copyright © 2009 elsevier canada, a division of reed elsevier canada, ltd. legal and ethical issues...

Copyright © 2009 Elsevier Canada, a division of Reed Elsevier Canada, Ltd.

Legal and Ethical Issues

Ethics

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Learning Outcomes Describe the historical background that led to the

development of ethical guidelines for the use of human subjects in research.

Identify the essential elements of an informed consent form.

Evaluate the adequacy of an informed consent form.

Describe the research ethics board’s role in the research review process.

Identify populations of subjects who require special legal and ethical research considerations.


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Learning Outcomes (cont’d)

Appreciate the nurse researcher’s obligations to conduct and report research in an ethical manner.

Describe the nurse’s role as client advocate in research situations.

Discuss the nurse’s role in ensuring that Health Canada guidelines for testing of medical devices are followed.

Discuss animal rights in research situations. Critique the ethical aspects of a research study.


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Ethics and History

History places ethics in perspective Those who fail to study history are

condemned to repeat it Ethics: Disciplined study of morality Morality: What should one’s behaviour and

character be?


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Historical Ethical Dilemmas

Nazi experiments Milgram’s shock study Untreated syphilis in Black males (Tuskagee study) San Antonio contraceptive study Cameron’s LSD and brainwashing studies Jewish chronic disease study Willowbrook Hospital—hepatitis studies Ivory Coast AIDS/AZT studies


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•Milgram’s study: Milgram sought to understand whether people will obey unethical orders. The Nuremberg war trials often had people saying they were just following orders

Brief outline of study Subjects believed they were administering shocks to

other “subjects” (in fact a confederate who faked pain and begged for mercy!)

Subjects told to continue with the shocks. (Each time an error was made a shock of increasing amount was administered)

2/3 of subjects administered shocks labeled as “dangerous”

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US National Commission

Identify the basic ethical principles that underlie the conduct of research involving human subjects

Develop guidelines to ensure that research is conducted in accordance with those principles


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Basic Human Rights

Right to self-determination Right to privacy and dignity Right to anonymity and confidentiality Right to fair treatment Right to protection from discomfort and

harm


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Basic Ethical Principles

Respect for persons Beneficence Justice


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Respect for Persons

Treat individuals as autonomous agents Do not use a person as a means to an end Allow people to choose for themselves Give extra protection to those with limited

autonomy


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Beneficence

Acts of kindness or charity that go beyond duty

Obligations derived from beneficence– Do no harm– Prevent harm– Prevent evil– Promote good


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Justice

Treat people fairly Fair sharing of burdens and benefits of

research Distinguish procedural justice from

distributive (society as a whole) justice


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Principles Applied

Respect: Informed consent, respect for privacy

Beneficence: Sound research design, competent investigators, favourable risk-benefit ratio

Justice: Equitable selection of subjects


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Definition of Human Subject

A living individual about whom an investigator . . . conducting research obtains:– Data through intervention or interaction

with the individual, or – Identifiable private information


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Informed Consent Process

Does NOT Equal

Informed Consent Form!


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Informed Consent

What it is– Ongoing process of communications and

mutual understanding– Shared responsibility for protection

What it is not– Piece of paper– Moment in time– Legal contract


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Elements of Informed Consent Form Study involves research

– Purpose of research– Expected duration for subject– Description of procedures– Identification of experimental procedures


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Elements of Informed Consent Form (cont’d) Reasonably foreseeable risks or

discomforts– How can risks be minimized?

Reasonably foreseeable benefits for subjects or others– How can benefits be maximized?

