Research Ethics

Dr Mary Tully

School of Pharmacy and Pharmaceutical Sciences & Chair of Salford & Trafford NHS Ethics Committee (2007-2009) Combining the strengths of UMIST and The Victoria University of Manchester

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 1 st 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

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 Sponsor ensures scientific review Trust approval at each site Favourable Provisional Unfavourable Modifications Modifications & reapply Appeal

www.myresearchproject.org.uk/

Membership of committees

• 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

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!