CPI: Generation Study: recruit, enrol and sample

The competencies required to recruit, enrol and obtain samples from participants in the NHS-embedded Generation Study

The Generation Study will sequence the genomes of 100,000 newborns to look for a specific set of rare genetic conditions that affect babies and can be acted on. It is being led by Genomics England and delivered by the NHS.

The Generation Study-supporting pathway, developed via the Clinical Pathway Initiative (CPI), has been broken down into three components:

recruit, enrol and sample;
sequence, analyse and inform (publication pending); and
return results and care (publication pending).

This page focuses on the recruit, enrol and sample component of the clinical pathway, which is about recruiting, enrolling and taking samples from study participants. It describes the competencies that are required to deliver each step within the pathway and provides supporting information and education.

How to use this page

The pathway is broken down into key steps, numbered below. Each step has associated competencies, each listed within a blue box, that a healthcare professional should have to be able to deliver that step. Clicking a blue box will expand the competency to provide associated learning and participant resources.

You can use this pathway to plan service delivery, identify and address workforce training needs, or to assess and develop your own knowledge and skills. This framework has been designed to be a developmental tool to support staff involved in the Generation Study. It is not intended as a grading or assessment tool.

There are different routes to competence; we have provided a range of resources to support staff, but it is up to sites and Principal Investigators to ensure relevant staff receive appropriate training. Individual competencies should be interpreted in the context in which a healthcare professional is involved in delivering the study and considering their scope of practice.

Who developed this CPI pathway?

This CPI pathway was developed, in collaboration with NHS England’s Genomics Education Programme, by Genomics England’s Newborns team and Newborn Genomics Programme education and training working group. Feedback is very welcome, please get in touch.

Content access requests

Some of the additional information and associated learning are hosted on the Generation Study workspace on the FutureNHS platform. If you have not already had an invitation to join, please contact the Genomics England service desk.

Content may evolve over time. We will endeavour to keep links up to date, should you have any issues accessing the content, let us know.

Key

We have identified the type of competency in each of the drop-down boxes below:

G: General competency
P: Pathway-specific competency
St: Step-specific competency
K: Knowledge
S: Skills
A: Attitudes

STEP 1

Introduce the study

Competencies

A. Recognises difference between this research study and related programmes, such as standard NHS screening programmes. (P, A)

Associated learning:

Genomics England: Generation Study: Overview & Sampling Basics (future.nhs) (video, 15 minutes)
Genomics England: Generation Study: Protocol (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)
NHS England’s e-Learning for Healthcare: About the NHS Screening programmes
NHS England’s Genomics Education Programme: GeNotes: The Generation Study

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

B. Demonstrates knowledge of the study’s recruitment process, including inclusion and exclusion criteria. (St, K)

Associated learning:

Genomics England: Generation Study: Protocol (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

C. Has awareness of relevant resources for signposting. (P, K)

Associated learning:

Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

D. Demonstrates knowledge of general genetic and genomic concepts in relation to the scope of the study. (P, K)

Associated learning:

Genomics England: Generation Study: Online engagement session for health professionals (future.nhs) (video, 47 minutes)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
NHS England’s Genomics Education Programme: Genomics 101: Genomics in Healthcare
NHS England’s Genomics Education Programme: GeNotes: The Generation Study

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

Workforce groups

Principal investigator (doctor, nurse or midwife), research midwives and other research team members at study site, clinical midwife, community midwife, other antenatal staff (sonographer, obstetrician, midwifery support worker, fetal medicine specialist), research co-ordinator/assistant

STEP 2

Support decision making

Competencies

A. Outlines the scope, limitations, possible results and potential outcomes of the research study. (St, S)

Associated learning:

Genomics England: Generation Study: ‘Explain the Study’ (future.nhs) (video, 31 minutes)
Genomics England: Generation Study: Protocol (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)

Participant resources:

Genomics England: Generation Study
Genomics England: Generation Study: Participant Information Sheet (future.nhs)

