4130 Chapter 6: Legal and Ethical Issues

Ethics: study of theory that deals with moral values and moral conduct (morality)

Morality: what one's behavior, manor, conduct, or character should be 

• Nazi experiments on jewish WWII prisoners
• -poisoning
• -drinking sea water
• -bone transplant
• -high altitude
• -mustard gas
• -sterilization
• -vaccines
• -sulfa drugs
• -jaundice
• -twin genetics (getting rid of "inferior" race

untreated syphilis in Black males

• San Antonio contraceptive study: 70 poor mexican-american women not informed that they were the subjects of research or that they were receiving placebos
• =to evaluate efficacy of different kinds of contraception pills
• =high numbers of unplanned pregnancies in the placebo group

• D. Cameron's LSD & brainwashing studies:
• -psychiatrist that specialized in electroshock eherapy, experimental drugs, & LSD to unsuspecting & generally healthy patients who in some cases entered permanent comas
• -invited to Nuremberg to evaluate Rudolph Hess' psychological state and be a member of the Nuremberg Tribunal (Hess an ex Nazi leader)
• =induced sleep to his clients to the point of coma (7-10 days at end of his tx period)
• -became crazy and dx'ed Germany as the race most likely to rise and commit atrocities against humanity again SO he wanted to remove the weak from society (ppl who were mentally ill)

Jewish chronic disease study: intradermal injections of live human cancer cells into 22 chronically ill, debilitated non-cancer pts in 1963 without their consent in the Jewish Chronic Disease Hospital case, to learn if foreign cancer cells would live longer in debilitated non-cancer pts than in pts debiltated by cancer

Dr Mengele experimenting on Jewish children in concentration camps: looking for proof that jews and rats are from the same origin

• Willowbrook school hepatitis studies:
• 1950s-70s: healthy children were intentionally inoculated, orally and by injection, with the virus that causes the disease, then monitored to gauge the effects of gamma globulin in combating it

At the end of WWII the Nazis in Nuremberg shot massive #s of slave labor prisoners

More was wanted by the world for retribution so the allies held an international tribunal in which those responsible for the war crimes were tried 

Big 4: Russia, Britain, USA, & France represented countries whose populations were harmed by Germany during WWII

Aim: to make someone accountable for crimes against humanity, acknowledge that they occurred and ensure they don't happen again

• Many Nazi leaders were found guildy
•  

voluntary and informed consent

must be scientifically necessary, conducted by qualified personnel and benefit society

should be based on previous knowledge

based on a favorable risk/benefit analysis. The benefit to science must be weighed against risks and suffering of human research subjects

participants have the right to withdraw without penalty

US commission created for the protection of human subjects of biomedical and behavioral research

Purpose: identify basic ethical principles that underlie the conduct of research involving human subjects

• Guidelines were developed to ensure that research is conducted in accordance with 3 ethical principles of:
• 1. respect for persons
• 2. beneficence
• 3. justice 

• Canadian Regulations and Policy
• *Canadian Nurses Association has a code of ethics (lasted updated in 2008).

*Health Canada adopted the Good Clinical Practice: Consolidated Guidelines, 1997.

*CIHR, NSERC, and SSHRC developed the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2003.

• CNAs Code of Ethics
• *Promoting safe, compassionate, competent & ethical
• care.

*Promoting health & well-being.

*Promoting & respecting informed decision-making.

*Preserving dignity.

*Maintaining privacy & confidentiality.

*Promoting justice.

*Being accountable.

• 5 Basic Human Rights Guide Research
• *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

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.

Beneficence

Acts of kindness or charity that go beyond duty.

• Obligations derived from beneficence:
• -do no harm.
• -prevent harm.
• -prevent evil.
• -promote good.

Justice

*Treat people fairly.

*Fair sharing of burdens & benefits of research.

*Distinguish procedural justice from distributive (society as a whole) justice.

• Respect: 
• informed consent
• respect for privacy

• Beneficence:
• sound research design
• competent investigators
• favorable risk-benefit ratio

• Justice:
• equitable selection of subjects 

A living individual about whom an investigator...conducting research obtains

• -data through intervention or interaction with the individual, or
• -identifiable private information 

• Definition: 
• •ongoing process of communications & mutual understanding.
• •shared responsibility for protection.

• *What it is not:
• •piece of paper.
• •moment in time.
• •legal contract.

• Elements of informed consent form for research 
• •purpose of research.
• •expected duration for subject.
• •description of procedures.
• •identification of experimental procedures.
• •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.

Cont'd

• *Confidentiality.
• *Compensation for research-related injury.
• *Who can answer questions:
• •about study & research-related injuries.
• •about subject's rights.
• *Voluntary participation.

• *If a study involves a intervention included on a consent
• are:

• •unforeseeable risks.
• •situations where the researcher can terminate the subject's participation.
• •any additional costs.
• •consequences & procedures for subject's early withdrawal.
• •revelation of new findings.

* Noted is:

• •payment: total or prorated.
• •who has access to records.
• •probability of random assignment.
• •special qualifications of the investigator.

• *A informed consent is not valid unless the subject
• understands it.

• *The responsibility for understanding rests with the
• researcher, who must consider the:

•nature of the study population.

•type of information.

•circumstance & timing.

•language & culture.

Review research projects & 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 & adequate project review.

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

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

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

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

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

*if the study recruitment is fair.

*the study's inclusion & exclusion criteria.

*the investigator-subject relationship.

*the role of the REB in the study?

*the consent to maximize autonomy.

*Additional protections such as vulnerable subjects: children, prisoners, mentally disabled persons, economically disadvantaged, educationally disadvantaged, subtle vulnerability such as language, culture, pregnancy, students, employees, substance abuse, health status.

• *the risks & benefits: social, legal, physical,
• economic, psychological, medical & kinship.

*the consent forms & process.


 

*Guidelines (2003) set by Tri-Council as “good practices” for researchers and REBs to follow when research involves Aboriginal people.

*There must be an emphasis on Aboriginal involvement in research design, respect for cultural ways, making the research worthwhile to the people & working with people as partners.

*Approved by a REB board.

*Informed consent obtained & how.

*Also aware of the nature & purpose of the study.

*Participants protected from physical & emotional harm.

*Subjects aware of the potential risks or benefits.

• *Are benefits supported & risks minimized to the
• participants.

*Was subject autonomy protected & maintained.

• *Was data & information kept private &
• confidential.

• Consent
• an ethical principle that requires a research to obtain the voluntary participation of subjects after informing them of potential benefits and risks 

• Assent
• an aspect of informed consent that pertains to protecting the rights of children as research subjects 

NRC = reviews proposals for scientific merit and congruence with the institutional policies and missions

REB = reviews research proposals to ensure protectin of the rights of human subjects

Justice = idea that human subjects should be treated fairly and should not be denied any benefit to which they're entitled to

Expedited review = study of existing data that's of minimal risk to subjects may be a candidate for this

Unethical research study = ? 

children

pregnant women

prison

older people

unborn infants