Research Ethics

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Research Ethics

• Dave Webb
• Innovation North17 March 2008

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Research Ethics

• Outline of Session
• The need for a research ethics policy
• Background to development of the policy
• The role and purpose of Research Ethics
  Committees
• Consideration of the Leeds Met Policy and
  Procedures

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Ethics

• Ethics (via Latin ethica from the Ancient
  Greek ????? f???s?f?a "moral philosophy", from
  the adjective of ???? ethos "custom, habit"), a
  major branch of philosophy, is the study of
  values and customs of a person or group. It
  covers the analysis and employment of concepts
  such as right and wrong, good and evil, and
  responsibility. It is divided into three primary
  areas meta-ethics (the study of the concept of
  ethics), normative ethics (the study of how to
  determine ethical values), and applied ethics
  (the study of the use of ethical values).
• Wikipedia

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Need for a Research Ethics Policy

• Definitions of ethics usually include reference
  to morals or the rules or standards governing the
  conduct of a person or the members of a
  profession.
• It is sometimes argued that ethics relate to a
  persons own private considerations whereas morals
  relate to social matters.

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Origins of Research Ethics Committees

• The Declaration of Helsinki enunciated the
  principle of independent assessment of
  experimental procedures involving human
  subjects
• The design and performance of each experimental
  procedure involving human subjects should be
  clearly formulated in an experimental protocol.
  This protocol should be submitted for
  consideration, comment, guidance and where
  appropriate, approval to a specially appointed
  ethical review committee, which must be
  independent of the investigator, the sponsor or
  any other kind of undue influence. This
  independent committee should be in conformity
  with the laws and regulations of the country in
  which the research experiment is performed. The
  committee has the right to monitor ongoing
  trials. The researcher has the obligation to
  provide monitoring information to the committee,
  especially any serious adverse events. The
  researcher should also submit to the committee,
  for review, information regarding sponsors,
  institutional affiliations, other potential
  conflicts of interest, and incentives for
  subjects.

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Legal Framework

• The legal obligations relating to research ethics
  are not covered by any single Act. Some relevant
  legislation includes
• The Data Protection Act 1984
• The Childrens Act 1989
• Various privacy laws
• Human Rights laws and considerations
• Organisations have generally responded to their
  obligations via policy documents, codes of
  practice etc.

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Research Ethics Committees (RECs)

• The main objectives of a REC are to
• maintain ethical standards of practice in
  research
• to protect subjects of research and research
  workers from harm or exploitation
• to preserve the subjects rights, and
• to provide reassurance to the public that this is
  being done.

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Purpose of a REC

• The purpose of a REC is to review a proposed
  study and to ensure the dignity, rights, safety
  and well-being of all actual or potential
  research participants is protected

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Why do we need RECs?

• To Protect
• To ensure that all work involving human
  participants is conducted in accordance with
  internationally accepted ethical and professional
  standards

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Responsibilities of RECs

• To consider the ethical implications of all
  experiments, investigations and procedures
  involving human or animal subjects carried out in
  the University and/or under the auspices of the
  University and in doing so ensure that
• The proposed study is scientifically valid and
  justifiable in terms of its possible benefits
  compared with any risk of inconvenience or harm.
• Adequate steps have been taken to anticipate and
  avoid physical or psychological harm for research
  participants.
• That confidentiality of all personal and medical
  information is ensured and privacy maintained.
• Consent is truly valid (informed) and given
  without any form of duress.

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The University is Responsible for

• developing, operating and reviewing policies and
  guidelines which are consistent with recognised
  standards and best practice in the disciplines
• providing appropriate guidance.
• supporting researchers undertaking research,
  which is ethically sound through implementation
  of guidance and appropriate supervision
• establishing University and Faculty Research
  Ethics Sub-Committees (URESC, FRESC)

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Purpose of Ethical Approval

• Reflects a commitment to good ethical practice
• Assists researchers and supervisors in the
  identification of appropriate issues and how to
  address them in research proposals
• Acts as a safeguard to researchers, supervisors
  and students

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The Principles

• All research involving human participants must
  consider
• the value of the research
• informed consent
• openness and honesty
• right to withdraw without penalty
• confidentiality and anonymity
• protection from harm
• briefing and debriefing
• reimbursements, payments and rewards
• suitability/experience of researcher
• ethics standards of external bodies and
  institutions
• reporting on ethical issues throughout
• research for clients/consultants
• intended dissemination

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The Value of the Research

• Original contribution to knowledge, should be
  made apparent to all involved wherever possible
• In the case of deceptive or some covert research
  this does not apply to participants, but needs to
  be justified

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Informed Consent

• Adults assumed to be competent unless
  demonstrated otherwise
• Subjects should be informed of the aims, methods,
  benefits, hazards and any discomfort
• Comprehensible documentation for subjects
• Consent should be in writing and records kept
• Potential subjects free to withdraw without
  implication
• Subjects should be volunteers, decisions not to
  participate should not prejudice the subject in
  any way

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Informed Consent (cont.)

