Ethical Issues in Research

1
Ethical Issues in Research

• N503
• Session 11
• November 16, 2005

Katharina Kovacs Burns, PhD 1
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Overview Of Presentation

• 1. What is Ethics?
• 2. Historical Standards of Ethics
• 3. Current Standards of Ethics
• 4. How Ethics is considered in Research
• 5. Health Research Ethics Board/Panel
• 6. Process of Ethics Submission reviews(who
  does what, for whom, about what/whom, and how or
  why)

Katharina Kovacs Burns, PhD 2
3
What is Ethics?

• Ethics is
• the study of standards of right and wrong that
  part of science and philosophy dealing with moral
  conduct, duty and judgment
• The Senior Dictionary of Canadian English. 1973.
  p.399

Katharina Kovacs Burns 3
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Ethic of Research

• An ethic of research involving human subjects
  should include two essential components
• the selection and achievement or morally
  acceptable ends in terms of benefits of research
  for subjects, for associated groups, and for the
  advancement of knowledge and
• (2) the morally acceptable means to those ends,
  directed at ethically appropriate means of
  conducting research. (MRC, NSERC, SSHRC, 1998,
  Tricouncil Policy Statement, p.I.4)

Katharina Kovacs Burns 4
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Historical Standards of Ethics CIHR (2001).
Selected International Legal Norms on the
Protection of Personal Information in Health
Research.

• Nuremberg Code (1947) principles to satisfy
  moral, ethical, and legal concepts in human
  experimentation, with voluntary consent being
  absolutely essential.
• Universal Declaration of Human Rights (1948) is
  a recognition of and pledge to basic human rights
  for the international community human rights are
  protected by law
• Declaration of Geneva (1948) is a physicians
  oath to devote life to the service of humanity
• American atrocities Tuskegee Syphilis Study on
  American Black men (1932 1972) injecting live
  cancer cells into elderly Jewish patients
  radiation experiments on prisoners (1940s)
• Declarations of Helsinki (1964, 1975, 2000)
  Ethical Principles for Medical Research Involving
  Human Subjects(research procedures, risk
  assessment duties, issues of informed consent)

Katharina Kovacs Burns 5
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Continued historical accounts

• Belmont Report National Commission for the
  Protection of Human Subjects of Biomedical and
  Behavioral Research published report (1978) under
  National Research Act affecting government
  research. Three principles became pillar of
  ethics standards Beneficence, respect for human
  dignity, and justice.
• U.S. Office of Human Research Protections
  federal policy for the protection of human
  subjects (http//ohrp.osophs.dhhs.gov)
• Organization for Economic Co-operation and
  Development (OECD) Personal Data Protection
  Principles (1980)
• United Nations Guidelines (1990) on Computerized
  Personal Data File

Katharina Kovacs Burns 6
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Belmont Report 3 Principles

• 1. Beneficence
• Freedom from harm identify risks and minimize
  through exclusion criteria with participants,
  further debriefing with participants
• Freedom from exploitation
• Benefits from research
• Do good Above all, do no harm.
• The risk/benefit ratio

Katharina Kovacs Burns 7
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Potential Risks/Benefits

• RISKS
• Physical harm side effects
• Physical discomfort, fatigue, etc
• Psychological or emotional distress
• Social risks stigma, loss of status, effect on
  personal relationships, etc.
• Loss of privacy
• Loss of time
• Monetary costs (e.g. child care, transportation,
  time lost from work or family,etc).

• BENEFITS
• Access to intervention(s) otherwise unavailable
• Comfort in discussing issues with objective
  person interested in area of concern
• Increased knowledge about themselves their
  condition
• Escape from normal routine exciting to be part
  of ground-breaking initiative
• Satisfaction that information from study may help
  others
• Direct monetary or material gains through
  stipends, incentives, or products

Katharina Kovacs Burns 8
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Risk/Benefit Ratio
Predict the Outcome of the study
Assess the risks
Assess the benefits
Benefit-Risk Ratio
Benefits are greater than the risks
Risks outweigh the benefits
Reject the Study
Approve the Study
Katharina Kovacs Burns 9
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Continued Belmont Principles

• RESPECT FOR HUMAN DIGNITY
• The Right to Self-Determination
• Freedom from coercion
• Voluntary participation
• Freedom from penalty or prejudicial treatment
• Right to ask questions for clarification, or to
  refuse to answer questions
• Right to terminate their participation

• Right to Full Disclosure (to make informed,
  voluntary decisions based o full clear
  information about the study

Katharina Kovacs Burns 10
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Continued Belmont Principles

• 3. Principle of Justice
• The right to fair treatment (fair selection of
  participants for risks and benefits,
  non-prejudicial treatment, access to information
  and professional help , respect for culture
  diversity, etc)
• The right to privacy (participant can withhold
  any information not relevant to study, and to
  expect that their information will be held in the
  strictest confidence)
• Anonymity inability for researcher or others to
  link person with his/her data aggregate data
• Confidentiality -- when anonymity is impossible,
  then pledge to ensure information is never made
  public or shared with others beyond research team
  (strategies codes for names, keeping data in
  locked cabinets, entering no identifying data on
  computer, researchers sign pledge, etc.)