B. Outlines the potential benefits and risks of data and sample storage and use. (St, S)

Associated learning:

Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)

Participant resources:

Genomics England: Generation Study
Genomics England: Generation Study: Genomic Consent Webinar (future.nhs) (video, 2 hours)
Genomics England: Generation Study: Participant Information Sheet (future.nhs)

C. Assesses potential participants’ understanding, expectations and concerns and addresses these appropriately. (St, S)

Associated learning:

Genomics England: Generation Study: Informed Choice Scenario Cards (future.nhs)
Genomics England: Generation Study: Genomic Consent Webinar (future.nhs) (video, 2 hours)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)

Participant resources:

Genomics England: Generation Study
Genomics England: Generation Study: Participant Information Sheet (future.nhs)

D. Understands the influence of ethnicity, culture, religion, ethical perspectives and values on an individual’s choice to take part in genomic research. (P, K)

Associated learning:

Genomics England: Generation Study: Genomic Consent Webinar (future.nhs) (video, 2 hours)
Genomics England: Generation Study: Informed Choice Scenario Cards (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
National Institute for Health and Care Research: Equality, Diversity and Inclusion Strategy 2022-2027

Participant resources:

Genomics England: Generation Study
Genomics England: Generation Study: Participant Information Sheet (future.nhs)

E. Has awareness of relevant resources for signposting. (P, A)

Associated learning:

Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

F. Demonstrates knowledge of general genetic and genomic concepts in relation to the scope of the study. (P, K)

Associated learning:

Genomics England: Generation Study: Genomic Consent Webinar (future.nhs) (video, 2 hours)
Genomics England: Generation Study: Online engagement session for health professionals (future.nhs) (video, 47 minutes)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
NHS England’s Genomics Education Programme: Genomics 101: Genomics in Healthcare
NHS England’s Genomics Education Programme: GeNotes: Knowledge hub: Core concepts

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

Workforce groups

STEP 3

Facilitate consent to the study

Competencies

A. Explains the terms of the study. (St, K)

Associated learning:

Genomics England: Generation Study: Overview & Sampling Basics (future.nhs) (video, 15 minutes)
Genomics England: Generation Study: Protocol (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)
NHS England’s Genomics Education Programme: GeNotes: Knowledge Hub: Core concepts

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

B. Records consent in line with the study protocol and governance arrangements. (St, S)

Associated learning:

Genomics England: Generation Study: Consent Conversation Checklist (future.nhs)
Genomics England: Generation Study: Protocol (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)

C. Facilitates participant enrolment including relevant data entry. (St, S)

Associated learning:

Genomics England: Generation Study: Consent Conversation Checklist (future.nhs)
Genomics England: Generation Study: Portal Self Study Guide (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)

D. Explains the voluntary nature of the study, where one’s decision will not impact standard clinical care. (P, K)

Associated learning:

Genomics England: Generation Study: Consent Conversation Checklist (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

E. Demonstrates knowledge of general genetic and genomic concepts in relation to the scope of the test. (P, K)

Associated learning:

Genomics England: Generation Study: Genomic Consent Webinar (future.nhs) (video, 2 hours)
Genomics England: Generation Study: Online engagement session for health professionals (future.nhs) (video, 47 minutes)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
NHS England’s Genomics Education Programme: Genomics 101: Genomics in Healthcare
NHS England’s Genomics Education Programme: GeNotes: Core concepts

Participant resources:

Genomics England: Generation Study
Genomics England: Participating Facing Materials for Recruiting Sites (future.nhs) (such as a poster, leaflet and participant information sheet)

F. Applies knowledge of the consent processes, relevant professional guidance and legislation. (P, K)

Associated learning:

Genomics England: Generation Study: Genomic Consent Webinar (future.nhs) (video, 2 hours)
Genomics England: Generation Study Protocol (future.nhs)
National Institute for Health and Care Research: Good Clinical Practice (Courses)

