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Title: THE MODELING OF SCIENCE. Factors that influence Science.


1
THE MODELING OF SCIENCE. Factors that influence
Science.
Onofre Morán MD, MSc. Professor, Faculty of
Medicine, Universidad Autónoma de San Luis
Potosí, S.L.P. México. PhD Candidate University
of British Columbia, Vancouver, Canada.
2
FACTORS THAT MODEL THE MEDICAL SCIENCES
  •        Personal knowledge.
  •         Bioethics.
  •         Government Funding, Regulations.
  •         Industry.
  •         The media.
  •         Culture.
  •         Expert panels.
  •         Patients.
  •         Journal editors, etc.

3
PERSONAL KNOWLEDGE
  • A researcher can successfully develop a research
    on phenomena that are related to his main
    knowledge or capabilities.
  • This imposes a limitation in the field were the
    researcher will work and the kind of questions a
    researcher can answer within that field.

4
PERSONAL KNOWLEDGE
  • While the collection of data of the surrounding
    world depends in a great deal on the
    physiological integrity of our senses, another
    very important part is the inner state of our
    minds, which will itself depend on our cultural
    upbringing, our knowledge and our expectations,
    and will not be determined only by the physical
    properties of the surrounding objects.
  • (Chalmers, A.F. What is this thing called
    Science? 1999).

5
PERSONAL KNOWLEDGE
  • Furthermore, the relevance and interpretation of
    experimental results depend on the theoretical
    context, which in turn is influenced by previous
    knowledge.
  • (Chalmers, A.F. What is this thing called
    Science? 1999).

6
PERSONAL KNOWLEDGE
  • Scientific method
  • The principles and procedures used in the
    systematic pursuit of intersubjectively
    accessible knowledge and involving as necessary
    conditions the recognition and formulation of a
    problem, the collection of data through
    observation and if possible experiment, and the
    testing and the confirmation of the hypotheses
    formulated.
  • (Websters Third New International
    Dictionary. 1986)

7
PERSONAL KNOWLEDGE
  • Even researchers within the same field will have
    a different view of the scientific process and a
    different approach for the resolutions of the
    same problems.
  • This way, some researchers may prefer the
    falsificationist approach proposed by Popper,
    while others the verificationist approach
    proposed by inductivists.
  • (Rothman KJ. Causal Inference, 1988)

8
PERSONAL KNOWLEDGE
  • Half of what you are taught as medical students
    will in 10 years have been shown to be wrong. And
    the trouble is, none of your teachers knows which
    half . (Dr. Sydney Burwell, Dean of Harvard
    Medical School, 1956)
  • Currently, with the application of the scientific
    method, under the Evidence Medicine approach,
    over 90 of the studies published 5 years before,
    are still relevant. (ACP J Club. 1997
    Jan-Feb126(1)A16 )

9
PERSONAL KNOWLEDGE
  • In conclusion, personal knowledge, mainly of the
    proper knowledge required for scientific
    purposes, as well as personal experience, have a
    modeling effect in the entire scientific process
    from the researchers perception of the phenomena
    and the approach used to study those phenomena,
    to the inferences drawn from the results.

10
BIOETHICS
11
BIOETHICS
  • Since the Nuremberg Code in 1946, it was
    established that whatever the benefits
    potentially gained from the use of human beings
    as experimental subjects, there cannot be any
    justification for treating people as mere means
    to an end.
  • That the rights of the individual should remain
    paramount, and no scientific advance can outweigh
    the harm done by unethical research.

12
BIOETHICS
  • RECCOMENDATIONS
  • The Declaration of Helsinki in 1964. (World
    Medical Association )
  • The Belmont Report in 1979.
  • (The National Commission for the Protection of
    Human Subjects of Research)
  • The International Conference on Harmonization
    Good Clinical Practice guideline in 1989. (USA,
    Japan, Europe)
  • The International Ethical Guidelines for
    Biomedical Research Involving Human Subjects in
    1993.
  • (Council for International Organization of
    medical Sciences WHO)

13
BIOETHICS
  • FOUNDATIONS
  • Non-maleficence/beneficence Intends to
    assure that no harm will be done to the research
    subjects (primum non nocere).
  • Autonomy It recognizes that a person has the
    power to decide and act in her own best interest.
  • Justice It intends to prevent an unfair
    discrimination against any person who wishes to
    participate in the research (providing they
    fulfill the selection criteria of course).