Alternative procedures or treatments


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Elements of Informed Consent Form (cont’d) Confidentiality Compensation for research-related injury Who can answer questions

– About study and research-related injuries– About subject’s rights

Voluntary participation


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Present in consent that generally involves an intervention– May involve unforeseeable risks– Situations where researcher can terminate

subject’s participation– Any additional costs– Consequences and procedures for subject’s

early withdrawal– Revelation of new findings


Elements of Informed Consent Form (cont’d)

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Elements of Informed Consent Form (cont’d)

Payment: total or prorated Who has access to records? Probability of random assignment Special qualifications of investigator


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Comprehension

Not valid unless subject understands Responsibility for understanding rests with

researcher, who must consider:– Nature of population– Type of information– Circumstance and timing– Language and culture


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Research Ethics Boards (REBs) Review research projects and assess that ethical

standards are met in relation to the protection of the rights of human subjects

1. At least five members of various backgrounds to promote complete and adequate project review

2. Members qualified by virtue of expertise, experience, and reflect professional, gender, racial, and cultural diversity

3. Membership must include one member whose concerns are primarily non-scientific (lawyer, member of clergy, ethicist)


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Research Ethics Boards (cont’d)

4. At least one member from outside the institution (community member)

5. REB members have mandatory training in scientific integrity and prevention of scientific misconduct, as do principal investigators of a research study and research team members

6. REB is responsible for protecting subjects from undue risk and loss of personal rights and dignity


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REB Role Assessing recruitment: Is it fair? Evaluating inclusion and exclusion criteria Investigator-subject relationship Role of REB in study? Consent: Maximize autonomy Additional protections Assessing risk and benefit Assessing consent forms and process


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Recruitment

Plans and materials must be reviewed by REB

Public service announcement or ads also reviewed


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Approval Categories Exempt: Low risk, non-vulnerable, non-

sensitive, short duration (6 categories; e.g., educational)

Expedited review: Minimal risk (no substantive increase beyond risks of ordinary life), non-vulnerable, non-sensitive topic (9 categories; e.g., chart review, questionnaires)

Full board reviewCopyright © 2009 Elsevier Canada, a division of Reed Elsevier Canada, Ltd.

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Full Board Review

All members participate and review All members participate in discussion and

make comments Decision is rendered by a majority of

assembled quorum No member has a conflict of interest


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Approval Criteria

Risks minimized Risks balanced by

benefits Subject selection

equitable Procedures for

obtaining informed consent

Procedures for consent documentation

Data monitoring provisions

Privacy and confidentiality measures

Safeguards for vulnerable subjects


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Risk Assessment

Probability of harm occurring as a result of participation

Quantified by probability and magnitude Types: Social, legal, physical, economic,

psychological May apply to individual or society


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Benefit Assessment

Valued or desired outcome, an advantage Quantified by probability or magnitude Types: Medical, psychological, kinship May apply to individual or society


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Special Considerations Vulnerable subjects

– Children– Prisoners– Mentally disabled persons– Economically disadvantaged– Educationally disadvantaged– Subtle vulnerability: language, culture,

pregnancy, students, employees, substance abuse, health status


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CNA’s Code of Ethics, 2008

Promoting safe, compassionate, competent, and ethical care

Promoting health and well-being Promoting and respecting informed decision-making Preserving dignity Maintaining privacy and confidentiality Promoting justice Being accountable


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Critical Thinking Decision Path: Evaluating

the Risk–Benefit Ratio of a Research Study


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Research Involving Aboriginal People Guidelines (2003) set by Tri-Council (CIHR,

NSERC, SSHRC) as “good practices” for researchers and REBs to follow when research involves Aboriginal people

Emphasis on Aboriginal involvement in design, respect for cultural ways, making the research worthwhile to the people, working with people as partners


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Scientific Fraud and Misconduct

Fraudulent studies increase risk to all Misconduct and unauthorized studies

increase risk as well Can harm subjects Basing clinical practice on false data Nurses obligated to report if they witness


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Product Testing

Nurses often asked to participate in product testing of medical products

Be aware of Health Canada guidelines for health products research


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Research with Animals

Canadian Council on Animal Care (CCAC) assesses all agencies who work with animal research every three years (with random spot inspections in between)

