Ethics Ethics Applied to Research

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 – The Nuremberg Code of 1949 The Declaration of Helsinki of 1964 (rev. 1975) –Therapeutic vs. non-therapeutic research The Tuskegee Syphilis Study – –200 with and 200 without syphilis paid $35 The Jewish Chronic Disease Hospital – 1965 –Live cancer cells injected Milledgeville, GA Drug Case – 1969

Historical Events Which Affected Ethical Codes San Antonio Contraceptive Study – 1969 –Latina women did not know may have placebo Willowbrook Hospital Admissions – 1972 –To admit children parents had to agree to research Classroom Schoolteachers – 1973 –Told smart kids were dumb and dumb were smart Psychology Studies – 1973 –Told to cause pain to subjects behind one-way mirrors who were actually acting as if they were in pain – to see if continued causing pain when told to

Ethical Principles for Research Principles necessary for the conduct of research on human subjects –Respect for Persons – right to self-determination –Beneficence – know the good that will occur and do no harm –Justice – treat subjects fairly

Human Rights To be Protected 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 –Violations – withholding information in the interest of protecting the validity of the study

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 similar to that experienced in daily life Unusual levels of temporary discomfort experience discomfort during the study and sometimes afterward Risk of permanent damage – physically, emotionally, socially, personality, reputation Certainty of permanent damage may benefit others but not subject

Institutional Review Board (IRB) required by law 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

Assessments – Risk/Benefit Ratio Risks – type, degree and number, actual or potential, physical, emotional, social, economic – likelihood must be minimized, must be reasonable 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 coercion –Offer to withdraw

Documentation of Consent Waived consent – in studies 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