14
BIOETHICS
  • Non-maleficence/beneficence
  • A research proposal cannot be ethical if it
    lacks scientific validity poorly designed
    research entails putting the subjects at risk or,
    at least, to some inconvenience, for no clear
    benefit.
  • This means that every research proposal
    should have a clear hypothesis stated and that
    hypothesis should be relevant to the medical
    knowledge and of potential benefit to society.
  • The hypothesis should be properly answered by
    the design of the study and the methods should be
    appropriate, in order to provide a valid
    scientific answer.

15
BIOETHICS
  • Non-maleficence/beneficence
  • In therapeutic research, if one of the
    treatments could cause harm, then the research
    should never begin.
  • On the other hand, one cannot justify
    withholding a treatment of known benefit to
    patients, merely in the interest of research.

16
BIOETHICS
  • Non-maleficence/beneficence
  • To ensure scientific validity, besides a
    randomized allocation to the treatments under
    comparison, the researchers and subjects under
    study should be blinded therefore it is obvious
    that therapeutic trials involve some element of
    risk to the subjects.
  • A research of this kind is acceptable only when
    the safety of subjects throughout the study
    period is assured.
  • Specific monitoring procedures and safety
    measures should be clearly stated in the research
    protocol.

17
BIOETHICS
  • Autonomy
  • In all types of research, the provision of
    comprehensive and accurate information to the
    subjects, or the proxy decision-makers, through
    the informed consent, is crucial.
  • Without such information, the consent granted
    will not be valid.

18
BIOETHICS
  • Autonomy
  • Giving informed consent is not to be confused
    with the signing of a consent form.
  • To achieve the fully valid consent, great
    attention must be paid to the quality of the
    communication about the research project. All
    explanations must be in non-technical and easily
    understandable language.

19
BIOETHICS
  • Autonomy
  • The information provided in the informed consent
    format, should include a clear description of the
    aims, methods, anticipated benefits and potential
    hazards of the study and the discomfort it may
    entail.
  • He or she should be informed that they have the
    liberty to abstain from participation in the
    study and that refusal to participate will in no
    way alter the medical care the subject is
    receiving.

20
BIOETHICS
  • In conclusion, there are many factors, introduced
    by Bioethics, that should be considered in the
    planning and execution of a research project
    involving human subjects.
  • All these factors have changed in a great deal
    the way Medical research has been carried out in
    the last few decades and they likely will
    continue changing it in the future.

21
GOVERNMENT
22
GOVERNMENT
  • Funding
  • By defining the characteristics a research
    project should have to be funded.
  • Regulations
  • By imposing legal actions on unaccepted
    behaviors.

23
GOVERNMENT
  • BUDGET
  • NIH gt 5.8 billion for clinical research only.
  • (NIH Grants Policy Statement. Mar, 2001)
  • CIHR 230 million in 2000-2001.
  • (Canadian Institutes of Health Research, 2001)
  • CONACYT 2 million in 2000-2001.
  • (SEP-CONACYT. Apoyos a la Investigación
    Científica. México, 2000.)

24
GOVERNMENT
  • NIH grant policy
  •  Human Subjects. Confidentiality.
  •  Education in the Protection of Human Research
    Participants.
  •  Data and Safety Monitoring.
  •  Investigation of New Drugs.
  • Measuring system.
  •  Inclusion of Women, Children, and Minorities in
    Clinical Research.
  •  Age Discrimination.
  •  Civil Rights.
  •  Sex Discrimination.
  •  Handicapped Individuals.
  •  Biosafety in Microbiological and Biomedical
    Laboratories.
  •  Use of Laboratory animals.
  • Availability of Research Results Publications,
    Intellectual Property.
  •  Rights, and Sharing Biomedical Research
    Resources.
  •  Types of new Research that will and will NOT be
    funded.

25
GOVERNMENT
  • NIH grant policy
  •  A grantee may not conduct research involving
    human subjects or expend Federal funds for
    research involving human subjects, unless it has
    an Office for Human Research Protections
    (OHRP)-approved assurance of compliance with the
    requirements of 45 Code of Federal Regulations
    (CFR) and the research has been approved by an
    Institutional Review Board (IRB).

26
GOVERNMENT
  • NIH grant policy
  •  Require that women and members of minority
    groups and their subpopulations be included in
    any NIH-supported research project involving
    human subjects, unless a clear and compelling
    rationale and justification establishes that
    inclusion is inappropriate with respect to the
    health of the subjects, the purpose of the
    research, or other circumstances.

