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East London & The City HA Local Research Ethics Committee 2 Annual Report 1 April 2007 - 31 March 2008 Part 1 – Committee Membership and Training Name of REC: East London & The City HA Local Research Ethics Committee 2 Type of REC: Authorised Committee Type of Flag: Tissue Bank Chair: Ms Dora Opoku Vice-Chair: Dr Cliff Chaplin Co-ordinator: Sandra Grote Assistant Co-ordinator: Committee Address: 2nd Floor, Burdett House Mile End Hospital Bancroft Road London E1 4DG Telephone: 020 8223 8602 Fax: Email: firstname.lastname@example.org Chair’s overview of the past year: For most of this year, Committee 2 benefited from stability of membership and administrative support. Although attendance of individuals fluctuated there was a core number of members who attended regularly and made the backbone of the committee. A number of planned meetings were cancelled either because of low number of applications or failure to achieve quorum. The practice of seeking confirmation prior to the meeting members’ intentions regarding their intention to attend the meeting or otherwise allows decisions to be made by the co-ordinator and the Chair whether to invite members from the other sister committee or to cancel that months meeting and transfer applications to another committee. On these occasions, submitted proposals were transferred in a timely fashion to the other committees within the East London and the City HA. This meant that researchers were able to attend in person to speak to their applications. Six meetings went ahead as scheduled. Though they reviewed a whole range of topic areas, as is usual, the ethical issues around consent and information to research participants engaged much of the committee’s deliberations with different perspectives being contributed by different members. The most proposals reviewed were between 5 and 6. In the majority of applications, the Chief/Principal Investigator or their nominee were in attendance to answer questions and clarify points raised by members. While they tended to prolong meetings, these attendances increased the chance of an application receiving a favourable opinion or a provisional with few amendments. East London & The City HA Local Research Ethics Committee 2 Annual Report Page 2 The sub-committee made up of the Chair and her deputy saw an increase in SSAs and applications for substantial amendments. It is anticipated that this trend will continue in the coming months as a result of remaining the only operational committee in the East London and the City HA for quite a long period of 2008. Student Application decreased particularly from undergraduate students. Post-graduate students made up the majority of applicants. Of continuing concern to committee members is the poor quality of some of the undergraduate applications. These showed evidence of little or no input from their Academic Supervisors. Where this was highlighted as a problem, a specific reference was made in the response to the applicant. To prepare for reviewing research involving human tissue, 5 members attended NRES workshops on the Human Tissue Act and Ethical Review. This is in addition to 4 members who attended the previous year. Subsequently, the committee has reviewed a number of applications which should feature in the 2008/9 annual report. With regards to the confidence with such reviews, my overall assessment is that it is “work in progress”. All applications were time compliant. Looking ahead, I am pleased to report that Committee 2 will cease to exist as it is now once all the details have been worked out for the merged East London and the City REC Alpha. A number of current members have expressed an interest in continuing their research ethics work in this area. This is very pleasing news for me as Chair. During this period, I resumed Chairmanship of the committee having stepped down for a period of time due to medical reasons. I wish to express my personal appreciation for the commitment, common sense and enthusiasm that each one has shown throughout the year. I have no doubt that they will carry these qualities with them to their future work in ensuring that the