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Service Evaluation Schedule
NHS Genomic Medicine Centres’ National Service Evaluation

of the Consent Process and Participant Materials used in the
100,000 Genomes Project
Version 1.0 11/03/16
Authors
Caroline Benjamin1, Markella Boudioni1, Eliot Marston1, Antje Lindenmeyer1, Helen Ward1
Mark Caulfield2, Tom Fowler2, Anneke Lucassen2, Fiona Rennie2, Laura Riley2, Michael
Parker2, Vivienne Parry2, Ellen Thomas2
Alison Cranage3, Lisa Dinh3
1
Service Evaluation Project Team
2
Service Evaluation Steering Group
3
Genomics England support for the Evaluation
Contents
1 Title ..................................................................................................................................... 4
2 Aims .................................................................................................................................... 4
3 Shared purpose and scope of project ................................................................................ 4
4 Background to the 100,000 Genomes Project ................................................................... 5
5 Research questions ............................................................................................................. 7
6 Accountability and Governance ......................................................................................... 8
6.1 Membership of the Service Evaluation Steering Group ............................................. 8
7 Contractual Arrangements ............................................................................................... 10
8 Service Evaluation plan ..................................................................................................... 11
8.1 Wider stakeholders ................................................................................................... 12
8.2 Report distribution .................................................................................................... 12
9 Expected deliverables ....................................................................................................... 13
9.1 Timescale ................................................................................................................... 13
9.2 Outputs...................................................................................................................... 14
10 Methodology................................................................................................................. 15
10.1 Improvement methodology .................................................................................. 15
10.2 Wider conceptual frameworks .............................................................................. 15
10.3 Evaluation methodology........................................................................................ 16
11 Data and measures ....................................................................................................... 18
11.1 Activity 1 - Seeking opinion from patient and public involvement groups/leads
linked to NHS Genomic Medicine Centres........................................................................... 18
11.2 Activity 2 – Health professional feedback on consent process and ease of use of
the current participant documentation ............................................................................... 20
11.3 Activity 3 – 100,000 Genomes Project participants .............................................. 21
11.4 Synthesis and Final Research Project Report Presentation .................................. 23
11.5 Data management ................................................................................................. 23
12 Budget ........................................................................................................................... 25
13 Impact ........................................................................................................................... 25
14 References .................................................................................................................... 26
15 Appendices.................................................................................................................... 27
Appendix 1 - Index of materials (activity 1) ............................................................................. 27
SERVICE EVALUATION SCHEDULE | v1.0 11/03/16 2

Appendix 1A - Participant Information Sheet (PIS) (activity 1) ............................................... 28
Appendix 1B – Consent Form (activity 1 - PPI telephone interviews and focus groups) ........ 30
Appendix 1C - Overview of introduction and material to be used (activity 1) ........................ 31
Appendix 1D - Question guide (activity 1) ............................................................................... 35
Appendix 1E – Demographic questionnaire (activity 1) .......................................................... 37
Appendix 2A - Operational considerations (activity 2) ............................................................ 40
Appendix 2B - Email to health professionals (activity 2) ......................................................... 41
Appendix 2C - Participant Information Sheet (activity 2 - health professionals) .................... 42
Appendix 2D - Healthcare Professionals Survey (activity 2) .................................................... 44
Appendix 3 - Survey postcards for 100,000 Genomes Project participants (activity 3) .......... 49
Appendix 4 - Budget and resources ......................................................................................... 54
Appendix 5 – Intellectual property and publication ................................................................ 56

1 Title
Service Evaluation Schedule
NHS Genomic Medicine Centres’ National Service Evaluation of the Consent Process and
Participant Materials used in the 100,000 Genomes Project.
2 Aims
1. To evaluate participant material (consent documentation)
2. To evaluate the consent discussion process
3. To provide evidence to inform development of consent materials and processes for
the NHS in this area
Consent documentation:
Any material produced by Genomics England to provide potential participants with
information about participation in the 100,000 Genomes Project (including all REC approved
materials) and also the consent forms used for the participant to provide evidence of
consent.
The consent discussion process:

This includes how potential participants (existing NHS patients and their family members)
become aware of the 100,000 Genomes Project, their interaction with health professionals
with whom they might discuss the project and also health professionals who are involved
with facilitating the discussion and documenting informed consent.
This is a national service evaluation to determine the facilitators and barriers related to
perceptions and processes in consent conversations in the initial stages of recruitment into
the 100,000 Genomes Project.
3 Shared purpose and scope of project

To gather robust evidence for Genomics England of views from the 100,000 Genomes
Project participants, consent-takers, public and involvement (PPI) groups/leads linked to
NHS Genomic Medicine Centres (GMCs) about the consent documentation/process.
A commitment to evaluate the consent materials is already outlined in section 12.2.1 of the
100,000 Genomes Project approved Protocol v 2.0 for the 100,000 Genomes Project, dated
February 2015: ‘Genomics England intends to further evaluate and revise its literature, and
patient and public materials at the 10,000 participant recruitment point 1. As such this
schedule is in accordance with the Protocol v 2.0 as approved by the NRES REC, and requires
no change to be made to this.

Some NHS GMC PPI feedback has suggested that the consent documentation would benefit
from an evidenced review, which this service evaluation also aims to provide.
4 Background to the 100,000 Genomes Project

In December 2012, the Prime Minister announced a programme of whole genome
sequencing (WGS) as part of the UK Government’s Life Sciences Strategy2. During the NHS
65th Anniversary celebrations in 2013, the Secretary of State for health announced the
formation of the DH-owned company Genomics England, to carry out the 100,000 Genomes
Project.3
A principal objective of the 100,000 Genomes Project is to sequence 100,000 genomes from
around 70,000 patients with cancer, rare disorders, and infectious disease. Then to link the
sequence data to clinical and other diagnostic information to inform the overall
interpretation of the genome sequence and its expression for diagnostic and management
of care purposes.
The 100,000 Genomes Project is also an NHS transformation project, which follows
established legal and regulatory standards for seeking the informed consent of its
participants, or those who could consent on their behalf.
Drawing on relevant guidance and exemplars of good practice, the participant materials (i.e.
participant information sheets, assent and consent forms, personal consultee declaration
forms) have been developed in accordance with the key principles in the Key Ethical
Principles document and Ethical Governance Framework, and with the advice of the Ethics
Advisory Committee, with comments from the Science Committee, and other stakeholders
including patients, and the appropriate guidance.1
Copies of the most recently REC-approved participant consent materials and consent forms
are available on the Genomics England website along with FAQs about the project.4
Genomics England will undertake a two-phased approach to the evaluation to meet the
commitment made in the 100,000 Genomes Project protocol. Phase 1 responded to initial
feedback from the NHS GMC Patient and Public Involvement (PPI) leads and clinicians,
requesting a summary sheet and a video; additional materials have also been produced and
are available on the Genomics England website. Initial changes were also made to the
written participant information in response to a consultative exercise which took place in
the Summer of 2015.
This schedule outlines phase 2, which is a service evaluation of recruitment across all GMCs,
covering the consent process and participant materials.
There are two key contact points for patients within the scope of the 100,000 Genomes
Project:
1. Patients under the care of the NHS in England will be referred by their treating
clinician for invitation to join the 100,000 Genomes Project, because they have either

a (suspected) rare inherited disease, or certain forms of (suspected) cancer. The
consent discussion with participants seeks to draw attention to key elements of the
100,000 Genomes Project that may be regarded as having particular ethical, legal or
social implications. Eligible family members of participants with (suspected) rare
inherited disease will also be invited to join as participants.
2. Findings from participant samples regarding their main condition (the cancer or rare
disease regarding which the participant joined the Project) will be confirmed in the
NHS, before being reported to the NHS teams caring for the patients, who will discuss
these findings with the participant.
The national service evaluation proposed here focusses on the consent materials used and
consent discussion process experienced by participants who have been referred to the
100,000 Genomes Project by their treating clinician i.e. contact point 1 above, and also their
family members who become participants. It will help to inform further evaluation work
across wider aspects of the project and improve participant experience. Data will be
synthesised from three stakeholder groups that will be approached to take part in this
evaluation (see page 11):
1. NHS GMC PPI group members
2. Healthcare professionals (recruiters) and
3. 100,000 Genomes Project participants (participants)
The main areas of topics for research enquiry are covered in the agreed 10 key focus areas
of this evaluation (see page 17).
Pending the outcome of the evaluation, the Service Evaluation Project Team may make
recommendations which could inform an amendment to the consent materials and improve
participant experience. Any proposed amendments to materials would be subject to a wider
stakeholder review and standard governance process. The development of new consent
materials, systems and processes is outside the scope of this proposal.

5 Research questions
The service evaluation outlined in this schedule aims to provide evidence to inform the
following questions.
Participants
 Are participants in the 100,000 Genomes Project satisfied with the current consent
process for this Project overall? (i.e. the experience of having their consent sought
and their opinion of the consent documentation they used to facilitate informed
decision regarding choice of participation).
 Do health professionals perceive participants to experience any difficulty in
understanding sections of the consent form?
 Do participants feel the documentation could be made easier (for themselves
personally) to understand?
 Which items of participant information materials (videos, short summary
documents, mandatory participant information sheet (PIS)) has the participant
accessed?
 Are levels of satisfaction, difficulty, understanding or access to consent elements
significantly associated with independent variables e.g. age, participant status (adult
patient with a rare disease, parent of a participating child etc.), NHS GMC region or
arm of project?
PPI group members

 What are PPI group members’ opinions on the current 100,000 Genomes Project
approach to using broad consent for additional findings?
 What do NHS GMC PPI group members think about the current process of asking
participants if they wish to opt-in to receive additional health-related or
reproductive findings? The participant is not provided with the specific details of
conditions but is asked to give broad consent for the feedback of such results by
their NHS clinician.
Healthcare professionals
 What are health professionals’ perceptions of the reasons why participants decline
to participate in the 100,000 Genomes Project?
 Are levels of confidence, specific areas of difficulty, or perception of integration into
future NHS services significantly associated with independent variables e.g.
professional group, NHS GMC region or arm of project?

