By: Gilbert T. Manacmul R.N.

Development of ethical codes and guidelines

1947 Nuremberg Code criteria for research 1. Inform the subjects about the study 2. Qualified to conduct research 3. Based on animal experiments , if possible 4. Avoid injury to research subjects 5. Good of society 6. Stop the study if problems occur

1. Respect for person- the research subjects should

have autonomy and self-determination 2. Beneficence- research subjects should be protected from harm 3. Justice- research subjects should receive fair treatment

Elements of Informed Consent- concerns subjects participation in research in which they have full understanding of the study before the study begins. It is the principal means for ensuring that the rights of research subjects are protected. 1. researchers identified and credentials presented 2. subject selection process is described

one of the primary goal of all researchers is to choose an unbiased sample

purpose of the study is described The purpose of the study should be clearly presented. The material should be in the preferred language of the potential subjects and at the subjects reading level for all printed material. The researcher should be honest in presenting the purpose of the study. 4. study procedures are discussed All aspect of the study should be fully explained. Debriefing- is a meeting with research participants that ensures their understanding of the reasons and justification for the procedure used in the study.
3.

5. 6. 7. 8. 9.

potential risk are described

Subject must be told of the discomfort either physical or psychological as a result of participations.
All research that should be conducted must benefit the society, a research that is conducted to satisfy the researcher curiosity is unethical. Monetary compensation should be avoided and all compensations if possible should come from the listed possible benefits of the study.

potential benefits are described

compensation if any is discussed

alternative procedure if any are disclosed anonymity or confidentiality is assured

Anonymity- occurs when no one, including the researcher, can link the subjects with the data they provided. Confidentiality- involves protection of the subjects identity by the researcher.

10.

right to refuse or to participate or to withdraw from the study without penalty is assured

All participation in nursing research must be voluntary. No form of coercion should be involved and there must be no penalty involve for non participation.

11. 12.

offer to answer all questions is made means of obtaining study result is presented

Documentation of informed consent

Consent can be obtain in a written form Oral permission may be obtain in a presence of a third subject A legally authorized representatives can give consent for subjects who are incapable of proper decision making.

The nurse researcher as patient advocate

responsibility to protect the privacy and the dignity of the

people involve in the research and to protect them from harm.

Clinical trials are studies conducted to evaluate new treatments,

new drugs, and new or improve medical equipment. Assent- means that the underage child or adolescent freely chooses to participate in the study.

1.

2. 3.
4. 5. 6. 7. 8.

The study must be approved by the international review board. Obtain Informed consent from the subjects. There is available information about provisions for anonymity or confidentiality. Selection process of subjects used must not be biased. Subjects must not have been coerced into acting as subjects. Benefit of participation in the study must outweigh the risk involved. Provide the subject the opportunity to ask questions about the study and told how to contact the researcher if other questions arose. Subjects must be told how they could get the results of the study.

S Scientific Objective conductive research for a good

purpose or object for your pt C Cooperation and Consent. Do not conduct data/experiment w/o a consent (legally the patient owns the chart. However the hospital owns the chart) I Integrity worked hard on the research E Equitable acknowledging works or contribution of others N Nobility protect the rights of your subjectsT Truthfulness put only the data you have collected I Importance importance to the nursing profession F Factual facts or data I Ideal (follow the 11 steps of research) C Courage

Right not to be harmed

(physical, mental, moral harm) usually done during experimental research Physical Harm/ Negligence - undeliberate physical harm
Commission

done outside the standard practice of nursing (eg. urinary catheter placed on the nose of the pt) Omission from the very start, you did not do something about it.

Moral Harm
Assault

mental fear/threat without physical harm Battery physically you harm the pt

Restraint is never an independent nursing order

physical

restraint eg. Jacket chemical restraint eg. use of psychotropic drug

Moral harm
Slander

oral defamation Libel published or placed in the newspaper

Right to self-determination Right to privacy

Anonymity identity of subject may not be disclosed. Privacy of the

Informant (pt) eg. conduct a study on HIV pt. but the pt wants his name to be written in the newspaper as Mr. X, Mr. Y or Mr. W Confidentiality information acquired must be disclosed. Privacy of the information eg. conduct a study on HIV pt. but the pt wants the nurse should only know