Research Integrity and Research Ethics

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Research Integrity and Research Ethics

• Catherine Fieulleteau
• Ethics Integrity Manager

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Research Integrity

• The University has a responsibility to ensure
• that research is conducted with integrity
• and good research practices are upheld.
• The University conducts high quality,
• innovative research and is guided by the
• principles and standards outlined in The
• Concordat to Support Research Integrity,
• Research Governance Framework for
• Health and Social care and other
• documents.
• Source The Concordat to Support Research
  Integrity, 2012 http//www.universitiesuk.ac.uk/h
  ighereducation/Documents/2012/TheConcordatToSuppor
  tResearchIntegrity.pdf

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Research Integrity

• The core elements of research integrity
• are
• Honesty in all aspects of research.
• Accountability in the conduct of research.
• Professional courtesy and fairness in working
  with others.
• Good stewardship of research on behalf of others.
  
• Source Singapore Statement, 2010
  http//www.singaporestatement.org/

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Research Integrity

• Demonstrate openness and transparency when
  reporting results including sharing negative
  results.
• Acknowledge all contributors who had significant
  involvement in the research. Provide a full and
  accurate bibliography.
• Comply with all legal, ethical and contractual
  requirements.
• Source The Concordat to Support Research
  Integrity, 2012 http//www.universitiesuk.ac.uk/h
  ighereducation/Documents/2012/TheConcordatToSuppor
  tResearchIntegrity.pdf

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Experienced and New Researchers

• The University recognises that both senior
  researchers and new researchers should understand
  their responsibilities.
• Researchers should be aware of and keep actively
  up-to-date with research integrity issues.
• Comply with legal and ethical requirements when
  conducting or collaborating in research in other
  countries. Both UK and legislation of the other
  countries must be observed.

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Background

• In the 20th century significant abuses prompted
  action to improve the governance of research
  ethics, including
• Nazi atrocities including scientific
  experimentation on human beings without consent.
• Medical research conducted without informed
  consent, such as Tuskegee Syphilis Study and
  Thalidomide drug testing.
• Increased research governance has meant that an
  appropriate functioning system of ethical
  scrutiny in research Institutions should be in
  force, to ensure that there is an explicit
  discussion of ethical concerns before a project
  goes ahead.

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When is ethical approval required?

• Research involving the following requires ethical
  approval
• Human participants including simple, anonymous
  questionnaires, interviewing professionals at
  their place of work, focus groups, observations
  and taught courses/practicals.
• Human data, personal, sensitive data even if
  anonymised, may require ethical approval.
• Research on animals.
• Raises social and environmental issues.

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Why is ethical approval necessary?

• Protects the safety and well-being of research
  participants.
• Protects researchers.
• Ensures you conduct your research to high ethical
  standards. Protecting integrity of ethics.
• Informed consent (written where possible) or
  recorded verbal consent.
• Meet the criteria of funding bodies/sponsors.

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UEL Ethics Committees

• University Research Ethics Committee (UREC)
  reviews research involving
• human subjects submitted by staff, PhD, MPhil,
  professional doctorates and Masters by research
  students.
• School Research Ethics Committees (SRECs) review
  applications for ethical approval from
• undergraduate and taught Masters students.
• Source UEL Research Ethics web page
• http//www.uel.ac.uk/gradschool/ethics/

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UEL Ethics Committees

• Collaborative Research Ethics Committees (CRECs)
  are Partner Institutions of UEL who conduct
  research with human subjects or human data.
• UREC, SRECs and CRECs are made up of a Chair,
  Deputy Chair and subject area representatives
  reflecting the mix of School disciplines within
  each Committee.
• Each discipline at UEL has a SREC that reviews
  applications for ethical approval. This includes
  non health/medical research for all Schools
  Social Sciences, Law, Business, Education,
  Engineering, Arts and Humanities, as well as
  Health, Sport and Bioscience.
• Staff and students conducting research with human
  participants must obtain ethical approval. UEL
  does not grant retrospective approval.

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What does UREC look for?

• Design of the study rationale, hypothesis
• Expertise/experience of researchers
• Benefits of the research present or future?
• Recruitment of participants approach.
• Care and protection of participants.
• Informed consent!
• Confidentiality.
• Risks minimised.
• Compliance issues DPA, DBS and legal
  regulations.