6 Accountability and Governance
This service evaluation schedule has been reviewed by Genomics England and the Ethics
Advisory Committee. A Service Evaluation Steering Group has provided ongoing oversight.
The Service Evaluation Project Team reports to the Service Evaluation Steering Group, which
reports to 100,000 Genomes Project Ethics Advisory Committee.
6.1 Membership of the Service Evaluation Steering Group

Genomics England
Dr Tom Fowler, Director of Public Health
Laura Riley, Head of Ethics
Vivienne Parry, Head of Engagement
Dr Ellen Thomas, Clinical Lead for NHS Genomic Medicine
Genomics England Ethics Advisory Committee (EAC)

Professor Michael Parker, Chair and Director, ETHOX Centre, University of Oxford
Genomics England Clinical Interpretation Partnership (GeCIP) Ethics and Social Sciences
Domain
Professor Anneke Lucassen, Professor of Clinical Genetics, Wessex NHS GMC/Southampton
University (also a member of EAC)
NHS England - Fiona Rennie, Head of NHS GMC Operations
Service Evaluation Project Team

 North West Coast (NWC) NHS GMC / University of Central Lancashire (UCLan) –
Project lead and activity 2 leader - Caroline Benjamin, North West Coast (NWC) NHS
GMC WC Professional Advisor PPI Group and Guild Research Fellow College of Health
& Wellbeing, UCLan
 West London (WL) NHS GMC / Imperial College London– Activity 1 leader - Markella
Boudioni GMC PPI lead and Patient and Public Involvement (PPI) Manager with the
Patient Experience Research Centre (PERC) and the NIHR Imperial Biomedical
Research Centre (BRC) and Helen Ward, Professor of Public Health, Imperial College
London
 West Midlands (WM) NHS GMC / University of Birmingham – Activity 3 co-leads -
Eliot Marston, NHS GMC PPI Lead and Deputy Head of Research & Knowledge
Transfer, College of Medical & Dental Sciences, University of Birmingham and Antje
Lindenmeyer , Lecturer in Qualitative Methods at the Department of Primary Care
Clinical Sciences , University of Birmingham
Genomics England and NHS England will support communications with each NHS GMC,
including a statement that access to patients and recruiting staff for this evaluation project
at each local delivery partner site is covered by Genomics England’s NRES REC approval.

Genomics England will also host the on-line anonymous health professional and optional
participant anonymous surveys on their website.
During the course of the service evaluation, the Service Evaluation Project Team will provide
the Service Evaluation Project Steering Group with bi-monthly updates as to progress and to
highlight any difficulties encountered. Caroline Benjamin will provide updates for the
Operational Management Group of the NWC NHS GMC to ensure local governance. A final
report with analysis from the Service Evaluation Project Team will be delivered via NWC NHS
GMC to Genomics England.

7 Contractual Arrangements
Genomics England will contract with NWC NHS GMC for this work. This project will be led by
the NWC GMC Translational Medicine Group and hosted by the College of Health and
Wellbeing, University of Central Lancashire. NWC NHS GMC will sub-contract this work to
UCLan, who will enter into collaboration agreements with the University of Birmingham and
Imperial College London. Collaboration agreements will be signed by UCLan, the other
Universities and Genomics England. UCLan will hold responsibility for the production of the
final report and delivery to NWC NHS GMC.
Figure 1. Outline of governance for evaluation proposal
NRES REC
Genomics England
Steering Group
NHS GMC representatives

(NWC, WM, WL)
Genomics England, NHS England
NHS GMC PPI NHS Healthcare 100,000 Genomes

Groups Professionals Project participants
Project sponsor
Genomics England

8 Service Evaluation plan
The evaluation is being part funded by Genomics England. It is designed to be a
developmental evaluation, defined as, “Where innovation assumptions are revised over
time, with the results that the goal of the intervention may be changed. This type of
formative evaluation also facilitates close to real-time feedback to the intervention team. It
assists with trying out new ideas, documenting activities and their short-term
consequences, identifying processes and outcomes as they emerge and helping people
make sense of them.” 5
The service evaluation covers three key stakeholder groups:
1. NHS GMC PPI group members
2. Healthcare professionals (recruiters) and
3. 100,000 Genomes Project participants (participants)
Each group will be invited to provide feedback which will be analysed within a pre-defined
conceptual framework regarding their experiences of participating in or delivering the
100,000 Genomes Project. The aim being that views can be collated and any problems can
be resolved for the benefit of future participants, although re-design of the consent
materials is beyond the remit of this service evaluation.
Figure 2. Three stakeholder groups
Participants
Documentation
& Consent
Interaction
Recruiting NHS GMC PPI

Staff Groups

8.1 Wider stakeholders
 All NHS GMC PPI Groups will be invited to participate in activity 1 (see page 18). These
PPI groups are usually facilitated by professional members of staff and comprise a mix
of current and past patients and members of the public who have volunteered their
time. The constitution of the groups varies between NHS GMCs. Some NHS GMCs
have dedicated 100,000 Genomes Project groups whilst other GMC PPI Leads seek
comment from a range of PPI groups within their area.
• NHS recruiting clinicians involved in the project will be invited to participate in activity
2 (see page 20).
8.2 Report distribution

A copy of the final research project report will be shared with the following stakeholders:
• Health Education England – Val Davison, Scientific adviser to Health Education
England's Genomics Education Programme
• Caldicott Guardian – Professor Frances Flinter, Clinical Director Rare Diseases South
London GMC
• NHS GMC Clinical leads
• GeCIP Domains
• The Ethics Advisory Committee to Genomics England

9 Expected deliverables
This national service evaluation will consist of three co-ordinated evaluation activities
linked by delivery of five work-packages.
9.1 Timescale
The Gantt chart below (figure 3) details development work already performed and the
onwards plan.
GMC National Service Evaluation Project – Consent Process & Consent Documentation (07.07.15 to 31.09.16)
Q3 15 Q4 15 Q1 16 Q2 16 Q3 16
ID Task Name Start Finish
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep
1 WP1- Proposal submitted to Genomics England 17/07/2015 31/08/2015
WP1 - GE review of proposal and sign off - Contractual arrangements

2 01/08/2015 28/11/2015
between NWC GMC and partners/governance confirmed
WP1- Allocation of 1st staged payment of resources to NWC GMC - Duration

3 31/01/2016 28/02/2016
of funding for the project (8 months)
WP2- core project team meeting to jointly develop conceptual framework for
4 the evaluation and priority questions, followed by drafting of an evaluation 14/10/2015 14/10/2015
protocol.
WP2- Steering group meeting to discuss operational issues relating to

5 30/11/2015 30/11/2015
delivery and ‘sign-off of Protocol.
6 WP2 - Recruitment of resources (people/in kind) 01/02/2016 03/03/2016
WP2- Genomics England agrees final evaluation protocol and takes to REC
7 18/01/2016 03/03/2016
to confirm project status as service evaluation.
WP3 - Secure agreement from each NHS Trust and GMC who will participate
8 16/12/2015 14/02/2016
and data-sharing arrangements between the three universities.
WP3 - Develop instruments for data collection for all activities, pilot testing.
9 17/11/2015 18/01/2016
Discuss at 3rd core project team meeting January.
WP4 - National roll out – toolkit for data collection to all 11 GMCs 2 months –
10 01/04/2016 30/05/2016
activities; 1- PPI feedback, 2- Health professionals and 3 participants.
11 WP4 - Data analysis (all activities) and data synthesis (between activities). 01/04/2016 04/09/2016
WP5 - Report writing and submission of report to Ethics Advisory Committee

12 to Genomics England 01/07/2016 30/09/2017
Project development activity

 July to October 2015 – historical review of prior commissioned work and initial
feedback from GMCs and PPI leads.
 November – Draft 2 evaluation protocol to Genomics England
 December/January 2016 - pilot testing of questions with two PPI focus groups and
short consultation period for on-line feedback from GMC and PPI leads

Service evaluation project
 April/May - survey and focus group data collection
 June/July - data entry/cleaning/verification
 July/August - data synthesis
 August/September - research project report issued to Genomics England
Delivery schedule
The analysis and research project report production may extend into September 2016. This
project relies on the goodwill of all NHS GMCs and communication of the project by
Genomics England and NHS England is vital to its success.
9.2 Outputs
A project report will be provided to Genomics England which details a synthesis of the
results from each of the evaluation activities. This will allow comparison of views and
drafting of the evaluation team’s recommendations with regard to the scope of any changes
and additional materials/clarifications required.
Recommendations and suggested areas for improvement will be provided to Genomics
England in a final report.
Data will be collated and presented as identified barriers and facilitators related to
perceptions and processes in consent conversations in the initial stages of recruitment to
the 100,000 Genomes Project, from three differing perspectives; participants, the recruiting
health professional and the PPI opinions from the NHS GMCs.

