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Research Ethics for JPCFM (Jan2011)
 

Research Ethics for JPCFM (Jan2011)

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A lecture I gave for the PG residents of the Joint Program of Community and Family Medicine in Jeddah, Saudi Arabia (Jan. 2011)

A lecture I gave for the PG residents of the Joint Program of Community and Family Medicine in Jeddah, Saudi Arabia (Jan. 2011)

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  • At the end of World War II, the International Military Tribunal prosecuted Nazi war criminals, including Nazi doctors who performed experiments on concentration-camp prisoners. The tribunal’s decision includes what is now called the Nuremberg Code , a 10-point statement outlining permissible medical experimentation on human participants. Other provisions require the minimization of risk and harm, a favorable risk/benefit ratio, qualified researchers using appropriate research designs, and freedom for the participant to withdraw at any time.
  • In 1972, the public became aware of the Tuskegee study, which took place in the southern United States from 1932 to 1972. More than 400 men with latent syphilis were followed for the natural course of the disease rather than receiving treatment. As a result, in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established. In 1978, the commission submitted its report titled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research . Those principles—respect for persons, beneficence and justice—are accepted as the 3 fundamental principles for the ethical conduct of research involving human participants.
  • In 1993, CIOMS issued the International Ethical Guidelines for Biomedical Research Involving Human Subjects , with the purpose to indicate how the ethical principles of the Declaration of Helsinki can be applied effectively, particularly in developing countries. • informed consent • research in developing countries • protection of vulnerable populations • distribution of the burdens and benefits • role of ethics committees
  • These Nazi experiments included hypothermia experiments depicted in this slide whereby prisoners were submerged in a tank filled with cold water. The goal of this type of these experiments was to determine how long German pilots, who had to parachute into the cold north sea, would survive.
  • High altitude experiments were performed to test how long pilots would survive after being ejected from their planes. Prisoners were put into low-pressure tanks with little oxygen. Many of those who did not die immediately were put under water until they died. Autopsies followed. .
  • Prospective IC: This approach suffers from all the weaknesses associated with advance directives, and is rarely applicable to the conditions relevant to emergency research, such as sudden cardiac arrest or motor vehicle trauma.
  • Recorded data: audio, video, photo Quotes: direct quotes or specific anecdotes (e.g. “this tall guy who works at O’Grady’s”) could be identifying
  • The conflict lies in the situation, not in any behavior or lack of behavior of the individual. That means that a conflict of interest is not intrinsically a bad thing.
  • Last point: but TCPS acknowledges that there may be points where this overlaps with research
  • Undergraduate course-based research is reviewed by a departmental TCPS-compliant REB. The instructor must submit a template to the REB. Graduate course-based research is reviewed by the University’s Ethics Boards.

Research Ethics for JPCFM (Jan2011) Research Ethics for JPCFM (Jan2011) Presentation Transcript

  • INTRODUCTION TO RESEARCH ETHICS Ghaiath M.A. Hussein Assistant Professor, Faculty of Medicine King Fahad Medical City King Saud Bin Abdulaziz University for Health Sciences Contacts: [email_address] ; 00966566511653
  • OUTLINE OF PRESENTATION
      • Introduction
      • What is research ethics?
      • Historical background: How did research ethics develop?
      • Ethical principals of research: What makes research ethical?
    Research Ethics, Jan. 2011
  • OUTLINE OF PRESENTATION
      • What are the ethical issues that arise in research?
        • Benefit/harm analysis
        • Vulnerability (Risk-Vulnerability Matrix)
        • Informed Consent
        • Fairness and equity in research participation
        • Privacy and confidentiality
        • Conflict of Interests (COI)
        • Research ethical review
        • Clinical trials
        • Special topics in research ethics
      • Ethical issues after the conduct of research: ethics of results presentation & publication
    Research Ethics, Jan. 2011
  • INTRODUCTION
      • What is research?
      • Where does research fit in the knowledge Management Cycle (KMC)
      • Where are we in terms of research?
    Research Ethics, Jan. 2011
  • WHAT IS RESEARCH?
      • “ research” is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.
      • A determination that research is the intended purpose of the undertaking is key for differentiating activities that require ethics review by an ethics review and those that do not.
      • Systematic Methodolic scientific approach for basic facts around a certain problem in order to find solutions based on these facts.
    Research Ethics, Jan. 2011
  • خريطة توضح حجم دول العالم من حيث الإنفاق على البحوث والتنمية وأكثر واقل عشر دول إنفاقا على البحوث في العالم ( بالدولار لكل مواطن لكل عام ). المصدر : www.worldmapper.org Research Ethics, Jan. 2011
  • خريطة توضح حجم دول العالم من حيث عدد المقالات العلمية المنشورة، وجدول يوضح عدد المقالات العلمية المنشورة لكل مليون من السكان لعام 2001 م . المصدر : www.worldmapper.org Research Ethics, Jan. 2011
  • Research Ethics, Jan. 2011
  • THE KNOWLEDGE MANAGEMENT CYCLE Research Policy makers Statistics Clinicians Research Ethics, Jan. 2011
  • HOW DOES RESEARCH IMPROVE HEALTH? 3/15/2010 Research Ethics. Ghaiath Research Ethics, Jan. 2011
  • WHAT MAKES A GOOD RESEARCH? Research Ethics, Jan. 2011
  • CRITERIA OF “GOOD” RESEARCH
      • Systematic: The research developed, implemented and reported in a systematic manner.
