A branch of philosophy that involves clarification of the should and ought of individuals and society.

Deals with:

should and should nots that are related to behavior or actions taken by an individual. The questions of why an action is reprehensible or not reprehensible.

What are the ethical issues in this example?

Research investigators should be aware of the ethical,legal, and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in the Declaration of Helsinki (Helsinki, 2004, 9).

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)

Violation of traditions

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. Emanuel
2005. The American Journal of Bioethics 5(5)

In the past not given attention Changed with Nuremberg trial findings

Nuremberg Code (1948)

Thalidomide (late 1950s) Declaration of Helsinki (1964) Tearoom Trade (1960s) Milgram (1963) Tuskegee Syphilis Study (1932-1972)

To protect rights and welfare of research participants

and

to protect the wider society or community within which the research is being conducted

Ethical regulations or guidelines Law Universal principles of human rights

In research, help to make and to justify decisions Are abstract and difficult to implement in practical situations Key phrases:
Voluntary participation Informed consent

Risk of harm
Confidentiality Anonymity

Respect for human dignity Respect for free and informed consent Respect for vulnerable persons Respect for privacy and confidentiality Respect for justice and inclusiveness Balancing harms and benefits Minimizing harm Maximizing benefit

 Cardinal Principle

Basis of ethical obligations Two essential components

The selection and achievement of

morally acceptable ends The morally acceptable means to those ends

Protect the multiple and interdependent interests of the person (bodily, psychological, cultural integrity)

Presumption that individuals have capacity and right to make free and informed decisions In research = dialogue, process, rights, duties, requirements for free and informed consent by the research subject Your research cannot proceed without consent Consent must be maintained throughout

Ethical obligations towards vulnerable persons

Diminished competence Diminished decision-making capacity

Entitled to special protection, special procedures to protect their interests Entitlement (based on grounds of human dignity, caring, solidarity, fairness) to special protection against abuse, exploitation, discrimination

Fundamental to human dignity Standards protect the access, control, dissemination of personal information Helps to protect mental, psychological integrity

Balance critical to ethics of human research Foreseeable harms should not outweigh anticipated benefits Harms-benefits analysis affects welfare and rights of subjects

i.e., fairness and equity Procedural justice

Application process

Distributive justice
Harms and benefits

Duty to avoid, prevent or minimize harm No unnecessary risk of harm Participation must be essential to achieving scientifically and societally important aims that cannot be realized without the participation of human subjects Minimizing harm requires smallest number of human subjects that will ensure valid data

The duty to benefit others The duty to maximize net benefits Produce benefits for subjects themselves, other individuals Produce benefits for society as a whole and for the advancement of knowledge (usually the primary benefit)

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

Quantitative Techniques
Can be easier Anonymity of

Qualitative Techniques
Smaller

the firm sometimes impossible Pseudonyms common but do not eliminate problem

sample sizes Informed consent more critical Problems with data presentation / publication

Follow code of ethics

Objectivity No misrepresentation Preserve anonymity and

confidentiality Competing research proposals

Right to informed consent Obligation to be truthful Right to privacy Right to confidentiality Right to no harm Right to be informed

The language you use is very, very important. What may be clear to you may not be clear to the reader. The reader, who is your prospective participant, is in a different world than you dont expect the reader to read your mind, to know your intentions.

Poverty

Age Gender Ethnicity

Impaired capacity

Consult our vulnerable research subjects Our knowledge about the risks from the methodology Guidance from ethics review committee

FGD Participant observation (debate) Visual documentation

Autonomy capability to decide freely knowledge about the research & role in it risks, benefits Comprehension Process of decision making Freedom to decide Undue inducement

Example: KAP study signed consent form doesn't mean the informing process can be glossed over written or verbal consent

Before the actual study - know your study group as much as you could - prepare your own personal mentality, psychology, ethical competence - be ready to forego/stop the study when risk of harm is ethically unacceptable - when you are not prepared financially, methodologically, timewise to make adjustments for ethical requirements

During the study - make periodic ethical audit - reaffirm/reiterate consent (for qualitative study) - make clear plan for withdrawal and post research work

Post research - did you go back to validate? - to discuss how community will use the results? - did you have concrete plan (not merely promises) for post research benefit to community?

Ensure autonomy is real (not theoretical) and protected a. informed decision making (informed consent) (iterative consent taking) Enhance protective ability Erode the power hierarchy Ensure benefit and ownership

The researchers in the Philippine team are all active in advocacies and projects for social justice. We directly work with underserved/ impoverished communities as volunteers. All the senior researchers are also academics straddling academia and social activism. We believe that gender is a determinant of poverty and ill health.

Ethics review committee Provide supportive environment

Question on students research

Responsibilities ethics audit guide monitor (adverse event reporting) Composition Competence Conflict of interest

why we do it? knowledge about the questions we ask or subject matter to: focus use in writing the analytic framework decide on methodology

good Coherent (the main message per paragraph is clear)

bad enumeration of authors & data main message not clear

RRL is your chance to make your case about the significance of your study and your assumptions

plagiarism is wrong (even if un intentional) (del Castillo SC) when does plagiarism take place? citation style

Thank you very much