ExperiencesSHARENCT07663058
Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS
An observational study of Experiences and Lived Experiences, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This PhD explores the views of clinical research nurses (CRNs) and research-patients as they take part in clinical research within their respective roles, i.e., as a specialised staff member and as a patient volunteer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Experiences, Lived Experiences, Research Participation
- What is being tested?
- Interviews and Non-participant observations
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Aug 2026to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CRN, research-patients
Who may be able to join
- Research-patients aged above 18 years old.
- Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over) at GSTT.
- Research-patients who are willing and able to provide informed consent.
- INCLUSION CRITERIA FOR CRNS Clinical research nurses (CRNs) currently working in adult clinical research at Guys and St Thomas' NHS Foundation Trust.
- CRN willing and able to give consent.
Who cannot join
- Patients who showed an interest in taking part in research but were not recruited, e.g. due to screen failure, or ineligibility.
- Research-patients recruited to research via proxy consent, e.g., next of kin.
- Patients unable to provide informed consent, e.g., lacking mental capacity.
- Research-patients considered vulnerable or at risk of harm, by the research team
- Research-patients taking part in mental health or maternity trials or studies
- Research-patients not fluent in English or not able to converse well in English
- Clinical research midwives and clinical research nurses working in mental health, maternity, and paediatric research are excluded from this study.
- CRNs not willing or unable to give consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London
Research and Development GSTT R&D GSTT, 002071887188 ext. 88888, gstt.randd@nhs.net
Zareen Bheekhun, MSc
About this study
This PhD explores the views of clinical research nurses (CRNs) and research-patients as they take part in clinical research within their respective roles, i.e., as a specialised staff member and as a patient volunteer. Clinical research is supported by NHS England as the best way to improve patient care by finding out whether a new treatment is better than what is available. CRNs are specialist nurses who manage and coordinate clinical research. CRNs are responsible for the safe running of research; they ensure the right information is collected for the research/trial to be successful. CRNs support the well-being of research-patients, by taking note of any new, or existing healthcare needs of research-patients while they take part in research. CRNs coordinate the activities that research requires, biological samples, scans, documentation. Balancing their responsibility towards research-patients, on the one hand, and research management, on the other, can bring unique challenges for the CRN. CRNs can feel conflicted between these two responsibilities, e.g., when they think that a drug trial, or the research activities in a study is at odds with the research-patient's best interest despite the research-patient's consent to take part in research. CRNs are tasked with maintaining/facilitating recruitment of research-patients, this can be a challenging aspect of their role especially if they feel pressured to approach patients to take part in research. Currently, we know little about how CRNs balance these two responsibilities, or what other problems CRNs have in their everyday role when balancing these responsibilities. Finding out more about these aspects of the CRN role is important because it may not only improve job experience but can also give a better understanding of what can be changed to improve how CRN perform their role which could ultimately improve research-patients' experience of taking part in research. To address this issue, this PhD will explore CRNs and research-patients' views about clinical research, the challenges CRNs face, how CRNs balance their responsibilities, and what role does the relationship between CRNs, and research-patients play overall in what they say about their experience of taking part in clinical research. The researcher will interview and shadow CRNs and research-patients at a central NHS Hospital. This is a LISS/ESRC funded PhD at King's College London and supported by Guy's and St Thomas NHS Foundation Trust.
Read the detailed description
The purpose of this study is to explore how research patients and Clinical Research Nurses (CRNs) describe their experiences of participating in clinical research within their respective roles.
The study involves two main activities:
- Interviewing CRNs and research-patients via online (separately). Semi-structured interviews will be conducted using an interview guide based on themes identified in the existing literature. The guide will be refined and finalised based on feedback from Patient and Public Involvement and Engagement (PPIE), as discussed in the PPI section of the IRAS application.
- Observations of research activities at research departments including research consultations between CRNs and research-patients.
Research activities refer to various assessments or tasks carried out to generate data for a research protocol. The CRN's role includes conducting these activities, which may involve obtaining patient consent, collecting biological samples (e.g., blood, urine), or dispensing experimental drugs as part of a clinical trial. These activities typically occur during 'research visits' which are appointments or consultations between the CRN and the research patient.
