Coiste Eitice Taighde
Research Ethics Committee
Tuarascáil Bhliantúil
2006/07
Annual Report

NUI Galway Research Ethics Committee - Tuarascáil Bhliantúil 2006/07

Clár

1. Introduction 3

2. Membership and membership changes 4

3. Number and dates of meetings held 4

4. Attendance of members; confirmation of participation by required categories of members 5

5. Substantive changes to the standard operating procedures (SOP) 7

6. List of training undertaken by members 7

7. A list of proposals considered and the decision reached on each 7

8. Time taken from acceptance of application to final decision on each proposal 9

9. List of projects completed or terminated during the year 11

10. Other relevant topics 11

11. Website and contact details 11

1.  Introduction

We are very pleased to produce the Second Annual Report (Academic year 2006/7) of the Research Ethics Committee of NUI, Galway. The format of the report is as mandated by the Standard Operating Procedures.

The aim of the NUI, Galway Research Ethics Committee (REC) is to ‘safeguard the health, welfare and rights of humans and researchers in research studies and to afford dignity to the handling and treatment of biological materials, taking into account the scientific procedures and concerns of the local community’. Members come from a wide variety of backgrounds including law, basic science, social science, professional care (specifically mental health), ethicists and lay members. We wish to acknowledge and thank the most significant commitment and contributions of the REC members. It is important to note that such commitment is provided on a strictly voluntary basis.

We also wish to warmly acknowledge the key contributions of Committee Secretary, Pádraic de Búrca, supported by Eithne O’Connell.

The objectives of the NUI, Galway REC are to provide

1. timely, comprehensive and independent reviews of the ethics of proposed studies

2. NUI, Galway researchers (staff and students) with resources for understanding and addressing ethically significant problems which might arise in their research and to promote responsible research and practice.

The report provides detailed information on how the first objective has been achieved in the past year. The average time taken to reach initial and final decisions were 26.7 and 55.7 calendar days respectively. The second objective has been partly addressed through the provision of relevant web information. How to approach this more comprehensively will form a key component of REC strategy in the short term.

The remit of the REC was extended this year to all postgraduate research, apart from taught Masters. Clearly a balance needs to be struck between expanding the remit of the REC and the ability to respond in a timely and comprehensive manner. Developing a strategy for further incremental expansion, particularly at under graduate level, is a second key challenge.

In conclusion, this report represents the required public record of the activities of the NUI, Galway Research Ethics Committee in it’s second year of operation. We look forward to continuing to contribute to the vibrant research culture within NUI, Galway.

Professor Andrew W Murphy (Chairperson)

Dr. Saoirse Nic Gabhainn (Vice Chairperson)

Dr. Heike Schmidt-Felzmann (Acting Vice Chairperson)

2.  Membership and membership changes

Membership at start of year:

Full Member Alternate

Law Dr Padraic Kenna Ms Mary Keys

Social Science Dr Saoirse NicGabhainn Dr Molly Byrne

Dr Pat Dolan Ms Ann Byrne

Professional Care and Prof Andrew Murphy (Chair) Prof John Morrisson

treatment of people Dr Kathy Murphy Dr Edina Moylett

Mental Health Prof Colm McDonald Mr Brian McGuire

Ethics Training (1-2) Dr Richard Hull Dr Heike Schmidt Felezmann

Lay Members (2-4) Mr Bernard Kirk Ms Cait Ni Mhaille

Rev Patrick Towers Sr Avril O’Regan

Sciences Prof Chris Dainty Dr Nathan Quinlan

Dr John Kelly Dr Karen Doyle

Post Grad Representative Mr Mark Hanniffey

Committee Secretary Mr Padraic De Búrca

Current Membership: Full Member Alternate

Law Dr Padraic Kenna Ms Mary Keys

Social Science Dr Molly Byrne (Vice Chair) Dr Saoirse Nic Gabhainn

Dr Pat Dolan Ms Ann Byrne

Professional Care and Prof Andrew Murphy (Chair) Prof John Morrisson

treatment of people Dr Kathy Murphy Dr Edina Moylett

Mental Health Prof Colm McDonald Mr Brian McGuire

Ethics Training (1-2) Dr Richard Hull Dr Heike Schmidt Felezmann

Lay Members (2-4) Mr Bernard Kirk Ms Cait Ni Mhaille

Rev Patrick Towers Sr Avril O’Regan

Sciences Prof Chris Dainty Dr Nathan Quinlan

Dr John Kelly Dr Karen Doyle

Post Grad Representative Mr Mark Hanniffey

Committee Secretary Mr Padraic De Búrca

3.  Number and dates of meetings held

A total of 6 meetings were held since the last Annual Report in July 2006. The full list of dates are;

