University of Hertfordshire

UNIVERSITY OF HERTFORDSHIRE

ETHICS COMMITTEE FOR STUDIES INVOLVING HUMAN PARTICIPANTS

A meeting of the Ethics Committee for Studies Involving Human Participants of the Academic Board will be held on Wednesday, 1 February 2017, at 14.00 hours, in the Woburn Room.

(Agenda papers for this meeting have been issued to members, named alternates and officers in attendance only. Non-confidential papers may be obtained on request from Governance Services (Telephone: 3410; e-mail:p.j.ashworth).)

Apologies should be conveyed to Mrs J H Allen, Clerk, Telephone: 01707 284902; e-mail: [email protected]

A G E N D A

1 APOLOGIES

To receive apologies for non-attendance at the meeting.

2 MEMBERSHIP

2.1 ECDA, Health and Human Sciences

To note that Rev Dr K P Goode, Vice-Chairman, ECDA, Health and Human Sciences, will attend on behalf of Dr R L V Southern and to welcome her to the meeting.

Officers in attendance

2.2 To note that this will be the last meeting to be attended by Mrs L Powell, Academic Services Officer (Ethics), who will leave the University on 5 April 2017.

3 MINUTES – 26 OCTOBER 2016

To confirm and sign minutes. - Paper 3 (Confidential)

4 MATTERS ARISING FROM THE MINUTES

4.1 Storage of raw data – Minutes 935.1.4 and 954.1 refer

To note that the document 'Cyber security and managing Personal and Confidential Information' (PCi) (v1, September 2015), produced by Library and Computing Services (LCS), which includes advice on electronic storage, will be produced for use by students by Dr W J Worthington, Research and Scholarly Communications Manager, LCS.

4.2 Visibility of Ethics StudyNet site to research students - Minutes 936.1 and 954.2 refer

To establish whether the problem of visibility of the Ethics StudyNet site for those entering the site from the Doctoral College StudyNet pages has been resolved.

Ethics Agenda 1.2.17 1/7 4.3 Frequently Asked Questions (FAQ) - What constitutes a study? (Activities that are not studies but currently go through ethical clearance process - Minutes 935.3.2 and 954.3 refer

(Agenda item 6.2.1 refers.)

4.4 Annual Reports 2015-2016 and applications for renewal of delegated authority: Social Sciences, Arts and Humanities - Minute 955.4 refers

To receive the Annual Report for the ECDA, Social Sciences, Arts and Humanities - Paper 4.4 (Confidential) 4.5 Breach of Protocol flowchart - Minute 955.2.3 refers

To note the flowchart, amended to take account of any effects on participants of a breach of protocol. - Paper 4.5

4.6 Disclosure and Barring Service (DBS) clearance - Minute 957.2 refers

4.6.1 To note Note 12 of the meeting of ECDA Chairman on 10 January 2017 concerning the principles in respect of DBS clearance and to agree to adopt those principles (Agenda Paper 6.1, refers).

4.6.2 To consider proposed amendment to Form EC1 to take account of the principles to be adopted (Agenda item 11, refers).

4.7 School children aged 'rising 5' - Minute 957.3 refers

To establish whether clarification has been obtained from the School of Education in respect of the triage process being relevant to children participants from Reception classes rather than Early Years classes.

4.8 Validation/revalidation of programmes/MA Optometry ('MOptom') - Minute 957.3.2 refers

4.8.1 To note Note 4 of the meeting of the ECDA Chairmen on 10 January 2017 (Agenda Paper 6.1, refers).

4.8.2 To receive an oral report from Ms Rendell concerning the ethical standards required by the General Optical Council for class practical activities undertaken by MOptom students.

4.8.3 To receive an oral report from Mrs L Powell, Academic Services Officer (Ethics) to establish whether all the procedures being undertaken by students on the MOptom programme are covered by the Class Protocol.

