Invitation to Tender for the Evaluation:
Avoidance of Mitochondrial Disease –
A Public Dialogue
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1.
Overview
1.1.
The Government has asked the Human Fertilisation and Embryology
Authority (the UK’s independent regulator of assisted reproduction and
research involving human embryos) to engage with the public on
emerging IVF techniques designed to prevent mitochondrial disease.
Please see Annex A for a summary of these techniques.
1.2.
Mitochondria are tiny structures present in human cells that produce a
cell’s energy. They, and the small amounts of DNA within them, are
inherited exclusively from the mother through her eggs. Problems in the
DNA can result in a number of rare but serious and potentially fatal
diseases. The Human Fertilisation and Embryology Authority (HFEA) has
licensed research projects to explore techniques, known as mitochondria
transfer, through which mothers could avoid passing on mitochondrial
diseases to their children.
1.3.
These techniques are currently prohibited for treatment purposes under
the Human Fertilisation and Embryology (HFE) Act 1990 (as amended) as
they involve altering the nuclear or mitochondria DNA of eggs or embryos.
Parliament could, however, introduce secondary legislation (Regulations)
to permit the use of these techniques in treatment to prevent serious
mitochondrial disease.
1.4.
The purpose of the project is to review the ethical, social and regulatory
issues, if techniques to avoid mitochondrial disease were to be permitted
in clinical treatment, and to contribute to HFEA advice to the Secretary of
State for Health. The HFEA wishes to be in a position to report to the
Secretary of State for Health on:
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The process of deliberation people use to form views on techniques
to avoid mitochondrial disease
The informed public views on these techniques
Analysis of the ethical and regulatory issues involved
1.5.
The HFEA is collaborating with the Sciencewise Expert Resource Centre
(Sciencewise-ERC)1. Sciencewise-ERC is co-funding the project as well
as providing expert advice and guidance on the dialogue and evaluation
processes.
1.6.
For more information see on the HFEA see: http://www.hfea.gov.uk
2.
Project objectives, aims, outputs and methodologies
2.1.
There will be two strands to the project: the first involving a public
dialogue process and the second a broader public consultation exercise.
The methodology will be designed to deliver a robust dialogue and
consultation process. The whole project, both dialogue and consultation,
is expected to be completed by autumn/winter 2012 and the results fully
1
The Sciencewise Expert Resource Centre (Sciencewise-ERC) is funded by the Department for Business,
Innovation and Skills (BIS) and helps policy makers to understand and use public dialogue to inspire, inform and
improve policy decisions around science and technology. See http://www.sciencewise-erc.org.uk/cms/
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analysed and reported by the project delivery contractor to the HFEA by
January 2013.
2.2.
The aim of the project is to assist HFEA in understanding:
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The ethical issues entailed in licensing techniques to avoid
mitochondrial disease;
How people comprehend ethical issues involved in techniques to
avoid mitochondrial disease;
The deliberative process people go through to form views on
techniques to avoid mitochondrial disease;
The difference between informed and uninformed views on
techniques to avoid mitochondrial disease;
Interested stakeholders’ arguments for and against techniques to
avoid mitochondrial disease;
2.3.
The project is being managed by the HFEA. An independent Oversight
Group will advise the HFEA on the content and process of the dialogue.
The project is being co-funded by the Sciencewise Expert Resource
Centre (Sciencewise - ERC) which is funded by the Department for
Business, Innovation and Skills. A key requirement of this project is that it
follows the government’s approach to public dialogue on science and
technology2.
2.4.
The project will involve the following elements:
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2.5.
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Testing – a process which discovers what special interest groups
and lay members of the public see as the ethical and social issues
involved in techniques to avoid mitochondrial disease, and how
their views may be influenced by different framings of the issues.
Qualitative views – a process which finds out what people think
when they have the opportunity to deliberate on the issues, and
discovers how peoples’ views are formed and what influences
them.