      • Methodolic: Adopt & use skillfully the research methods, materials ,approaches in order to ensure reliability of the results & findings.
      • Scientific : The research should be scientifically sound through utilizing scientific approaches , tools & techniques.
    Research Ethics, Jan. 2011
  • WHAT’S RESEARCH ETHICS?
      • It is the field of ethics that systematically analyze the ethical and legal questions raised by research involving human subjects.
      • Its main focus is to ensure that the study participants are protected and, ultimately,
      • that clinical research is conducted in a way that serves the needs of such participants and of society as a whole.
      • It works when and only when it is applied before the research is conducted
    Research Ethics, Jan. 2011
  • HISTORICAL BACKGROUND Born in Scandal… The Evolution of Research Ethics Research Ethics, Jan. 2011
  • EIGHTEENTH AND NINETEENTH CENTURY
      • James Lind “scurvy study in sailors - Salisbury
      • Edward Jenner cowpox vaccine test
      • 1897 Guiseppe Sanarelli yellow fever test
      • 1900 Walter Reed established several [first ever] “ safeguards”
      • Self-experimentation
      • Only adults would be enrolled in research
      • Written informed consent
      • Reimbursement (inducement)
    Research Ethics, Jan. 2011
  • HISTORY OF RESEARCH ETHICS
      • Pre-World War II
      • Research standards left up to the discretion of the individual researcher
      • World War II
      • Experiments conducted on inmates of Nazi concentration camps
      • 1945-1949 - Trials in Nuremberg, Germany– physicians convicted of crimes against humanity
    Research Ethics, Jan. 2011
  • NAZI DOCTORS’ EXPERIMENTATION Research Ethics, Jan. 2011
  • INTERNATIONAL RESEARCH GUIDELINES
    • Nuremberg Code (1947)
      • As a result of WWII Nazi experiments
      • First international code in research ethics
      • Voluntary consent absolutely essential (restricting research with infants, children, developmentally challenged, etc.)
      • Risk/Benefit Analysis essential to ethics review
      • Scientific Soundness is important to ethics review
    Research Ethics, Jan. 2011
  • THE NUREMBERG CODE (1947)
      • The first provision of the code requires that “ the voluntary informed consent of the human subject is absolutely essential .” The code provides other details implied by such a requirement:
      • capacity to consent
      • freedom from coercion
      • comprehension of the risks and benefits involved
      • Experiment to be conducted by highest qualified persons
    • The code on the web: http://ohsr.od.nih.gov/nuremberg.php3
    Research Ethics, Jan. 2011
  • THE DECLARATION OF HELSINKI (DOH)
      • The World Medical Association created the Declaration of Helsinki in 1964 & amended in: Tokyo (1975), Venice (1983), Hong Kong (1989), South Africa (1996), Edinburgh (2000), Washington (2002), and Tokyo (2004)
      • “ The well-being of the subject should take precedence over the interests of science and society”
      • Consent should be in writing
      • Use caution if participant is in dependent relationship with researcher
      • Limited use of placebo
      • Greater access to benefit
    Research Ethics, Jan. 2011
  • WORLD MEDICAL ASSOCIATION WMA(1964)
      • Respect for Persons – people are not a means to an end; researchers have duty to protect life, health, privacy and dignity of research participants
      • Standard of care must be best available, even for control group
      • Proxy consent and assent for vulnerable populations
    Research Ethics, Jan. 2011
  • Research Ethics, Jan. 2011
  • WILLOWBROOK STUDY, NEW YORK 1956-1972, NYU
      • 800 Children - Willowbrook State School for the Mentally Retarded
      • Researchers injected students with mild form of hepatitis
    Research Ethics, Jan. 2011
  • THE BELMONT REPORT (1979)
      • In 1972, the public became aware of the Tuskegee study, which took place in the southern United States from 1932 to 1972.
      • In 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established.
      • In 1978, the commission submitted its report titled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research .
      • Those principles—respect for persons, beneficence and justice—are accepted as the 3 fundamental principles for the ethical conduct of research involving human participants.
    Research Ethics, Jan. 2011
  • COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCE (CIOMS) GUIDELINES (1993)
      • Informed consent
      • Research in developing countries
      • Protection of vulnerable populations
      • Distribution of the burdens and benefits
      • Role of ethics committees
    Research Ethics, Jan. 2011
  • INTERNATIONAL CONFERENCE ON HARMONISATION (ICH)
      • Formed by US, Japan and Europe
      • Its goal is to standardize the process by which new drugs are developed, tested and brought to market.
      • The ICH guidelines require review by an ethics committee and informed consent of participants .
    Research Ethics, Jan. 2011
  • IS IT OVER?... TORVAN TRIAL IN KANO, NIGERIA
      • Kano Trovan clinical trials in 1996, on pediatric age group, during the worst ever meningococcal meningitis.