4.9 Any other matters arising from the minutes not taken elsewhere on the Agenda.

5 MATTERS REFERRED FROM ECDAs

To note that there are no matters referred from ECDAs that have not already been dealt with.

6 CHAIRMAN/ECDA CHAIRMEN TERMLY MEETINGS

6.1 To note the Notes of the meeting of the Chairman and ECDA Chairmen on 10 January 2017. - Paper 6.1 (Confidential)

6.2 Matters referred to the Committee

Ethics Agenda 1.2.17 2/7 6.2.1 Activities that are not studies but currently go through the ethical review process

i To agree the adoption of the flowchart as a decision tool to determine whether the proposed activity requires ethical clearance, as reported in Note 3 of the meeting of ECDA Chairmen on 10 January 2017 (Agenda Paper 6.1) (Agenda item 11.2.3, refers).

ii To agree the adoption of a new EC1 form to accompany the flowchart decision tool, designed to be used for all activities in the classroom or outside where ethical clearance is not required (Agenda Item 11.2.3, refers).

iii To agree to the merging of the current Form EC1D, 'Class Practical Application for Ethical Approval for a Student Activity involving Human Participants' into Form EC1E, 'Class Protocol Application for Ethical Approval of a Study involving Human Participants' (Agenda item 11.2.2, refers.)

6.3 Validation/revalidation of programmes/MA in Optometry

(Agenda item 4.8, refers.)

6.4 Reconfiguration of ECDAs

(Agenda item 7, refers)

6.5 Disclosure and Barring Service

(Agenda item 4.6, refers.)

6.6 Frequently Asked Questions

(Agenda item 10, refers.)

7 RECONFIGURATION OF ECDAs

7.1 To receive a report concerning a proposal to reduce the number of ECDAs. - Paper 7.1 (Confidential) 7.2 To receive an oral report from the Chairman.

7.3 To recommend for approval by the Academic Board revisions to the Terms of Reference of the Ethics Committee. - Paper 7.3

7.4 To recommend for approval by the Academic Board revisions to the Terms of Reference of the ECDAs:

7.4.1 ECDA, Social Sciences, Arts and Humanities; - Paper 7.4.1

7.4.2 ECDA, Health, Science, Engineering and Technology. - Paper 7.4.2

7.5 To recommend for approval by the Academic Board minor revisions to UPR RE01, 'Studies Involving Human Participants'. - Paper 7.5

Ethics Agenda 1.2.17 3/7 8 SPONSORED STUDIES: ETHICAL APPROVAL BY THE HEALTH RESEARCH AUTHORITY (HRA) - Minutes 904 and 938 refer

8.1 To note that the arrangements for the Ethics Committee to review all applications for studies being sponsored, including both clinical trials and non-clinical trials, agreed with Mrs S C Grant, Secretary and Registrar, and Professor J M Senior, Pro Vice-Chancellor (Research and Enterprise) are now in place and that the Terms of Reference for the Ethics Committee will be amended appropriately, reviewed by the Standing Working Party of the Academic Board and, subject to agreement, approved by Action of the Chairman of the Academic Board.

8.2 Sponsored studies applications log

8.2.1 To note a summary of studies current and/or approved by the Health Research Authority between September and December 2016. - Paper 8.2.1 (Confidential)

8.2.2 To note that information on clinical trials will be extracted from the summary and forwarded to the University’s insurers, via Mr P Wickham, Arthur J Gallagher, its insurance broker.

8.3 Clinical trials - Standard Operating Procedures (SOPs)

To note that SOPs are being developed in respect of the operation of clinical trials and that this opportunity will be used to undertake a wider review of UPR RE02, 'Research Misconduct', and UPR RE03, 'Research'.