27
GOVERNMENT
  • NIH grant policy
  • Grantees are responsible for meeting Federal,
    State, and local health and safety standards,
    such
  • -Biosafety in Microbiological and Biomedical
    Laboratories , U.S. Department of Health and
    Human Services, Centers for Disease Control and
    Prevention, and the National Institutes of
    Health. HHS Publication No. (CDC) 93-8395. 29
    CFR 1910.1030
  • -Bloodborne Pathogens 29 CFR 1910.1450.
  • -Occupational Exposure to Hazardous Chemicals
    in Laboratories Prudent Practices for Safety in
    Laboratories (1995), National Research Council
    42 CFR Part 72
  • - Interstate Shipment of Etiological Agents
    Procedures for Domestic Handling and Transport
    of Diagnostic Specimens and Etiologic Agents,
    1994 (3rd ed.)
  • -National Committee for Clinical Laboratory
    Standards.
  • -Nuclear Regulatory Commission Standards and
    Regulations, pursuant to the Energy
    Reorganization Act of 1974.

28
GOVERNMENT
  • NIH regulatory requirements
  • Regulations are codified at Title 45, Part 46 of
    the Code of Federal Regulations, Protection of
    Human Subjects.
  • (Code of Federal Regulations. Chapter
    VI--National Science Foundation Title 45--Public
    Welfare, Volume 3, Parts 500 to 1199. October 1,
    2000. )

29
GOVERNMENT
  • Regulations
  •         Informed Consent
  •         Institutional Review Boards
  •         Confidentiality
  •         Misconduct in Science

30
GOVERNMENT
  • Regulations
  • INFORMED CONSENT
  • No investigator may involve a human being as a
    subject in research, unless the investigator has
    obtained the legally effective informed consent
    of the subject or the subject's legally
    authorized representative.

31
GOVERNMENT
  • Regulations
  • INFORMED CONSENT
  • An IRB may waive the requirement if it finds
    that either
  • a) That the only record linking the subject and
    the research would be the consent document and
    the principal risk would be potential harm
    resulting from a breach of confidentiality or
  • b) That the research presents no more than
    minimal risk of harm to subjects and involves no
    procedures for which written consent is normally
    required outside of the research context.
  • In cases in which the documentation requirement
    is waived, the IRB may require the investigator
    to provide subjects with a written statement
    regarding the research.

32
GOVERNMENT
  • Regulations
  • Criteria for IRB approval of research
  • Risks to subjects are minimized By using
    procedures which are consistent with sound
    research design.
  • Risks to subjects are reasonable in relation to
    anticipated benefits,
  • Selection of subjects is equitable.
  • Informed consent appropriately documented.
  • The research plan makes adequate provision to
    ensure the safety of subjects.
  • There are adequate provisions to protect the
    privacy of subjects and to maintain the
    confidentiality of data.

33
GOVERNMENT
  • Regulations
  • Misconduct
  • Misconduct means fabrication, falsification,
    plagiarism, or other serious deviation from
    accepted practices in proposing, carrying out, or
    reporting results.
  • Actions
  • Could range from sending a letter of reprimand
    to the individual, to immediately suspend an
    active award and debar or suspend an individual,
    department, or institution from participation in
    NSF programs for a specified period. They are not
    exhaustive and do not include possible criminal
    sanctions.
  • (Title 45 of the CFR, in Sec. 689.1)

34
GOVERNMENT
  • FDA LIST OF RESEARCHERS WITH SCIENTIFIC
    MISCONDUCT (examples)
  • ANGELIDES, KIMON J (ORI ADMINISTRATIVE ACTION)
    INSTITUTION THAT LED INVESTIGATION BAYLOR
    COLLEGE OF MEDICINE CITY/STATE HOUSTON TX
    SANCTIONED AGAINST/ACTION REQUIRED
    APPLYING/RECEIVING FEDERAL GRANTS, CONTRACTS OR
    LOANS Y EFFECTIVE DATE 02/22/1999 EXPIRATION
    DATE 02/21/2004 SERVING ON COMMITTEE Y
    EFFECTIVE DATE 02/22/1999 EXPIRATION DATE
    02/21/2004 CORRECTION/RETRACTION AGREEMENT Y
    EFFECTIVE DATE 02/22/1999 EXPIRATION DATE
    03/24/1999 NARRATIVE WITHIN 30 DAYS OF 2/22/99,
    DR. ANGELIDES IS REQUIRED TO SUBMIT A LETTER TO
    THE EDITORS OF PROCEEDINGS OF THE ROYAL SOCIETY
    OF LONDON, ANNALS OF THE NEW YORK ACADEMY OF
    SCIENCE, GLIA, AND PROCEEDINGS OF THE NATIONAL
    ACADEMY OF SCIENCE REQUESTING RETRACTION OF THE
    FALSIFIED FIGURES AND TEXT IN THE FOUR SCIENTIFIC
    PAPERS. PROC. R. SOC. LONDON 23839-51, 1989,
    ANN. N.Y. ACAD. SCI. 633255-271, 1991, GLIA
    2353-369, 1989, PROC. NATL. ACAD. SCI. (USA)
    879290-9294, 1990.