      • Lack of proper Governmental authorization and informed consent during the studies publicized in 2000, by Washington Post.
      • Court trial and release of investigation panel reports stalled in Nigeria.
      • Suit for 5.8 billion USD moved to the USA and report leaked there too.
      • Settlement out of court being discussed.
    Research Ethics, Jan. 2011
  • ETHICAL PRINCIPLES OF RESEARCH What makes research ethical? Research Ethics, Jan. 2011
  • WHAT MAKES THE RESEARCH ETHICAL?
    • 1- Social or Scientific Value:
      • Improve health and wellbeing
      • Increase the knowledge
    • 2- Scientific Validity
      • Acceptable methods including analysis techniques to produce valid data (Test the objectives)
    • 3- Justice and Inclusiveness:
      • Stigmatized and vulnerable are not targeted
      • Rich not favored for the benefit of research
      • Clear inclusion and exclusion criteria according to the objectives.
      • Clear Strategies for recruitment
    Research Ethics, Jan. 2011
  • WHAT MAKES THE RESEARCH ETHICAL? (CONT.)
    • 4- Favorable Risk-Benefit Ratio:
      • Identification and Minimization the risk
      • Enhancement of the potential benefit
      • Risk to the subject are appropriate to the benefits to the subject and society.
    • 5- Independent Review:
      • Review of the Design, the proposed subject selection and risk-benefit ratio.
    Research Ethics, Jan. 2011
  • WHAT MAKES THE RESEARCH ETHICAL? (CONT.)
    • 6- Free & Informed Consent:
      • Provision of Information
      • Voluntarily and Consists with the values
    • 7- Respect for the potential and enrolled subjects & Respect for Vulnerable Persons :
      • Right to withdrawal
      • Privacy and confidentiality
      • Informing about the new discovered risks or benefits
      • Maintaining the welfare of the subjects.
    Research Ethics, Jan. 2011
  • WHAT ARE THE ETHICAL ISSUES THAT ARISE IN RESEARCH? Benefit/harm analysis Vulnerability (Risk-Vulnerability Matrix) Informed Consent Fairness and equity in research participation Privacy and confidentiality Conflict of Interests (COI) Research Ethics, Jan. 2011
  • BENEFITS
      • Benefits to research subjects
      • Benefits to society
        • Specific new, effective intervention
        • Knowledge which some time in the future may lead to effective interventions
    Research Ethics, Jan. 2011
  • BENEFITS TO RESEARCH SUBJECTS
      • Direct Benefit
        • arising from the intervention being studied
        • information that can influence care, e.g., diagnostic
      • Collateral “indirect” Benefit
        • Arising from being a subject, even if one does not receive the experimental intervention
        • extra supervision from being in the research study (?)
        • access to medical care not available for economic reasons
        • unplanned or unanticipated benefits
    Research Ethics, Jan. 2011
  • BENEFITS TO RESEARCH SUBJECTS
      • Inspirational
      • Aspirational
        • benefit to society (arises from the results of the study)
      • Payments or incentives – benefits???
    • Any level of research risk could be offset by such gains if they were significant enough
    Research Ethics, Jan. 2011
  • BENEFITS TO RESEARCH SUBJECTS
      • No benefits from the research
        • Phase I trials testing maximum tolerated dose
        • Non-therapeutic research procedures
          • Mechanism of disease
    Research Ethics, Jan. 2011
  • RISK/HARM
      • Risk:
    • Means any harm or injury that affect the subject or the participant under study.
      • Risk:
    • “ A state of uncertainty where some of the possibilities involve a loss, catastrophe, or other undesirable outcome. ”
    Research Ethics, Jan. 2011
  • TYPES OF RISKS
      • Physical risks:
      • Cold: Nazi Experiments with ice tanks
      • Pressure: Nazi experiments in high altitude
      • Heat: Heat stroke; Burn; Exhaustion
      • Noise: High noise may lead to impairment or loss of hearing
      • Light: Dim light may affect the vision
    • .
    Research Ethics, Jan. 2011
  • NAZI EXPERIMENTS Research Ethics, Jan. 2011
  • HIGH ALTITUDE EXPERIMENTS Research Ethics, Jan. 2011
  • TYPES OF RISK…CONT.
      • Medical Risks:
      • Therapeutics: (Tuskegee expirement)
      • Preventive: (Trials of polio vaccine)
    • 3. Diagnostic:
      • Irradiation:
    • - Teratogenic effect to the fetus.
    • - Carcinogenic effect.
      • Samplings:
    • - Biopsies: tissues that contain genetic information about the participant.
    • - Surgical hazards.
    • -Too risky procedures (under anesthesia)
    Research Ethics, Jan. 2011
  • THE FORGOTTEN RISKS!
      • Social Risks:
    • Stigma (e.g. research on HIV-AIDS, STDs).
      • Emotional Risks:
    • On families when their children chosen for trial of new vaccine; research in war.
      • Psychological Risks:
    • Questionnaires with sensitive questions to participants in sensitive positions, as to ask poor people about there nutrition and houses.