best interest of individuals agreeing to participate in research in north-east London is always given careful consideration. East London & The City HA Local Research Ethics Committee 2 Membership: Name Occupation Expert or Dates Lay Appointed Resigned Dr Nawal Albustani Acting Consultant in Expert Community Paediatrics August 06 Mrs Joanne Apfel Lawyer Lay Sept 06 Dr John Martin Carrier Non-Clinical Academic Lay March 05 Dr Cliff Chaplin Lecturer in Health Care Ethics Expert May 2004 Mr Michael Craft Lay Member Lay July 06 Mr Edward Grudus Lay Member, Research Lay Nurse July 06 Ms Alison Higgs Lay Member Lay July 06 Mr John Lynch Lay Member Lay Oct 05 Ms Dora Opoku Head of Midwifery Expert May 2004 Ms Sylvia Richards Research Nurse Expert Feb 06 Dr Andrew James Webb Pharmacologist Expert Feb 05 Ms Gemma Dorer Occupational Therapist Lay July 07 Miss Danielle Dunne Systematic Reviewer Lay 2006 July 2007 East London & The City HA Local Research Ethics Committee 2 Annual Report Page 3 Deputy Members Name Occupation Expert or Meeting date attended Lay Co-opted Members Name Occupation Expert or Meeting date attended Lay Member Bank Name Occupation Expert or Meeting date attended Lay East London & The City HA Local Research Ethics Committee 2 Annual Report Page 4 Meetings for Full Ethical Review 1 April 2007- 31 March 2008: Month Date Number of Members Present at Meeting April 11/04/2007 9 May 09/05/2007 7 June 13/06/2007 7 July 11/07/2007 9 November 07/11/2007 8 February 13/02/2008 8 East London & The City HA Local Research Ethics Committee 2 Annual Report Page 5 Attendance of Members: 1 April 2007 – 31 March 2008: Name Number of Meetings Attended Dr Cliff Chaplin 6 Mr Michael Craft 6 Ms Dora Opoku 5 Ms Sylvia Richards 6 Mr Edward Grudus 5 Miss Danielle Dunne 3 Mr John Lynch 3 Dr John Martin Carrier 3 Dr Nawal Albustini 3 Ms Alison Higgs 2 Dr Andrew James Webb 1 Mrs Joanne Apfel 1 Number of inquorate meetings held: 3 cancelled due to inquoracy East London & The City HA Local Research Ethics Committee 2 Annual Report Page 6 Training 1 April 2007 – 31 March 2008: 26/06/2007 Social Science Methodology Workshop Mr Michael Craft NRES NRES 14/09/2007 No consent, no research Mr Michael Craft NRES NRES 24/10/2007 Active public involvement in Research Mr Michael Craft NRES NRES 24/10/2007 Active public involvement in Research John Lynch NRES NRES Human Tissue Act & Ethical Review 28/02/2008 Workshops Sandra Grote NRES NRES Human Tissue Act & Ethical Review 03/03/2008 Workshops Mr Edward Grudus NRES NRES Human Tissue Act & Ethical Review 03/03/2008 Workshops Ms Gemma Dorer NRES NRES 03/03/2008 Human Tissue Act & Ethical Review Dora Opoku NRES NRES Human Tissue Act & Ethical Review 03/03/2008 Workshops Mr John Lynch NRES NRES List of Training Events Organised Locally by the Co-ordinator: Event Date East London & The City HA Local Research Ethics Committee 2 Annual Report Page 7 Part Two: REC Workload 1 April 2007 – 31 March 2008: Summary of Work Types 1 April 2007 – 31 March 2008: Applications for full ethical review – Type Number % Clinical Trial of Investigational Medicinal Product 0 0.0 Phase 1 0 0.0 Gene Therapy 0 0.0 Research Tissue Bank 0 0.0 Research Database 0 0.0 Others 28 100.0 Total Applications Reviewed 28 100.0 Number of applications transferred in from other RECs 2 Number of applications transferred out to other RECs 11 Number of invalid applications received 2 Number of studies withdrawn prior to the meeting 0 Number of studies withdrawn after the meeting 1 Site Specific Assessment 86 Number of student applications reviewed 19 Number of substantial amendments reviewed 12 Number of Section 30 applications reviewed 0 Summary of Decisions Made 1 April 2007 – 31 March 2008: Decisions taken at meetings following review of Number % applications Favourable Opinion 4 14.3% Unfavourable Opinion 4 14.3% Provisional Opinion 19 67.9% Other 1 3.6% Total 28 100% Number of studies sent back to full committee meeting 0 for final opinion Status of applications at date of generation of report Number % Further Information Favourable Opinion 18 66.7% Further Information Unfavourable Opinion 0 0.0% Favourable Opinion 4 14.8% Unfavourable Opinion 4 