Coiste Eitice Taighde Research Ethics Committee. Tuarascáil Bhliantúil 2010/11 Annual Report

Transcription

1 Coiste Eitice Taighde Research Ethics Committee Tuarascáil Bhliantúil 2010/11 Annual Report

2 Clár 1. Introduction Membership and membership changes Number and dates of meetings held Attendance of members; confirmation of participation by required categories of members Substantive changes to the standard operating procedures (SOPs) List of training undertaken by members A list of proposals considered and the decision reached on each Time taken from acceptance of application to final decision on each proposal List of projects completed or terminated during the year Website and contact details

3 1 Introduction We are very pleased to produce the sixth Annual Report (Academic year 2010/11) 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 significant commitment and contributions of the REC members. It is important to note that such commitment is provided on a strictly voluntary basis. 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 (both 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 20.2 and 57 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. In conclusion, this report represents the required public record of the activities of the NUI Galway Research Ethics Committee in its third year of operation. We look forward to continuing to contribute to the vibrant research culture within NUI Galway. Dr Saoirse Nic Gabhainn (Chairperson) (to March 2011) Dr Brian McGuire (Vice Chair) (from March 2011) 3

4 2. Membership and Membership Changes Membership at start of year September 2010 Full Member Alternate Law Ms Mary Keys Ms Maureen O Sullivan Social Science Dr Molly Byrne Dr Anne Byrne Dr Kevin Davison Dr Allyn Fives Professional Care and Dr Saoirse Nic Gabhainn (Chair) Dr Edina Moylett treatment of people Prof Declan Devane Mental Health Dr Brian McGuire (Vice Chair) Ethics Training (1-2) Dr Heike Felzmann Lay Members (2-4) Mr Patrick Towers Ms Breda Dolan Sciences/Engineering Mr Enda Fallon Dr Karen Doyle Dr Xinmin Zhan Post Grad Representative Tba Committee Secretary Gary Lupton Membership at end of year August 2011 Full Member Alternate Law Ms Mary Keys Ms Maureen O Sullivan Social Science Dr Molly Byrne Dr Anne Byrne Dr Kevin Davison Dr Allyn Fives Professional Care and Dr Saoirse Nic Gabhainn (Chair) Dr Edina Moylett treatment of people Prof Declan Devane Mental Health Dr Brian McGuire (Vice Chair) Ethics Training (1-2) Dr Heike Felzmann Lay Members (2-4) Mr Patrick Towers Ms Breda Dolan Sciences/Engineering Enda Fallon Dr Karen Doyle Dr Xinmin Zhan Post Grad Representative Tba Committee Secretary Gary Lupton 4

5 3. Number and dates of meetings held A total of 6 meetings were held since the last Annual Report in July The dates were: 10.30am, Tuesday September 28 th, am, Wednesday November 17 th pm, Thursday January 27 th am, Tuesday March 15 th pm, Wednesday May 11 th am, Tuesday June 28 th 2011 * Please note the meeting scheduled for Wednesday August 10 th 2011 was re-scheduled to 7 th September 2011, due to an insufficient quorum. 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, and - One lay person The full list of attendees is as follows: September 28 th, 2010 Category Full Member Alternate Member Law Ms Mary Keys Social Science Dr Molly Byrne Dr Anne Byrne Dr Kevin Davison Dr Allyn Fives Professional Care and treatment of people Mental Health Dr Saoirse Nic Gabhainn (Chair) Dr Brian McGuire (Vice Chair) Ethics Training Lay Members Mr Patrick Towers Ms Breda Dolan Sciences/Engineering Dr Karen Doyle Dr Xinmin Zhan Post Grad Representative Committee Secretary Dr Gary Lupton 5