Workforce groups

STEP 4

Collect, store and register samples

Competencies

A. Understands and can implement the study sampling process including collection, transport, access, storage and troubleshooting. (St, K, S)

Associated learning:

Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Sampling Guide for Recruiting Sites (future.nhs)
Genomics England: Generation Study: Sluice Room poster (future.nhs)
Genomics England: Sample Taking Overview (future.nhs) (video, 4 minutes)

B. Facilitates sample collection while reaffirming participant’s choice to take part in the study. (St, K)

Associated learning:

Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Sampling Guide for Recruiting Sites (future.nhs)
Genomics England: Generation Study: Sluice Room poster (future.nhs)
Genomics England: Sample Taking Overview (future.nhs) (video, 4 minutes)

C. Facilitates participant enrolment including relevant data entry, with awareness of study protocol and local processes. (St, K, S)

Associated learning:

Genomics England: Generation Study: Portal Self Study Guide (future.nhs)
Genomics England: Generation Study: Protocol (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Sampling Guide for Recruiting Sites (future.nhs)
Genomics England: Generation Study: Sluice Room poster (future.nhs)
Genomics England: Sample Taking Overview (future.nhs) (video, 4 minutes)

D. Demonstrates familiarity with national and local requirements for human tissue samples. (St, K)

Associated learning:

Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Sampling Guide for Recruiting Sites (future.nhs)
National Institute for Health and Care Research: Good Clinical Practice (courses)

Workforce groups

ALL STEPS

Fundamental principles relevant to all steps

Competencies

A. Recognises potential EDI-related barriers to participation and demonstrates how to overcome them. (G, S)

Associated learning:

Genomics England: Generation Study: Genomic Consent Webinar (future.nhs) (video, 2 hours)
Genomics England: Generation Study: Informed Choice Scenario Cards (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
National Institute for Health and Care Research: Equality, Diversity and Inclusion Strategy 2022-2027

B. Employs effective communication skills to support participant choice without coercion or bias. (G, S)

Associated learning:

Genomics England: Generation Study: Genomic Consent Webinar (future.nhs) (video, 2 hours)
Genomics England: Generation Study: Informed Choice Scenario Cards (future.nhs)
Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
National Institute for Health and Care Research: Good Clinical Practice (courses)

C. Recognises when to initiate onward referrals to other specialists or regional clinical genomics service. (G, S)

Associated learning:

Genomics England: Generation Study: Recruiting Site Full Training Slide Set (future.nhs)
Genomics England: Generation Study: Study Guide for Recruiting Sites (future.nhs)
National Institute for Health and Care Research: Good Clinical Practice (courses)

D. Provides information in a language, format and level to facilitate participant understanding. (G, S)

Participant resources:

Genomics England: Generation Study
Genomics England: Generation Study (with Google Translate for target language translation)
Genomics England: Generation Study: Participant Information Sheet (future.nhs)
Genomics England: Generation Study: Translated participant information

Workforce groups

All roles and professions

CPI: Generation Study: recruit, enrol and sample

The competencies required to recruit, enrol and obtain samples from participants in the NHS-embedded Generation Study

Key

STEP 1

Introduce the study

Competencies

Associated learning:

Participant resources:

Associated learning:

Participant resources:

Associated learning:

Participant resources:

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Participant resources:

Workforce groups

STEP 2

Support decision making

Competencies

Associated learning:

Participant resources:

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Participant resources:

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Participant resources:

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Workforce groups

STEP 3

Facilitate consent to the study

Competencies

Associated learning:

Participant resources:

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Participant resources:

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Participant resources:

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Workforce groups

STEP 4

Collect, store and register samples

Competencies

Associated learning:

Associated learning:

Associated learning:

Associated learning:

Workforce groups

ALL STEPS

Fundamental principles relevant to all steps

Competencies

Associated learning:

Associated learning:

Associated learning:

Participant resources:

Workforce groups

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