35
GOVERNMENT
  • FDA LIST OF RESEARCHERS WITH SCIENTIFIC
    MISCONDUCT (examples)
  • DREYER, EVAN B (ORI ADMINISTRATIVE ACTION)
    INSTITUTION THAT LED INVESTIGATION HARVARD
    MEDICAL SCHOOL CITY/STATE BOSTON MA SANCTIONED
    AGAINST/ACTION REQUIRED APPLYING/RECEIVING
    FEDERAL GRANTS, CONTRACTS OR LOANS EFFECTIVE
    DATE 11/15/2000 EXPIRATION DATE 11/14/2010.
    SERVING ON COMMITTEE Y EFFECTIVE DATE
    11/15/2000 EXPIRATION DATE 11/14/2010 VOLUNTARY
    EXCLUSION Y EFFECTIVE DATE 11/15/2000
    EXPIRATION DATE 11/14/2010 NARRATIVE VOLUNTARY
    EXCLUSION AGREEMENT INCLUDES PROVISION THAT
    SUBJECT WILL EXCLUDE HIMSELF FROM SERVING AS A
    MENTOR TO ANY GRADUATE STUDENT, FELLOW, OR OTHER
    INDIVIDUAL WHO APPLIES FOR OR RECEIVES FEDERAL
    FUNDING.

36
GOVERNMENT
  • In conclusion, there are currently many
    economical and regulatory factors, usually linked
    with bioethical aspects, influencing the research
    performed in the Health Sciences.
  • In the USA they are structured very efficiently
    in the most important institutions that legislate
    and fund health research at the national level.
    Furthermore, researchers who do not comply with
    these regulations receive moral, professional and
    even criminal sanctions by the corresponding
    government institutions.

37
INDUSTRY
38
INDUSTRY
  • - Biotechnology Industry
  • - Pharmaceutical Industry
  • - Tobacco Industry

39
INDUSTRY
  • Biotechnology Industry
  • Serologic Diagnostic Tools
  • Many instruments are now indispensable for the
    valid measurement of substances in the serum and
    other body fluids in clinical and toxicological
    research
  • Automated Blood Cell Counters.
  • Electrophoretic methods.
  • Nephelometry.
  • Polymerase chain reaction.
  • Mass spectrometry, etc.

40
INDUSTRY
  • Biotechnology Industry
  • Image Diagnostic Studies
  • Similarly, no valid research can be carried out
    in our time without the use of sensitive
    technologies that allow the detection of anatomic
    abnormalities
  • Computerized Tomography.
  • Magnetic Resonance Imaging.
  • Nuclear Medicine studies.
  • Digital Substraction Angiography, etc.

41
INDUSTRY
  • Biotechnology Industry
  • Endoscopic studies
  • Currently it would be considered unethical to
    conduct many clinical research studies without
    the use of Endoscopic procedures (biopsies,
    brushings, washings, etc).

42
INDUSTRY
  • Pharmaceutical Industry
  • Multinational, randomized clinical trials of
    vaccines and therapeutic drugs that have been
    supported by the Pharmaceutical industry
  • -The Scandinavian Simvastatin Survival Study
    5 European countries 4,444 patients 5 y.
  • (Lancet. 1994 Nov 19344(8934)1383-9. Merck
    Research Laboratories)
  • - The LIPID study
  • gt9,000 patients 250 clinicians 6 yr.
  • (N Engl J Med. 1998 Nov 5339(19)1349-57.
    Bristol-Myers Squibb Co.)

43
INDUSTRY
  • Pharmaceutical Industry
  • Potential Problems
  • a) Increased drug prices.
  • b) The relationship between industry and
    investigators or universities has been
    strengthened and has become increasingly complex,
    creating a variety of situations which have the
    potential of leading to ethical compromises.