14.8% Provisional Opinion 0 0.0% Other 1 3.7% Total 27 100% East London & The City HA Local Research Ethics Committee 2 Annual Report Page 8 Other Management Information 1 April 2007 – 31 March 2008: Average number of applications reviewed per full meeting 4.0 Number of applications for full ethical review over 60 days 2 Number of applications over 60 days as a % of total 4.1% Number of days taken to final decision - average 40 Number of days taken to final decision - mode 28 Number of SSAs reviewed 86 Number of applications for SSA review over 25 days 5 Number of applications for SSA review over 25 days as % of 5.8% all SSAs Number of substantial amendments over 35 days 0 Number of substantial amendments over 35 days as a % of 0% total substantial amendments Number of Section 30 applications over 60 days 0 Number of Section 30 applications over 60 days as a % of 0% total Section 30 applications East London & The City HA Local Research Ethics Committee 2 Annual Report Page 9 East London & The City HA Local Research Ethics Committee 2 Annual Report 2007/08 Proposals Considered between 1 April 2007 and 31 March 2008 Further Information Favourable Opinion 07/H0704/100 Multiple Sclerosis Tissue Study, version 1 52 07/H0704/101 Serological and DNA markers as predictors of kidney transplant outcome 67 07/H0704/54 HIV and Immigration policies: The experiences of Zimbabweans in the UK 56 07/H0704/56 Soft tissues in Hypodontia 88 07/H0704/58 Immune reactions to BCG vaccination 57 07/H0704/99 Maternal fish oil supplementation in high risk pregnancies 52 07/Q0604/20 Immune response to novel HBcAg presentation system 46 07/Q0604/23 Molecular mechanisms in malignant melanoma 49 07/Q0604/24 The EPOCH Study 39 07/Q0604/25 Links between inflammation and ovarian cancer Version 2.0 43 07/Q0604/30 Validation of oral mucosal transudate for hepatitis B testing 46 07/Q0604/32 Adult neural stem cells and brain tumours v1 37 07/Q0604/34 The role of immunoglobulin, IL3R and CD160 in B-CLL 32 07/Q0604/36 Recto-anal coordination in health and in hindgut dysfunction 35 07/Q0604/42 Clinical outcomes following Self Harm presentation at A&E 59 08/H0704/15 Extremely preterm birth in Hackney: a pilot case control study 69 08/H0704/16 Attentional modulation of visceral pain processing 49 08/H0704/17 Autologous platelet gel 55 Favourable Opinion 07/H0704/102 Cytokine responses to exercise and activity in patients with CFS 34 07/H0704/53 TESTING OF PARTNERS AT NEWHAM (TOPAN) 28 07/Q0604/22 RELACHS: Stress, Mind & Body 40 07/Q0604/41 To measure the cerebral venous oxygen saturation (CSvO2) 31 Further Information Unfavourable Opinion Unfavourable Opinion 07/H0704/55 Effect of Growth Hormone Receptor genotype on GH responsiveness 51 07/H0704/57 Urothelial biofilms in overactive bladder with significant pyuria 46 East London & The City HA Local Research Ethics Committee 2 Annual Report Page 10 East London & The City HA Local Research Ethics Committee 2 Annual Report 2007/08 Proposals Considered between 1 April 2007 and 31 March 2008 07/Q0604/19 To measure the cerebral venous oxygen saturation (CSvO2) 33 07/Q0604/45 Validation of a human model of nausea 31 Provisional Opinion Other Decisions 07/Q0604/40 Human tissue harvesting project 31 Not requiring review by NHS REC Full applications for ethical review over 60 day timelines Further Information Favourable Opinion 07/H0704/56 Soft tissues in Hypodontia 88 Further Information Favourable Opinion 07/H0704/101 Serological and DNA markers as predictors of kidney transplant outcome 67 SSAs over 25 day timeline No Objection 07/H0704/114 Efficacy, Tolerability, Safety of subcutaneous IgPro20 in PID 38 No Objection 07/H0704/115 After Diagnosis Diabetes Research Support System, version 2 32 No Objection 07/H0704/116 ADOPT (Apixaban Dosing to Optimise Protection from Thrombosis) 32 No Objection 07/H0704/117 JNJ-16269110 dose-ranging obesity phase II study 32 No Objection 08/H0704/29 PERSEPHONE 27 Substantial amendments over 35 day timeline Section 30 applications over 60 day timeline East London & The City HA Local Research Ethics Committee 2 Annual Report Page 11
"MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998 - DOC"