What will we do with your response?
The HRA has a commitment to transparency. We will analyse the comments we receive, and publish a report on our website explaining how we will address them. The results will be used to inform future guidance.
The published report will compare the views of different organisations and groups of individuals.
Organisational responses: In the interest of transparency, comments made on behalf of an organisation may be published and attributed unless an explanation is provided with your response as to why you consider the information should not be. (Please note the
Confidentiality of Information section below.).
Individual responses: Comments will be summarised in a way that does not identify individual respondents unless we have your permission to identify you.
If we receive a consultation response without an accompanying form we will adopt the position that organisational responses are attributed and individual responses anonymised.

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Are you responding in an organisational or personal capacity?
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☐ Patient
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I am willing for my response, and any quotes used from it, to be made identifiable in any consultation report and any future HRA publications
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If you have checked the box above please provide your contact details below. By providing these contact details, you are giving your consent for a member of HRA staff to contact you about your submission. The HRA takes data protection very seriously. We promise we will not pass your details on to any other organisations or use them for any other purposes.
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Q1. Are the suggested general principles regarding the seeking of consent identified in 2.5 reasonable?
Principle Yes No
Not sure
Informed consent is central to the ethical conduct of research and desirable should be sought in all cases unless a strong justification can be provided for dispensing with this important requirement
Informed consent procedures should always be proportionate to the nature of what is proposed, the risk of the research and the ethical issues at stake
Informed consent should always be documented
Q2. Are the suggested principles regarding the use of simplified means for obtaining informed consent identified in 2.6 reasonable?
Principle Yes No
Not sure
Following the normal consent process would place a disproportionate burden in terms of time and resources in relation to the perceived risk
The study addresses a clinical question where there is uncertainty regarding the relative merits of relevant interventions
All medicines used in the trial are in routine use and within the terms of their licence
The study involves little or no deviation from usual care
(including monitoring for adverse effects, extra research-specific laboratory tests, study visits, questionnaires etc.)
All interventions/diagnostic tests are in routine use within the NHS and will be undertaken by those qualified to do so
Research risks are no greater than those involved in standard care/not greater than minimal (e.g. extra blood tests/tissue samples taken during a ‘clinically directed’ procedure)
The use of simplified means to obtain consent does not adversely affect the rights or welfare of study participants
Healthcare Professionals (HCPs) have the option of using an intervention other than the one assigned if they believe doing so is important for a particular patient
Patient has not expressed a strong preference for any particular treatment
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Q3. Many treatments routinely used in children have never been properly tested or licensed. Could a simplified consent process be used in ‘simple and efficient’ research comparing existing treatments with children?
Yes ☐
No
☐
Not Sure ☐
Q4. Could a simplified consent process be used in ‘simple and efficient’ research involving adults unable to consent?
Yes ☐
No
☐
Not Sure ☐
Q5. Do you think that the “Suggested Short Information Sheet” (in conjunction with the medicine information leaflet which covers side-effects and possible interactions with other drugs etc.) would provide sufficient information for patients to make an informed decision regarding taking part in a ‘simple and effi cient trial’?
Yes ☐
No ☐
Not Sure
☐
Q6. Could the information provided in the “Suggested Short Information Sheet” sheet be simplified further (without compromising consent)?
Yes
No
Not Sure
☐
☐
☐
If ‘yes’: what could be removed from the information sheet?
Q7. Can you foresee any practical difficulties in conducting simple and efficient trials in the NHS? What additional support or changes to current systems might be required e.g. IT systems/coding/technical/administrative/other?
Q8. Do you think that seeking patients’ consent to take part in simple and efficient trials might affect the relationship between the patient and their doctor?
Yes
☐
No ☐
Not Sure
☐
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Scenario 1: Explicit consent (short information sheet) - Clinical trial of Statins
(GP Surgery)
Q9. Do you think that the GP handing the patient a short information sheet and asking if they have any questions constitutes an adequate “interview” and opportunity for the patient to ask questions?
Yes ☐
No
☐
Not Sure ☐
Additional comments:
Scenario 2
– ‘Deemed’ consent (opt-out) - Patient asked to confirm consent -
Randomised Cluster Trial (GP Surgery)
Q10. In order to satisfy the cluster trials requirements in the forthcoming EU Clinical
Trials Regulation the information regarding the trial would have to be “given” to the patient.
Do you think displaying a poster in a waiting room satisfies that requirement?
Yes
No
Not Sure
☐
☐
☐
Additional comments:
Scenario 3 – ‘Deemed’ consent (opt-out) – Patient not asked to confirm consent - Randomised Cluster Trial (GP Surgery)
Q11. Is it ever acceptable for consent to be ‘deemed’ or assumed to have been given even where consent to be involved in (low risk) research could be sought directly from patients?
Yes
No
Not Sure
☐
☐
☐
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Q12. In order to satisfy the cluster trials requirements in the forthcoming EU Clinical
Trials Regulation the information regarding the trial would have to be “given” to the patient. Do you think displaying a poster in a waiting room satisfies that requirement?
Yes
No
☐
☐
Not Sure ☐
Q13. Do you think the use of a poster with no further information provided by the GP
(option 2) would mean that participants are “being informed”?
Yes Fully
Yes Partially
No
☐
☐
☐
Not Sure ☐
Q14. Is ‘deemed consent’ coupled with asking the patient whether they would wish to decline to take part (opt-out) an acceptable approach in low-risk research?
Yes
No
Not Sure
☐
☐
☐
Additional comments Regarding Scenario 3:
Scenario 4: No Consent - Cluster Trial (Hospital Ward)
Q15. Is it acceptable not to seek consent in very low-risk trials, such as the mattress study, where the patient is likely to receive this as part of their standard treatment anyway?
Yes
☐
No
Not Sure
☐
☐
Are there other scenarios where not seeking consent would be acceptable?
Yes
☐
No ☐
Not Sure
☐
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Additional comments:
Q16. Should verbal consent be sought (documented in the medical notes) to access the patient’s medical data for the purposes of the research?
Yes
No
Not Sure
☐
☐
☐
Additional comments Regarding Scenario 4:
Q17. Any further comments or feedback:
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Confidentiality of information
The HRA will process your personal data in accordance with the DPA and in most circumstances this will mean that your personal data will not be disclosed to third parties without your permission or unless required by law.
Information we receive, including personal information, may be published or disclosed in accordance with the access to information regimes (primarily the
Freedom of Information Act 2000 (FOIA), the Data Protection Act 1998 (DPA) and the Environmental Information Regulations 2004).
If you want the information that you provide to be treated as confidential, please be aware that, under the FOIA, there is a statutory Code of Practice with which public authorities must comply and which deals, amongst other things, with obligations of confidence. In view of this it would be helpful if you could explain to us why you regard the information you have provided as confidential. If we receive a request for disclosure of the information we will take full account of your explanation, but we cannot give an assurance that confidentiality can be maintained in all circumstances.
An automatic confidentiality disclaimer generated by your IT system will not, of itself, be regarded as binding on the HRA.
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Please send the completed response form by email to hra.seekingconsent@nhs.net
with
‘ Seeking consent in simple and efficient trials ’ as the subject line.
If you would prefer to respond by post, please send your completed response form (please mark the envelope “Seeking Consent”) to:
Clive Collett
HRA Ethics Guidance & Strategy Manager
Health Research Authority
Ground Floor
Skipton House
80 London Road
London SE1 6LH
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