307 Module 1 Ethics

Willowbrook Study

Mid 1950's to early 1970's- research on hepatitis at an institution for children with disabilities Subjects- children- deliberately infected with hepatitis virus 20- year-study Research continued to new admits Parents were forced to give permission for their child in order to gain their child's admission to the institution Published findings Researchers claimed that obtained consent from the parents and that various committees had reviewed and approved the study. They were coerced or forced. By 1969, Willowbrook, designed with a capacity for 4,000 patients, reached its peak of 6,200. It was the largest mental institution in the United States, and host to some of the country's most deplorable living conditions. Such neglect was especially significant in light of a patient population in which 60 percent were not toilet-trained and 64 percent were incapable of feeding themselves. The stench in these rooms, coming from the unclean, unattended, and disregarded patients, to Rivera resembled "disease" and "death."

What happened? Code of Ethics

Nuremberg Code- International set of ethical standards Declaration of Helsinki: adopted in 1964 and last revised (2013) by the World Medical Association (WMA) Belmont Report and subsequent government-imposed codes Codes for professional disciplines (e.g., by the American Nurses Association)

Malcolm Pearce

OB, reported he could transplant a ectopic pregnancy to uterus and live birth. no one could find any results he fabricated data and came up with fake patients in his POCS studies

Beneficence

One should do good and above all, do no harm (physical, psychological, or financial) •Right to freedom from harm and discomfort, freedom from exploitation -Beneficence- maximize good -Nonmaleficence- minimize harm exploitation esp in vulnerable pops

examples of vulnerable populations

Socioeconomically depressed / homeless illiterate children low cognitive capabilities such as dementia, Down's Syndrome, Angleman's Syndrome, etc. psychiatric patients prisoners fetuses pregnant women terminally ill/hospice students employees comatose patients elderly

Dick van Velzen

he was an expert in cot death / SIDS and they found organs from 850 children without appropriate permission, this led to the Human Tissue Act of 2004. He did not get consent and fabricated data.

Respect for human dignity

humans have the right to self-determination and right to full disclosure they are capable of self-determination and controlling their own destiny

Principle of respect for human dignity

includes 2 things -Right to self-determination (absence of coercion) -Right to full disclosure (absence of deception or concealment) deception can even be giving informed consent in language human participant in cannot understnad typicallY in FOURTH GRADE LEVEL, DEFINING ALL TERMS

Nuremberg Code of Conduct (1947)

international code of ethics one of the first specific to trying to put some ethical reform into research involving human subjects followed the Nazi Medical Experiments

Geoffrey Chamberlin

linked to malcolm pearce, he affected "gift authorship" of his paper

Informed Consent

means that participants: -Have ALL the information they need about the research whats the aim, question, risks, benefits? -Can comprehend information (literacy) most do not have a healthcare background. written in 4th grade level, very much defined, etc -Have free choice in deciding whether to participate in or withdraw from the study and that they will receive the standard of care

Ethical Historical Background

- "unethical studies"- led to the development of Ethical Codes and Regulations some unethical studies: - Nazi Medical Experiments - Tuskegee Syphilis Study - Willowbrook Study - Jewish Chronic Disease Hospital Study

Why Do We Have Ethical Guidelines?

- Face many ethical dilemmas in practice -Vulnerable participants, or patients or clients - To protect people receiving health care and the interventions and treatment regimes in the system - To protect the public from harm, physical and mental

Procedures for Protecting Study Participants

- Risk-benefit assessments - Informed consent - Confidentiality procedures (de-identifying stuff on forms, HIPAA guidelines) - Debriefings and referrals (treating psych impacts and negative outcomes) - Treatment of vulnerable groups (double assure they are not getting taken advantage of) - External reviewers (e.g., IRB)

Tuskegee Syphilis Study

1932- U.S. Public Health Service initiated a study of syphilis in African-Americans in the small rural town of Tuskegee, Alabama. - Study continued for 40 years - This study was to determine the course of syphilis in the adult African-African male 2 groups: n = 400 untreated syphilis (treatment group); n = 200 without syphilis (control group) They wanted to see what happened if someone has Syphilis and they don't treat it. Consent- participants not informed about the purpose and procedures Deliberate steps to keep subjects from receiving treatment (even when treatments became available) No effort to stop the study / 1972 Whistleblower ended study

Nazi Medical Experiments

1940's- unethical activities implemented by the Third Reich in Europe - Medical experiments conducted on prisoners without consent: Sterilization Euthanasia High altitude/low pressure experiments Physiological response to extreme conditions ex) individuals placed in ice cold water •Doctors included "Angel of Death" Josef Mengele (escaped), plus several put on trial and hanged •Led to Nuremberg Code of conduct for research involving human subjects (1947)

Beneficence

Beneficence: researchers should have the welfare of the research participant as a goal of any clinical trial or other research study. we have to do GOOD for participants/subjects. The antonym of this term is maleficence

The principle of justice ensures a research subject's right to which of the following? A.Self-determination B.Full disclosure C.Protection from harm D.Privacy