44
INDUSTRY
  • Tobacco Industry
  • The tobacco industry has been an influence on
    Science, and policies implemented based on
    scientific results.
  • By using the industry's size, wealth, and legal
    resources to intimidate individuals and local
    governmental bodies spending large sums of money
    to frame the public debate about smoking
    regulations around 'rights and liberty' rather
    than health, and portraying its tobacco company
    adversaries as extremists 'investing' thousands
    of dollars in campaign contributions to
    politicians and using financial resources to
    influence science.
  • (Br Med Bull. 1996 Jan52(1)183-92)

45
INDUSTRY
  • In conclusion, the Industry may influence the
    scientific process from the feasibility of a
    study, to the procedural aspects, including
    ethical issues associated to economical
    interests.

46
THE MEDIA
47
THE MEDIA
  • The media has an effect on the Medical Sciences
    through the increase awareness and modification
    of the public behavior.
  • Epidemiology is a Science especially prone to
    suffer from the media influence, because it deals
    with cause-effect relationships and Public Health
    issues, which are very commonly exploited by the
    media.

48
THE MEDIA
  • POTENTIAL INFLUENCES
  • Feasibility
  • Selection Bias
  • Information Bias
  • Results (Scientific Credibility)

49
THE MEDIA
  • Feasibility
  • The widespread adoption of measures
  • by the general public can cause problems in the
    feasibility of a study.

50
THE MEDIA
  • Selection bias
  • The media may play a role in the health
    consciousness of the public.
  • Volunteerism to participate in a research study
    is likely to be associated with age, sex,
    socioeconomic status and other correlates of
    health consciousness that may significantly
    influence subsequent morbidity and mortality. (J
    Chronic Dis. 197629331-9)
  • Direct influence when research participants are
    invited to participate through the media.
  • Those willing to participate in clinical trials
    tend to experience lower morbidity and mortality
    than those who do not.

51
THE MEDIA
  • Information bias
  • In (MRFIT) after 7 years of follow-up, there was
    a non-significant 7 decrease in deaths from CHD
    in the special intervention group, compared with
    those allocated to usual medical care. One factor
    that contributed to the inability of the study to
    detect a significant difference, despite of the
    important reductions on the levels of the 3 risk
    factors in the special intervention group, was
    that a large proportion in the usual care group
    also stopped smoking, received and/or complied
    with anti-hypertensive medication, and lowered
    their blood cholesterol through weight loss or
    dietary changes. (J.A.M.A. 19822481465-77)
  • An undetermined, but likely important component
    of these behavior modifications can be attributed
    to the media

52
THE MEDIA
  • Results (Scientific Credibility)
  • Millions of dollars are being awarded by
    injuries and a major company has been forced into
    bankruptcy because of litigation over silicone
    breast implants. Yet scientific research hasn't
    established a link between the implants and
    disease.
  • Marcia Angell, executive editor of the New
    England Journal of Medicine, blames the tort
    system, junk science, and the gullibility of the
    news media.
  • She worries that it's now become politically
    correct to bash the scientific method in the name
    of diversity, multiculturalism, and feminism.
  • (Med Econ. 1996 Sep 973(17)131-3, 136,
    139-40)

53
THE MEDIA
  • In conclusion, the media may be responsible of
    providing information that may be inaccurate and
    therefore create confusion in the public
    furthermore, the media can induce the believe
    that evidence from anecdotic cases have the
    same, or even more weight than the scientific
    evidence, neglecting the reality of the
    multifactorial complexity involved in scientific
    research.

54
CULTURE
55
CULTURE
  • Like other sciences, Epidemiology is not value
    free but colored by and reflective of cultures,
    customs and traditions in the place where it is
    practiced.
  • A well-conducted Epidemiological study should be
    directed towards the improvement in the health of
    a community, and in order to achieve this,
    researchers have to consider the cultural values
    and traditions of the specific community under
    study.
  • Not knowing those values and traditions may lead
    to an invalid study because the data provided by
    the members of the population could be distorted.
  • Not knowing and understanding the cultural
    factors of a community may even make a study
    impossible.

56
Conclusions
57
Conclusions
  • Many factors influence and model the scientific
    process in the Health Sciences Its objectives,
    methods and analysis.
  • Being aware of them improves our understanding of
    research, as an activity subject to the
    complexity of human strengths and weaknesses.
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