Nurses should be aware of the guidelines of animal rights and report any observed infractions


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Human Gamete, Embryo, Fetus

Tri-Council guidelines—2003 (available online)

Restricts cloning, any attempts to create, or to use, gametes/embryos/fetuses in unethical research

Allows in utero research procedures to treat embryo with genetic or congenital disorders


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Film: The Pill (overview)

Drive to find a solution to unwanted pregnancy – to increase women’s reproductive choices and to control the population

At What cost? Ethical considerations Experiment on women (women as guinea pigs) Deception (say pill was safe and effective) & women did not know they were part

of experiment (Lack of informed consent) Fought to cover up side-effects (one side effect was death) Sexist, racist and classist climate– viewed women as inferior – suggestions they

would not experiment on men, not just due to different biological make up but also due to how men perceived their reproductive responsibility- experimented outside the US on poor Hispanic women. (Inequality in society - women had little control over their own reproductivity including the power to say NO – many desperate for pregnancy prevention)

Later Pills banned in US – used in developing countries – over the counter – not prescription – no doctor monitoring

(also consult your notes on film for more details)

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The Tri-Council Ethics Statement

Following is a condensed version of the Tri-Council ethics statement. 1. Respect for Human Dignity: The cardinal principle of modern research ethics is respect for human dignity. This

principle aspires to protecting the multiple and interdependent interests of the person -- from bodily to psychological to cultural integrity. This principle forms the basis of the ethical obligations in research that are listed below. It is unacceptable to treat persons solely as means (mere objects or things), because doing so fails to respect their intrinsic human dignity and thus impoverishes all of humanity. Second, the welfare and integrity of the individual remain paramount in human research.

2. Respect for Free and Informed Consent: Individuals are generally presumed to have the capacity and right to make free and informed decisions. Respect for persons thus means respecting the exercise of individual consent. The principle of respect for persons translates into the process and requirements for free and informed consent by the research subject.

3. Respect for Vulnerable Persons: Respect for human dignity entails high ethical obligations towards vulnerable persons -- to those whose diminished competence and/or decision-making capacity make them vulnerable. Children, institutionalized persons or others who are vulnerable are entitled, on grounds of human dignity, caring and fairness, to special protection against abuse, exploitation or discrimination. Ethical obligations to vulnerable individuals in the research enterprise will often translate into special procedures to protect their interests.

4. Respect for Privacy and Confidentiality: Respect for human dignity also implies the principles of respect for privacy and confidentiality. Privacy and confidentiality are considered fundamental to human dignity. Thus, standards of privacy and confidentiality protect the access, control and dissemination of personal information. In doing so, such standards help to protect mental or psychological integrity.

5. Respect for Justice and Inclusiveness: Justice connotes fairness and equity, and concerns the distribution of benefits and burdens of research. On the one hand, distributive justice means that no segment of the population should be unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are vulnerable and unable to protect their own interests in order to ensure that they are not exploited for the advancement of knowledge. On the other hand, distributive justice also imposes duties neither to neglect nor discriminate against individuals and groups who may benefit from advances in research.

6. Balancing Harms and Benefits: The analysis, balance and distribution of harms and benefits are critical to the ethics of human research. Modern research ethics, for instance, require a favourable harms-benefit balance -- that is, that the foreseeable harms should not outweigh anticipated benefits.

7. Minimizing Harm: Research subjects must not be subjected to unnecessary risks of harm, and their participation in research must be essential to achieving scientifically and societally important aims that cannot be realized without the participation of human subjects. In addition, it should be kept in mind that the principle of minimizing harm requires that the research involve the smallest number of human subjects and the smallest number of tests on these subjects that will ensure scientifically valid data.

http://www.von.ca/Research%20Ethics/Tri-council%20Policy%20Statement.pdf

copyright © 2009 elsevier canada, a division of reed elsevier canada, ltd. legal and ethical issues...

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