• Potential participants under the age of 18 or are
  people over 18 (e.g adults with learning
  disabilities) who are unable to reach informed
  decision about participation, additional, need
  separate consent forms from parents/guardians,
  alongside informed agreement from the child,
  where applicable

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Openness and Honesty

• Research should be carried out in an honest and
  open manner
• Participants should be fully and honestly
  informed about the research rationale, method(s)
  and outcomes
• Some research (deceptive and some forms of covert
  research) may be exceptions and must be agreed

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Right to Withdraw Without Penalty

• Potential participants should, as part of the
  informed consent process, realise that they are
  free to withdraw without penalty from the
  research project - even if they have received
  inducements or payments
• May also request consent be withdrawn
  retrospectively and any relevant data destroyed
• If consent has been given through a surrogate can
  themselves request to withdraw from the research

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Protection from Harm

• The relationship should one of mutual respect and
  based on trust
• Researchers have responsibility to ensure that
  physical, social and psychological well-being of
  participants is not affected in an adverse manner
  by the research
• Responsibility for protection from harm does not
  end with the research project - may extend to the
  life of the data set
• Undue risk is considered to be that above and
  beyond risks run in the normal everyday life of
  the participant
• Particular care needed when participants are from
  vulnerable and/or powerless groups
• Particular care needed when discussing results of
  research projects with those in loco parentis or
  other consenting positions - may prejudice
  attitudes toward the participants

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Briefing and Debriefing

• Participants should be adequately briefed as to
  how the research is to be carried out from
  inception to dissemination
• Participants should receive information relating
  to the outcomes of the research
• Debriefing may sometimes involve remedial action
  to negate post-participatory effects, for example
  where negative moods have been induced

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Suitability/Experience of Researcher

• Investigators should have relevant
  academic/professional competence to carry out the
  research project
• They (individual or team) should have experience
  of dealing with the ethical dimensions of the
  research

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Ethics Standards of External Bodies Institutions

• Where external bodies and institutions (either
  those funding the research, or professional
  bodies to which the researcher belongs) have
  their own ethical codes these must be followed
• If there is any conflict with Leeds Met
  principles and procedures these should be
  identified as soon as possible and relevant
  academic managers notified

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Reporting on Ethical Issues Throughout

• If there are interim reports, whether verbal or
  written, ethical issues should be acknowledged
  and discussed throughout

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Research for Clients/Consultants

• Where necessary, ethical positions should be
  clarified (in writing) with external clients and
  organisations prior to the research beginning
• Data ownership rights and rights to publish (on
  both sides) should be established
• Ethics guidelines and/or professional codes
  should not be compromised

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Intended Dissemination

• Should be relayed to participant as part of the
  consent process
• Summaries of research findings should be relayed
  to participants wherever possible

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Leeds Met Procedures for Ethical Clearance

• Ethical Clearance is required for all research
  involving human subjects undertaken by staff,
  postgraduate students (PGR and PGT) and final
  level undergraduate students undertaking a
  research project as a final year dissertation

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Leeds Met Procedures for Ethical Clearance

• Your research project will fall into one of the
  following categories
• Excluded Matters research not involving human
  participants/subjects
• Research involving Human Participants
• Research involving Human Subjects
• You must complete the appropriate Ethical
  Approval Form submit with Confirmation of
  Registration documents

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Leeds Met Procedures for Ethical Clearance

• Human Participants are
• living human beings, including embryos and
  foetuses, human tissue and body parts
• human beings who have recently died, including
  cadavers, human remains and body parts
• collective organisations for example companies,
  corporations, community groups.
• Human Subjects are the subject(s) of data and
  records which have been collected and stored as a
  record at individual level - for example medical,
  genetic, financial, personnel, criminal and
  administrative records and test results
  including scholastic achievements.

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Authorisation and Approval of Research Projects
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Ethical Authorisation or Approval at Local,
Faculty University Level

• Local AuthorisationConfirms that the proposed
  research project is an excluded matter and
  therefore does not need ethical approval.
• Local ApprovalShould only be given to low-risk
  projects where the ethical issues are not complex
  or sensitive and there is minimal risk of harm
  either to any human participants or the
  researcher and (for undergraduates and
  postgraduates) where adequate supervision of the
  project is demonstrable.