10 Methodology
10.1 Improvement methodology

To align this project with the NHS Improving Quality programme it will use the NHS Change
Model as a framework to influence making effective and sustainable change. 6
10.2 Wider conceptual frameworks

This work forms part of Genomics England’s evaluation of the 100,000 Genomes Project
consent documentation and consent discussion process.
This service evaluation of consent process and participant materials will use the Donabedian
model as a conceptual framework7. This well-regarded public health conceptual model
provides a framework for examining health services and evaluating quality of health care.
The health care provided here is defined as ‘offering a good quality consent service to
potential participants related to the principles of quality consent following the Heath
Research Authority guidance 1’ 8,9,10 and relates to the administration of informed consent
to an individual participant and their family. Using this model will ensure that data collection
and analysis will be achievable within the constraints of the evaluation and that synthesis of
data between the activities results in meaningful and useful outputs.
Figure 4. Structure – Process-Outcome - The Donabedian Model

10.3 Evaluation methodology
The evaluation proposal is based on a mixed methods service evaluation using a
triangulation approach to gathering evidence11. A review of methods to improve patient
recruitment to clinical trials has strongly suggested that issues relating to consent process
and materials are of utmost importance12. Rather than seeing triangulation as a method for
validation or verification, qualitative researchers generally use this technique to ensure that
an account is rich, robust, comprehensive and well-developed, checking the consistency of
findings generated by different data collection methods.
Specific areas of interest covering both the rare disease and cancer 100,000 Genomes
Project pathways, include:
• Consent discussion process - the context within which the discussion occurs, are
participants given appropriate time to read information about the project and discuss
with others before making their decision to participate, how long does the consent
interview last, what facilities are available to the participant and health professional?
• Participant Information Sheets – content, visual impact, layout, logical order/flow of
topics
• Participant Consent Forms – content, visual impact, layout, logical order/flow of topics
• Health Professional Support – Are the recruiting health professionals supported in
providing the participant with an explanation of the project and answering participant
questions? How easy or difficult do they find consenting participants for this project?
Working with three different stakeholder groups will permit evaluation of the consent
experience in multiple geographic sites. Materials for data collection have been piloted and
field tested for face validity and were amended. It is anticipated that the materials will then
be used by all NHS GMC sites to feed data back to the Service Evaluation Project Team for
analysis and synthesis. Each site will have the option to include either or both rare disease
and cancer participants.
Genomics England has set out a phased framework for the evaluation and adaptation of the
consent documentation and process. Phase 1 is now complete and consisted of seeking
feedback from PPI leads and clinicians within the NHS GMCs as recruitment began. This has
resulted in various new REC-approved items of participant information materials, for
optional use, which aim to respond to (potential) participants’ different needs. These
include introductory summaries of the 100,000 Genomes Project or Prezis presenting PIS in
a more accessible way with voiceover and dynamic visual content. A video for potential
participants aimed at assisting the consent process is also currently being developed in
response to this feedback. These REC approved consent documentation and materials will
be evaluated in this project.
This evaluation (part of phase 2) will mainly consist of elements of process evaluation 13 with
some formative elements, e.g. asking participants their satisfaction with the consent

process. It will assess if the current intervention (consent process) methods are acceptable
to the people involved.
The intervention being evaluated: The current 100,000 Genomes Project consent materials
and consent discussion process.
Outcome of intervention: Participants are well supported in making an informed decision to
accept or decline participation in the 100,000 Genomes Project.
Comparison: The intervention will be compared to itself over time. At the start of
recruitment to the 100,000 Genomes Project at baseline (March 2015) concern was raised
by recruiting clinicians and GMC PPI leads regarding specific elements of the consent
documentation and process.
This project starts with 10 pre-determined areas of focus, which were extrapolated by the
Project team from their discussions with the Steering Group, the NHS GMC PPI group
network, the EAC, NHSE, and other wider stakeholders.
10 areas of focus
Project Documentation
1. Logical Flow
2. Complexity of project structure (complex project – consent material is complex)
3. Complexity and consistency of use of scientific/genomic terminology
4. Issues related to main findings, additional (opt in/opt out) & incidental findings
5. Data security (privacy) and data sharing (private companies) – Inc. impact on insurance
Process of Consent Interaction

6. Nature and timing of approach to participant – (personal/letter)
7. Seeking broad vs. specific consent
8. Time taken for participant to consent (at initial contact, after several contacts)
9. Consent Interview – location/length/ease
10. Flexibility vs. pre-determined pathway

11 Data and measures
This Service Evaluation covers the geographical range of England as covered by the 100,000
Genomes Project via the 13 NHS Genomic Medicine Centres, as well as the variety of
participants (disease, ethnicity, and social class), therefore a simple data collection strategy
is suggested.
All data is anonymous and not linked to the participants’ 100,000 Genomes Project data.
The data-collection materials should be capable of being used by each of the NHS GMCs.
Each survey question is conceptually attributed to one or more of the 10 key focus areas
above and the Donabedian model (figure 4). There is a trade-off between in-depth enquiry
and seeking wider opinion with survey methods.
This project uses a mixed methods design14 of integrating qualitative and quantitative data
focusing on the 10 pre-determined areas of focus given above.
Data collection will be performed across three activity areas.
11.1 Activity 1 - Seeking opinion from patient and public involvement

groups/leads linked to NHS Genomic Medicine Centres
Activity 1 will elicit NHS GMC PPI groups’ feedback on consent material, process and ease of
use of the current participant documentation in place during the snap-shot survey time
period.
Methods
NHS England will contact the NHS GMC Clinical Directors and they, in collaboration with the
NHS GMC PPI Leads Network, will nominate a local contact for their NHS GMC. The
nominated PPI leads will be the local contacts to collaborate with Markella Boudioni in this
activity; they will discuss how best to facilitate convening the focus groups or telephone
interviews with GMC PPI group members. A participant information sheet will be provided
for research activity 1 to PPI group members/potential participants; they will be asked to
sign a consent form before the focus groups/telephone interviews. Focus groups will be
convened in a purposeful way to ensure that most disease groups (rare disease and cancer)
and localities (rural and urban) are represented. It is envisaged that the evaluation will cover
4-6 focus groups, with each group consisting of between 5 and 8 members. The locations of
the focus groups will be spread geographically and linked with various NHS GMCs across
England. A short demographic questionnaire will be completed by focus group participants
(appendix 1E).
Focus groups consisting of invited GMC PPI members will be facilitated to explore the issues
in more depth. Members of the Genomics England Participant Panel will also be invited to
take part in a separate focus group. Focus group participants will be provided with travel
expenses for attending the meeting, in line with INVOLVE guidelines.15

Telephone interviews will be conducted with PPI Leads/members if there are practical
difficulties in bringing together groups of people in specific localities or if potential
participants wish to voice certain issues privately or in confidence. It is envisaged that no
more than 10 telephone interviews will be conducted.
The focus group activity will concentrate on the following three topic areas:
1. Logical Flow of consent documentation
2. Complexity of project structure (what impact this has on the consent documentation
and consent discussion)
3. Seeking broad vs. specific consent in consent to opt in or opt out of receiving
additional findings
These three areas have been chosen for the focus group activity as the complexity of the
issues is best evaluated by qualitative data. However, the facilitators will remain open to
other themes/issues if they arise.
All focus groups and telephone interviews will be digitally recorded, subject to the
participants completing the written consent form. Recordings will be professionally
transcribed. Data derived will be grouped thematically within ten pre-existing key areas16
which have been identified from previous patient and public research concerning the
consent materials. Data will be analysed by Imperial College London and higher level themes
will be sent to UCLan; these data together with quantitative and qualitative data from the
other 2 activities will be synthesised to provide a report describing the identified barriers
and facilitators related to perceptions and processes in consent conversations in the initial
stages of recruitment into the 100,000 Genomes Project.
Appendix 1 provides the documents below:
A) Participant Information Sheet (PIS) – Focus groups/telephone interviews.
This will be given to potential participants beforehand to provide information about
the project.
B) Participant Consent Form – Focus groups/telephone interviews.
This will be given to potential participants to sign before the focus groups/telephone
interviews.
C) Overview of Introduction to 100,000 Genomes Project and material to be used during
the focus groups/telephone interviews to ensure awareness and understanding.
- The optional 100,000 Genomes Project Introductory Leaflet, the Introduction to
the 100,000 Genomes Project booklet, and the mandatory 100,000 Genomes
Consent Forms and PIS are REC approved for use with participants.4 These
documents will be sent to participants and will be also handed to them prior to
the focus groups/telephone interviews.
- Introductory paragraphs giving the context for regulatory and legal issues,
issues arising from health records linkage, and implications for rare disease
families. These paragraphs are only for the personal use of the facilitator; they
won’t be presented/ distributed to participants.