    Research Ethics, Jan. 2011
  • RISK TO THE SOCIETY:
      • Manipulating environmental factors (Pathogenic organisms and toxic chemicals).
      • Economic risk
      • Legal risks:
      • Vulnerable groups, e.g., prisoners, children, pregnant women.
    Research Ethics, Jan. 2011
  • CATEGORIZATION OF RISK
    • risk is categorized by severity into:
      • Minimal Risk: As routine blood sample , throat swabs, vaginal swabs, sputum exams
      • Above Minimal Risk: That can be minimized, and within the toleration of the participant.
      • Too Risky: the most dangerous type, and the Researcher should not be allowed to conduct A research that endanger the life of the participants e.g. live cancer cells , live virus
    Research Ethics, Jan. 2011
  • MINIMAL RISK
      • The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during routine performance of physical or psychological examination or tests
    Research Ethics, Jan. 2011
  • CLINICAL EQUIPOISE
      • Clinical equipoise means a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial.
      • The tenet of clinical equipoise provides a clear moral foundation to the requirement that the health care of subjects not be disadvantaged by research participants.
    Research Ethics, Jan. 2011
  • CLINICAL EQUIPOISE
      • The start of the trial, there must be a state of clinical equipoise regarding the merits of the regimens to be tested, and the trial must be designed in such a way as to make it reasonable to expect that, if it is successfully conducted, clinical equipoise will be disturbed."
    Research Ethics, Jan. 2011
  • Research Ethics, Jan. 2011
  • MINIMIZATION OF RISK
      • Adequate facilities ,procedures and personnel for dealing with emergencies .
      • Arrangement made for monitoring and detecting adverse out comes .
      • All trials should be reviewed by a Data Safety Monitoring Board (DSMB).
      • All potential toxins, mutagens or teratogens used should be justified.
      • The National Committee for Atomic Energy should completed risk assessment for the use of the radiation and radioactive substances .
    Research Ethics, Jan. 2011
  • MINIMIZATION OF RISK
      • For Drugs:
    • - Registration, its trade name, chemical name and pharmacological class .
    • - Recommended dose, form of administration in the study.
    • - Known or possible interaction with other drugs, side effects and adverse reactions.
    • - Placebo should be justified.
    Research Ethics, Jan. 2011
  • MINIMIZATION OF RISK
      • Social Risks:
    • - The research should have potential to enhance the future health of the society .
      • For vulnerable groups :
    • - Additional safeguards needed to protect there rights and welfare .
      • For recruitment materials:
    • (posters, newspapers, T.V, videos ……).
    • Should be acceptable if submitted .
    Research Ethics, Jan. 2011
  • MINIMIZATION OF RISK
      • For Psychological Risks :
      • Sensitive questions for sensitive group like those with AIDS ,STDs,T.B, can be questioned through 3 rd person or ask the help of psychologists .
      • Economic Risks :
      • Traveling cost can be solved out.
      • Absentees issues should also be solved out.
    Research Ethics, Jan. 2011
  • MINIMIZATION OF RISK
      • Legal :
    • - The risk should be reasonable in relation to the anticipated benefits to the subjects or society .
    • - Privacy of subject should be adequately protected .
    • - For tissue samples containing genetics information the subject should have option to withdraw at any time .
    Research Ethics, Jan. 2011
  • VULNERABILITY (RISK-VULNERABILITY MATRIX)
  • DEFINITION
      • Vulnerable: “Vulnerable persons are those who are relatively (or absolutely) incapable of
      • protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources strength, or other needed attributes to protect their own interests.” (CIOMS, 2002)
    Research Ethics, Jan. 2011
  • WHO IS VULNERABLE? Making use of this definition… let’s brainstorm! Research Ethics, Jan. 2011 www.amanet-trust.org
  • WHO IS VULNERABLE?
    • 1. WOMEN
      • Women in the reproductory age group are usually excluded in drug/vaccine studies where the possible effects on foetus are not known.
      • As justice to women, their health conditions should be addressed through involving them in research.
      • Types of research that benefit women directly include, obstetrics and gynaecology, sexually transmitted infections, vitamin studies etc.
    Research Ethics, Jan. 2011
  • WHO IS VULNERABLE?
    • 2. PREGNANT WOMEN
      • Should be awarded special protection because of additional health concerns during pregnancy and the risk of damage to the foetus.
      • pregnant women must be excluded from research unless the purpose is to meet the health needs of the mother, and
      • the foetus will be placed at risk only to the minimum extent necessary to meet such needs or
      • the risk to the foetus is minimal
    Research Ethics, Jan. 2011
  • WHO IS VULNERABLE?
    • 3. CHILDREN
      • particularly vulnerable group. The major ethical issue for involving children is that parents are the primary decisions makers for their minor children.
      • there must be no undue inducement to participate for parent, guardian or child, although reimbursement of expenses is allowed.
      • A “small gift” to the child after completion of the research is however acceptable.