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Local Level Approval

• All undergraduate dissertations/projects are
  expected to be able to be approved at local level
• Depending on the nature of the project, local
  level approval may also be given to postgraduate
  and staff proposals
• It is impossible to specify in detail or in
  absolute terms those projects which can be
  approved at local level
• Key factors will include the experience of the
  researcher assessment of the level of risk the
  complexity and sensitivity of proposals and
  appropriate safeguards like experienced
  supervision being in place

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Principles for Local Level Approval

• RE Co-ordinators should be aware of the
  sensitivity of social issues (divorce, sexual
  orientation) and criminal/deviant issues
  (domestic violence, drug abuse)
• Depending on the level of experience of the staff
  member as researcher and/or postgraduate
  supervisor, some projects might be referred to
  the faculty sub-committee
• In cases of doubt, a RE Co-ordinator should seek
  advice from other RE Co-ordinators in the Faculty
  and/or the Chair of FRESC

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Principles for Local Level Approval

• ApprovableLow-risk projects, which include the
  following
• projects in which the ethical issues are not
  complex or sensitive
• projects where there is minimal risk of harm
  either to participants or researcher
• (for undergraduate and postgraduate proposals)
  where adequate supervision of the project is
  demonstrable
• Not approvable at local level
• projects which do not comply with the approvable
  provisions
• research into human subjects by undergraduates
• projects involving children or vulnerable
  persons
• all requests for approval of Occluded or Covert
  research projects

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Ethical Authorisation or Approval at Local,
Faculty University Level

• Faculty approval should be sought when
• there are substantial or complex ethical issues
  involved
• when the consent of external bodies (e.g. NHS)
  are required or
• when it is a requirement for funding by an
  external body (e.g. the MRC or the ESRC)
• FRESC will consider proposals and, if necessary,
  refer them back to the applicant for further
  details or remit the final decision to Chairs
  action
• FRESC will bear in mind the need of the applicant
  for a timely response to the application

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Ethical Authorisation or Approval at Local,
Faculty University Level

• University approval should be sought by the
  faculty when
• when it cannot agree the ethical propriety of the
  proposed research
• they pose complex institution-wide ethical issues
  - all proposals for covert research should be
  forwarded to the URESC for final authorisation
• The decisions of the URESC on matters referred to
  it are final and there is no appeal mechanism

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Example A Case of Plagiarism

• May is a second-year graduate student preparing
  the written portion of her qualifying exam. She
  incorporates whole sentences and paragraphs
  verbatim from several published papers. She does
  not use quotation marks, but the sources are
  suggested by statements like "(see . . . for more
  details)." The faculty examiners note
  inconsistencies in the writing styles of
  different paragraphs of the text and check the
  sources, uncovering May's plagiarism.
• After discussion with the faculty, May's
  plagiarism is brought to the attention of the
  academic member whose responsibility it is to
  review such incidents. The faculty regulations
  state that "plagiarism, that is, the failure in a
  dissertation, essay, or other written exercise to
  acknowledge ideas, research or language taken
  from others" is specifically prohibited.
  Consequently May is expelled from the program
  with the stipulation that she can reapply for the
  next academic year.

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A Case of Plagiarism

• Is plagiarism like this a common practice?
• Are there circumstances that should have led to
  May's being forgiven for plagiarising?
• Should May be allowed to reapply to the program?

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Plagiarism

• A broad spectrum of misconduct falls into the
  category of plagiarism, ranging from obvious
  theft to uncredited paraphrasing that some might
  not consider dishonest at all.
• In a lifetime of reading, theorizing, and
  experimenting, a person's work will inevitably
  incorporate and overlap with that of others.
• However, occasional overlap is one thing
  systematic use of the techniques, data, words, or
  ideas of others without appropriate
  acknowledgment is another.

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Milgram Experiment

• In the 60s, a Yale University professor by the
  name of Stanley Milgram set out to test the
  limits of human deference.
• Adolf Eichmann claimed a few years earlier that,
  even though he had masterminded the Nazi
  destruction of the Jewish people, he "was only
  obeying orders
• Milgram was convinced that none of his countrymen
  would ever have obeyed such orders

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Milgram Experiment

• He persuaded volunteers to take part in a study
  on the effects of punishment on learning.
• One would be the "teacher", the other the
  "learner" - with the latter strapped into a chair
  with electrodes attached to his wrists.
• If the learner made a mistake in a series of
  simple memory tests, the teacher would zap him
  with a shock.
• However, the "learner" was actually an actor, and
  that the shocks were all fake.

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Milgram Experiment

• Eventually the learner would be writhing in mock
  pain on the other side of the glass, crying out
  for mercy - in some cases, he might complain of a
  heart condition or, at 330 volts, fall silent, as
  if unconscious or dead
• However, the volunteers, of all ages and across
  all social groups, repeatedly agreed to increase
  the voltage, no matter how loud the protests of
  their victim
• 65 of the sample were prepared to obey the most
  heinous orders, administering the maximum shock
  of 450 volts - even if it seemed lethal

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Milgram Experiment

• Interestingly the results were highest when the
  "researcher" supervising the experiment wore a
  white coat. If he was just in a suit, the
  obedience rates dropped considerably.
• People were deferring to the costume of the
  doctor-scientist, even to the extent of
  suspending their own consciences. If they
  protested, the researcher would merely say "The
  experiment must continue." And so it would

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Milgram Experiment

• Could this type of experiment be performed today?
• Should it be?

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Further information

• Faculty Research Student Handbook
• See the University Research Ethics Policy,
  available at
• http//www.leedsmet.ac.uk/research/PublishedPolicy
  Framework(res_Ethics).doc