Quantitative views – a process which discovers what randomlyselected lay members of the public think of the acceptability of
techniques to avoid mitochondrial disease, in the absence of
detailed information or deliberation, and which key pieces of
information or argument have the most influence on their views.
Web-based public consultation – to give interested stakeholders
and self-selecting members of the public the opportunity to express
their views.
Public consultation events – to give interested stakeholders and
self-selecting members of the public the opportunity to voice and
debate their views.
There will be a range of audiences with perspectives which will be
relevant to the project. A strategy for targeting special interest groups and
affected stakeholders will be outlined at each stage of the project.
http://www.sciencewise-erc.org.uk/cms/guiding-principles/
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2.6.
All elements of the project will be informed by the testing phase. In
addition, we will aim to utilise findings from the qualitative and quantitative
phases in the design of the materials and process for the wider
consultation elements.
3.
Aim and Scope of the Evaluation
3.1.
The evaluation will consider the project as a whole, covering all the
activities summarised in section 2.3 above.
3.2.
The evaluation must be conducted independently of the design and
delivery of the project, and in accordance with the ‘Requirements for
evaluating Sciencewise-ERC Projects’ 3.
3.3.
The objectives for the evaluation are:
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3.4.
To provide an independent assessment of the project's credibility,
effectiveness and success against its objectives
To contribute to the overall Sciencewise-ERC aim of creating
excellence in public dialogue to inspire and inform better policy
making in science and technology through:
 gathering and presenting objective and robust evidence
of the activities, achievements and impacts of the overall
project
 identifying lessons from practice to support SciencewiseERC work in capacity building across Government, and
the development of good practice in public dialogue.
To identify how well the project has worked in order to identify clear
lessons to feed into future HFEA engagement work
To identify how well the different elements of the project have
interacted with each other and contributed to the overall aims of the
HFEA review.
The impact of the project on the HFEA’s advice to Government.
The evaluation should cover both the process of the project (e.g. what
was done and how well did that work?) and the impacts of the project (e.g.
what difference did the project make?). It should include consideration of
seven key questions:
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Has the project met its objectives?
Has the project met standards of good practice (Sciencewise-ERC
principles)4?
Have those involved been satisfied with the project (value to
them)?
3
Sciencewise Expert Resource Centre (2008). SWP07 Requirements evaluating Sciencewise-ERC Projects.
http://www.sciencewise-erc.org.uk/cms/assets/Uploads/TrackedDocuments/Funding-Docs/SWP07-Requirementsfor-Evaluation.pdf?phpMyAdmin=oHPjaCSrPMAdI04AYEPthe913wb
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Sciencewise Expert Resource Centre (2008). The Government's approach to public dialogue on science and
technology. http://www.sciencewise-erc.org.uk/cms/publications/
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How successful has the governance of the project been, including
the role of the Oversight Group, the HFEA and the SciencewiseERC support role?
What difference/impact has the project made?
What was the balance overall of the costs and benefits of the
project?
What are the lessons for the future (what worked well and less well,
and more widely)?
3.5.
Further details of what the evaluation should achieve, and how it might be
conducted, can be found in SWP07: Requirements on Evaluating
Sciencewise-ERC Projects5 and proposals should show understanding of
these.
4.
Evaluation contractor specification
4.1.
Applicants should demonstrate a sound understanding of the brief, and
should have experience of:
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Evaluation of public dialogue and/or other public engagement
processes
Applying best practice techniques to evaluating dialogue processes
involving the general public, experts and policy-makers.
Contacts
4.2.
Throughout the evaluation process, the evaluation contractor will:
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work with Sciencewise-ERC and the HFEA project manager to
define and agree a detailed evaluation programme and evaluation
activities
provide regular updates to HFEA and Sciencewise-ERC at agreed
stages
4.3.
The contract will be formally between the evaluator and HFEA. The point
of contact at HFEA is Danielle Hamm, Senior Policy Manager. Additional
support is available from Diane Warburton, Sciencewise-ERC Evaluation
Manager.
