Research ethics
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Research Ethics. Dr Mary Tully School of Pharmacy and Pharmaceutical Sciences & Chair of Salford & Trafford NHS Ethics Committee (2007-2009). Presentation. Remit of NHS ethics committees Imminent changes Ethics application process within NHS

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Research Ethics

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Research Ethics

Dr Mary Tully

School of Pharmacy and Pharmaceutical Sciences &

Chair of Salford & Trafford NHS Ethics Committee (2007-2009)


Presentation

  • Remit of NHS ethics committees

  • Imminent changes

  • Ethics application process within NHS

  • Information required for ethical consideration of research


Key Principles of Ethical Research

  • Well-being of subject takes precedence over interests of science and society

  • It is the duty of the physician to protect the life, health, privacy and dignity of the human subject

  • Conform to generally accepted scientific principles by appropriately qualified persons

  • Assessment of predictable risks and burdens in comparison with foreseeable benefits – the former should outweigh the latter

  • Subjects must be volunteers and informed participants


NHS Research Ethics Committees Organisation

  • NHS ethics committees were previously independent bodies

  • Now controlled by a single body (NRES) with a single set of Standard Operating Procedures

  • Operate under the Governance Arrangements for Research Ethics Committees (GAfREC)

  • Use a single form for all ethics committees

  • Approval from a single ethics committee is acceptable to all other committees


Currently - Studies Needing NHS REC Approval

  • Those that involve:

    • patients and users of the NHS

    • relatives or carers of patients and users of the NHS

    • access to data, organs or other bodily material of past and present NHS patients

    • foetal material and IVF involving NHS patients

    • the recently dead in NHS premises

    • the use of, or potential access to, NHS premises or facilities

    • NHS staff - recruited by virtue of professional role


GAFREC version 2 – out for consultation

  • 2.3.2 Those that involve:

    • past or present users of NHS & adult social services

    • relatives or carers of past or present users of these services;

    • collection of tissue/information from users of these services;

    • use of previously collected tissue or information from which individual past or present users of these services could be identified


2.3.5 – Legislation requires REC review of research involving:

  • (a) people who lack (or lose) the capacity to give informed consent to take part (or to keep taking part) in the research;

  • (b) processing of confidential patient information without consent where this would otherwise breach confidentiality;

  • (c) material consisting of or including human cells (unless anonymous & obtained with consent);

  • (d) people who are cared for in the private and voluntary sector, e.g. in nursing homes or residential care homes;

  • (e) exposure to ionising radiation;

  • (f) medical devices that are not CE-marked (i.e. not compliant with European Directives) or CE-marked medical devices that have been modified or are being used for a new purpose;

  • (g) investigational medicinal products;

  • (h) practising midwives conducting a clinical trial; or

  • (i) protected information from the Human Fertilisation and Embryology Authority register.


“No material ethical issues”

  • Proportionate ethical review pilot in London from 1st September 2009

    • Research using data or tissue that is anonymous TO THE RESEARCHER

    • Research using existing tissue samples already taken with consent for research

    • Research using “extra tissue” (e.g. further blood taken at time of routine sampling or tissue taken at “clinically directed” operation)

    • Questionnaire research that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences

    • Research interview / focus group that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences

    • Research surveying the safety or efficacy of established non drug treatments, involving limited intervention and NO change to the patients’ treatment


http://www.nres.npsa.nhs.uk/applications/guidance/#appguide


From April 2009

Sponsor ensures

scientific review

Complete ethics application

form

Phone to book in &

get number

Submit study to R&D

office at each site

Submit completed form and

supporting documentation

Application reviewed by

main REC

Modifications

& reapply

Favourable

Provisional

Unfavourable

Appeal

Trust approval

at each site

Modifications


www.myresearchproject.org.uk/


Salford & Trafford as an example

Pharmacist

Paediatric oncologist

GP

Nurse x 3

Anaesthetist

Medical statistician

Clinical psychologist

Community health care worker

Retired physicist

Engineer

Professor in Cell Biology

Builder

Membership of committees


How to really annoy an ethics committee!

  • Assume we are all experts in your area

  • Assume that we are all stupid

  • Assume that the research participant is an expert in your area

  • Don’t answer the questions on the form

  • Don’t bother proofreading

  • Be really careless


Lay language

  • “It is crucial that your answers to these questions are written in a way that will be understood by lay members of the Committee.

  • Lay members may not have worked in the NHS or have any experience of clinical research.

  • It is not acceptable to cut and paste from the protocol.

  • You could be asked to rewrite your answers if you do not adhere to this guidance.”


  • “The principal objective is to study the frequency of different allelic forms of immune response genes that may contribute towards the pathogenesis of various rheumatic and/or autoimmune diseases. Specific genetic polymorphisms may contribute to either the development of disease (susceptibility), the development of specific disease features (e.g. pattern of joint involvement and extra-articular manifestations) or alternatively may contribute to disease severity.”


What does committee look for?

  • Scientific design & conduct of study

  • Recruitment of research participants

  • Consent

  • Care & protection of research participants

  • Protection of participants’ confidentiality

  • Other considerations


Scientific design & conduct of study e.g.

  • Will this research answer the question the researcher has posed?

  • Does the research involved a placebo? How ethical is this? Have subjects being told?

  • What are the criteria for prematurely withdrawing research participants?

  • Etc …


Recruitment of research participants e.g.

  • How will initial contact and recruitment be conducted?

  • What are the inclusion and exclusion criteria for research participants, and are they justified?

  • Etc …


Consent e.g.

  • How will consent to be obtained?

  • Is the information given appropriate, complete and understandable?

  • What is the justification for including individuals who cannot consent?

  • Etc …


Subject Information Sheets e.g.

  • Question and answer format – standard NRES format

  • Plain, concise English

  • Should be true and not withhold information

  • Risks and benefits outlined - of both arms in a controlled study

  • Etc …


Care and protection of research participants e.g.

  • Are there any plans to withhold or withdraw standard therapies?

  • Will the research participants received any compensation/reward for their participation?

  • Etc …


Protection of participants’ confidentiality e.g.

  • Who will have access to the personal data of the research participants?

  • To what extent will information about participants be anonymous?

  • Will data be sent outside the EU?

  • Etc …


Conclusions

  • Changes are coming to the system in next 6 months

    • New GAFREC

    • Proportionate review system

  • Take advice from as many people as you can

  • Take advice from ethics committee members or coordinator

  • Getting ethics approval may not be as awful as you think!


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