·  11am, Tuesday September 26th 2006

·  2.00pm, Wednesday November 29th 2006

·  11.00am, 30th January, (cancelled) (Not a physical meeting).

·  2pm, Tuesday March 27th 2007

·  11am, Tuesday May 29th, 2007

·  2pm, Tuesday July 10th, 2007

4.  Attendance of members; confirmation of participation by required categories of members

A minimum of seven members of the Ethics Committee were present at every meeting. Each meeting also had a reasonable representation of member categories at each meeting including at least the following:

- The chairperson

- One clinician or one scientist,

- One lay person

The full list of attendees is as follows:

September 26th 2006

Category / Full Member / Alternate Member
Law / Padraic Kenna / Mary Keys
Social Science / Saoirse Nic Gabhainn
Pat Dolan / Molly Byrne
Prof Care & treatment of people / Andrew Murphy (Chair)
Kathy Murphy / John Morrisson
Edina Moylett
Mental Health / Laura Mannion / Colm McDonald
Ethics Training / Richard Hull / Heike Schmidt Felezmann
Lay Members / Bernard Kirk
Patrick Towers / Avril O’Regan
Sciences / Chris Dainty
John Kelly / Nathan Quinlan
Karen Doyle
Post Grad Representative / Andrew Cronin
Committee Secretary / Padraic De Burca

November 29th 2006

Category / Full Member / Alternate Member
Law / Padraic Kenna / Mary Keys
Social Science / Saoirse Nic Gabhainn
Pat Dolan / Molly Byrne
Prof Care & treatment of people / Andrew Murphy (Chair) / Edina Moylett
Mental Health / Padraig MacNeela / Colm McDonald
Ethics Training / Richard Hull / Heike Schmidt Felezmann
Lay Members / Bernard Kirk / Gabriel Henry
Avril O’Regan
Sciences / Chris Dainty
John Kelly / Nathan Quinlan
Karen Doyle
Post Grad Representative / Andrew Cronin
Committee Secretary / Padraic De Burca

30th January 2007 (cancelled)

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NUI Galway Research Ethics Committee - Tuarascáil Bhliantúil 2006/07

March 27th 2007

Category / Full Member / Alternate Member
Law / Padraic Kenna
Social Science / Saoirse Nic Gabhainn / Molly Byrne
Prof Care & treatment of people / Andrew Murphy (Chair)
Kathy Murphy / John Morrisson
Mental Health / Padraig MacNeela / Colm McDonald
Ethics Training / Richard Hull
Lay Members / Bernard Kirk
Patrick Towers / Avril O’Regan
Sciences / Chris Dainty
John Kelly / Karen Doyle
Post Grad Representative
Committee Secretary / Padraic De Burca

May 29th 2007

Category / Full Member / Alternate Member
Law / Padraic Kenna / Mary Keys
Social Science / Saoirse Nic Gabhainn
Pat Dolan / Molly Byrne
Ann Byrne
Prof Care & treatment of people / Andrew Murphy (Chair)
Kathy Murphy / Edina Moylett
Mental Health / Padraig MacNeela / Colm McDonald
Ethics Training / Richard Hull / Heike Schmidt Felezmann
Lay Members / Bernard Kirk
Patrick Towers / Avril O’Regan
Sciences / Chris Dainty / Nathan Quinlan
Karen Doyle
Post Grad Representative / Mark Hanniffey
Committee Secretary / Padraic De Burca

July 10th 2007

Category / Full Member / Alternate Member
Law
Social Science / Saoirse Nic Gabhainn
Prof Care & treatment of people / Andrew Murphy (Chair) / Edina Moylett
Mental Health
Ethics Training / Richard Hull
Lay Members / Bernard Kirk
Patrick Towers
Sciences / Chris Dainty / Karen Doyle
Post Grad Representative / Mark Hanniffey
Committee Secretary / Padraic De Burca

5.  Substantive changes to the standard operating procedures (SOP)

The references to Clinical Trials were removed from the Standard Operating Procedures as the NUI Galway REC does not deal with clinical trials.