4.4.
Regular discussions will also be needed with the Sciencewise-ERC
Dialogue and Engagement Specialist (DES) advising on the project.
Design and delivery
4.5.
The Evaluator will develop the evaluation process and provide detailed
methodology, including success criteria and performance metrics as
5
This document provides detail on the aims and objectives for evaluating Sciencewise-ERC projects, as well as
some key questions for evaluating public dialogue within the Sciencewise-ERC, and some key principles for
evaluation that need to be met in all circumstances. http://www.sciencewise-erc.org.uk/cms/project-guidance/
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appropriate. The Evaluator will be required to take part in an inception
meeting with the HFEA and Sciencewise-ERC.
4.6.
The Evaluator must undertake all aspects of the evaluation, including data
collection, collation and analysis. The Evaluator should outline the support
they would require from the HFEA and Sciencewise-ERC in aspects of the
process (e.g. data collection).
Formative Evaluation
4.7.
The Evaluator should be prepared to provide on-going advice and
feedback to support the development of the project.
Reporting
4.8.
The Evaluator will be required to produce the following written reports:
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Monthly progress updates
Draft evaluation report
Final evaluation report: in a form that can be published
Final evaluation summary: in a form that can be published
Follow up
4.9.
Ideally the evaluation will include feedback from those involved following
the production of the final reports from the project. However, this is not
always possible within the timescales for evaluations. In the longer term,
applicants should indicate whether, and how, they would be prepared to
support mid- to long-term evaluation of the project and indicate
appropriate follow up costs.
Flexibility
4.10.
Applicants should demonstrate how they would be prepared adapt to
developments or changes in the project schedule.
Sub-contractors
4.11.
A single contract will be let for the evaluation. Applicants should provide
details of any sub-contractors, or support staff, which the evaluator
intends to use. Details of oversight procedures should be provided.
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Monitoring
4.12.
The Evaluator must be prepared to grant access to HFEA and
Sciencewise-ERC to allow inspection of the work at any time. The
Evaluator must also be prepared to provide further information to these
parties should it be requested.
4.13.
The Evaluator must co-operate with Sciencewise-ERC so that the project
can be monitored for compliance with the Government’s Approach to
Public Dialogue on Science and Technology.6
Media activity
4.14.
Applicants should be mindful of any media activity around the project and
its evaluation, and should suggest opportunities in which materials
developed in the evaluation can be included in the project media strategy.
4.15.
The HFEA will retain responsibility for the management of all
communications activities, including the publication of the final evaluation
report, with Sciencewise-ERC.
Cessation of work
4.16.
The Evaluator will be required to inform HFEA and Sciencewise-ERC
promptly, in writing, of any cessation of work and of any event or
circumstance likely to significantly affect the satisfactory completion of the
evaluation.
Timescales
4.17.
The key dates are:
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4.18.
Submission of applications: midday, Tuesday 8 May 2012
Interview: morning, Thursday 10 May 2012, at HFEA
Appointment: Friday 11 May 2012
Project inception meeting: 10am - 1pm, Monday 14 May 2012, at
HFEA
Final reporting date: March 2013
The Evaluator will be expected to begin work immediately on appointment
on Friday 11 May 2012 and to maintain evaluation throughout and
immediately after the project.
Sciencewise Expert Resource Centre (2008). The Government's approach to public dialogue on science and
technology. http://www.sciencewise-erc.org.uk/cms/publications/
6
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Financial arrangements
4.19.
Tenders for the evaluation are invited up to £15,000 + VAT. Approaches
that meet the requirements of the brief and provide a cost effective
solution are encouraged. Payments will be linked to appointment and
reporting.
4.20.
Applications should detail the involvement of each named staff member.
Please provide a breakdown of costs, including daily rates of all staff who
would be involved in this project, travel, project materials and external
costs.
Application format and content
4.21.
Applications should not exceed 10 pages in length (excluding any
appendices) and should be submitted in the following format:
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4.22.