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Recruitment Documents

• Information Sheets
• Given in advance.
• Lay language and age appropriate.
• I.S. for each group of participants. In writing
  (preferable) or script to be read.
• Understandable by all participants, e.g. parents,
  guardians and children.
• Emphasise that participation in the study is
  voluntary.
• State right to withdraw and deadlines for
  withdrawal of data, normally up to the point of
  anonymisation.
• State whether you hope to publish the data.

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Recruitment Documents

• Consent Forms
• Given in advance.
• Must obtain consent from relevant authorities and
  gatekeeper organisations.
• Permission to publish the data.
• Researchers should provide
• Draft interview topic guide, copy of
  questionnaire(s), permission letters and adverts
  for the study.
• IMPORTANT
• Apply for ethical approval in good time!

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Processes for submission

• UREC and SRECs processes differ.
• Applications made to UREC are required to use
  UREC application form and template recruitment
  documents.
• One hard, ink-signed copy of the full
  application, including recruitment documents
  should be submitted.
• One electronic copy of the full application form
  in PDF format should be emailed to
  researchethics_at_uel.ac.uk.
• UREC will not accept applications that do not
  bear an ink-signed signature.
• Source UEL Research Ethics web page
  http//www.uel.ac.uk/gradschool/ethics/

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SREC Process for submission

• SRECs may have a simpler, condensed version of
  the research ethics application form.
• Recruitment documents are still required. All
  applications should include an Information Sheet
  and a Consent Form, where applicable.
• Each SREC has its own procedures for granting
  ethical approval. Supervisors should be aware of
  the processes. Consult the SREC Chair for
  guidance.
• Any amendments to approved applications, however
  minor, must be submitted to the relevant research
  ethics committee.

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Research requiring NHS Approval

• NHS Research Ethics Committees (RECS) review
  research involving
• Patients, users of the NHS and their carers.
• Patients who fall under the Mental Capacity Act
  2005.
• Research governed by Human Tissue Act 2004
• Social Care Research Ethics Committees review all
  social care research funded by the Department of
  Health. Applies to users of the social care
  system.

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Responsibilities of staff and students

• Academic staff members involved in the
  supervision and development of other researchers
  must be aware of their responsibilities and
  ensure that they have the necessary training,
  time and resources to carry out that role.
  Academic staff should request support, if
  required.
• Research staff and students, at all levels, are
  expected to comply with all legal, ethical and
  other requirements or guidelines that apply to
  research.
• UEL Code of Practice for Research, June 2013
  http//www.uel.ac.uk/gradschool/currentstudents/li
  brary/

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Training

• Research Integrity Modules - provide guidance and
  support to conduct high quality research.
• Ethics Integrity Manager - provides training,
  guidance and support, from Codes of Practice to
  the UEL application process.
• Drop in sessions at both Docklands and
  Stratford campus for staff and students.
• External training provided e.g. Association for
  Research Ethics (AfRE).
• Chair of UREC runs bi-annual PGR and staff
  research ethics training.
• New polices, guidelines, support and best
  practice are communicated via the web page, Deans
  of School, email and UELs inFocus magazine.

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Advice and Support

• Research Ethics Department in
• Graduate School.
• 0208 223 6683
• researchethics_at_uel.ac.uk
• University of East London
• EB1.43, Docklands Campus
• 4-6 University Way
• London E16 2RD

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Useful references

• UEL Site http//www.uel.ac.uk/qa/research/
• IRAS Site https//www.myresearchproject.org.uk/
• The Concordat to Support Research Integrity
  http//www.universitiesuk.ac.uk/highereducation/Do
  cuments/2012/TheConcordatToSupportResearchIntegrit
  y.pdf
• European Code of Conduct for Research Integrity
  http//www.nsf.gov/od/iia/ise/Code_Conduct_Researc
  hIntegrity.pdf
• Research Governance Framework for Health and
  Social Care. Second edition, Department of Health
  2005 https//www.gov.uk/government/uploads/system/
  uploads/attachment_data/file/139565/dh_4122427.pdf
  
•  A Framework of Policies and Procedures for
  University Research Ethics Committees. The
  Association of Research Ethics Committees, 2013
  http//s3.spanglefish.com/s/21217/documents/indepe
  ndent-membership/12-11-13-framework-complete.pdf