is Prof Anne-Marie Tobin. Please contact researchethics@tuh.ie and queries will be forwarded to Prof Tobin.

PURPOSE OF THE JREC

- The St. James’ Hospital (SJH) / Tallaght University Hospital (TUH) Joint Research Ethics Committee (REC) provides ethical review of research studies in which patients, staff and sometimes healthy volunteers are either:

• Direct participants (Clinical Trial, Observational Study)
• Their medical records are used (Retrospective Chart Review)
• Their biological samples are used (Clinical Trial, Observational Study)

- The aim of the JREC is to ensure the safety of our participants at all times

TYPES OF STUDIES THE JREC REVIEW

- Clinical Trials:

• The SJH/TUH JREC is a Recognised REC, thus the JREC is approved to provide ethical review of clinical trials of medicinal products (CTIMP) as required under European Communities Regulation (S.I. Number 190/2004). 
• The SJH/TUH can review Clinical Trials which are multi-site i.e. REC approval for a Clinical Trial is only required from one Recognised REC in Ireland for multi-site studies
• All Clinical Trials require a contract between the Principle Investigator (PI), the Hospital and the Sponsor (LINK TO CT SIGN OFF) 
• PLEASE NOTE: A new European Clinical Trials Regulation (536/2014) has been adopted and will be implemented in Ireland. In anticipation of the implementation of this Regulation, the Department of Health have established the National Research Ethics Committee (NREC). In May 2021 the  NREC will begin reviewing CTIMP applications. As of the 17th November the JREC will no longer review CTIMPs.

- Observational Research Studies:

• Observational Research studies involve recruitment of patients or staff to the research study. The study may include a chart review, bio-specimen procurement, interviews, questionnaires, etc.

- Retrospective Chart Review:

• Retrospective chart reviews are considered research. They do not require consent if the researcher is a Health Practitioner or other employee of the Data Controller (SJH or TUH) and would normally have access to patient charts. The study must also be low risk with respect to data protection (Please see Data Protection Section - LINK).

HOW THE SJH/TUH JREC FUNCTIONS

• The SJH/TUH REC follows the Operational Procedures for RECs Guidance issued by the Irish Council for Bioethics (2004) (available at: Irish Council for Bioethics)
• The full REC meets 10 times each year and reviews between 6 and 10 applications at each meeting.
• Researchers must submit all research studies to the JREC for review via the online Ethics Review Manager 
• As of May 2021 the JREC no longer reviews Clinical Trials, or Device Trials (subject to legislation), which are instead submitted to the National REC (NREC). Device Trials (not subject to legislation) may be submitted via the online review portal.
  - If applicable, submissions are booked into the next available committee meeting (please note timelines below).
  - If reviewed at the committee meeting, a letter with review comments will be issued to the applicant within 2 weeks of the committee meeting date.

• Submissions following initial review or approval for ALL types of studies:

- Response to comments:

- Amendments:

- Reports/Notifications:

• Decisions: 

- The REC issues one of the following decisions in relation to a valid application:

I.  The study is APPROVED (Final Opinion): The study is approved. The applicant may conduct the research as outlined in the application form submitted to the REC.

II.  The study is PROVISIONALLY APPROVED: The study is approved subject to recommended revisions to the   application and/or responses to questions posed. The applicant must resubmit any revisions and/or responses to   the REC before receiving final approval for the study. No research may be conducted prior to receiving final approval.

III.  Further Information required: The REC requires further information from the applicant and/or referee (expert opinion) before a decision can be reached.

IV.  A decision on study approval is DECLINED: The REC has not approved the study. The applicant is  given a full explanation of the REC’s decision with or without an invitation to resubmit a substantially altered proposal for reconsideration.

ADDITIONAL INFORMATION

• Health Research Consent Declaration Committee (HRCDC):

- Researchers conducting studies involving patients who lack capacity to give their own informed consent or researchers who do not plan on seeking explicit consent from the patient must apply to the HRCDC for a consent declaration for the processing of the patients data. Provisional JREC approval must be in place before applying to the HRCDC.