- Broad vs specific consent paragraphs and examples/scenarios: These will be
explained/introduced either verbally or as a short PowerPoint presentation to
introduce the concepts to participants.
D) Question Guide – Focus groups/telephone interviews. This guide is for use by the
facilitator/interviewer and won’t be shared with participants.
E) Demographic Questionnaire for those attending the focus groups
Appendix 1 also provides in detail the question themes to be used at the focus groups.
11.2 Activity 2 – Health professional feedback on consent process and ease of

use of the current participant documentation
The aim of this activity is to elicit the opinion of NHS GMC health professionals who are
actively recruiting around the snap-shot survey period (April-May 2016). We expect this
number to be between four and twenty health professionals per GMC, as there are 13 NHS
GMCs this gives a potential sample size of between 60 and 300. It is anticipated that a
response rate of 40% would be achieved based on similar on-line survey response rates.
Activity 2 will focus on the consent materials and consent discussion process in place during
the snap-shot survey time period.
Methods
NHS England will contact the Clinical Director of each NHS GMC and ask them to nominate a
member of their GMC who would act as a local contact for the health professional recruiter
survey. The NHS GMC Clinical Directors or their nominee will be asked to send an invitation
email to their recruiters, this email would include an activity 2 Participant Information Sheet
for health professionals, a link to the anonymous survey and a generic password. For
assessment of an accurate response rate Clinical Directors or their nominee will be asked to
supply the number of recruiting health professionals to whom they sent the survey link.
The anonymous survey will be password protected and hosted on the Genomics England
website. Only those health professionals who have been sent the email link and password
will be able to access the survey. We will ask respondents to state their location (GMC),
gender, profession and age. The survey will take about 10-15 minutes to complete and
consist of around 20 questions. There will be no specific consent form for this activity and it
is assumed that by completion of the on-line survey the health professionals consent to
provide feedback is implied. Health professionals will remain free to complete or not
complete the survey, as stated in the Introductory Email, and the colleague inviting them to
take part will not be able to know whether or not the individual health professional has
done so.
The survey questions have been piloted and amended accordingly.

The Health Professional Survey, introductory email, participant information sheet and
survey questions are found in appendix 2.
11.3 Activity 3 – 100,000 Genomes Project participants

The aim is to ask participants who have been recruited for the 100,000 Genomes Project
their feedback on the consent process they experienced and ease of use of the current
consent documentation.
Methods
The Clinical Directors of each GMC will be asked to name a local contact within the NHS
GMC who would be able to facilitate the distribution of participant survey postcards to
recruiting health professionals.
Each NHS GMC will be asked to estimate how many participants they expect to consent
during the evaluation period of 2 months. Current estimates are 200 in total per week
across all recruiting GMCs for rare disease group, which would mean over the 2 month
evaluation period 200 x 8 weeks = 1,600 potential 100,000 Genome Project participants for
the service evaluation participant survey. The cancer arm of the project has fewer
participants and there is expected to be a total of 40 100,000 Genomes Project participants
a week across all recruiting GMCs, which would mean over the 2 month period 40 x 8 = 320
potential service evaluation participants.
The Service Evaluation team will then supply to each GMC a pack containing two sets (rare
disease participants and cancer participants) of numbered survey postcards which have a
unique postcard number, linked to their NHS GMC. This number does not link to the
patient’s clinical or 100,000 Genomes Project identifiers. The participant survey is
anonymous.
The recruiting health professionals will be asked to briefly explain the survey to the 100,000
Genomes Project participant. The participant will be asked if they wish to take part in the
survey and if they do then be handed a survey postcard before leaving their consent
interview.
The recruiting health professional will be asked to pass a postcard to each individual for
whom they counter-signed a consent form. A postcard will not be given to individuals who
decline participation in the 100,000 Genomes project.
If consenting an individual both as an adult participant ‘with or without a rare disease’ and
additionally as a ‘parent giving consent for a child’, two cards will be handed out and the
participant asked to complete one to feedback on their personal experience as a participant,
and the other postcard for their experience of consenting as a parent of a participating
child.
The aim of this postcard distribution strategy is to calculate a response rate based on the
number of signed consents uploaded to the OpenClinica system over the period (monitored

by Genomics England) vs. the number of postcards returned by participants during the snap-
shot survey date window.
The postcard will state the aim of the evaluation and confirms that all feedback is
anonymous. The reference number on the postcard refers to the centre recruiting the
individual and the individual survey number and does not link back to any personal
identification. Participant information about the Service Evaluation is printed on the
postcard and explained verbally by the health professional presenting the postcard. Consent
is inferred by the participant returning the postcard.
Participants will also be given the option to complete the survey on-line by going to
www.genomicsengland.co.uk/evaluation/participants and entering their unique postcard
number. The question set is identical on the on-line option, apart from one additional
question – which allows the participant to provide more open comments.
The website option will facilitate accessibility options such as large font and to be able to be
used with text readers.
The postcards will be returned to the Service Evaluation Project Team for analysis. The data-
set from the on-line responses will be returned to Genomics England and shared with the
Service Evaluation Project Team for analysis.
Suggested analysis - basic descriptive statistics
 Does response rate vary between NHS GMCs, disease group, type of participant,
gender?
 Is there geographical representation across all NHS GMCs in relation to responses?
 Are there significant differences in satisfaction with consent process according to the
following variables: gender, age, NHS GMC site, disease group, participant type?
 Are there differences in the rating (4 item scale) of written information about the
project according to standard variables, gender, age, disease group, participant type,
NHS GMC.

11.4 Synthesis and Final Research Project Report Presentation
Data obtained on the three activity areas will be analysed and compared to obtain a
synthesis of similarities and differences thus building a national picture. sThe final synthesis
and explanatory accounts will use a narrative description of the barriers and facilitators to
quality consent found in this evaluation.17
The final research project report will consist of individual results chapters detailing the data
and analysis from each of the three activities with an additional results chapter providing a
synthesis of the project results.
11.5 Data management

The raw data-files (anonymised Microsoft Excel files containing the on-line survey responses
and postcard responses) from activity 2 and 3 will be provided to Genomics England at the
end of the project.
Due to the confidential nature of the digital audio files and written transcripts of activity 1
these files and documents will remain securely stored within the research environment at
Imperial College London. The Participant Information Sheet for activity 1 states that only
the evaluation research team can access the focus group participant data, this is due to the
confidential nature of the focus group.
At the end of the project the University of Central Lancashire will retain access to the
analysed data files for all three activities for such a period as required by each of the
collaborating universities research regulations.

Figure 5. Mapping of individual survey questions onto the 10 key topic areas. PPI questions, Participant questions, Health Professional
questions.
Map of Focus Areas against Questions 10 Key Focus Areas

Documentation Process
1 2 3 4 5 6 7 8 9 10
Consent
Scientific/ Nature and Seeking broad Flexibility vs. pre-
Complexity of Issues related to Data security and Duration of Interview
Logical Flow genomic timing of vs. specific determined
project structure findings sharing process location/length/e
terminology approach consent pathway
ase
PPI 4,5 PPI 6, 7 PPI 8-10

PPI Groups Focus Group Topics PPI 1, 2,
PPI 4,5 PPI 3
P9 P8
P1
Evaluation Questions
Participant Survey Questions

P7 P 2- 5
P3 P5 P2
HP1 HP1
HP5 HP5
HP6 HP6
HP7 HP7 HP7
Health professionals Survey Questions HP8 HP8 HP8
HP9
HP10 HP10
HP11 HP 11

12 Budget
Detailed in Appendix 4.
13 Impact
Genomics England has agreed that that the results of this project will be published as a
report with service evaluation project leaders as co-authors alongside members of the
Steering Group.
It will be submitted to Genomics England Ethics Advisory Committee to consider alongside
other evidence to decide if there is a need to amend the existing consent materials.
Genomics England have commissioned this service evaluation as a measure of the extent to
which participants are receiving a quality consent experience, based on the principles
documented by the Health Research Authority. Genomics England have committed that
they will consider the results of this service evaluation when amendments are made to the
participant materials or Protocol.
This evaluation will contribute evidence on how consent for whole genome sequencing
could be introduced into the NHS.

14 References
1. The 100,000 Genomes Project v 2.0 Protocol:
http://www.genomicsengland.co.uk/?wpdmdl=5168
2. https://www.gov.uk/government/news/dna-tests-to-revolutionise-fight-against-cancer-and-
help-100000-nhs-patients
3. https://www.gov.uk/government/speeches/nhs-65th-anniversary
4. http://www.genomicsengland.co.uk/
5. Dozois, E., et al. (2010). A practitioners guide to developmental evaluation.
www.mcconnellfoundation.ca/de/resources/publication/de-201-a-practitioner-s-guide-to-
developmental-evaluation
6. http://www.nhsiq.nhs.uk/capacity-capability/nhs-change-model.aspx (NHS England 2015).
7. Donabedian, A. (2005). "Evaluating the quality of medical care 1966." The Milbank quarterly 83(4): 691-
729.
8. General Medical Council (2013). General Medical Council Good Medical Practice Guidance on Consent
to Research. www.gmc-uk.org/guidance/ethical_guidance/5993.asp
9. British Medical Association, (2015). British Medical Association consent toolkit.
http://www.bma.org.uk/support-at-work/ethics/consent/consent-tool-kit
10. Health Research Authority, (2015). Health Research Authority Guidance on consent and participant
information sheet preparation guidance. www.hra-decisiontools.org.uk/consent/index.html
11. Creswell, J. W., Plano Clark, V L, (2011). Designing and conducting mixed methods research. Los
Angeles, CA,, Sage.
12. Bower, P., et al. (2014). "Interventions to improve recruitment and retention in clinical trials: a survey
and workshop to assess current practice and future priorities." Trials [Electronic Resource] 15(1): 399.
13. Moore, G. F., et al. (2015). "Process evaluation of complex interventions: Medical Research Council
guidance." BMJ 350.
14. Greene, J. C. (2006). Toward a methodology of mixed methods social inquiry.
15. http://www.invo.org.uk
16. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology.
2006;3:77-101.
17. Mason, J. (2002) Qualitative Researching. London: Sage.