D. Privacy Rationale: The principle of justice ensures a research subject's right to privacy and fair treatment. The right to self-determination and the right to full disclosure are ensured by the principle of respect for human dignity. The right to protection from harm is ensured by the principle of beneficence.

external review

Ethical aspects of a study are increasingly likely to be reviewed before permission is granted to conduct a study -Human subjects committees -Institutional Review Boards (IRBs) -Research Ethics Board (in Canada)

Ethical Dilemmas

Ethical dilemma in research: a situation in which the rights of study participants are in direct conflict with requirements of a study ex) I want to do a study, but it may be unethical. some researchers look at $ or fame

Principles of Justice Right to privacy

HIPAA! Assuring that research is not more intrusive that it needs to be & that the participant's privacy is maintained throughout the study. usually study #, not my name. anything in computer that captured data will be off # and not individual so you cannot go back and look up names.

Raj Persaud

His book "From the Edge of the Couch" contained material plagiarised from four academic articles written by nine authors. Four of his articles also contained plagiarized passages from an article and book by Professor Thomas Blass, The Man Who Shocked the World. The case against him began after a complaint by the Church of Scientology.

Informed Consent documentation

Implied consent (e.g., for self-administered questionnaires) you send me a survey and I do it on my own Process consent (renegotiated over time, qualitative studies getting consent again several years/decades down the line so they remember, study has same design and aim, still willing

Jewish Chronic Disease Hospital Study (Conducted by the USPHS)

In 1960's- two physicians at the Brooklyn Jewish Chronic Disease Hospital injected ill elderly patients with live hepatic cancer cells without their informed consent. Conduced by US Public Health. Purpose to determine the patients' rejection responses to live cancer cells or "rejection of human cancer cells" N = 22- injected with a suspension containing live cancer cells that had been generated from human cancer tissue Rights of patients not protected, not informed, study was never presented to the research committee of the Jewish Hospital

Jon Sudbo

In addition to three publications for which Dr. Sudbo admitted falsifying and/or fabricating data, the Investigation Commission found at least twelve other publications that warranted retraction because they could not be considered valid. He lost his PHD

Is the following statement True or False? Children require special protection when they are involved in a research study.

True Rationale: Children because of their inability to make a truly informed decision about voluntary participation in a research study, are considered vulnerable, and thus require special protection.

Is the following statement True or False? The Nuremberg Code was one of the first established sets of ethical standards.

True Rationale: One of the first international efforts to establish ethical standards was the Nuremberg Code. after WW2 after Nazi experiments

Certificate of confidentiality-

a certificate obtained to prevent forced disclosure of confidential information to authorities (from NIH, and allows refusal to disclose any information) if you get federal money for research, you have to get this bc it's extra for more protection

Vulnerable subjects

are study participants who require special protections. •Persons who are relatively or absolutely incapable of protecting their own interests -Some (e.g., children) cannot make a truly informed decision about voluntary participation. ex) get consent from parents, and do best to explain to child, getting assent if kid says no, cannot participate -Others (e.g., pregnant women) are at higher-than-average risk). consenting for herself, but who is protecting fetus?

James Wilson

conducted clinical trial in which Jesse Gelsinger, the 1st person publicly identified in a clinical trial for gene therapy died. He failed to report adverse reactions from animal testing so was banned for consent, conduction, and a financial conflict of interest put a hold on gene therapy for a decade

Maleficence

describes a practice which opposes the welfare of any research participant. why we say, "nonmaleficience, to do ALL THE THINGS WE CAN to LIMIT HARM" ex) surgery is harmful, but we do the best to minimize this antonym of beneficence

Confidentiality Procedures

developed by researchers to ensure study results cannot be tied back to any of the participants or research subjects. Assign a research identifier.

Anonymity

even researchers are unable to link participants to their data; may be difficult if some participants are very unique (e.g., 102-year-old patient) deidentified by giving numbers ex) 102 year old women or one male in nurse study is participant #6592

Principles of Justice Right to fair treatment

ex) doing a study, two groups. one is getting the new treatment, but the other group still has to get the "standard of care" treatment if you are giving new chemo med, still have to treat the nausea and things you normally would that this may end of causing.

Hwang Woo-Suk

fabrication and falsification. he also obtained human eggs by unethical means, and embezzlement.

Vipul Bhrigu

fabrication through sabotage

IRB (Institutional Review Board)

from healthcare and community looking at ALL aspects of study making sure they meet federal guidelines and ensure protection of human subjects job is to sit on committees, they go through checklist for studies to meet exact guidelines and change, clarify things or deny them. penalties why you have to keep checking back up with them while you are gaining participants, etc.

Autonomy

voluntarily participate and withdrawal (no coercion, full disclosure, no deception, voluntary consent) Self Determination: "ok i signed up for this study, but i do not want to continue, i quit." like a patient saying I do not want any more chemo, i'm done. Self Disclosure: the participant is enrolled in a voluntary basis. ex) testing new COVID vaccine, anyone who participates cannot be coerced, pushed, 100% voluntary and can withdraw. FULL disclosure, risks and benefits. like in surgery