6.  List of training undertaken by members

Although there was no training undertaken during 2006/2007, a training session, similar to that taken in 2005/2006 with Keele University, is being organised for the following year.

7.  A list of proposals considered and the decision reached on each

September 2006

Applicant / Initial Decision / Final Decision
Una Fitzgerald / Provisional Approval / Approval
Diarmuid O'Donovan / Provisional Approval / Approval
Eamonn O’Shea / Provisional Approval / Approval

November 2006

Applicant / Initial Decision / Final Decision
Mark Elliott / Provisional Approval / Approval
Catherine Houghton / Approval / Approval
Pauline Meskill / Approval / Approval
Dympna Casey / Approval / Approval

January 2007

(*Please note A physical meeting did not take place)

Applicant / Initial Decision / Final Decision
Sinead Hahessy / Provisional Approval / Approval
Sinead Hahessy / Provisional Approval / Approval

March 2007

Applicant / Initial Decision / Final Decision
Padraig MacNeela / Chair Approval / Approval
Chris Dainty / Chair Approval / Approval
Chris Dainty / Chair Approval / Approval
Aine Connolly / Provisional Approval / Approval
Maria Walsh / Deferral / Deferral
Eamon O’Shea / Approval / Approval
Rena Lyons / Approval / Approval
Caroline Heary / Approval / Approval
Colm McDonald / Provisional Approval / Approval
Fidelma Dunne / Provisional Approval / Approval
Ian Stewart / Approval (studies 1&4)
Deferral (studies 2&3) / Approval (studies 1&4)
Deferral (studies 2&3
Thomas Barry / Provisional Approval / Approval
Heike Schmidt-Felzmann / Approval / Approval
Mark Hogan / Provisional Approval / Approval
Mark Elliott / Provisional Approval / Approval

May 2007

Applicant / Initial Decision / Final Decision
Maria Logue Kennedy / Chair Approval / Approval
Mary Pat O’Malley / Chair Approval / Approval
Winnie McDonagh / Provisional Approval / Approval
Todd Morrisson/T Ryan / Provisional Approval / Approval
Brian McGuire / Provisional Approval / Approval
Maria Walsh / Provisional Approval / Approval
Ian Stewart / Provisional Approval / Approval

July 2007

Applicant / Initial Decision / Final Decision
Zyed Zulquernain / Chair Approval / Approval
Gearoid O’Laighin / Chair Approval / Approval
Gearoid O’Laighin / Chair Approval / Approval
Gearoid O’Laighin / Chair Approval / Approval
Louise Horrigan / Approval / Approval
Laoise Ní Dhuda / Deferral / Deferral
Pat Dolan / Deferral / Deferral

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NUI Galway Research Ethics Committee - Tuarascáil Bhliantúil 2006/07

8.  Time taken from acceptance of application to final decision on each proposal

The average time in days taken to reach initial and final decisions are recorded in the Table below. The former may be considered largely the responsibility of the REC, the latter of the applicants.

Table 1 :Time (days) taken to reach initial and final decisions

Mean / Standard deviation / Median / 95% Confidence intervals
Initial decision / 26.71 days / 9 / 22 / 23.8 days to 29.6 days
Final decision / 55.71days / 27 / 45 / 47 days to 64.4 days

September 2006

Applicant / Date of acceptance / Date of Initial Decision / Date of Final Decision
Una Fitzgerald / 04/09/2006 / 26/09/2006 / 06/11/2006
Diarmuid O'Donovan / 31/08/2006 / 26/09/2006 / 4/12/2006
Eamonn O’Shea / 04/09/2006 / 26/09/2006 / 21/11/2006