Katharina Kovacs Burns 11
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Nurses Codes for Practice Research

• American Nurses Association (1995) Ethical
  Guidelines in the Conduct, Dissemination,
  Implementation of Nursing Research . Nurse
  researcher must
• - respect autonomous research participants
  capacity to consent to participate without
  negative consequences
• - prevent or minimize harm, promote good to
  all participants
• - respect personhood or diversity of
  participants
• - ensure burdens and benefits of research are
  equitably distributed amongst participants
• - protect privacy of participants to maximum
  degree
• - ensure ethical integrity of research process
• - report suspected, alleged or known scientific
  misconduct
• - maintain competency in subject matter and
  methodologies
• - with animals, maximize benefits with least
  possible harm/suffering

Katharina Kovacs Burns 12
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Canadian Nurses Codes for Practice and Research

• CNA
• www.cna-nurses.ca/CNA/practice/ethics/guidelines
• Nursing Values Research ? Safe, competent
  ethical research practice health well-being
  choice dignity confidentiality justice
  accountability and quality research
  environments.
• AARN www.nurses.ab.ca

Katharina Kovacs Burns 13
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Current Standards of Ethics

• Tri-Council Policy Statement Ethical Conduct for
  Research Involving Humans, MRC, NSERC, SSHRC.
  1998.(www.www.hreb.ualberta.ca/links.htm)
• Describe standards and procedures for governing
  research involving human subjects in Canada
• Promote research that is conducted according to
  the highest ethical standards
• Require all researchers and their institutions
  apply the ethical principles and the policy
  articles through Research Ethics Boards
• Norms for ethics of research include the need for
  research and the research community, moral
  imperatives and ethical principles and the law
  (p.i.4)

Katharina Kovacs Burns 14
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Continued Guiding Ethical Principles

• The principles adhered to in Canada come from the
  Tricouncil Policy Statement Ethical Conduct for
  Research Involving Humans, and other statements
  from the international community
• Principles include
• Respect for human dignity
• Respect for free informed consent
• Respect for vulnerable persons
• Respect for privacy and confidentiality
• Respect for justice inclusiveness
• Balancing harms and benefits
• Minimizing harm
• Maximizing benefits

Katharina Kovacs Burns 15
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Continued Current Standards

• Food Drug Act (Canada) clinical trials
  (defined as investigation of the effects of drug
  in humans) involving Phase I, II, III research
  and off-label use.
• International Conference on Harmonization of
  Technical Requirements for Registration of
  Pharmaceuticals for Human Use (FDA Health
  Canada)
• The University Standards for the Protection of
  Human Research Participants (revised 2002)
  purpose of these ethical standards is not to
  limit research activities, but to promote and
  facilitate the conduct of all research in ways
  that respect the dignity and preserve the
  well-being of human research participants.

Katharina Kovacs Burns 16
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Continued Other Legislation

• The Human Research Ethics Board adheres to laws
  and policies of the Alberta and Canadian
  Governments including
• Child Welfare Act
• Freedom of Information and Protection of Privacy
  Act
• Health Information Act
• Protections for Persons in Care Act
• Others

Katharina Kovacs Burns 17
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How Ethics is Considered in Research

• Integrity in research scholarship
• Developing awareness of the need for the highest
  standards of research involving human subjects
• The rights of research subjects must be protected
  to the fullest possible extent
• Not always easy to see the harms or benefits of
  research to subjects or society
• All research must/should undergo ethics review so
  that integrity is maintained/supported, and
  potential harms are identified prior to the start
  of research study.

Katharina Kovacs Burns 18
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Building Ethics into Study Design

• Research Design Will participants get allocated
  to different treatment groups fairly? Will
  research controls add to the risks participants
  will incur? Will the setting for the study be
  selected to protect against participant
  discomfort?
• Intervention Is the intervention designed to
  maximize good and minimize harm? Under what
  conditions might a treatment be withdrawn or
  altered?
• Sample Is the population defined so as to
  unwittingly and unnecessarily exclude important
  segments of people (e.g. women, minorities)? Is
  the population defined in such as way that
  especially high-risk people (e.g. unstable
  patients) could be excused from the study? Will
  potential participants be recruited into the
  study equitably?
• Data Collection Will data be collected in such a
  way as to minimize respondent burden? Will
  procedures for confidentiality of data be
  adequate? Will data collection team be
  appropriately trained?
• Reporting Will participants identities be
  adequately protected?

