Chapter 009

1Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.

Chapter 9

Ethics in Research


Principal Issues Related To Nursing Research

Protection of research subjects Prevention of researcher misconduct


Protection of Research Subjects

Research may only be conducted if there is an identified gap in the knowledge base and the benefits of filling the gap outweigh the costs for the subjects (physical, mental, privacy, and so forth)

Consent is required for most research Protection of raw data is imperative Anonymity of subjects must be maintained Institutional review for protection of subjects

is required for all research


Prevention of Researcher Misconduct

Funding source must be revealed in all research reports (written or other)

Findings must be represented honestly Raw data must be retained and made

available if honesty is questioned All substantive authors and contributors must

be revealed All stated authors must take part in the

research process


Key Points

Ethical issues begin with justification of a reason for the study to be performed

They continue throughout planning, conduct of the study, preparation for publication, and theafter-publication phase

They extend through the memory lifespan of theresearcher, since he or she is responsible forprotecting anonymity and confidentiality,indefinitely


Historical Events

Four egregious research programs: Nazi medical experiments Tuskegee Syphilis Study Willowbrook Study Jewish Chronic Disease Hospital study

Each example contains specific transgressions against human subjects


Nazi Medical Experiments

Little useful scientific knowledge generated An excuse to maltreat persons identified as

non-Aryan Research ethics outgrowth of the Nazi trials—

the Nuremberg Code (1949)


Nuremberg Code: Principal Points

Voluntary consent Overt benefit to society Animal research first, then human Do no harm—avoid unnecessary suffering

and injury No death or disabling injury foreseen


Nuremberg Code: Principal Points (Cont’d)

Benefit outweighs risk Protection of subjects Researcher qualifications—highest degree of

skill and care Subjects may withdraw from the experiment Researcher must terminate experiment if

injury, disability, death foreseen


Declaration of Helsinki

Generated in 1964 by the World Medical Association (WMA) General Assembly and revised at intervals to reflect current problems and viewpoints

Differentiates therapeutic from nontherapeuticresearch Therapeutic: ill patient may receive an

experimental treatment Nontherapeutic: “basic” research; patients are

not ill


Principles of the Declaration of Helsinki

Life, well-being, health, privacy, and dignity of subject protected

Benefits must outweigh potential harm Withholding the usual therapeutic intervention

not allowed unless justifiable argument forexperimental treatment

Clinical trials must focus on improving treatment without subject exposure of additional risk


Tuskegee Syphilis Study

Forty-year study (started in 1932) of the natural course of syphilis in the adult black male

Descriptive in nature Two cohorts—one with syphilis, one without Periodic examinations; no treatment given


Transgressions in theTuskegee Syphilis Study

Inadequate information given to subjects Some individuals not aware that they were subjects

in the study Many not informed of the study’s purpose and

procedures Even after penicillin was developed and found to be

an effective treatment, subjects were not informed of penicillin’s availability

Ethical violations: researchers did not protect subjects from harm by treating their syphilis


Willowbrook Study

Hepatitis research Mentally retarded children deliberately

infected with hepatitis virus Coerced consent of parents Rationalizations about the likelihood that the

children would acquire hepatitis upon admission to institution


Jewish Chronic Disease Hospital Study

Twenty-two patients injected with live cancer cells

No patient consent or awareness that they were research subjects

No institutional review of the research by Jewish Chronic Disease Hospital or by Sloan-Kettering (the institution of the principal researcher)


U.S. Department Of Health, Education, And Welfare (DHEW) Regulations

First set of regulations published in 1973, updated since

Protection provided for persons with limited consent

All research involving human subjects underwent institutional review

PROBLEM: the system became bogged down because of too much work


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

Research (1978) Formed due to concerns with DHEW

regulations Developed The Belmont Report: principles of

respect for persons, beneficence, justice Federal regulations instituted in 1981 to

protect human research subjects; revised since


U.S. Department of Health and Human Services (DHHS)

U.S. DHHS now oversees research, nation-wide Provides direction for:

Protection of human subjects, with special attention to vulnerable populations (pregnant women, human fetuses, neonates, children, and prisoners)

Documentation of informed consent Implementation of the institutional review board process Applies to all funded research, and to all research in public

institutions and schools


HIPAA

Health Insurance Portability and Accountability Act (2003)

Protection of information Affects all research conducted using

databases with protected health information


Human Rights

Claims and demands that have been justified in the eyes of an individual or by the consensus of a group of individual

Necessary for the self-respect, dignity, and health of an individual

Protected by researchers and reviewers of research because of ethical responsibility


Protection of Human Rights

Five human rights that require protection in research: Self-determination Privacy Anonymity/confidentiality Fair treatment/justice Protection from discomfort and harm


Right to Self-determination

Based on the ethical principle of respect for persons

Prospective subjects treated as autonomous agents

Voluntary participation (may refuse, without penalty)

Right to withdraw at any time Persons with diminished autonomy have

additional protection


Preventing Violation of Research Subjects’ Right to Self-determination

No coercion through either threat, harm, or lure of excessive reward

No covert data collection: subjects must know they are research participants

No deception: the purpose of the research must be stated and clear


Protecting Persons With Diminished Autonomy

Vulnerable groups of individuals, include pregnant women, human fetuses, neonates, children, mentally incompetent persons, and prisoners, among others

Researchers must justify including subjects with diminished autonomy in a study; need for justification increases as the subjects' risk and vulnerability increase.