6 November 17 th 2010 Category Full Member Alternate Member Law Ms Mary Keys Social Science Dr Anne Byrne Dr Kevin Davison Dr Allyn Fives Professional Care and treatment of people Mental Health Ethics Training Dr Saoirse Nic Gabhainn (Chair) Dr Brian McGuire (Vice Chair) Dr Heike Felzmann Lay Members Mr Patrick Towers Ms Breda Dolan Sciences/Engineering Mr Enda Fallon Dr Karen Doyle Post Grad Representative Committee Secretary Dr Gary Lupton January 27 th 2011 Category Full Member Alternate Member Law Social Science Ms Mary Keys Dr Molly Byrne Dr Kevin Davison Dr Allyn Fives Professional Care and treatment of people Mental Health Ethics Training Lay Members Dr Saoirse Nic Gabhainn (Chair) Prof Declan Devane Dr Brian McGuire (Vice Chair) Dr Heike Felzmann Mr Patrick Towers Sciences/Engineering Mr Enda Fallon Dr Karen Doyle Post Grad Representative Committee Secretary Dr Gary Lupton 6

7 March 15 th 2011 Category Full Member Alternate Member Law Ms Mary Keys Ms Maureen O Sullivan Social Science Dr Molly Byrne Dr Anne Byrne Dr Kevin Davison Dr Allyn Fives Professional Care and treatment of people Mental Health Ethics Training Lay Members Sciences/Engineering Post Grad Representative Committee Secretary Dr Saoirse Nic Gabhainn (Chair) Prof Declan Devane Dr Brian McGuire (Vice Chair) Dr Heike Felzmann Dr Gary Lupton Dr Edina Moylett Seamus MacLoone Dr Karen Doyle May 11 th 2011 Category Full Member Alternate Member Law Ms Maureen O Sullivan Social Science Dr Molly Byrne Dr Anne Byrne Dr Kevin Davison Professional Care and treatment of people Mental Health Ethics Training Lay Members Dr Heike Felzmann Mr Patrick Towers Sciences/Engineering Mr Enda Fallon Dr Karen Doyle Post Grad Representative Dr Xinmin Zhan Committee Secretary Dr Gary Lupton 7

8 Tuesday June 28 th 2011 Category Full Member Alternate Member Law Social Science Professional Care and treatment of people Mental Health Ethics Training Dr Kevin Davison Prof Declan Devane Dr Brian McGuire (Vice Chair) Dr Allyn Fives Dr Edina Moylett Lay Members Mr Patrick Towers Ms Breda Dolan Sciences/Engineering Mr Enda Fallon Dr Karen Doyle Post Grad Representative Committee Secretary Dr Gary Lupton 5. Substantive changes to the standard operating procedures (SOP) No changes in List of training undertaken by members A training day was held on Monday 29 th November 2010 from 10am to 5pm in the Seminar Room, Science and Engineering Technology Building. 8

9 7. A list of proposals considered and the decision reached on each. September 2010 Applicant Initial Decision Final Decision Adeline Cooney Provisional Caroline Kenny Provisional John Lally Provisional Ronan Conway Provisional Cliodhna O'Keeffe Provisional Yetunde John-Akinola Provisional Mary Keogh Provisional Therese McIntyre Provisional Charles O'Mahony Withdrew application Withdrew application Michael Browne Deferral Deferral Christina Murphy Provisional Suzanne Foley Provisional Tereza Brumovska Provisional 9

10 November 2010 Applicant Initial Decision Final Decision Aideen Gallagher Provisional Brian Hughes (a) Brian Hughes (b) Ciaran Morrisson Cormac Forkan Eimear Lee (a) Eimear Lee (b) Emma Brannlund Fiona Morrissey Fodhla Coogan Geraldine McBride Ian Stewart Jennifer O'Mara Joanne Rolfe Manigandan Chockalingam Margaret McGrath Mary Tinnelly Michael Browne (re-sub) Michael Doane Niamh Higgins Rosemary Geoghegan Ruth McMenamin Sarah Thompson Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Deferral Withdrew application Deferral 10

11 January 2011 Applicant Initial Decision Final Decision Andrea Gibbons Provisional Annmarie Creaven Bernadine Brady Ian Stewart Jenna O'Neill Joanne Rolfe Margaret McGrath Maureen Kelly Sarah Thompson Sean Dinneen Susan O'Flanagan Thomas Scharf Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional March 2011 Applicant Initial Decision Final Decision Anne Cassidy Provisional Ann-marie Morrissey Claire O'Driscoll Colm McDonald Gearoid O'Laighin Hanora D Tuohy Jennie Galvin Jennifer Dagg Lynda Donnellan Marguerita O'Donoghue Pauline Meskell (postgrad) Pauline Meskell (undergrad) Sinisa Malesevic Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional 11