    Research Ethics, Jan. 2011
  • REQUIREMENTS FOR INVOLVING CHILDREN IN RESEARCH
      • the purpose of the research is to obtain knowledge relevant to the health needs of children
      • a parent or legal representative of each child should give permission;
      • the agreement (assent) of each child has been obtained to the extent of the child`s capabilities; and
      • a child`s refusal to participate or continue in the research should be respected.
    Research Ethics, Jan. 2011
  • ASSESSMENT OF RISK IN CHILDREN
      • Minimal Risk- risk in relation to normal experience of average, healthy normal children – daily life/routine physical psychological exams
      • Minimal Risk varies with age but not social status, illness or circumstances
      • Consultation with experts – paediatricians , social workers etc
    Research Ethics, Jan. 2011
  • WHO IS VULNERABLE?
    • 4. MENTALLY ILL / MENTALLY HANDICAPPED PERSONS
      • Is s/he capable of self-determination?
      • Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated (Belmont Report)
      • it is usually that informed consent will be provided by a surrogate/ legal representative of that person.
      • The golden rule for involving mentally ill or handicapped people is that ; The objections of these subjects to involvement should be honoured, unless the research entails pro-providing them a therapy unavailable elsewhere.
    Research Ethics, Jan. 2011
  • WHO IS VULNERABLE?
    • 5. THE ELDERLY
      • Old age alone does not render a person incapable of consenting to health research.
      • In the absence of any indication to the contrary, elderly patients are generally assumed to be competent to consent to research.
      • However, consideration should be given to the possibility of mental deterioration, the ability to comprehend, and the dependence and vulnerability of the elderly
    Research Ethics, Jan. 2011
  • WHO IS VULNERABLE?
    • 6. PRISONERS
      • Prisons are organisational structures exacerbate vulnerability of the incarcerated individuals.
      • They have limited economic power, inadequate protection of human rights, limited availability of health care and treatment options.
      • The prison structure makes the incarcerated prisoners confined, stressed, crowded, psychologically devastated with symptoms such as psychosis, severe depression, and complete social withdrawal.
    Research Ethics, Jan. 2011
  • WHO IS VULNERABLE?
    • 7. CAPTIVE/DISPLACED/RETURNING POPULATIONS
      • Have constrained movements and choices
      • refugees, those in police custody, and displaced population,
      • hospitalised patients, students, institutionalised persons and military personnel.
      • readily available for research activities for extended periods, enhancing their attractiveness to research enterprise.
      • Researchers should always have to be sure if participant’s decision making capacity is not compromised.
    Research Ethics, Jan. 2011
  • HOW TO DECIDE?
      • Nature and degree of risk,
      • The condition of the particular population involved, and
      • The nature and level of the anticipated benefits.
      • Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process
    Research Ethics, Jan. 2011
  • ASSESSMENT OF RISK-VULNERABILITY Research Risk depends on both Level of Invasiveness (physical, psychological or emotional) and Vulnerability of participants. Vulnerability is generally a pre-existing condition, in that it exists regardless of whether the research is conducted or not. It can be inherent or situational .
  • TRI-COUNCIL POLICY STATEMENT ETHICS REVIEW (CONT.) Invasiveness : consider the physical, psychological, emotional and legal harms that could be caused by or exacerbated by the research. Group Invasiveness Vulnerability Low Medium High Low Exp. Exp. Full Medium Exp. Full Full High Full Full Full
  • EXAMPLES: Low Vulnerability/Medium Invasiveness: Anonymized survey of health care practitioners to determine whether their work environment poses challenges to their practice. High Vulnerability/Medium Invasiveness: Determining whether obese children aged 9 to 12 adhered to a diet recommended by their family physician.
  • RISK/VULNERABILITY MATRIX Research Ethics, Jan. 2011
  • CONCLUSION
      • Vulnerability is considered to offer better protection, not to stop research on the vulnerable
      • Vulnerable groups should not be denied their right to participate in relevant research
      • The risk assessment varies with the degree of vulnerability
    Research Ethics, Jan. 2011
  • INFORMED CONSENT
  • DEFINITION :
      • "autonomous authorization of a medical intervention…by individual patients/participants" (Beauchamp and Faden, 2004)
      • It's the practical expression of patient's autonomy, and the respect for him/her personality
    Research Ethics, Jan. 2011
  • COMPONENTS OF FIC :
      • " Disclosure " refers to the provision of relevant information by the clinician and its comprehension by the patient.
      • " Capacity " refers to the patient's ability to understand the relevant information and to appreciate those consequences of his or her decision that might reasonably be foreseen.
      • " Voluntariness " refers to the patient's right to come to a decision freely, without force, coercion or manipulation.
    Research Ethics, Jan. 2011
  • Disclosure VOLUNTARINESS Capacity Research Ethics, Jan. 2011
  • 1. DISCLOSURE
      • This refers to the process during which physicians provide information about the proposed research to the participant.
