Research Process and Ethics

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 19331945 The Nuremberg Code of 1949 The Declaration of Helsinki of 1964 (rev. 1975) Therapeutic vs. non-therapeutic research The Tuskegee Syphilis Study 1932-72 200 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 IDd. 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 Reynolds 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 - 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 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 subjects legally authorized representative Needs a witness. Long form signed by subject and witnessed