November 2006

Applicant / Date of acceptance / Date of Initial Decision / Date of Final Decision
Mark Elliott / 08/11/2006 / 29/11/2006 / 17/01/2007
Catherine Houghton / 19/10/2006 / 29/11/2006 / 17/01/2007
Pauline Meskill / 18/10/2006 / 29/11/2006 / 18/01/2007
Dympna Casey / 25/10/2006 / 29/11/2006 / 18/01/2007

January 2007

Applicant / Date of acceptance / Date of Initial Decision / Date of Final Decision
Sinead Hahessy (07/JAN/01) / 08/01/2007 / 01/02/2007 / 02/03/2007
Sinead Hahessy (07/JAN/02) / 08/01/2007 / 01/02/2007 / 02/03/2007

March 2007

Applicant / Date of acceptance / Date of Initial Decision / Date of Final Decision
Padraig MacNeela / 05/03/2007 / 27/03/2007 / 11/04/2007
Chris Dainty (07/MAR/14) / 06/03/2007 / 27/03/2007 / 11/04/2007
Chris Dainty (07/MAR/15) / 07/03/07 / 27/03/2007 / 11/04/2007
Aine Connolly / 28/02/2007 / 27/03/2007 / 26/04/2007
Maria Walsh / 05/03/2007 / 27/03/2007 / 11/04/2007
Eamon O’Shea / 05/03/2007 / 27/03/2007 / 11/04/2007
Rena Lyons / 05/03/2007 / 27/03/2007 / 11/04/2007
Caroline Heary / 05/03/2007 / 27/03/2007 / 11/04/2007
Colm McDonald / 05/03/2007 / 27/03/2007 / 16/05/2007
Fidelma Dunne / 12/02/2007 / 27/03/2007 / 2/03/2007
Ian Stewart / 05/03/2007 / 27/03/2007 / 11/04/2007
Thomas Barry / 26/01/2007 / 27/03/2007 / 9/05/2007
Heike Schmidt-Felzmann / 05/03/2007 / 27/03/2007 / 11/04/2007
Mark Hogan / 05/03/2007 / 27/03/2007 / 04/05/2007
Mark Elliott / 14/02/2007 / 27/03/2007 / 16/05/2007

May 2007

Applicant / Date of acceptance / Date of Initial Decision / Date of Final Decision
Maria Logue Kennedy / 25/04/2007 / 29/05/2007 / 31/05/2007
Mary Pat O’Malley / 3/05/2007 / 29/05/2007 / 31/05/2007
Winnie McDonagh / 08/05/2007 / 29/05/2007 / 31/05/2007
Todd Morrisson/T Ryan / 08/05/2007 / 29/05/2007 / 24/08/2007
Brian McGuire / 08/05/2007 / 29/05/2007 / 21/08/2007
Ian Stewart / 08/05/2007 / 29/05/2007 / 10/07/2007
Maria Walsh / 08/05/2007 / 29/05/2007 / 10/07/2007

July 2007

Applicant / Date of acceptance / Date of Initial Decision / Date of Final Decision
Zyed Zulquernain / 19/06/2007 / 10/07/2007 / 17/07/2007
Gearoid O’Laighin (07/JULY/04) / 18/06/2007 / 10/07/2007 / 17/07/2007
Gearoid O’Laighin (07/JULY/05) / 18/06/2007 / 10/07/2007 / 17/07/2007
Gearoid O’Laighin (07/JULY/06) / 18/06/2007 / 10/07/2007 / 17/07/2007
Louise Horrigan / 29/05/2007 / 10/07/2007 / 6/09/2007
Laoise Ní Dhúda / 08/06/2007 / 10/07/2007 / 13/07/2007
Pat Dolan / 18/06/2007 / 10/07/2007 / 19/07/2007

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NUI Galway Research Ethics Committee - Tuarascáil Bhliantúil 2006/07

9.  List of projects completed or terminated during the year

There were no projects reported to the REC as having been completed or terminated during the year.

10.  Other relevant topics

Remit of the Research Ethics Committee

The remit of the REC was expanded to include all research coming from Doctoral & “Research Degree” postgraduates and staff.

11.  Website and contact details