    Research Ethics, Jan. 2011
  • EIGHT REQUIRED ELEMENTS [45 CFR 46.116(A) & 21 CFR 50.25]
      • Statement that study is research and information on purposes / duration / procedures / experimental procedures
      • Reasonably foreseeable risks or discomforts
      • Reasonably expected benefits
      • Alternative procedures
      • How confidentiality will be maintained
    Research Ethics, Jan. 2011
  • EIGHT REQUIRED ELEMENTS [45 CFR 46.116(A) & 21 CFR 50.25]
      • Information on compensation for injuries (unless minimal risk)
      • Contact persons for information on research, injury, subject’s rights
      • Voluntary participation, no penalty or loss of benefits for refusal or withdrawal
    Research Ethics, Jan. 2011
  • SIX ADDITIONAL ELEMENTS
      • Statement that there may be risks which are unforeseeable
      • Under what circumstances investigator could terminate subject’s participation
      • Additional costs to subjects
      • Consequences of subject’s withdrawal from research
      • Statement that will be told of new findings
      • Approximate number of subjects in study
    Research Ethics, Jan. 2011
  • FORMS OF CONSENT
      • Normally, should be provided by participants themselves.
      • • Deferred consent is where the subject is entered into a research study and consent is gained from surrogates after a specified period of time for continuation of the subject’s inclusion in the trial.
      • • Prospective informed consent represents an attempt to canvass support in advance from a population considered at risk of developing a serious illness.
      • • Surrogate consent (SDM): ideally a substituted judgment made by a person responsible for health care decision-making for a particular patient under the relevant legislation
    Research Ethics, Jan. 2011
  • WAIVER OF INFORMED CONSENT
      • REC must find and document that the folwoing criteria have been satisfied:
        • Poses no more than Minimal risk research
        • Waiver or alteration will not adversely affect the rights and welfare of the subjects
        • Research could not practicably be carried out without the waiver or alteration
        • Does not involve a therapeutic intervention
        • Subjects will be provided with additional pertinent information
    • * All of the above must apply
    Research Ethics, Jan. 2011
  • DOCUMENTATION OF INFORMED CONSENT
      • Written consent document
      • Language understandable to the subject or the subject’s Legally Authorized Representative (LAR)
      • Signed by subject or subject’s LAR
      • Copy SHALL be given to subject
      • Opportunity to read before signing
    Research Ethics, Jan. 2011
  • PRINCIPLES FOR PROVIDING INFORMATION TO THE PARTICIPANT:
      • make it clear; avoid jargon
      • use language appropriate to the patient's level of understanding in a language of their fluency
      • pause and observe patients for their reactions
      • invite questions from the patient and check for understanding
      • invite the patient to share fears, concerns, hopes and expectations
      • watch for patients' emotional response: verbal and non-verbal
      • show empathy and compassion
      • summarize the imparted information
      • provide contact information (and other resources)
    Research Ethics, Jan. 2011
  • 2. CAPACITY :
      • refers to the presence of a group/set of functional abilities a person needs to possess in order to make a specific decisions (Griso and Applebaum, 1998).
    • These include:
      • To UNDERSTAND the relevant information
      • To APPRECIATE the relatively foreseeable consequences of the various available options available.
    Research Ethics, Jan. 2011
  • 3. VOLUNTARINESS :
      • refers to a participant’s right to make participation decisions free of any undue influence.
    • Influences include:
      • Physical restraint or sedation
      • Coercion involves the use of explicit or implicit threat to ensure that the treatment is accepted
      • Manipulation involves the deliberate distortion or omission of information in an attempt to induce the patient to accept a treatment
    Research Ethics, Jan. 2011
  • VOLUNTARINESS
      • Free of undue influence
      • Persuation: appeals to reason
      • Manipulation
      • Coercision: explicit or implicit threats
      • Force: restraint or sedation
    Research Ethics, Jan. 2011
  • MANIPULATION
      • Distortion of facts or omission
      • Non-coercive alternation of choices
      • Undue financial payment
      • Undue influence, government funding only at grade 8 for hpv
    Research Ethics, Jan. 2011
  • PRACTICAL CHALLENGES TO A "FULLY INFORMED CONSENT"
      • Diagnostic uncertainty
      • Complexity of medical information
      • Linguistic and cultural differences
      • Overworked health personnel
      • Paternalistic approach in doctor-patient relationship in developing countries, including Sudan.
    Research Ethics, Jan. 2011
  • INFORMED CONSENT FROM CHILDREN
      • Written Parental/Guardian consent only required for those below the “legal age”
      • Assumption : best interests of the child should be regarded
      • Both parents of the child should sign or just one?
      • Institutionalised children?
      • Children without any recognisable legal guardian?
    Research Ethics, Jan. 2011
  • ASSENT
      • After the age of 7 and below legal consenting age (which is different for different countries depending on regulations) those who are competent to understand the opinion of the child should be respected
      • “ A child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent” Silence Assent
      • Waiver of parental consent may be granted in adolescent research in certain circumstances i.e. drug abuse, sexual behaviour etc.