12 May 2011 Applicant Initial Decision Final Decision Adeline Cooney (A) Adeline Cooney (B) Bernadine Brady Brid Oliver Charles O'Mahoney Declan Coogan Deirdre Twomey Eamon O'Shea Loise Kinlen Margaret McGrath Niall McUidhilin Ronan Kennedy Sheila Garrihy Tanja Kovacic Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional Provisional June 2011 Applicant Initial Decision Final Decision Aideen Gallagher Carol Baumann Cormac Forkan Leanne Robbins Margaret O'Halloran Yvonne Conway Marie Coggins Provisional Provisional Provisional Provisional Deferral Provisional Deferral Deferral 12

13 August 2011 * Please note the meeting scheduled for Wednesday August 10 th 2011 was re-scheduled to 7 th September 2011, due to insufficient quorum. 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 days to days Final Decision days to 66 days September 2010 Applicant Date of Acceptance Date of Initial Decision Date of Final Decision Adeline Cooney Caroline Kenny John Lally Ronan Conway Cliodhna O'Keeffe Yetunde John-Akinola Mary Keogh Therese McIntyre Charles O'Mahony Michael Browne Christina Murphy Suzanne Foley Tereza Brumovska

14 November 2010 Applicant Date of Acceptance Date of Initial Decision Date of Final Decision Aideen Gallagher Brian Hughes (a) Brian Hughes (b) Ciaran Morrisson Cormac Forkan Eimear Lee (a) Eimear Lee (b) Emma Brannlund Fiona Morrissey Fodhla Coogan Geraldine McBride Ian Stewart Jennifer O'Mara Joanne Rolfe Manigandan Chockalingam Margaret McGrath Mary Tinnelly Michael Browne (re-sub) Michael Doane Niamh Higgins Rosemary Geoghegan Ruth McMenamin Sarah Thompson

15 January 2011 Applicant Date of Acceptance Date of Initial Decision Date of Final Decision Andrea Gibbons Annmarie Creaven Bernadine Brady Ian Stewart Jenna O'Neill Joanne Rolfe Margaret McGrath Maureen Kelly Sarah Thompson Sean Dinneen Susan O'Flanagan Thomas Scharf March 2011 Applicant Date of Acceptance Date of Initial Decision Date of Final Decision Anne Cassidy Ann-marie Morrissey Claire O'Driscoll Colm McDonald Gearoid O'Laighin Hanora D Tuohy Jennie Galvin Jennifer Dagg Lynda Donnellan Marguerita O'Donoghue Pauline Meskell (a) Pauline Meskell (b) Sinisa Malesevic

16 May 2011 Applicant Date of Acceptance Date of Initial Decision Date of Final Decision Adeline Cooney (A) Adeline Cooney (B) Bernadine Brady Brid Oliver Charles O'Mahoney Declan Coogan Deirdre Twomey Eamon O'Shea Loise Kinlen Margaret McGrath Niall McUidhilin Ronan Kennedy Sheila Garrihy Tanja Kovacic June 2011 Applicant Date of Acceptance Date of Initial Decision Date of Final Decision Aideen Gallagher Carol Baumann Cormac Forkan Leanne Robbins Margaret O'Halloran Yvonne Conway Marie Coggins

17 9. List of projects terminated during the year There were no projects reported to the REC as having been terminated during the year. 10. Website and contact details. The REC website can be found at This has provided a very useful tool in dissemination of information to the research community. The website contains four sections; Making an application Regulations/ Directives governing ethical conduct of research Policy and Guidance Documents on ethical issues related to research Further Reading / Ethics Articles Should you have any comments or queries on this report, please contact the Research Ethics Committee at: NUI Galway Research Ethics Committee Office of the Vice President for Research NUI Galway Tel: Fax: eithne.oconnell@nuigalway.ie 17