• Health Products Regulatory Authority (HPRA):

- Research involving Investigational Medicinal Products or Devices may require approval from the HPRA.  Please consult with the HPRA regarding your study before applying to the JREC.

Committee Meeting Dates 2023:

January 24th 2024
February 21st 2024
March 20th 2024
April 17th 2024
May 22nd 2024
June 19th 2024
July 24tht 2024
August – No Meeting
September 18th 2024
October 23rd 2024
November 20th 2024
December – No Meeting

TYPES OF STUDIES THE JREC DO NOT REVIEW

Clinical Audit:

• Clinical audit is the systematic review and evaluation of current practice against standards with a view to improving clinical care for service users.

Quality Improvement Initiatives:

• Improving quality is about making healthcare safe, effective, patient – centred, timely, efficient and equitable.
• Quality Improvement is the framework we use to systematically improve the ways care is delivered to our patients. Healthcare consists of thousands of interlinked processes that result in a very complex system. Processes are defined, measured, analysed, improvements implemented and then controlled.

Service Evaluation:

• An internal evaluation of a service provided to a select set of patients for a given period of time in order to identify issues/good practice and implement appropriate changes if necessary.

* The JREC will not review these types of studies ethically but the JREC will issue a letter stating the type of study being conducted

- Registration is made via the Registration Form

Clinical Audit Contact Details: Clinical Audit Manager, Ms Sinead Palmer – Sinead.Palmer@tuh.ie, 01-4142855

Quality Improvement & Service Evaluation:

Contact Details, Quality Improvement Lead, Ms Mary Hickey – Mary.Hickey@tuh.ie, 01-4142854

Research Data Protection

First Line Contact Details:  Dr Sadhbh O’Neill, Saidhbh.ONeill@tuh.ie

• The General Data Protection Regulation (GDPR) was signed into law on the on the 28th May 2018 for all of Europe (https://gdpr-info.eu/)
• Irelands Interpretation of GDPR Ireland, namely the Data Protection Act of 2018 (http://www.irishstatutebook.ie/eli/2018/act/7/enacted/en/html) was implemented in Ireland on the 8th August 2018.
• The Department of Health (DoH) in Consultation with the Data Protection Commission (DPC) (https://www.dataprotection.ie/) published the Health
• Research Regulations 2018 (http://www.irishstatutebook.ie/eli/2018/si/314/made/en/pdf), which is Irelands Interpretation of GDPR/Data Protection Act 2018 for Health Research.
• Therefore all Health Research taking place in Ireland is subject to the GDPR, the Data Protection Act and the Health Research Regulation     

BUT

• What does this mean for Health Research in Ireland?

GDPR, the Data Protection Act of 2018 and the Health Regulations (HRR) required consent to be sought for all research taking place. However in January 2021 amendments to the HRR were enacted by the DoH and the DPC. These amendments concerned a number of areas but of particular interest to researchers are the amendments to:

1. Retrospective Chart Reviews - Consent is no longer required for this type of study BUT only when the study meets certain criteria: (i) the data is protected by a unique coding system (ii)a data protection risk assessment has concluded that the study is low risk (iii) it is performed by a healthcare practitioner who is an employee of TUH or a student healthcare practitioner (iii) is another employee of TUH who in their normal  duties has access to medical records (iv) the data will not be shared unless completely anonymous (v) the published results will not identify any individual and (vi) the Research Ethics Committee must review and approve.
2. Pre-screening – pre-screening is the process researchers use to identify patients that may be suitable for the research study they wish to undertake. This involves accessing medical records for the purpose of identifying patients but no data is removed/copied/recorded. This is only done by healthcare practitioners, student healthcare practitioners within TUH and hospital employees who normally have access to medical records. Patients will not be contacted to give consent for pre-screening, however, should they be deemed suitable they will be contacted in order to provide them with information about the study and, if they feel comfortable and happy, to obtain their consent.
3. Health Research Consent Declaration Committee 
   - Research involving patients who lack capacity to provide their own informed consent for their participation in research require a consent declaration by the Health Research Consent Declaration Committee (HRCDC)
   - The data controller must apply to the HRCDC for a consent declaration
   - The HRCDC is a separate committee to the Ethics committee. Their role is to review applications regarding the processing of a patient's data without seeking consent from the patient
      I.  Personal data (i.e. name. address, MRN, email address, DOB, etc)
      II. Personal sensitive data (i.e. patients medical data)
   - The HRCDC committee make a decision as to whether there is significant public interest in the study and this public interest outweighs an individual's rights to give their consent for their data to be processed
   - The HRCDC will require assent to be sought from the patients next-of-kin.
   - More information and the HRCDC application form can be found at the following link HRCDC
   - Please refer to GDPR Article 6  for the options under personal data and GDPR Article 9 for options under sensitive personal data