      • Assent documents may include – age appropriate information sheets and forms where applicable
    Research Ethics, Jan. 2011
  • PRIVACY AND CONFIDENTIALITY
  • PRIVACY & CONFIDENTIALITY
      • Duty to protect personal information “to the extent permitted by law”
        • must report child abuse, intent to harm oneself or others
      • Access, control and dissemination of personal information must be subject to safeguards:
        • Anonymity – data stripped of identifying characteristics (incl. recorded data, quotes)
        • Locks
        • Computer Passwords
  • PRIVACY
      • The right to be left alone and to keep personal information inaccessible to others (the condition of limited access to a person)
  • PRIVACY
      • Relates primarily to Process of clinical examination and collecting data
        • Often Challenging in Natural Environment
        • Can inconvenience research participants
        • Can encounter participants in public
        • Procedures and processes can compromise privacy
        • Some institutions & cultures not accustomed to privacy, or do not value it
  • PRIVACY
      • Research requiring massive bodies of data involves the disclosure of medical and other confidential records to third parties, creates a threat to privacy
      • Privacy should be aggressively protected
  • INFRINGEMENTS OF PRIVACY
      • Infringements is justified under certain circumstances; if:
      • Necessary for research conduct
      • Doesn’t create harm to participants
      • There is societal benefit
  • CONFIDENTIALITY
      • The duty to respect the patient’s/research participant confidence that the researcher/doctor will not disclose the information s/he received as part of research of health care.
      • How someone will deal with the information that was disclosed to him in confidence
      • Failure to keep private information is an infringements of confidentiality
        • Deliberate
        • Accidental
  • MEASURES TO RESPECT CONFIDENTIALITY
      • Avoid identifiable data
      • Encode the collected data
      • Limit access to data
      • Keep in password-protected PC
      • Destroy the original copies after analysis, or publication
      • Training of research team on confidentiality
      • Release information without identification
    • To each of the previous conditions, there are ethically-acceptable exceptions
    Research Ethics, Jan. 2011
  • BREAKING CONFIDENTIALITY
      • Court order
      • Communicable diseases
      • Vulnerable person abuse/neglect
      • Driving/flying/machine safety
      • Dangerous patients
  • UNANTICIPATED PROBLEMS: EXAMPLES
      • STDs research – placement of clinic. Sign on door.
      • Waiting with others, who knows you?.
  • IMPORTANT CONSIDERATIONS:
      • Retention of data after the study is complete
      • Secondary uses and linkage of data (i.e. databases)
      • How much personal information is actually necessary for the study?
  • CONFLICTS OF INTEREST (COI)
  • WHAT IS AN INTEREST?
      • An interest may be defined as a commitment, goal, or value held by an individual or an institution.
      • Examples include a research project to be completed, gaining status through promotion or recognition, and protecting the environment. Interests are pursued in the setting of social interactions.
    Research Ethics, Jan. 2011
  • WHAT IS COI?
      • COI exists when two or more contradictory interests relate to an activity by an individual or an institution.
      • Conflicts of interest are “situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator’s judgement in conducting or reporting research.” AAMC, 1990
      • “ A conflict of interest in research exists when the individual has interests in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance compromise the integrity of the research.” NAS, Integrity in Scientific Research
    Research Ethics, Jan. 2011
  • LEVELS OF COI
      • Researchers
      • The REB should assess the likelihood that the researcher’s judgement may be influenced, or appear to be influenced, by private or personal interests, and assess the seriousness of any harm that is likely to result from such influence or from the mere appearance of undue influence (TCPS, 200)
    Research Ethics, Jan. 2011
  • LEVELS OF COI
    • Conflicts of Interest by REB Members
      • It is of the highest importance that members of the REB avoid real or apparent conflicts of interest .
      • For example: when their own research projects are under review by their REB or
      • when they have been in direct academic conflict or collaboration with the researcher whose proposal is under review.
    Research Ethics, Jan. 2011
  • LEVELS OF COI
    • Institutional Conflicts of Interest
      • Situations may arise where the parent organization has a strong interest in seeing a project approved before all ethical questions are resolved.
      • The REB must act independently from the parent organization.
      • Institutions must respect the autonomy of the REB and ensure that the REB has the appropriate financial and administrative independence to fulfill its primary duties.
    Research Ethics, Jan. 2011
  • WHAT COMPRISES COI?
      • Stock ownership
      • Paid employment Board membership
      • Patent applications (pending or actual)
      • Research grants (from whatever source)
      • Travel grants and honoraria for speaking or participation at meetings
      • Gifts Membership of lobbying organizations
      • Relationship with the National Research Ethics Review Committee, or with possible reviewers of the paper
      • Relationship with organizations and funding bodies Membership of a government advisory board
    Research Ethics, Jan. 2011
  • IS IT ALWAYS BAD?
      • 33% of guideline authors have financial interests in the drug
      • 50% guidelines had no COI documentation
      • 34% of guidelines stated no COIs
      • 50% had at least one author receiving research support
      • 43% had at least one author who had been a paid speaker for the company Derived from National Guideline Database
    • Nature, Oct 20,2005
    Research Ethics, Jan. 2011
  • IS IT ALWAYS BAD?
