ETHICS IN RESEARCH.pptx

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    A branch of philosophy that involvesclarification of the should andought of individuals and society.

    Deals with:

    should and should nots that arerelated to behavior or actions takenby an individual.

    The questions of why an action isreprehensible or not reprehensible.

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    What are the ethicalissues in this example?

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    Research investigators should be aware

    of the ethical,legal, and regulatoryrequirements for research on human

    subjects in their own countries as wellas applicable internationalrequirements. No national ethical,legal orregulatory requirement should

    be allowed to reduce oreliminate anyof the protections for human subjectssetforth in the Declaration ofHelsinki (Helsinki, 2004, 9).

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    Do no harm to the people involved in our study

    Examples of harm:

    exploitation (ex: drug trials)physical, emotional, psychological, economic,social (examples)

    Respect for person (Harm: violation of dignity

    (examples) Respect for autonomy (harm: deception, undue

    inducement)

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    Violation of traditions

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    Exploitation taking unfair advantage

    of another for ones own interest;

    wrongful instrumentalization of one

    party for the benefit of another; taking

    advantage of altruism/kindness

    - undue inducement

    (Ezekiel J. Emanuel2005. The American Journal of Bioethics5(5)

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    To protect rights andwelfare of research

    participantsand

    to protect the wider society orcommunity within which theresearch is being conducted

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    Ethical regulations or guidelines

    Law

    Universal principles of human

    rights

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    In research, help to make and to justifydecisions

    Are abstract and difficult to implement in

    practical situations Key phrases:

    Voluntary participation

    Informed consent

    Risk of harm Confidentiality

    Anonymity

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    Respect for human dignity

    Respect for free and informedconsent

    Respect for vulnerable persons

    Respect for privacy andconfidentiality

    Respect for justice and inclusiveness Balancing harms and benefits

    Minimizing harm

    Maximizing benefit

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    Cardinal Principle

    Basis of ethical obligations

    Two essential components The selection and achievement of

    morally acceptable ends

    The morally acceptable means to thoseends

    Protect the multiple andinterdependent interests of theperson (bodily, psychological,cultural integrity)

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    Presumption that individuals have capacity and right tomake free and informed decisions

    In research = dialogue, process, rights, duties,

    requirements for free and informed consent by theresearch subject

    Your research cannotproceed without consent

    Consent must bemaintained throughout

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    Ethical obligations towards vulnerable persons Diminished competence

    Diminished decision-making capacity

    Entitled to special protection, special procedures toprotect their interests

    Entitlement (based on grounds of human dignity,caring, solidarity, fairness) to special protection against

    abuse, exploitation, discrimination

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    Balance critical to ethics of human research

    Foreseeable harms should not outweigh

    anticipated benefits Harms-benefits analysis affects welfare and

    rights of subjects

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    i.e., fairness and equity

    Procedural justice

    Application process Distributive justice

    Harms and benefits

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    Duty to avoid, prevent or minimizeharm

    No unnecessary risk of harm

    Participation must be essential toachieving scientifically andsocietally important aims thatcannot be realized without theparticipation of human subjects

    Minimizing harm requires smallestnumber of human subjects that willensure valid data

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    The duty to benefit others

    The duty to maximize net

    benefits Produce benefits for subjects

    themselves, other individuals

    Produce benefits for society as awhole and for the advancementof knowledge (usually theprimary benefit)

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    Quantitative Logic rests on generalizability &

    representativeness

    Sample size is criterion for judging rigour

    Respondents can refuse to answer questions

    Qualitative approaches Designed to best reflect experiences

    Therefore most qualitative research less formally

    structured Logic rests on notice of saturation the point at

    which no new insights are likely to be obtained

    Saturation guides sample size

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    QuantitativeTechniques

    Can be easier Anonymity of

    the firmsometimesimpossible

    Pseudonymscommon butdo noteliminateproblem

    QualitativeTechniques

    Smallersample sizes

    Informedconsent morecritical

    Problemswith datapresentation/ publication

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    Follow code of ethics

    Objectivity

    No misrepresentation Preserve anonymity and

    confidentiality

    Competing research proposals

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    Right to informed consent

    Obligation to be truthful

    Right to privacy Right to confidentiality

    Right to no harm

    Right to be informed

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    The language you use is very,very important. What may be

    clear to you may not be clear tothe reader. The reader, who isyour prospective participant, isin a different world than you

    dont expect the reader to readyour mind, to know yourintentions.

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    Poverty

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    Age

    GenderEthnicity

    Impaired capacity

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    http://www.fotoevidence.com/sites/default/files/iveraldas09.jpg
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    Consult our vulnerable research subjects

    Our knowledge about the risks from the

    methodology Guidance from ethics review committee

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    FGD

    Participant observation (debate)Visual documentation

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    Autonomycapability to decide freely

    knowledge about the research& role in it

    risks, benefits

    Comprehension

    Process of decision

    makingFreedom to decide

    Undue inducement

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    Before the actual study- know your study group as much asyou could

    - prepare your own personalmentality, psychology, ethicalcompetence- be ready to forego/stop the studywhen risk of harm is ethically

    unacceptable- when you are not preparedfinancially, methodologically, time-wise to make adjustments for ethicalrequirements

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    During the study

    - make periodic ethical audit

    - reaffirm/reiterate consent (for qualitativestudy)

    - make clear plan for withdrawal and post

    research work

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    Post research

    - did you go back to validate?

    - to discuss how community will use theresults?

    - did you have concrete plan (not merely

    promises) for post research benefit tocommunity?

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    The researchers in the Philippine team areall active in advocacies and projects forsocial justice. We directly work withunderserved/ impoverishedcommunities as volunteers. All thesenior researchers are also academics -

    straddling academia and socialactivism. We believe that gender is adeterminant of poverty and ill health.

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    Responsibilities

    ethics audit

    guidemonitor (adverse eventreporting)

    Composition

    Competence

    Conflict of interest

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    why we do it?

    knowledge about the questions

    we ask or subject matter to:focus

    use in writing the analytic

    frameworkdecide on methodology

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    good bad

    Coherent enumeration of

    (the main message authors & dataper paragraph is clear) main messagenot clear

    RRL is your chance to make your caseabout the significance of your study andyour assumptions

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    plagiarism is wrong (even if unintentional) (del Castillo SC)

    when does plagiarism takeplace?

    citation style

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    Thank you very much

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