Ethical Framework of Studies

Violation of Human Rights in the Name of Research
Nazi medical experiments 1933-1945 - infecting wounds, sterilization, drug testing, hypothermia, high altitude
Japan death camp - horse blood transfusions, gas gangrene bombs, vivisection for pain
Jewish Chronic Disease hospital study - 1960's injection of live cancer cells
Tuskegee Syphilis study - 1932-1972 (play/movie Miss Evers= Boys)
	USPHS investigated the natural course of syphilis
	black males in small town - Tuskegee
	experimental group = 400; control = 200; Consent but not informed
	No one received PCN after it was discovered as effective tx for syphilis in 1950's
	information withheld from subjects about tx
	In 1969 CDC decided to continue studies
	Stopped in 1972 when public heard

Development of Ethical Codes and Guidelines
Nuremberg Code (1949) guidelines to protect human subjects (biomedical primarily)
Declaration of Helsinki in 1964, revised 1975
	differentiated therapeutic from non-therapeutic research
	adopted by World Medical Assembly
Belmont Report - see next section
ANA Human Rights Guidelines

Belmont Report
National Commission for the Protection of Human Subjects of Biomedical and Behavioral research
made recommendations to DHEW/DHHS concerning
	Informed consent requirements
	Documentation of informed consent
	IRB review of research
	Exempt and expedited review procedures for certain kinds of research
	Criteria for IRB approval of research
identified 3 ethical principles
	Beneficence
		do no harm
			Research only by qualified scientists
			Terminate study whenever participant could be injured, disabled, stressed, or die
			Tx. tested on animals prior to humans
			Distress may be more psychological than physical, so researcher must be sensitive to any type of subject stress
		freedom from exploitation
			Subject must fully understand his/her participation in the study
			Fully prepared
			Information shared remains confidential and cannot be used against the subject
			Avoid taking advantage of people=s vulnerabilities; eg afraid to refuse because researcher is his/her physician or nurse and does not want to make him/her angry with patient
		risk-benefit ratio
			Assess both potential benefits and risks (costs)
			Benefits must exceed risks
			Think of subject as self or family member
			Minimal risks are those encountered in normal life
			Informed consent covers both potential benefits and risks
	Respect for human dignity
		Right to self-determination; freedom to participate
			Autonomous individual
			Subjects voluntarily choose to participate in study or withdraw from study without penalty
			Freedom from coercion - no threats if person chooses to not participate or no significant rewards if does participate
			Careful use of stipends or incentives
		Right to full disclosure
			Researcher fully describes the nature of the study, subject=s right to refuse, researcher's responsibilities, risks, & benefits
			Full disclosure may result in biases
			If full knowledge of study may influence subject and subject is at minimal risk, full disclosure may be provided during a debriefing session after data is collected. If subject chooses to withdraw, then the data is destroyed immediately and not used.
				Covert data collection - concealment done when subject's awareness might change data/behavior or use of existing records with no risk to subjects
				Deception - misinformation purposefully given to subjects so subjects will consent; unethical
	Justice
		Right to fair treatment
			Fair tx. before, during and after study
			Non-discriminatory selection of subjects
			Sharing of risks & benefits
			Nonprejudicial tx of subjects who withdraw from study
			Honoring all agreements, eg stipends
			Subjects access to personnel to clarify information r/t study
			Subjects access to professional help for injury r/r study
			Debriefing if necessary to share information withheld prior to study
			Respectful & courteous tx
		Right to privacy
			Information kept in strictest confidence
			Anonymity occurs when even researcher cannot link a subject to the information from the subject
			Confidentiality - any information subject provides will not be publicly reported in a manner that identifies the subject or make data accessible to parties other than those involved in the study

ANA Human Rights Guidelines
Concerning the protection of human rights
Self-determination - coercion, diminished capacity, deception, covert data collection, terminally ill, institutionalized
Privacy - invasion of privacy
Anonymity and confidentiality
	Anonymity - subject cannot be linked with his/her responses
	Confidentiality - privacy of information
Fair treatment - fair selection of subjects and fair treatment
Protection from discomfort and harm = No anticipated effects, temporary discomfort, unusual levels of temporary discomfort, risk or certainty of permanent damage
Risk/benefit ratio
	benefits > risks or benefits = risks, then do research
	if risks > benefits, then do NOT research

Vulnerable Populations
Pregnant women	Infants/Children	Elderly	Prisoners
Homeless	Indigent	Mentally ill or handicapped	Terminally ill
Sedated or Unconscious	Captive Audience	Diminished mental capacity	Institutionalized
Anyone who might be vulnerable to coercion to participate in research

Elements of informed consent

Researcher name and credentials

Subject selection process

Purpose of study

Study procedures

Potential risks

Potential benefits

Compensation for participants

Alternative procedures

Anonymity or confidentiality

Right to refuse to participate

Offer to answer all questions, with phone # of investigator

Means of obtaining study results

Documentation of informed consent
Waived consent
	Minimal or no risk
	Questionnaires
	Cover letter discusses elements of consent & included statement that completion and return of questionnaire represents subjects= informed consent
Written consent
	Short form - verbal explanation with witness
	Long form - complete information
	Minor/incompetent - guardian, parent, etc.; may use assent form with school-age children along with parental consent form
	3 signed copies - 1 copy given to subject to keep, 1 copy for investigator=s records stored in locked box or file cabinet separate from the data; 1 copy in subject=s medical record at facility (clinic; nsg. home; md/np office; hospital)
Video/audiotaped consent

Institutional Review Boards

(aka human studies committee in some institutions)

Purpose - protection of subjects rights

Researcher needs written approvals of all facilities involved in the study

Students also need university (HSC) approval prior to approaching any potential subjects

Specific forms required; some institutions require use of a prescribed informed consent format written by the facility or university

Annual report often needed for continued permission to conduct the study

All changes in the research protocol must be approved by IRB prior to initiating

Final report on study completion or discontinuance required.

IRB/HSC requirements based on federal guidelines discussed earlier (Belmont Report)

Nurse-Researcher as Patient Advocate

Protect privacy and dignity

Protect from harm and refrain from harming patient

Protect vulnerable populations, i.e. children, elderly, prisoners, PWA, homeless, indigent, mentally handicapped, sedated, unconscious

Report questionable research practices

Critiquing Ethical Aspects of Study

Was the study approved by an institutional review board (IRB)?

Was informed consent obtained from the subjects?

Is there information about provisions for anonymity or confidentiality?

Were vulnerable subjects used?

Does it appear that subjects might have been coerced into acting as subjects?

Does it appear that the benefits of participation in the study outweighed the risks involved?

Were subjects provided the opportunity to ask questions about the study and told how to contact the researcher if other questions arose?

Were the subjects told how they could get the results of the study?

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