Legally and Mentally Incompetent Subjects

Persons not able to consent for themselves Neonates and children The mentally impaired Unconscious patients


Legally and Mentally Incompetent Subjects (Cont’d)

Difficult to obtain consent unless: There is a potential benefit to participants The research uses a mixture of vulnerable and

non-vulnerable subjects Previous research provides data for assessing

potential risks to subjects Risk is minimized The consent process is strictly followed (consent

by next of kin, spokesperson, parent, conservator, etc.)


Special Considerations with Vulnerable Subjects

Neonates: under no conditions can research be performed on a non-viable neonate, in order to gain information that would help a viable neonate

Children: assent must be obtained for children 7 and older, even though their parents’ consent; children should potentially benefit by the research and should not suffer permanent harm


Special Considerations With Vulnerable Subjects (Cont’d)

Pregnant women: require additional protection in research because of the fetus; research should be of potential or direct benefit to mother or fetus; no pregnancy termination inducements may occur

Fetuses in utero: fathers must also consent if there may be a direct benefit only to the fetus

Adults with diminished capacity: legally authorized representative consents; adults themselves assent, if they can understand what this means


Standards for Participation of Incompetent Individuals (Levine)

Best-interest standard: doing what is best for the individual on the basis of balancing risks and benefits

Substituted judgment standard: recommends the course of action that incompetent individuals would take if they were capable of making a choice


Special Considerations with Vulnerable Subjects

The Terminally Ill: Researcher must determine: Who will benefit Whether having someone else benefit by research

on terminally ill subjects is acceptable Whether or not subjects wish to participate Whether the study is ethical


Special Considerations With Vulnerable Subjects (Cont’d)

Hospitalized/other institutionalized patients: May perceive that they should participate in

research and feel coerced The researcher must be attuned to subtle coercion

Prisoners: Fear of harm and expectation of special treatment

may pose coercion potential Risks of research must be no greater for them Must be given option to refuse to participate Purposeful selection of research participants in

prisons is forbidden


Right to Privacy

An individual’s right to determine the time, extent, and general circumstances under which personal information will be shared with or withheld from others

Includes one’s attitudes, beliefs, behaviors, opinions, and records


Right to Privacy (Cont’d)

Privacy Act of 1974 Right to refuse Right to be consented before research

participation Right to access one’s own records Extended by HIPAA Privacy Rule Does not extend to a researcher who

receives permission to use “de-identified data” from a limited database or data set (no consent required for this)


De-identifying Protected Health Information Under The Privacy Rule

Involves removing the 18 elements that could be used to identify an individual or persons connected with the individual

After these elements are removed, the individual is not identifiable


Limited Data Set and Data Use Agreement

Covered entities (healthcare provider, health plan, and healthcare clearinghouse) may use and disclose a limited data set to a researcher for a study without an individual subject’s authorization or an IRB waiver

A limited data set is considered protected health information, and the covered entity and the researcher must have a data use agreement


Right To Autonomy And Confidentiality

Anonymity: The subject’s identity cannot be linked with his/her data, even by the researcher

Confidentiality: the researcher's management ofprivate information shared by a subject that must not be shared with others without the authorization of the subject

A breach occurs when An unauthorized person gains access to raw data The subject’s identity is accidentally revealed


How Confidentiality is Maintained

All subject data is stripped of identifiers and given a code number, either one created by theresearcher, or one generated by the subject

A master list of the subjects’ names and numbers is kept in a locked place, separate from the data set

When the data analysis phase is complete, the master list is destroyed

The same end can be achieved by giving each subject a pseudonym, which is then used by the researcher in publications resulting from the research


Special Issues for Qualitative Research

Participants reveal personal details during interviews that can lead to identification

Identifiers are intentionally changed, as are details of narratives, when reporting data: “A middle-aged Hispanic woman, Muriel,….” is, in actuality,

Henry: a 56-year-old African-American man

The general rule is, “When in doubt, don’t.....” when using a quotation that might inform too much about a participant

Real names are never mentioned on tapes Videotapes should cloud faces and disguise voices


Right to Fair Treatment

Based on the ethical principle of justice: each person should be treated fairly and should receive what he or she is due or owed

The selection of subjects and their treatment during the course of a study should be fair


Fair Selection of Subjects

The privileged should not be over-included intherapeutic research, when a definite benefit is anticipated; benefit should be shared across groups

The underprivileged should not be over-included in research, if harm is a distinct possibility; the risk should be borne equally by all


