Ethics

Ethics Applied to ResearchBack to Class 2

Ethics in Nursing Research Scientific Misconduct – a fabrication,

falsification, plagiarism or other practice that seriously deviates from those that are commonly accepted within the scientific community. It does not include honest error or honest differences in interpretation or judgments of data. It does include irresponsible authorship. (PHS, 1989)

Historical Events Which Affected Ethical Codes The Nazi medical experiments from 1933-

1945 – The Nuremberg Code of 1949 The Declaration of Helsinki of 1964 (rev. 1975)

The Tuskegee Syphilis Study – 1932-72 The Jewish Chronic Disease Hospital – 1965 Milledgeville, GA Drug Case – 1969 San Antonio Contraceptive Study – 1969 Willowbrook Hospital Admissions – 1972 Classroom Schoolteachers – 1973 Psychology Studies – 1973

Ethical Principles for Research Identified by the National

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Respect for Persons Beneficence Justice

Human Rights To be Protected Belmont Report - 1978 The right to self-determination

Violations – coercion, covert collection, deception, diminished autonomy

The right to privacy and dignity Violations – invasion of privacy – sharing

information, collecting information The right to anonymity and confidentiality

Violations, breech of confidentiality, lack of coding or grouping, reporting so individual can be ID’d.

Human Rights To be Protected Right to fair treatment

Violations – unfair selection, unfair treatment during study

Right to protection from discomfort and harm Violations – physical, psychological,

social, or economic discomfort or harm Right to full disclosure

Specific Things the Subject Should Know about a Project

Nature, duration and purposes Processes by which data will be collected Use to which findings will be put Any and all inconveniences Andy results or side effects Alternatives to participating Right to refuse Identities of investigators – how to contact

them

Reynold’s Five Categories of Discomfort or Harm No anticipated effects Temporary discomfort Unusual levels of temporary

discomfort Risk of permanent damage –

physically, emotionally, socially, personality, reputation

Certainty of permanent damage

Institutional Review Board (IRB) required by law - 1974 Must have at least five members who

reflect expertise and professional, gender, racial and cultural diversity. One must be primarily nonscientific and one must be from an outside agency.

Exempted reviews and expedited reviews

Satisfaction of the Code of Federal Regulations – p. 294 text

Assessments Risks – type, degree and number, actual

or potential, physical, emotional, social, economic – likelihood

Benefits – knowledge to be gained, improvement expected – physical or otherwise, rewards

Ratio – benefits and risks should balance or benefits should outweigh the risks

Informed Consent Essentials

Introduction of research activities Statement of purpose How or why subject was selected Explanation of procedures Description of risks or discomforts Description of benefits Alternatives Confidentiality Offer to answer questions Claim of no coersion Offer to withdraw

Documentation of Consent Waived consent – instudies that have only

minimal risk – questionnaires Short form consent – “The elements of

informed consent required by law have been presented orally to the subject or the subject’s legally authorized representative” Needs a witness.

Long form – signed by subject and witnessed Children from 7 -18 years should be given the

right to assent – they do not have to sign Back to Class 2