Executive Summary (one page)
Understanding of the requirements and context
Proposed methodology and approach
Staff resources and track record: highlight previous work in this
field or similar activities. Include details of any sub-contractors, and
relevant oversight procedures. Staff CVs and examples of previous
work should be appended
Project management: include brief details of how you will liaise with
the HFEA project manager and Sciencewise-ERC and how you
might respond to changes in scope as the project progresses
Financial details.
Applications should also take into account the assessment criteria set out
below.
Selection criteria and process
4.23.
Applications will be assessed against the following criteria (in no particular
order):
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Understanding of the aims of HFEA, Sciencewise-ERC and of the
project
Understanding of the objectives of the evaluation process
A clear, well-justified, evaluation methodology and programme
Initial ideas on criteria / metrics by which the project could be
assessed, and suggestions for how these may be developed and
finalised
Track record of the team in core skills or work of this kind
Diversity and depth of resource to cope with change
Innovative approach where appropriate
Value for money.
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Conflicts of interest
4.24.
To ensure the independence of the evaluation, the contract cannot be
awarded to applicants with either professional or personal interests in the
contractor responsible for delivering the project. Applicants must therefore
indicate such interests, as well as any additional conflicts of interest which
may compromise the independence of the evaluation.
Submission of applications
4.25.
Applications should be submitted to Danielle Hamm, Senior Policy
Manager at danielle.hamm@hfea.gov.uk no later than midday,
Tuesday 8 May 2012.
4.26.
Applications will be confirmed by e-mail. Those received after the deadline
will only be accepted in exceptional cases.
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Annex A – overview of scientific methods
What are the techniques being developed to avoid mitochondrial disease?
Researchers believe that new techniques, known as pronuclear and maternal
spindle transfer, may allow women who carry mitochondrial diseases to avoid
transmitting the disease to their offspring.
Both maternal spindle transfer and pronuclear transfer involve the creation of
embryos containing nuclear DNA from a man and a woman, plus mitochondrial DNA
from another woman.
These techniques are only permitted in research at present.
Pronuclear transfer - An early embryo contains two pronuclei. These pronuclei
contain nuclear genetic material from the egg and sperm as well as mitochondria
from the egg.
An early embryo contains two pronuclei. These pronuclei contain nuclear genetic
material from the egg and sperm as well as mitochondria from the egg.
Pronuclear transfer involves transferring the pronuclei from the embryo with
unhealthy mitochondria and placing it into an embryo with healthy mitochondria,
leaving the unhealthy mitochondria behind. This new embryo contains DNA of the
father and mother, and the mitochondria from an egg donor.
Pronuclear transfer - the process
Maternal spindle transfer- Maternal spindle involves transferring the nuclear DNA
from an egg (instead of an embryo) with unhealthy mitochondria and placing it into
an egg with healthy mitochondria.
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Maternal spindle transfer- the process
Our public dialogue will explore what people think about the possible use of these
techniques in treatment – the transfer from the laboratory to clinic.
Related information
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Press release - HFEA to consult on ethics of mitochondria transfer:
http://www.hfea.gov.uk/6898.html
2011 review of scientific methods to avoid mitochondrial disease:
http://www.hfea.gov.uk/6372.html
Scientific and Clinical Advances Advisory Committee meeting papers - May
2010: http://www.hfea.gov.uk/5906.html
Ethics and Law Advisory Committee meeting paper - June 2011:
http://www.hfea.gov.uk/6477.html
Scientific review
In Spring 2011, the Secretary of State for Health asked the HFEA to conduct an
inquiry into the current state of scientific understanding of possible methods to avoid
mitochondrial disease. The Authority established a small panel, with broad-ranging
expertise, to collate and summarise scientific evidence submitted from a wide range
of experts in the field. The HFEA submitted a report of the panel’s findings to the
Department of Health on 18 April 2011.
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2011 review of scientific methods to avoid mitochondrial disease:
http://www.hfea.gov.uk/6372.html
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