1. Consent for Health Research must be dual consent, (i) consent for participating in research and (ii) consent for processing a patients data. The DoH have published their guidance for seeking explicit consent from patients

Link to privacy notice

Clinical Research at Tallaght University Hospital - Information for Patients

Clinical Trial & Observational Study Agreement Sign Off

The review and sign off of Clinical Trials and Studies is managed by Dr Sadhbh O’Neill

Ms. Deirdre O’Brien, the Clinical Trials and Studies Contracts Officer is the first line of contact for contract review and sign off.

Deirdre is available from Tues to Fri 09:30 – 14:00 at deirdre.obrien02@tuh.ie or (01) 414 2952

The following documents are required to be reviewed for a Clinical Trial:

• Clinical Trial Agreement (CTA) / Contract / Research Collaboration Agreement (The sponsor, or legal representative of the sponsor must be established within the European Economic Area)
• Data Protection Agreement (DPA), either as a section in the agreement or standalone document (including Standard Contractual Clauses if required)
• Research Ethics Committee favourable opinion, listing TUH as a site and TUH Principal Investigator name.
• HSE Clinical Trial Indemnity Form Version 4 (State Claims Agency template to be used – DO NOT AMEND)
• HPRA granted Authorisation for Clinical Trial or Clinical Investigation, if applicable
• Site Specific Assessment (SSA) or Site Specific Template signed and dated by Principal Investigator.
• Data Protection Impact Assessment (DPIA)
• Sponsor Insurance Certificate
• Letter of Authorisation/delegation of Authority, if applicable

The following documents are required to be reviewed for an Observational Study:

• Clinical Trial Agreement (CTA) / Contract / Research Collaboration Agreement (The sponsor, or legal representative of the sponsor must be established within the European Economic Area)
• Data Protection Agreement (DPA), either as a section in the agreement or standalone document (including Standard Contractual Clauses if required)
• Research Ethics Committee favourable opinion, listing TUH as a site and TUH Principal Investigator name.
• Data Protection Impact Assessment (DPIA)
• Letter of Authorisation/delegation of Authority, if applicable

When this documentation is reviewed and agreed, we make a submission to AON for approval through the Clinical Indemnity Scheme. On receipt of this final approval we can proceed to signing the contract.

Please Note: 

1. The Deputy CEO must be the last signature on the contract documentation when all the documents as outlined above are approved for sign off by the Clinical Trials and Studies Contracts Officer
2. The Adelaide and Meath Hospital, Dublin, incorporating The National Children's Hospital is the legal name for TUH and must be used on all documentation 
3. The Principal Investigator must approve the budget
4. Where the Pharmacy Department are involved in the trial they must approve the pharmacy budget pharmacy.clinicaltrials@tuh.ie. This approval must be sent to the Clinical Trial and Studies Contracts Officer

Online Portal

All documentation listed above must be submitted to our online submission portal  https://sjh-tuh.forms.ethicalreviewmanager.com/

1. Steps to create an account: (Please use the Chrome browser to access the portal)

• To begin click on the link above and click ‘ok’.
• Click on the white ‘Log in’ button in the top right hand corner.
• Click on the green ‘New User’ button.
• Complete the registration form including your email address and new chosen password.

