MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998 - DOC

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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:                           sandra.grote@nelondon.nhs.uk


 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

				
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