The researcher will observe research activity taking place in research departments by way of "observer placements" for up to five days. Placements can occur in any of the following research departments: gastrointestinal, liver, surgical, respiratory, diabetes and endocrinology, neurology, renal, gynaecology, rheumatology, cardiovascular imaging, and lupus, ageing and health. This wide range of departments has been intentionally selected to provide a broad perspective and to maximise exposure to diverse research activities across different disease specialities. These observation placements will allow the researcher to directly observe interactions between CRNs and research-patients during research activities. Observational data will provide insight into the real-world context in which CRNs and research patients communicate their understandings, expectations, and perceptions of research participation.
Combining observational data with interview data will support triangulation during reflexive thematic analysis.
The number of placements will depend on the opportunities available for the researcher to undertake observations during the PhD data collection period. While the total number of observations is flexible, it is anticipated that this will be in the region of 10-15 due to the overall timeline for completing the PhD. The final number will be informed by guidance from the academic supervisory team during the analysis phase, which will take place concurrently with ongoing data collection. The sample size will be guided by the principle of 'information power'.
Organisation of the observer placements within research departments will be supported by the research leads (research matrons) with whom the researcher has already made prior contact, discussed the aim of the study, and who are supportive and will help to facilitate the project's objectives.
- Conditions
- Experiences, Lived Experiences, Research Participation, Research Subjects, Nurse's Role, Research Ethics
- Being tested
- Interviews, Non-participant observations
- Keywords
- Clinical Research Nurses, Research-Patients, Research Experience, Therapeutic Misconception, Ethical Challenges, CRN Dual Role
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsOther
Semi-structured interviews
Non-participant observationsOther
Non-participant observations of clinical research visits
| Study group | Role | What they receive |
|---|---|---|
| Clinical Research Nurses (CRN Group) | CRNs working in adult clinical research Receives: Other: Interviews; Other: Non-participant observations | |
| Research-Patients | Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over) Receives: Other: Interviews; Other: Non-participant observations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of CRNs and Research-Patients
Recruitment of up to 15 CRNs and up to 15 research-patients for interviews
Measured: End of recruitment date is 30 Dec 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExperiencesStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663058
- Sponsor's protocol ID
- 334182
- Acronym
- SHARE
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS
- ClinicalTrials.gov ID
- NCT07663058
- Acronym / sponsor ID
- SHARE / 334182
- Conditions
- Experiences, Lived Experiences, Research Participation, Research Subjects, Nurse's Role, Research Ethics
- Keywords
- Clinical Research Nurses, Research-Patients, Research Experience, Therapeutic Misconception, Ethical Challenges, CRN Dual Role
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This PhD explores the views of clinical research nurses (CRNs) and research-patients as they take part in clinical research within their respective roles, i.e., as a specialised staff member and as a patient volunteer. Clinical research is supported by NHS England as the best way to improve patient care by finding out whether a new treatment is better than what is available. CRNs are specialist nurses who manage and coordinate clinical research. CRNs are responsible for the safe running of research; they ensure the right information is collected for the research/trial to be successful. CRNs support the well-being of research-patients, by taking note of any new, or existing healthcare needs of research-patients while they take part in research. CRNs coordinate the activities that research requires, biological samples, scans, documentation. Balancing their responsibility towards research-patients, on the one hand, and research management, on the other, can bring unique challenges for the CRN. CRNs can feel conflicted between these two responsibilities, e.g., when they think that a drug trial, or the research activities in a study is at odds with the research-patient's best interest despite the research-patient's consent to take part in research. CRNs are tasked with maintaining/facilitating recruitment of research-patients, this can be a challenging aspect of their role especially if they feel pressured to approach patients to take part in research. Currently, we know little about how CRNs balance these two responsibilities, or what other problems CRNs have in their everyday role when balancing these responsibilities. Finding out more about these aspects of the CRN role is important because it may not only improve job experience but can also give a better understanding of what can be changed to improve how CRN perform their role which could ultimately improve research-patients' experience of taking part in research. To address this issue, this PhD will explore CRNs and research-patients' views about clinical research, the challenges CRNs face, how CRNs balance their responsibilities, and what role does the relationship between CRNs, and research-patients play overall in what they say about their experience of taking part in clinical research. The researcher will interview and shadow CRNs and research-patients at a central NHS Hospital. This is a LISS/ESRC funded PhD at King's College London and supported by Guy's and St Thomas NHS Foundation Trust.