15 Appendices
Appendix 1 - Index of materials (activity 1)
Seeking opinion from patient and public involvement groups/leads linked to
NHS GMCs
This appendix includes the following documents:
A) Participant Information Sheet (PIS) – Focus groups/telephone interviews.
This will be given to potential participants beforehand to provide information about the
project.
B) Participant Consent Form – Focus groups/telephone interviews.
This will be given to potential participants to sign before the focus groups/telephone
interviews.
C) Overview of Introduction to 100,000 Genomes Project and material to be used
during the focus groups/telephone interviews to ensure awareness and understanding.
- The optional 100,000 Genomes Project Introductory Leaflet, the Introduction to the
100,000 Genomes Project booklet, and the mandatory 100,000 Genomes Consent
Forms and PIS are REC approved for use with participants. These documents will be
sent to participants and will be also handed to them prior to the focus
groups/telephone interviews.
- Introductory paragraphs giving the context for regulatory and legal issues, issues
arising from health records linkage, and implications for rare disease families. These
paragraphs are only for the personal use of the facilitator; they won’t be presented/
distributed to participants.
- Broad vs specific consent paragraphs and examples/scenarios: These will be
explained/introduced either verbally or as a short PowerPoint presentation to
introduce the concepts to participants.
D) Question Guide – Focus groups/telephone interviews. This guide is for use by the
facilitator/interviewer and won’t be shared with participants.
E) Demographic Questionnaire for those attending the focus groups

Appendix 1A - Participant Information Sheet (PIS) (activity 1)
PARTICIPANT INFORMATION SHEET
Study title:
100,000 Genomes Project: NHS GMCs National Service Evaluation of Consent Process &
Participant Materials
Invitation paragraph
You are being invited to take part in an evaluation study. Before you decide it is important for
you to understand why the study is being done and what it will involve. Please take time to
read the following information carefully and discuss it with others if you wish. Ask us if there
is anything that is not clear or if you would like more information. Take time to decide whether
or not you wish to take part. Thank you for reading this.
What is the purpose of the study?

The 100,000 Genomes Project aims to sequence 100,000 whole genomes from about 70,000
people across England. It is a service transformation project, which follows established legal
and regulatory standards for seeking the informed consent of its participants or those who
could consent on their behalf. This study is a national service evaluation to determine the
facilitators and barriers related to quality informed consent in the initial stages of recruitment
into the 100,000 Genomes Project. Activity 1 of this study explores the complexity of the
consent and the logical flow of the consent documentation; it also looks in the option for the
return of results, in addition to the main result.
Why have I been chosen?

You have been approached because of your Patient and Public Involvement (PPI) role in your
local/regional Genomics Medicine Centre (GMC). Your involvement within your GMC provides
a unique insight into the participant material and consent systems and processes. Your views
and experiences would therefore make a valuable contribution to the understanding of this
complex issue.
Do I have to take part?

It is up to you to decide whether or not to take part. If you decide to take part you are still
free to withdraw at any time and without giving a reason. A decision to withdraw at any time,
or a decision not to take part, will not affect you or your legal rights in any way.
What will happen to me if I take part?

If you agree to take part you will be given a copy of this information sheet and the consent
form to keep. You will be approached to take part in a telephone interview lasting between
30-60 minutes or a focus group lasting approximately 2 hours in your locality. The interview
or the focus group will be digitally recorded. Following this, the recordings will be transcribed
and analysed by a researcher. All information will be confidential and anonymised.
What do I have to do?

The researcher will contact you to confirm arrangements for the telephone interview or the
focus group at convenient date, time and location. Taking part in a telephone interview will
not involve you in travel or other expenses as the interview will be conducted in privacy at
your own location. Taking part in a focus group may involve you in travel locally or regionally;
we will reimburse travel expenses and offer refreshments at the location of the focus group.
What are the possible disadvantages and risks of taking part?

None. The telephone interview will take 30 to 60 minutes of your time arranged to suit your
convenience. The focus group will take approximately 2 hours of your time. The draft and final
reports will not identify you or your organisation’s identity.
What are the possible benefits of taking part? How will information be used?
There are no direct, immediate benefits to participants. However, study findings could be
helpful to provide evidence towards development of consent materials and processes for the
NHS in this area.
What happens when the research study stops?

Written feedback will be given to all participants in the form of a summary document
distributed through the 100,000 Genomes PPI Leads Network. The findings of the study will
be written up as a report to the NHS England and Genomics England. They will be presented
at conferences and will be published in peer-reviewed journals. Short reports may be
disseminated to patient groups and other interesting parties.
Will my taking part in this study be kept confidential?

All information which is collected about you during the course of the research will be kept
strictly confidential. Any information arising from interviews will be anonymised so that you
cannot be recognised from it. Anonymised data will be stored in secure, locked cabinets and
in computer files which can only be accessed by the named researchers. Processing of data
will comply with the Data Protection Act (1998). The data will not be sent outside the
European Economic Area. Data will be destroyed within 2 years of the end of the study, when
dissemination of the findings has been completed.
What will happen to the results of the research study?

Results of the research study will be disseminated as described under item 10 above. It will
take only 2-4 months before any results are available. Participants will not be identified in any
report or publication.
Who is organising and funding the research?

The study is partly funded by Genomics England and partly funded by Imperial College
London. The researcher conducting the study data collection is Dr Markella Boudioni.
What if I have any concerns?

If you have any concerns or other questions about the study, or the way it has been carried
out, you should contact the investigator, Dr Markella Boudioni, at Imperial College London on
0207 594 8994 or mboudion@imperial.ac.uk. You may wish to contact an independent
researcher linked to your organisation for independent research advice.

Appendix 1B – Consent Form (activity 1 - PPI telephone interviews and
focus groups)
Study title:
100,000 Genomes Project: NHS GMCs National Service Evaluation of Consent Process &
Participant Materials
Name of Researcher: Dr Markella Boudioni
Please initial
1. I confirm that I have read and understand the information sheet for the
above study and have had the opportunity to ask questions. 
2. I understand that my participation is voluntary and that I am free to withdraw
at any time, without giving any reason and without my legal rights being
affected. I understand that my name or other identifying information will not
appear on any interview transcripts, discussions, or publications. 
3. I agree to take part in the above study, by participating in a digitally-recorded
telephone interview or in a focus group.

____________________ ________________ ____________________
Name of Participant Date Signature
_________________________ ________________ ____________________

Name of Person taking consent Date Signature
(if different from researcher)
_________________________ ________________ ____________________

Researcher Date Signature
1 copy for participant; 1 for researcher

Appendix 1C - Overview of introduction and material to be used (activity 1)
100,000 Genomes Project introduction
Copies of the 100,000 Genomes Project Flyer, the Introduction to the 100,000 Genomes
Project booklet, sub-set of Consent Forms and PIS will be sent to participants and will be
also handed to them prior to the focus groups/telephone interviews.
Presentation paragraph of regulatory and legal issues (if needed)
“Traditionally, there has been a clear divide between medical research projects, and routine
healthcare in the NHS. Research aims to answer a specific research question, and is governed
by a different set of rules to healthcare. Participants may benefit from taking part in
research, but helping individual patients is not the main goal.
The 100,000 Genomes Project is trying to do things in a new way, by combining healthcare
and research in the same project. The project is a healthcare transformation project because
genome sequencing can be used to make diagnoses in patients who can’t get a diagnosis
using standard tests, and these diagnoses are used in healthcare. It is also a research project
because we don’t yet know how to use genome sequencing most effectively in healthcare,
and there are many other important research questions which can be answered using the
genome sequences and health information collected for the project.
The goal of this new type of project is to improve healthcare for participants and make
beneficial changes to routine NHS practice, while getting the most out of the project’s
genome sequences and health data for medical research.
Because this is the first project to try to combine research and healthcare in this way, there
are no set guidelines on good consent practice for transformational projects of this kind. The
project consent materials have been developed according to English legal and regulatory
standards for research. These standards concern data-protection, the mental health act (for
those who are unable to consent for themselves) and the involvement of children and young
adults in research. As with all research projects, the information available to participants to
help inform their consent decision has to cover these issues. We would like your opinion on
the current consent process and documentation with the intention to feedback to Genomics
England, who have stated their intention to review the findings and if necessary amend the
process and documentation if required.”
Presentation paragraph about linking with health records (if needed)
“A genome sequence contains 3 billion individual DNA ‘letters’, and interpreting what each
of these means for an individual is very complicated. In order to work out how a person’s
genome sequence is related to their health, the genome sequence needs to be examined
together with information about the medical conditions suffered by that person.
Health information is being submitted at the start of the project by each participant’s
medical team. In addition, the project is aiming to link each participant’s genome sequence

with their future healthcare records. This is to be able to answer more questions in the
future, for example if a participant has a bad reaction to a medication or develops a new
medical condition, there may be information relevant to this in their genome sequence. This
will mostly be for research purposes, but if something is found in future which relates to the
participant’s healthcare this information will be given to their clinical team to pass on to
them. This information will also be used to do research to try to help future patients with the
same condition.
Genomics England has received previous PPI feedback regarding the consenting for ongoing
health and social care data to be collected from participants, e.g. information about
hospitalisation and emergency treatment.”
Presentation paragraph on rare disease family implications (if needed)