      • COIs may result in:
    • 1. Loss of objectivity
    • 2. Reordering of priorities towards applied research
    • 3. Degradation of the nature of science as an open and collegial enterprise
    • 4. Exploitation of trainees
    • 5. Transfer of time and interest to Commercial ventures
    Research Ethics, Jan. 2011
      • In May 2004, the pharmaceutical giant Pfizer agreed to pay $430 million to settle a lawsuit by a former employee turned whistle-blower, who was joined in the lawsuit by the U.S. federal government and 11 state governments.
      • The lawsuit exposes various marketing practices by the company Warner-Lambert – later bought by Pfizer.
    Research Ethics, Jan. 2011
      • Leading academic researchers were paid to deliver promotional lectures at educational events and to publish favourable reports on the off-label use of its epilepsy drug, Neurontonin.
    • L. Kowalczyk “Pfizer Drug Strategy Probed: States Question Marketing Tactics for Neurontin,” Boston Globe, October 18, 2002,
    Research Ethics, Jan. 2011
  • CONFLICTS CAN OCCUR AT ALL LEVELS OF RESEARCH
      • In reviews/awarding of grant
      • In ethics review of grant
      • In recruitment of participants
      • In analysis of data
      • In presentation of data
    Research Ethics, Jan. 2011
  • THE CASE OF NANCY OLIVEIRI
      • In 1996, Olivieri found that the drug she was researching (deferiprone, active iron-chelating agent ) at the Hospital for Sick Children in Toronto was showing unexpected potential risks to some patients in the trials.
      • The drug company sponsoring her research abruptly terminated the trials and issued warnings of legal action against Olivieri should she inform her patients at the Hospital for Sick Children of the risks, or publish her findings.
    Research Ethics, Jan. 2011
  • THE CASE OF NANCY OLIVEIRI
      • The manufacturer (Apotex) issued more legal warnings to deter Dr Olivieri from communicating this second unexpected risk of L1 to anyone.
      • However, she published her findings in the New England Journal of Medicine and
      • She was subsequently dismissed from her position as Director of the Hospital for Sick Children Program of Hemoglobinopathies.
      • Apotex was planning to donate USD 100 Million to the University of Toronto
    Research Ethics, Jan. 2011
  • THE CASE OF NANCY OLIVEIRI
      • After more than seven years of legal battle, an independent committee of inquiry into the matter vindicated Olivieri and concluded that neither the university nor the hospital offered her appropriate support in her conflict with the drug company.
      • Olivieri was reinstated to her position at the Hospital for Sick Children and her actions have also been vindicated by several other independent reports.
    Research Ethics, Jan. 2011
  • THE OTHER SIDE OF THE STORY
      • Deferiprone which is the only effective orally active iron-chelating agent licensed for the treatment of patients with thalassaemia major and other disorders of transfusional iron overload.
      • It is the only alternative to deferoxamine—a drug that has to be given by daily subcutaneous infusions and fails in many patients worldwide because of lack of compliance, high cost, toxicity, or hypersensitivity.
    Research Ethics, Jan. 2011
  • THE OTHER SIDE OF THE STORY
      • No other clinicians using the drug had found evidence for long-term liver damage and her interpretation of the data was immediately questioned in letters to the New England Journal of Medicine .
      • Four of her patients in whom liver fibrosis had been suggested also had hepatitis C and all five had iron overload—both causes of liver fibrosis.
    Research Ethics, Jan. 2011
  • LET’S DEBATE…!
      • What do you think?
    OR ? Research Ethics, Jan. 2011
  • PRACTICAL STEPS TO RESOLVE
      • Disclosure / transparency
      • Stringent analysis of COI,
      • Review of contracts between funders and researchers
      • Close external monitoring
      • Blinding of study, when possible
      • Restrict review of colleague’s work
      • Peer review of manuscripts
    Research Ethics, Jan. 2011
  • ETHICAL REVIEW OF RESEARCH Research Ethics, Jan. 2011
  • WHAT IS ETHICAL REVIEW?
      • It is a process by which research proposals are reviewed for their compliance and accordance with the national/international ethical principles & guidelines for research involving human subjects.
    Research Ethics, Jan. 2011
  • RESEARCH REQUIRING ETHICS REVIEW
    • All research involving living human subjects by collecting identifiable information or materials including:
      • Research with human remains, cadavers, tissues, biological fluids, embryos and foetuses.
      • Interviews, surveys and questionnaires.
      • Secondary data analysis of data from living human subjects.
  • RESEARCH EXEMPT FROM ETHICS REVIEW:
      • Research about living individuals in the public arena or artists, based exclusively on publicly available information.
      • Participant observation of public demonstrations, political rallies and public meetings.
      • Quality assurance studies, performance reviews or normal educational testing.
  • PROGRAM EVALUATION/ QUALITY ASSURANCE AND RESEARCH Characteristic Research Evaluation Goal or Purpose Generate new knowledge for prediction Program or Policy Decision-Making Questions/ Nature of Problem To fill a gap in the literature – derived by scientist Derived to assess impact and outcome of program Guiding Theory/ Techniques Hypothesis testing Theory underlying program interventions Dissemination Scientific Journals Internal and External Reports Allegiance Scientific Community Funding source, policy makers
  • DISCUSSION… Q & A Research Ethics, Jan. 2011