Katharina Kovacs Burns 19
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More Importantly we consider ethical dilemmas
inherent in issues surrounding research, such as

• Informed consent
• Anonymity and confidentiality
• Participation must be voluntary
• Data generation sensitive qualitative vs.
  quantitative
• Treatment (1) individuals treated with dignity
  respect (2) clinical trials withholding
  interventions
• Publication
• Participant-researcher relationships
• Design conduct of research and researchers
  participants must not be harmed weighing
  benefits against costs

Katharina Kovacs Burns 20
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Anticipate Problems/Challenges Involving Ethics

• Violation of human rights related to obtaining
  truly informed consent, whether from subjects
  lack of understanding or the researchers failure
  to inform the subject adequately
• Uninformed consent is obtained by giving only
  partial information or giving false information
• Deception of research subjects is not tolerated
• Coercion of subjects to participate
• Withholding benefits from control subjects
• Invasion of privacy

Katharina Kovacs Burns 21
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Focus is on Informed Consent

• Three major elements
• 1. The type of information needed by the
  participant
• Amount and type of information
• About the study (nature, duration purpose,
  methods, how data collected will be used, etc)
• Potential risks and benefits
• Any compensation
• Follow up
• other

Katharina Kovacs Burns 22
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Continued informed consent

• 2. The degree of understanding required of the
  subject in order to give consent
• Informed in own language
• Level of reading and understanding (Grade 8 or
  less)
• Common vocabulary lay terminology
• Cultural considerations
• Balanced explanation without bias for consent
• No coercion

Katharina Kovacs Burns 23
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Continued Informed Consent

• 3. Participant has a free choice in giving
  consent
• No coercion
• Compensation should be mentioned after the fact
  (subject not compelled to consent for reward)
• Subject told he/she can withdraw at any time
  before or during the study without jeopardy
• Write out want you want the subject to know as an
  information sheet give this to subject
• Proxy consent with children or mentally
  challenged warrants additional attention
• Without full and clear informed consent, research
  is subject to criticism

Katharina Kovacs Burns 24
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Health Research Ethics Boards/ Panels at the UofA

• Two Panels, A B, follow Tricouncil and
  University Standards and regulations
• Panel A HREB for Biomedical Research
• Approves biomedical, invasive research such as
  clinical trials
• One-time fee is charged to for-profit
  organizations for which ethics is required (fee
  is 2,500 to cover review, amendments, etc)
• Panel B HREB for Health Research
• Approves health, non-invasive research

Katharina Kovacs Burns 25
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Process of Ethics Submissions and Reviews

• Who must submit Ethics?
• Faculty members, staff members, undergraduate or
  graduate students in the five U of A health
  sciences faculties
• Employees of Capital Health Authority
• Employees of the Caritas Health Group
• Other external researchers wishing to conduct
  research at U of A or University of Alberta
  Hospital

Katharina Kovacs Burns 26
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Continued Process for Ethics

• Research That Must Receive Ethics
• Whether funded or not (internal or external)
• From University or other sources
• Inside or outside of Canada
• In laboratory or field
• Conducted in person or by other means
• If quality assurance project has element of
  research
• Any research involving human subjects or involves
  human remains, cadavers, tissues, biological
  fluids, embryos or fetuses, data bases, except as
  stipulated.

Katharina Kovacs Burns 27
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Continued -- Process

• Ethics Application (on website at
  www.hreb.ualberta.ca)
• Read the guidelines!
• Fill out the application form
• Note whether your application is full review or
  expedited review
• Expedited reviews are limited to one of the
  following
• Analysis of blood, urine or other biological
  specimens already collected
• Examination of patient, medical or institutional
  records
• Modification of a previously approved protocol
• Secondary analysis of data
• Some surveys/questionnaire studies
• Use of biological specimens normally discarded

Katharina Kovacs Burns 28
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Ethics Submission Continued

• Note deadlines for submission each month
• Expedited applications go in anytime
• Follow instructions with application form
• Application Form and attachments
• Consent form templates and letters
• Proposal and budget
• Letters of support
• Other relevant information

Katharina Kovacs Burns 29
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Information Letter Consent Form

• Information letter must contain standard phrases
  and content (pp.7-10 of Instructions for
  Completing the HREB Request for Ethics Review
  Form)
• Consent form is also based on a standard template
  and is adjusted only to personalize the study
  (see pp. 11-15 of instructions)

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Health Research Ethics Board

• http//www.hreb.ualberta.ca/
• Look and integrate the requirements in the
  information letter
• Info downloaded from http//www.hreb.ualberta.ca/I
  nstructions.doc on Nov 12, 2004

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Application Form

• See attached form and review.
• Consider questions
• How did you/the researcher protect the physical
  and psychological well-being of the subjects?
• Is consent freely given? Is it voluntary? Is it
  well informed?
• Has confidentiality been maintained?
• How were vulnerable populations recruited and
  protected?
• What relationships are established with subjects?
  E.g. researcher- participant, others?

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