“Within the rare disease group it is expected that family members who have not been
diagnosed with the condition, as well as the individual who has been diagnosed will be asked
to participate. This is because comparing the genome sequence of family members who do
or don’t have the same disorder helps to interpret the genome results and makes it more
likely that a diagnosis will be found for the family. It is possible that results provided to one
family member will have health or reproductive consequences for other family members.”
Broad vs specific consent in the context of return of additional results to participants
 Additional results.* Results in addition to the main result (relating to the condition/illness
for which they or their family member sought treatment), which are known to have a
potentially severe health or reproductive impact, and for which there is some treatment
or surveillance available. Genomics England has a list of conditions where there is
evidence of potential health benefit (not necessarily for every individual participant), and
this list will increase as knowledge improves over the life of the project. Participants can
decide whether they wish to receive these findings or not, and they can change their
consent preference at any time by filling in an ‘opt-in’ or ‘opt-out’ form.
 Broad Consent. The individual participant consents to give permission for the researchers
to look for and send their NHS clinical team any additional results* for which there is
strong evidence of a possible treatable health benefit, or of significant implications for
the health of future children, without having been told about the clinical features and
consequences for each condition at the point of consenting for the 100,000 Genomes
project. Examples of the type of condition and possible implications of these results will
be discussed at the time of giving consent. It is expected that no more than 1% of
participants would be likely to receive an additional result of this kind. This broad
consent approach to results has been chosen by the 100,000 Genomes Project to allow
the project team to return the most informative set of results to every participant who is
interested in receiving this information. It is inappropriate to discuss a long list of
conditions with each participant at the point of consent, when the chance of that
individual having an additional finding relating to each separate condition is very low, and

they could receive an additional finding about another condition which hasn’t been
discussed with them in detail. As the understanding of genes improves, broad consent
allows the project to add to the list of genes which are known to have a potentially
severe health or reproductive impact, to be sent to a patient’s clinical team throughout
the patient’s life.
 Specific Consent. An alternative to broad consent is specific consent. This has not been
chosen by the 100, 000 Genomes Project but we would be interested in your thoughts
regarding these two approaches for the future implementation of this testing into
routine NHS care. The individual participant consents to give permission to look for and
send to their NHS clinical team additional results which are known to have a potentially
severe health or reproductive impact ONLY having first been told about the clinical
features and consequences of each known condition. As the understanding of genes
improves specific consent would require re-contact with the patient when each new
condition is tested for. In practice, it would be burdensome to both patients and
clinicians to re-consent participants regularly for each new condition to be tested for
(each of which would have a very low chance of affecting the individual participant), and
therefore most participants would only be tested for a short list of conditions which were
fully understood at the time at which they gave their consent, and not for conditions
which might be added to the list of genes after they gave their consent.
Examples/Scenarios:
Broad consent regarding the feedback of additional results is being sought from Mrs Smith,
age 57, who has a genetic condition affecting the heart (dilated cardiomyopathy). She has
agreed to join the project. Now she has to decide if she wishes to opt in or opt out of her
genome being tested for additional conditions with potentially severe health or
reproductive impact.
After discussions with her family and clinical team she decides that she does not wish to
consent to receiving these additional results. There is only a small likelihood she would
receive a result anyway and she feels she would want to know more information about the
conditions being tested for. She tells her consent-taker that she is not generally comfortable
with uncertainty, so she does not wish to consent to having tests in the future without more
specific information. She also understands that there is uncertainty over whether these
tests do actually offer a health benefit to each individual who opts in to receive them.
After discussions with her family and clinical team she decides that she does wish to
consent to receiving these additional results. As she is having genome sequencing anyway,
she would like to receive any additional health benefit from the information being
generated, and she is generally the kind of person who prefers to know about things if there
is a chance that she will be able to do something to reduce her future health risks. She takes
the view that as only results which her clinical team feel relate to conditions with potentially

severe health or reproductive impact will be provided, she would wish to receive this
information and is content to find out more detail at the time if she is given a specific result.
After a brief discussion with her clinical team, she decides that she is feeling quite
anxious about her heart condition, and does not feel able to make an informed decision
about whether to receive additional findings at that time. She therefore opts not to receive
additional findings, but takes the Participant Information Sheet away with her to read at
leisure and discuss with her family. Six months later, her health is more stable, and she has
discussed the project with her daughters, who both feel that this information could be
useful to all of them as a family, so she re-contacts her clinical team and fills in an ‘opt in’
form to change her consent preference about additional findings.

Appendix 1D - Question guide (activity 1)
General questions (100,000 Genomes Project)
1. What experience have you had to date with the 100,000 Genomes Project?
(Prompts: to explore experience of participants)
2. What do you think of the consent material used for the 100,000 Genomes Project?
(Prompts: to decide if rare disease or cancer adult PIS and consent form are used prior to
the group or telephone; open question to identify how familiar people are with the
consent material, i.e. information sheet, consent forms)
3. Are you familiar with the consent process? Could you describe the cancer/rare disease
consent process at your locality?
(Prompts: open question to identify familiarity with the consent process, similarities and
differences)
4. What do you think of the consent process? Is there anything working particularly well
or causing particular problems? (Prompts: good practice – how the consent process was
explained to them, easy/difficult to understand, participants’ preferences)
Logical flow (100,000 Genomes Project)

5. What do you think about the flow of information of the participant material?
(Prompts: does it flow logically, are there any gaps; language issues, i.e. dense,
technical, hard to take in, etc.…)
6. Are there any specific sections that you would like to discuss in more detail?
(Prompts: any specific sections, too much/too little information in individual PIS, any
suggestions…)
Complexity of project structure (100,000 Genomes Project)

7. What do you think about the project structure? What do you like/don’t like about the
project structure?
(Prompts re complex project, complex consent material: is it a simple project, is it a
complex project; language issues: complex sentence structure, ‘legalistic’ tone, clarity,
ease of understanding, use of bullet points, ‘key point’ boxes, cross referencing across
documents)
7. Could you possibly simplify some of these for participants? How? (Prompts re complex
project simplifications, improvements, suggestions)
Seeking broad vs. specific consent in relation to additional results (100,000 Genomes
Project-(findings)
9. What do you think about the current option of participants (who have given consent to
enter then project) being able to go on-line and opt-in or opt-out of their consent

decision to receiving additional results? (Prompts: may need to use the definitions and
examples at this point only or again; benefits, drawbacks)
10. What information do you think that Genomics England should supply on-line for
additional conditions that are being tested?
(Prompts: http://www.genomicsengland.co.uk/taking-part/results/, link to NHS Choices,
what, how much/how little, examples of information; benefits, drawbacks)
11. What do you think about the 100,000 Genomes project’s decision to ask patients to either opt-
out of receiving additional findings OR Opt-in giving broad consent for additional results only
relating to ‘the principle of conditions with potentially severe health or reproductive impact’.
(Further Info: Genomics England do not give participants the option for specific consent as this
would limit the range of conditions for which additional results can be provided; it is also
inappropriate and potentially overwhelming for participants to have to consider a long list of
complex genetic conditions, when their chance of receiving an additional finding for each of
these is very low.) (Prompts: examples of information; benefits, drawbacks)
Other barriers and facilitators

12. In addition or in relation to the above, what do you consider as barriers within the consent
process? (Prompts: too little or too much information, specific points; flow- specific points;
complexity- specific points)
13. In addition or in relation to the above, what could possibly facilitate/improve the consent
process? (as above)
Final general transformational and sustainability questions

14. How do you see the consent process being embedded/fit with the participants’ disease
pathway? How can the consent process be embedded, if genome sequencing is used in
clinical practice in the future?
(Prompts: can it be embedded in the process of diagnosis, along care pathways; can it
be seamless, does it require additional effort, etc.)
15. What do you think about the future of such projects? Do you think that we benefit/do
not benefit from such projects? Are there any drawbacks in general?
(Prompts: are these projects sustainable; one off/continuity, benefits/drawbacks in
general)
Final closing question
16. Do you have any other comments or suggestions about the consent material and the
consent process?

Appendix 1E – Demographic questionnaire (activity 1)
Demographic and condition-specific information asked of focus group participants by self-

completion of a paper questionnaire.
Demographic and condition-specific questionnaire

Many thanks for attending today. When presenting the findings of this service evaluation
we would wish to be able to describe the composition (by asking some basic demographic
questions) of those participating in the focus group today. We would be grateful if you could
complete this questionnaire and return it to the facilitator at the end of the meeting. Your
responses will remain confidential to the research team.
1. I am participating in this focus group (100,000 Genomes Project National Evaluation of
Consent Process and Documentation) as I am….
(please tick all that apply)
 A participant of the main 100,000 Genomes Project
 A member of a specific NHS Genomic Medicine Centre Patient and Public

Involvement Group (GMC PPI Group) (please state which GMC below)
……………………………………………………………………………………………
 A member of a Patient Group (or other group/organisation) linked with a specific

Genomic Medicine Centre – but not specifically a GMC PPI Group)
(please state which group/organisation below)
……………………………………………………………………………………………
 A member of the National 100,000 Genomes Project Participant Panel
 None of the above
 My attendance forms part of expectations of employment by an organisation (e.g.
NHS Trust/Charity/University/Private Sector) ………………………………………

 Other representation (please state below)
……………………………………………………………………………………..........
2. Have you been diagnosed with cancer or a rare condition? (please tick all that apply)
Yes, I am a patient with cancer (please state the cancer)

……………………………………………………………………………………………
Yes, I am a relative/carer of someone with cancer (please state the
cancer)..…………………………………………………………………………………
Yes, I am a patient with a rare disease (please state the rare disease)
………………………………………………………..………………………………….
Yes, I am a relative/carer of someone with a rare disease (please state the rare
disease
………………………………………………………..………………………………….
3. What is your gender? (please tick only one)
Male Female Other
4. What is your age? (please tick only one)
16-18
25-44
45-64
65-74
Over 75
5. What is your ethnic group? (please tick only one)

Choose ONE section from A to E, then tick the appropriate box to indicate your ethnic group.
A White
 British

 Irish
 Any Other White background (please state)…………………………..
B Mixed
 White and Black Caribbean
 White and Black African
 White and Asian
 Any Other Mixed background (please state)…………………………….
C Asian or Asian British

 Indian
 Pakistani
 Bangladeshi
 Any Other Asian background (please state)……………………………….
D Black or Black British

 Caribbean
 African
 Any Other Black background (please state)…………………………………
E Chinese or other ethnic group

 Chinese
 Any Other (please state)………………………………………………………..
5. To enable us to understand more about the composition of our focus groups for this evaluation could you
please provide the first three or four characters of your postcode (e.g. L17)
---------- ----------- ------------ ------------
Thank you.