Detailed description
The purpose of this study is to explore how research patients and Clinical Research Nurses (CRNs) describe their experiences of participating in clinical research within their respective roles.
The study involves two main activities:
- Interviewing CRNs and research-patients via online (separately). Semi-structured interviews will be conducted using an interview guide based on themes identified in the existing literature. The guide will be refined and finalised based on feedback from Patient and Public Involvement and Engagement (PPIE), as discussed in the PPI section of the IRAS application.
- Observations of research activities at research departments including research consultations between CRNs and research-patients.
Research activities refer to various assessments or tasks carried out to generate data for a research protocol. The CRN's role includes conducting these activities, which may involve obtaining patient consent, collecting biological samples (e.g., blood, urine), or dispensing experimental drugs as part of a clinical trial. These activities typically occur during 'research visits' which are appointments or consultations between the CRN and the research patient.
The researcher will observe research activity taking place in research departments by way of "observer placements" for up to five days. Placements can occur in any of the following research departments: gastrointestinal, liver, surgical, respiratory, diabetes and endocrinology, neurology, renal, gynaecology, rheumatology, cardiovascular imaging, and lupus, ageing and health. This wide range of departments has been intentionally selected to provide a broad perspective and to maximise exposure to diverse research activities across different disease specialities. These observation placements will allow the researcher to directly observe interactions between CRNs and research-patients during research activities. Observational data will provide insight into the real-world context in which CRNs and research patients communicate their understandings, expectations, and perceptions of research participation.
Combining observational data with interview data will support triangulation during reflexive thematic analysis.
The number of placements will depend on the opportunities available for the researcher to undertake observations during the PhD data collection period. While the total number of observations is flexible, it is anticipated that this will be in the region of 10-15 due to the overall timeline for completing the PhD. The final number will be informed by guidance from the academic supervisory team during the analysis phase, which will take place concurrently with ongoing data collection. The sample size will be guided by the principle of 'information power'.
Organisation of the observer placements within research departments will be supported by the research leads (research matrons) with whom the researcher has already made prior contact, discussed the aim of the study, and who are supportive and will help to facilitate the project's objectives.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Research Nurses (CRN Group) | – | Other: Interviews, Other: Non-participant observationsCRNs working in adult clinical research |
| Research-Patients | – | Other: Interviews, Other: Non-participant observationsResearch-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CRN, research-patients
Key inclusion criteria (5 listed)
- Research-patients aged above 18 years old.
- Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over) at GSTT.
- Research-patients who are willing and able to provide informed consent.
- INCLUSION CRITERIA FOR CRNS Clinical research nurses (CRNs) currently working in adult clinical research at Guys and St Thomas' NHS Foundation Trust.
- CRN willing and able to give consent.
Key exclusion criteria (8 listed)
- Patients who showed an interest in taking part in research but were not recruited, e.g. due to screen failure, or ineligibility.
- Research-patients recruited to research via proxy consent, e.g., next of kin.
- Patients unable to provide informed consent, e.g., lacking mental capacity.
- Research-patients considered vulnerable or at risk of harm, by the research team
- Research-patients taking part in mental health or maternity trials or studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsSemi-structured interviews | Other | Clinical Research Nurses (CRN Group), Research-Patients |
| Non-participant observationsNon-participant observations of clinical research visits | Other | Clinical Research Nurses (CRN Group), Research-Patients |
Primary outcome
Recruitment of CRNs and Research-Patients
Time frame: End of recruitment date is 30 Dec 2028
Recruitment of up to 15 CRNs and up to 15 research-patients for interviews
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Experiences
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Not yet recruiting
Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience.
Surgery Ambulatory, ENT Surgery
RecruitingPhase 1
The RECAP2 Study: Midazolam and Psilocybin
Psilocybin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Experiences and Lived Experiences, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of CRNs and Research-Patients (time frame: End of recruitment date is 30 Dec 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.