Fair Treatment of Subjects

Promised benefits must be delivered What the subjects are told will happen to

them must remain the case The sample should be, more or less, a cross-

section of the available population


Right to Protection from Discomfort and Harm

Beneficence: do good and, above all, no harm

If harm is likely, subjects must be informed and allowed to decline to participate

Researchers should try to bring about the greatest possible balance of benefits in comparison with harm


Five Levels of Discomfort and Harm

No anticipated effects (example: review of existent records; having one’s fingernails swabbed for cultures)

Temporary discomfort (examples: three blood draws; having to stand in one place for half an hour)

Unusual levels of temporary discomfort (examples: detailed narrative reporting of one’s experiences as a prisoner of war; bone marrow biopsies; prolonged sensory deprivation)


Five Levels of Discomfort and Harm (Cont’d)

Risk of permanent damage (examples: an experimental cancer treatment with 25% risk of severe hearing damage)

Certainty of permanent damage (examples: destruction of brain tissue that results in unilateral blindness, in order to cure an advanced cancer)


Predicting the Benefit-risk Ratio

If the benefit-risk ratio does not show more benefit than risk, the study will not be given Institutional Review Board approval. The benefit-to-risk ratio is part of the research protocol submitted to the Board


Predicting the Benefit-risk Ratio (Cont’d)

Individually: predict the outcome of the study,maximize potential benefits, minimize potential harm, and assess the individual’s likelihood of risks and of benefits

Collectively: predict the outcome of the study,maximize individual benefits and minimizeindividual harm, and then assess the world’slikelihood of benefit, in comparison with therisk to which the research subjects arecollectively subjected


Benefit-risk Ratio


Informed Consent

Subject is told what the study will involve, what will be done to/with the subject, how the data will be treated, and what the possible benefits and risks of participation are, including remuneration given for participation

Must involve information as to what will happen if the potential subject refuses to participate

Must disclose why the study is being conducted (academic requirement, internal review, external funding to test a product, etc.)


Obtaining Informed Consent

The subject must understand and must be allowed to ask questions; burden for confirming understanding is the researcher’s

The subject must be competent The subject must voluntarily agree, must

understand that refusal to participate is acceptable, and must be told that the subject can withdraw from the study at any time


The Consent Form

Should be typed Should be in plain English Should have short concise segments, with

titles (risks, benefits, freedom to refuse, etc.) Should provide a place for signature at the

end Should provide a place for initialing on each

page


Studies Without Written Consent

“Completing this questionnaire implies consent”: often used for anonymous participation—mailed questionnaires, online surveys, cards filled out in shopping centers

Studies in which written consent implies guilt for a crime (successful cat burglars and their descriptions of gaining access to second-story windows)


Institutional Review Board (IRB)

Committee of the researcher’s peers At least five members, from various backgrounds

(may not include the researcher) Collectively, they must understand the research and

the ethical concerns inherent for the study’slocation, population, procedures, etc.

Membership must include at least one non-scientist, and at least one person not affiliated with the institution


Institutional Review Board (IRB) (Cont’d)

Sole responsibility: to examine a study in order to assure ethical researcher behavior

Required for experimental research review in 1966

Required for all research since mid-1974 Realistically, limited to agencies with federal

grants or public funding Since 1990 all IRBs must be registered with

the federal Department of Health and Human Services


Levels Of Reviews Conducted By Institutional Review Boards

IRB determines the minuteness of the review required

Level of review (exempt, expedited, complete) isinitially indicated on application by the researcher, BUT the IRB may change this designation, if they feel that it is incorrect

Students typically complete one IRB review for the institution at which they are studying AND one at the institution at which they conduct research


No Apparent Risk = Exempt From Review

Examples: most educational research; use of de- identified specimens already collected byprevious research; most public behavior observations; research on how public serviceprograms are delivered

Caveat: the researcher needs to submit at least one copy of the protocol to the IRB Chairperson, so that one person can affirm that the research is exempt


Minimal Risk = Expedited Review

“Everyday” risk Examples: collection of body secretions

without pain, anonymous surveys, noninvasive monitoring, some blood draws, research on benign drugs (vitamin supplements)

Several copies of the research protocol are submitted to the IRB, and one or more of them review the protocol

Consent required


Greater than Minimal Risk = Complete IRB Review

More difficult to obtain but not impossible Protocol must carefully address minimization

of risk; risk:benefit ratio; equitable subject selection; the consenting process; how subjects will be monitored for safety

Researcher should expect revisions to the protocol, as these are made crystal-clear by IRB


Research Misconduct

Data fabrication or falsification Intentional fraud Misinterpreting findings Operating outside the approved protocol Consent violations Plagiarism Financial interest in results


Publication Guidelines for Researchers

Retain all raw data More than one person must be involved in each step

of the research process Individuals are listed as coauthors only if actively

involved in the conduct/publication of the research Disclose sponsorship Follow the protocol, and consent subjects properly If paraphrasing another author, give credit; do not

use exact words


Animals as Research Subjects

According to codes of conduct, experimentaltreatments that involve more than minimal risk should be first tested on animals

If animals are used as subjects, they require humane treatment

Federal guidelines and other guidelines

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