Appendix 2A - Operational considerations (activity 2)
• Genomics England will send a National Evaluation Project – recruiting health
professional invitation email to the agreed key contact at each NHS GMC. We would
then appreciate it if the GMC Directors or their nominee would send this invitation
email to all known health professionals within their GMC who will likely be actively
recruiting participants during March and April from either arm of the 100,000
Genomes Project. The number of health professionals to whom the email is sent
should be recorded and passed to the project team.
• The email will be in the form of a request and will include an attachment of a short
Participant Information Sheet (REC approved) to let the health professional know
what will happen to their data and that it is an anonymous survey.
• The one-off survey consists of 20 questions and should take 10-15 minutes to
complete.
We aim to survey how the process of consent interaction is working, and capture health
professional feedback on specific elements of the consent documentation.

Appendix 2B - Email to health professionals (activity 2)
Attached to this email will be the REC approved participant information sheet and consent
statements regarding this national evaluation project.
Dear [health professional],

Genomics England have requested me to ask if you would be willing to take part in the
following 20 question on-line survey. Please find the link below.
www.genomicsengland.ac.uk/evaluation-project and click on health professional survey.
You will need the generic password XXX to access the survey.
This survey has been approved by NHS REC and therefore we need to provide you with a
participant information sheet (PIS) regarding this survey. There is no consent form - as it is
up to you to decide if you wish to complete the survey or not. By completing the survey
your consent is implied.
I have attached the PIS for this survey to this email.
The survey should take about 10-15 minutes to complete, depending on how much
feedback you would like to give. We ask that you answer the survey questions with
reference to your experiences relating to the recruiting period 2 months prior to you
completing the survey.
The information from the survey will be collated alongside the results of the postcard survey
available to 100,000 Genomes Project participants recruited during March and April 2016,
and also a series of focus groups with GMC PPI members will be completed over the same
period.
The outcome of this evaluation will be a project report which will be considered by
Genomics England alongside other local evaluation projects or research that will provide
evidence relating to the consent experience in the initial phase of the 100,000 Genomes
Project.
Many thanks,
[GMC Representative or Clinical Director]

Appendix 2C - Participant Information Sheet (activity 2 - health
professionals)
Study title
100,000 Genomes Project: GMCs National Service Evaluation of
Consent Process & Participant Materials
Activity 2 – Survey of Recruiting Health Professionals
Invitation paragraph
You are being invited to take part in an evaluation study. Before you decide it is important for
you to understand why the study is being done and what it will involve. Please take time to
read the following information carefully and discuss it with others if you wish. Ask us if there
is anything that is not clear or if you would like more information. Take time to decide whether
or not you wish to take part. Thank you for reading this.
What is the purpose of the study?

The 100,000 Genomes Project aims to sequence 100,000 whole genomes from about 70,000
people across England. It is a service transformation project, which follows established legal
and regulatory standards for seeking the informed consent of its participants or those who
could consent on their behalf. This research study is a national service evaluation to
determine the facilitators and barriers related to quality informed consent in the initial stages
of recruitment into the 100,000 Genomes Project. Activity 2 of this study asks health
professionals who are actively recruiting to the project their experiences and allows feedback
relating to the consent process from their perspective.
Why have I been chosen?

You have been approached because of you have been selected by your Genomic Medicine
Centre as actively recruiting participants to the 100,000 Genomes Project. Your involvement
within your GMC provides a unique insight into the participant material and consent systems
and processes. Your views and experiences would therefore make a valuable contribution to
the understanding of this complex issue.
Do I have to take part and what do I need to do?

It is up to you to decide whether or not to take part – you just have to either complete or not
the on-line survey hosted on the Genomics England website. The survey will take 10-15
minutes and is anonymous, although we will ask you to name your Genomic Medicine Centre
and clinical specialty. You can choose to if you wish to provide these details. These details
allow us to monitor that we have health professional views from across the GMC geography
where recruitment activity is occurring.
What are the possible disadvantages and risks of taking part?

None. Completing the survey will take 10-15 minutes of your time.

What are the possible benefits of taking part? How will information be used?
There are no direct, immediate benefits to participants. However, study findings could be
helpful to provide evidence towards development of consent materials and processes for the
NHS in this area.
What happens when the research study stops?

Written feedback will be given to all participants in the form of a summary document
distributed through Genomics England. The findings of the study will be written up as a report
presented to Genomics England. The findings of this study will be presented at conferences
and will be published in peer-reviewed journals. Short reports may be disseminated to patient
groups and other interesting parties.
Will my taking part in this study be kept confidential?

All information which you provide in the anonymous survey will be kept strictly confidential.
The anonymous survey response data will be kept by Genomics England and stored in
computer files which can only be accessed by the Evaluation Project Research Team or
members of Genomics England or NHS England. Processing of data will comply with the Data
Protection Act (1998). The data will not be sent outside the European Economic Area. Data
will be destroyed within 2 years of the end of the study, when dissemination of the findings
has been completed.
What will happen to the results of the research study?

Results of the research study will be disseminated as described under item 8 above. It will
take only 2-4 months before any results are available.
Who is organising and funding the research?

The study is partly funded by Genomics England and partly funded by the University of Central
Lancashire. The researcher conducting the study data collection is Dr Caroline Benjamin.
What if I have any concerns?

If you have any concerns or other questions about the study, or the way it has been carried
out, you should contact the investigator, Dr Caroline Benjamin, at University of Central
Lancashire (UCLan) on (tel) or cbenjamin1@uclan.ac.uk. You may wish to contact an
independent researcher linked to The University of Central Lancashire for independent
research advice.

Appendix 2D - Healthcare Professionals Survey (activity 2)
This is an online survey. The questions will appear in a slightly different layout on the online
questionnaire: www.genomicsengland.co.uk/consent-evaluation
---------------------------------------------------------------------------------------------------------
Please answer the following questions based on your experience recruiting in the last two
months.
If you recruit participants for both rare disease and cancer you will be asked to repeat some
questions, providing feedback relating to the specific group.
Q1. Which NHS Genomic Medicine Centre (GMC) are you part of?
*Selectable drop-down list of GMCs*
Q2. Please state your health professional group
Nurse
Medical doctor
Other
If Other, please specify………………………………………………………..
Q3. What is your clinical specialty?

……………………………………….
Q4. Approximately how many health professional staff in your GMC recruit participants?
1-2
3-5
6-10
10+
Q5. In which section of the project have you recruited participants within the last 2
months?
(multiple responses allowed)
Rare Disease
Cancer
I have not recruited any participants in the last 2 months
Reason…………………………………………………………………………….

IF RARE DISEASE GROUP IS SELECTED - GO TO RARE DISEASE QUESTION SET A
IF CANCER GROUP IS SELECTED – GO TO CANCER QUESTION SET B
(Both question sets are identical, except the cancer set has amended text and responses
for cancer recruiters)
RARE DISEASE QUESTION SET A

Q6. We would be interested in your views about the rare disease participant information
sheet in its ability to help the participant make an informed choice about taking part in
the project.
Length Too long About right Too short
Scientific Terms & Words Too simple About right Too complicated
Amount of Information Too little About right Too much
Q7. Do you as a health professional providing consent think any further changes to the
rare disease participant information sheet are required in the following three specific
areas?
(These specific areas have been highlighted in previous feedback).
Yes Maybe No
Flow of sections……………………………………………………………………………
Consistency of use of the scientific terminology (e.g. genome)……
Consistency of use of project terminology/definitions
(e,g. additional findings, main findings)………………………………………
Please use this box to write any suggestions on ways to improve the participant information
sheet in these three specific areas.
…………………………………………………………………………………………………………………………
Q8. We are interested in your suggestions on ways we could improve any element of the
rare disease consent materials.
*Select from a drop down list of all information sheets and forms*
Please select the relevant materials and provide any comments

Q9. - We are interested in your perception of how often your participants have
experienced difficulty in understanding each section of the rare disease participant
consent form.
Rarely Sometimes Often Very often

Sections
INTRODUCTION ………………………………………….
TAKING PART……………………………………………….
SAMPLES…………………………………………………….
ACCESS TO MY DATA AND CONFIDENTIALITY………
FUTURE CONTACT…………………………………………
RESULTS………………………………………………………
LEAVING THE 100,000 GENOMES PROJECT………….

