Bioethics of Human Subjects Research Flashcards
What is bioethics?
the study of the ethical issues emerging from advances in biology and medicine
What is the institutional review board (IRB)?
an independent body made up of medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well being of human subjects involved in a trial by among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the method and material to be used in obtaining and documenting informed consent of the trial subjects
What is research misconduct?
a fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in a reporting research results
What is serious adverse event (SAE):
any experience that suggests a significant hazard, contraindication, side effect. or precaution that develops during a clinical trial
What is informed consent?
consent to participate in a medical experiment by a subject after achieving an understanding of what is involved. It is essential that participants understand that participating in a research study is completely voluntary; they can withdraw from the study at any time or choose not to participate without it having any impact on their clinical care
What is autonomy?
the capacity of an individual to make an informed uncoerced decision
What is a clinical trial?
systematic investigation of the effects of material or methods on a disease state conducted according to a formal study plan
What is good clinical practice?
a standard by which clinical trials are designed, implemented, and reported to assure that the data are scientifically sound and that the rights of the subjects are protected
Describe the work of Dr. James Lind
1747: published one of the first widely known clinical trials to help treat scurvy. Citrus fruit helped cure it
Describe the work of Dr. John Haygarth
1799: One of the first demonstrators of the placebo effect
What is the biological control act?
1902: regulated the production of vaccines and antitoxins. Came from in 1901 when 13 children died in St Louis from diphtheria antitoxin that was contaminated with tetanus spores
What is the pure food and drug act?
1906: required medications to report their ingredients, in response to The Jungle, banned selling of impure food
What is the therapeutics trials committee?
considered applications by companies for trials of new products
What is the Tuskegee syphilis study?
Researchers told 399 African American men with syphilis that they would treat them for “bad blood” but ended up not ever treating them for the disease
What is the nuremberg code?
Nuremburg Military tribunal’s decision about the Nazi medical experiments
16 doctors found guilty of war crimes and crimes against humanity
7 doctors executed
What is the nuremberg code 10 points?
- Consent must be voluntary
- possibility of important results; with no other means to get information
- trial must be justifiably based on past knowledge
- avoid all unnecessary physical and mental suffering
- no trial can be conducted where reason to believe that death or disabling injury will occur
- trial must be of more benefit than risk
- provisions must be made to protect patients from injury or death
- trial conducted by scientifically qualified persons
- right to patient to withdraw from study
- doctor must discontinue trial if new information suggests probable cause that trial could result in injury, disability or death
Describe the Willowbrook study
Doctors infected mentally ill children with hepatitis to see how it works in 1963. Parents gave consent for the study because if they didn’t, their children would not be treated by the hospital
Describe the Jewish Chronic Disease Hospital Study
1963; injection of live cancer cells into patients with various chronic illnesses, doctors did not tell parents that they were injecting cancer cells
What is the declaration of Helsinki?
1964: developed by the World Medical Association
outlines the ethical principles of medical research
Basic principles: doctors duty to protect the life, health, privacy and dignity of patient, research much be reviewed by independent committee, Benefit > risk, patients must volunteer, assent much be obtained from minors if capable
What is the national research act?
1974; created the national commission for the protection of human subjects of biomedical and behavioral research
group was formed to write basic ethical principles for research
led to creation of Belmont report
What does the National Commission for the protection fo human subjects of biomedical and behavioral research do?
publish on children, established rationale for pediatric research (1977)
What is the Belmont report?
ethical principles and guidelines for the protection of human subjects
What are the three fundamental principles of the Belmont report?
respect for persons
beneficence
justice
Describe respect for persons
autonomy of individuals
persons with diminished autonomy are entitled to protection
Describe beneficence
do no harm
maximize the benefit and minimize the risks
Describe justice
benefits and risks must be distributed equally
Describe clinical practice?
interventions designed solely to enhance the well being of the individual and that have a reasonable expectation of success
Describe research
activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalized knowledge
The national institute of health (NIH) craned the ______ to develop policies, procedures, and regulations to detect, investigate and prevent ________
office of research integrity (ORI), research misconduct
What are the goals of HIPAA?
make health insurance portable anywhere in the country
make patient information private and secure
reduce health care fraud and abuse
What does the privacy rule require providers to comply with?
- develop notices informing patients of their privacy rights and provider practices regarding PHI
- prepare authorization forms for release of PHI
- implement policies and procedures to protect patient medical records
- train office and clinical staff in privacy rule standards and their institution’s privacy practices
How does the IRB describe human subjects?
living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information.
What is individually identifiable?
describes private information regarding the identity of human subjects that an investigator may ascertain directly or through a coding system. If identity is knowable, the study is considered to be human subjects of research
What does the IRB do?
formally review and monitors biomedical research involving humans under oversight of the FDA
The NIH will consider your research to involve human subjects unless it meets both of the following conditions:
- you are not collecting samples by interacting or intervening with living people, TISSUES COLLECTED FOR OTHER REASONS
- none of the investigators or collaborators listed in the application can identify the subjects through coded private information or specimens
What is a investigator initiated clinical trial?
a trial run by a clinical sponsor (institution, investigator, collaboration) but without a company take the role as a sponsor
What is the Havasupai genetic study?
blood was collected from the Havasupai tribe to determine why there was such high cases of type II diabetes
Researches then ended up using blood for other studies without the tribes permission