9 ANNUAL REPORT 2015-2016

To approve the Committee's Annual Report for 2015-2016 to the Academic Board. - Paper 9 (Confidential)

10 FREQUENTLY ASKED QUESTIONS

10.1 I plan to involve minors/vulnerable participants in my study, do I need a DBS check? - Paper 10.1

10.2 I plan to use human tissue in my research. - Paper 10.2

10.3 There's the potential for participants to become distressed during my study, what should I do? - Paper 10.3

10.4 Do I need a risk assessment? - Paper 10.4

10.5 To endorse agreement by ECDA Chairman to the use of these FAQs for use by students.

11 FORMS

11.1 To receive an oral report from the Clerk concerning the Committee efforts to develop an online application process and the alternative measures that are being developed should this prove impossible.

11.1 To receive an oral report from Mrs Powell concerning the availability of a software product that will facilitate the production of forms for completion online.

Ethics Agenda 1.2.17 4/7 11.2 To agree the immediate development and implementation of the following forms which will replace the current Form EC1:

11.2.1 Form EC1A (individuals, groups and staff) - Paper 11.2.1

11.2.2 Form EC1B (Class and Class Activity Protocols) - Paper 11.2.2

11.2.3 Form EC1C (student activities involving human participants not considered studies) and flowchart. - Paper 11.2.3

11.2.4 Form EC1D, 'Declaration of Involvement in a non-UH approved Study' - Paper 11.2.4

12 AGENDA PART II

To note and approve Part II of the Agenda (items A-B).

Members wishing to comment on any item in Part II of the agenda (which consists of items requiring formal note and/or approval) are asked to inform the Chairman through Mrs J H Allen, ext 4902, e-mail [email protected] at least 48 hours before the meeting. If no such indications are received, Part II will be taken as noted and approved.

13 RISK

To consider any risks inherent in the matters dealt with by the Committee during the meeting but not discussed when the item concerned was taken.

14 PEOPLE DEVELOPMENT

To identify people development needs and to refer them to Mrs J Lees, Manager, People Development, Department of Planning, Development and Change.

15 EMERGENCY BUSINESS

(Admissible only with the consent of the Chair given prior to the meeting).

16 SCHEDULE OF MEETINGS 2016-2017

16.1 Ethics Committee

1400 hours, Wednesday 3 May 2017, Woburn Room, MacLaurin Building.

16.2 ECDAs

16.2.1 To note that the schedule of ECDA meetings is correct as at 1 February 2017 but that these may change depending on the outcome of discussions concerning the reconfiguration of ECDAs.

16.2.2 ECDA Health and Human Sciences

1400 hours, Wednesday 1 March 2017, Room 1H276, College Lane Campus; 1400 hours, Wednesday 17 May 2017, Room 2H250, College Lane Campus.

16.2.3 ECDA Social Sciences, Arts and Humanities

Ethics Agenda 1.2.17 5/7 1400 hours, Wednesday 22 February 2017, Sandringham Room, MacLaurin Building; 1400 hours, Wednesday 24 May 2017, Sandringham Room, MacLaurin Building.

16.2.4 ECDA Science and Technology

1400 hours, Wednesday 22 February 2017, Room 1H276, College Lane Campus; 1400 hours, Wednesday 24 May 2017, Room 2H250, College Lane Campus.

17 DATE OF NEXT MEETING

Wednesday, 3 May 2017, at 14.00 hours, in the Woburn Room, MacLaurin Building.

Items for the Agenda should be notified to the Clerk by Wednesday, 12 April 2017. Supporting papers should be provided to the Clerk by Wednesday, 19 April 2017 (e-mail: [email protected] Telephone:284902).

Ethics Agenda 1.2.17 6/7 A G E N D A - PART II

A RESEARCH COMMITTEE

To note the confirmed minutes of the Research Committee meeting of 20 October 2016. - Paper A

B ECDAs

To note the following unconfirmed ECDA Minutes:

B.1 ECDA, Health and Human Sciences, 19 October 2016; - Paper B.1 (Confidential)

B.2 ECDA, Science and Technology, 17 October 2016; - Paper B.2 (Confidential)

B.3 ECDA, Social Sciences, Arts and Humanities, 26 October 2016; - Paper B.3 (Confidential)

Ethics Agenda 1.2.17 7/7