INFORMATION RELATING TO THE MENTAL
CAPACITY ACT………………………………………………
Q10. In the past 2 months how many rare disease participants have you recruited?
I.e. been the health professional who counter signed their consent form?
Please count all participants including; an adult patient with a rare disease, an adult family
member of a patient with a rare disease, the parents signing on behalf of a participating
child, the parents of a deceased child, the nominated representative or personal consultee.
Young adults who sign own consent form. Please do not count children who do not sign a
consent form.
0-5……………
6-10………….
11-15………..
16—20……..
21-25………..
26-30………..
Over 30…….
Q11. Considering these participants. Please indicate how many face to face or telephone
appointments they had with YOU prior to signing the consent form.
Please state the approximate number of participants who had:

1 appointment
2 appointments
3 or more appointments
Q12. Considering these participants. Please indicate the total time you spent in face to
face or telephone discussion with the participant.
Please state the approximate number of participants who had
less than 30 minutes
30mins to 1 hour
1 to 2 hours
over 2 hours
Q13. Considering these participants. What proportion of these appointments took place
during the participant’s routine care clinical appointment?
Less than 25%.......
25-49%..................
50-74%..................
75% or greater……
Q14. Within the last 2 months how often have your rare disease participants presented
with specific needs which you needed to address as the consenting health professional
during the consent process?
rarely sometimes often very often
Extra explanation needed to understand the
participant information sheet &consent form
Low levels of literacy
Visual impairment
Deafness
Increased levels of anxiety related to current
health situation
Current mental health issue
Mental capacity issues

Q15. During the previous 2 months, approximately how many rare disease patients you
have met who declined participation?
0…………..
1-10………
11-20…….
21-30…….
31-40…….
Over 40…
Q16. In your opinion which factors do you think might have influenced these patients to
decline participation?
………………………………………………………………………………………………………………………
Q17. How confident do you feel in delivering a quality consent process to potential
participants in the rare disease arm of the 100,000 Genomes Project?
Very confident
Confident
Somewhat confident
Not confident
Would prefer not to say
Q17. Are there any ways in which Genomics England could support you as a health
professional more with the delivery of a quality consent process?
………………………………………………………………………………………………………

Appendix 3 - Survey postcards for 100,000 Genomes Project
participants (activity 3)
The attached reply paid postcard will be handed to 100,000 Genomes Project participants as
they leave their consent appointment by the health professional who has counter signed
the main 100,000 Genomes Project consent form.
The minimum font of the questions is 11. Large text versions of this survey are available to
complete on-line at www.genomicsengland.co.uk/consent-evaluation
There will also be more space provided to write comments. The following additional
question appears in the on-line version of these surveys:

For rare disease participants
Front and back of the postcard.

For rare disease participants
Inside of the postcard.
Inside of postcard.

For cancer participants
Front and back of the postcard.

For cancer participants
Inside of the postcard.

Appendix 4 - Budget and resources
Financial: This project is part-supported by Genomics England, with contributions from the
University of Central Lancashire, Imperial College London, the University of Birmingham and
the North West Coast Academic Health Science Network.
The expected breakdown of the budget set out in appendix 4 is indicative only and the
funds in each budget category may be viewed between the categories of spend within the
allocations to each of the collaborators.
Activity 1 - Led by Markella Boudioni, West London NHS GMC
Dr Markella Boudioni, NIHR Imperial BRC and PERC PPI Manager (provision of PPI leadership
to West London NHS GMC unfunded) offers half a day a week (0.1FTE) for supervision over
the whole period (8 months) (no cost). Prof Helen Ward will be able to spend half a day a
week (0.1.FTE) for two months of the duration of the project (£1,898). A Research Assistant
(Patient Experience), employed by the Imperial Patient Experience Research Centre (PERC)
and working with the West London NHS GMC will spend one day a week (0.2FTE) on
delivering the project between 1st September 2015 and 30th April 2016 (8 months) (no
cost). The main resources needed are training and transcription expenses to allow
qualitative analysis of the responses from each GMC PPI group (NVivo training*2: £520,
NVivo licence *1: £370, Transcription expenses: £2,880). Other resources needed are
related with posting and postal reply licence required for return of the questionnaires
(£500), telephone equipment for the telephone interviews (£250), recording equipment for
focus groups (£520) and travel expenses for staff to attend four-six focus groups nationally
(£800). Travel costs for participants covered by Genomics England.
Total: £7,738.
Activity 1 – Resources Offered ‘in kind’ by organisations

West London NHS GMC - Patient Experience Research Centre (PERC): Research Assistant -
0.2FTE over 8 months
West London NHS GMC - Patient Experience Research Centre (PERC): Markella Boudioni,
NIHR Imperial BRC and PERC PPI Manager (provision of PPI leadership to West London NHS
GMC unfunded) – additionally for this project offers Research Supervision - 0.1FTE over 8
months
Activity 2 - Led by Caroline Benjamin, West Coast NHS GMC/UCLan

Dr Caroline Benjamin, Health Professional Advisor to North West Coast Genomic medicine
Centre PPI Group and Guild Fellow University of Central Lancashire (UCLan). Eight months of
support at 0.2 FTE, one day a week required for Caroline Benjamin to provide the support
for activity 2 health professionals national evaluation (£7,860).Printing costs for the
production of postcards £420
Total - £7,860 + 424 = £8,2840
Activity 2 – Resources Offered ‘in kind’ by organisations

The resources of UCLan for access to SPSS and text analysis (NViVo) is offered free.
Research 0.05 of research administration support (£1130)

Provision of PPI leadership to NWC GMC 0.05 FTE is unfunded and supported by UCLan.
Additional funding - North West Coast Academic Health Science Network has offered
matched funding to support research staff (0.4 FTE) for 8 months for statistical and data-
entry tasks.
Activity 3 – Led by Eliot Marston and Antje Lindenmeyer

Senior support for design and validation of short questionnaire; contribution to report
writing (0.2 FTE) time for Dr Lindenmeyer over 6 months): £5,958
UHB IT support for system creation/maintenance: £1,920
Total £7,878
Resources Offered ‘in kind’ by organisations
Eliot Marston’s time 0.1 FTE for 8 months
CLAHRC PhD students for relevant data-entry, cleaning, validation and descriptive statistics
of responses
Overall oversight of the project (NWC GMC)

Caroline Benjamin 0.1 FTE (£3,939), half day a week. Travel costs for the team to attend
meetings (£1,815). Postal reply licence (£346).
Total - £6,100 (dependent if subject to VAT).
Outline of requirement Est. costs
Development of materials / evaluation with PPI groups £7,738

Development of materials / analysis etc. with healthcare £8,284
professionals
Development of materials, patient surveys, collation of information £7,878
Oversight for the programme (NWC GMC): £6,100
Approximate total required from Genomics England £30,000

Appendix 5 – Intellectual property and publication
This evaluation will adopt the Genomics England data ownership and intellectual property
terms as stated in the 100,000 Genomes Project protocol 2015-2017:
“Genomics England has received legal advice regarding intellectual property. This
recommends that Genomics England owns the combination of the whole genome sequence
and the clinical data for the entire dataset from the 100,000 Genomes Project. In addition,
Genomics England owns any new intellectual property generated from the data, but we will
license this to third parties on favourable terms.
There are very clear reasons why this is essential:
• It ensures that Genomics England Clinical Interpretation Partnership (GeCIP) investigators
can collaborate in academic/NHS partnerships and academic industry partnerships without
concern for the intellectual property being generated.
• The ready licensing with the capability to include all inventors offers a fair approach to
potential intellectual property.”
Genomics England publication policy
“Genomics England encourages publication. All publications will be on behalf of Genomics
England as a banner heading. The usual rules of authorship will apply and all co-authors will
be named. The position of authors on all papers will be based on work done with the
application of starred authorship to recognise that there may be multiple authors. The
Genomics England team will also be co-authors and will typically share key authorship and
corresponding author positions reflecting work done. The decision on authorships will
usually be made within GeCIP domains and the GeCIP Steering Committee will advise the
GeCIP Board whose decision will be final in the event of disagreement. There may be
academic users or industry users who are not GeCIP members and pay to access the data.
The same approach will apply to authorship and publication with the GeCIP Steering
Committee and Board having oversight. As this project is not within a GeCIP, the Evaluation
Project Steering Group would input to the Publication Committee of Genomics England in
conjunction with any potential publications to be considered.
Acknowledgements in all publications will recognise the contribution of the Department of
Health, NIHR and any other GeCIP funder with the following form of words: "Genomics
England is a wholly owned company of the Department of Health and this programme was
made possible by the National Institute for Health Research, NHS England, Public Health
England and Health Education England. Other GeCIP funders must also be acknowledged.”
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Consent Evaluation Schedule

Article · March 2016

Caroline M Benjamin Markella Boudioni

Tom Fowler Laura G Riley

SEE PROFILE SEE PROFILE

The user has requested enhancement of the downloaded file.

NHS Genomic Medicine Centres’ National Service Evaluation

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The consent discussion process:

3 Shared purpose and scope of project

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4 Background to the 100,000 Genomes Project

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PPI group members

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6.1 Membership of the Service Evaluation Steering Group

Genomics England Ethics Advisory Committee (EAC)

NHS England - Fiona Rennie, Head of NHS GMC Operations

Service Evaluation Project Team

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NHS GMC representatives

NHS GMC PPI NHS Healthcare 100,000 Genomes

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Recruiting NHS GMC PPI

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8.2 Report distribution

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1 WP1- Proposal submitted to Genomics England 17/07/2015 31/08/2015

WP1 - GE review of proposal and sign off - Contractual arrangements

WP1- Allocation of 1st staged payment of resources to NWC GMC - Duration

WP2- Steering group meeting to discuss operational issues relating to

6 WP2 - Recruitment of resources (people/in kind) 01/02/2016 03/03/2016

WP5 - Report writing and submission of report to Ethics Advisory Committee

Project development activity

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10.1 Improvement methodology

10.2 Wider conceptual frameworks

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Process of Consent Interaction

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11.1 Activity 1 - Seeking opinion from patient and public involvement

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11.2 Activity 2 – Health professional feedback on consent process and ease of

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11.3 Activity 3 – 100,000 Genomes Project participants

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11.5 Data management

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Map of Focus Areas against Questions 10 Key Focus Areas

PPI 4,5 PPI 6, 7 PPI 8-10

Participant Survey Questions

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