Passwords must be 10+ characters long but no longer than 64, contain both upper and lower case characters and contain at least one special character and one number *

• Click to agree to T&Cs and click the blue ‘Register’ button.
• An email will then be sent to you to verify your identity. Click on the link in your email to activate your account.
• Login using your email address and password. 

2. For Ethics Submission:

• You will need to log in and use the Main Application form – see SJH/TUH Joint Research Ethics Committee tab

3. For Contract Submission:

• You will need to log in and click ‘Create Project’ in the upper left hand corner.
• Type the name of the clinical trial in the Project Title* box.
• From the Form* drop down box select ‘Contracts – Clinical Trials and Studies’.
• From the Centre* drop down box select ‘Ethics Committee – SJH/TUH’ (This does not mean you’re applying for Ethics Approval, you just need to choose one for the system proceed)
• You can then use the tabs to upload the documentation.

Research Finance – Research Ethics Fees

• Research Ethics Fees:

- Research Ethics applications are charged as follows:

- Please note: am invoice will be sent to the email address entered into the Finance section of the Ethics Application within Infonetica
- Please include the Invoice Number, the REC Reference Number and 301624 on all payments

Contact Details:  Research Ethics and Clinical Trials Manager, Dr Sadhbh O’Neill - Researchethics@tuh.ie

Contact Details:  Finance Department – Invoice Queries ONLY, Ms Linda McDonnell – Linda.McDonnell@tuh.ie, 01-414 2841

Research Human Resources

• All TUH staff conducting research in TUH must create an account to register as research staff through the Research Registration Form
• All non-TUH staff who are entering TUH to undertake Research must have a co-investigator who is staff in TUH and all non-TUH staff must register with HR through the Research Registration page in Registration Form
• In order to conduct research in TUH, the following are required:

- Garda Vetting – If you are TUH staff this was conducted before you began working in TUH
- Insurance and Indemnity are also required – The CIS will cover all staff conducting research however non-staff will not be covered and external insurance is required. An example is TCD staff/students will need to submit a copy of TCDs insurance

Contact Details for Garda Vetting: talent.acquisition@tuh.ie

Contact details for medical staff:  medical.administration@tuh.ie

• In order to conduct research in TUH the following training must be completed:

- Data Protection Training (General training via www.hseland.ie and research specific training via the Research Office, in conjunction with the Centre for Learning and Development (CLD) and via www.hseland.ie)
- ICH-GCP Training – Full Introductory course and Refresher course offered via the Research Office, in conjunction with the CLD and via www.hseland.ie)
- In order to conduct research in TUH the following training may need to be completed depending on the nature of your study. For TUH staff these are mandatory training for employment
- Hand Hygiene (www.hseland.ie)
- An Introduction to Children First (www.hseland.ie)
- Fire Safety
- Manual Handling
- Sharps Education
- Breaking the Chain of Infection
- Personal Protective Equipment
- Basic Life Support training

Online Review Manager System- Infonetica

On the 26th February 2021 the TUH Research Office and SJH Research & Innovation Office in conjunction with the SJH/TUH Joint Research Ethics Committee launched our new online system for:

1. The registration of all research taking place in TUH
2. For applications requiring Research Ethics Committee review and approval
3. Research Data Protection
4. TUH clinical audit/service evaluation/quality improvement initiative registration and reporting
5. SJH clinical audit/service evaluation/quality improvement initiative Research Ethics Committee letter requests

The link for the new system can be found HERE.

The following video is provided to offer guidance to applicants when using the system.

Documentation

 1. Clinical Trials of Investigational Medicinal Products

I.  All Initial Clinical Trial submissions are via email to sadhbh.oneill@tuh.ie and cc researchethics@tuh.ie

1.Forms required include:

1. Form 1 – Clinical Trial of  IMP Application form

2. Form 3 – Site specific assessment (1 required per site)

3. Checklist

II.  Amendments, response to comments and reporting are through the online system – Click HERE.

2.Other forms of Research

I.All documentation is on the online system – Click HERE.

3.Other Documents

I.TUH DPIA – Please note there is also a DPIA within the Registration Form.