WEEK #5 - research methods Flashcards
what are ethics ?
a branch of philosophy that focuses on morality and a set of principles and practices that provide moral guidance for a particular field
what do ethics define ?
what it means to behave morally and helps provide guidance and a framework to achieve that goal
what are the four moral principles that apply to scientific research ?
1) weighing risks against benefits
2) acting responsibly and within integrity
3) seeking justice
4) respecting people’s rights and dignity
what are the three general groups that are affected by scientific research ?
1) participants
2) scientific community
3) society
what do research projects need to evaluate ?
the impact of these four principle on the three general groups in order in order to ensure that the research is being conducted ethically and responsibly
what are some beneficence weighing risks against benefits ?
- maximize possible benefits and minimize possible harm
FILL IN THE BLANK
risks and benefits are ___________
balanced
what are some forms that risks can come in ?
tasted resources, harmful consequences, inaccurate conclusions
what are some forms that benefits can come in ?
treatment, education, exploration, material benefits
discuss acting responsibly and with integrity ?
- research must be carried out in a thorough and competent manner
- research must promote trust and candor
- researchers must ensure they maintain the trust of the scientific community by ensuring that that conduct research in a thorough and competent manor and report their results in a transparent fashion
discuss seeing justice :
- required that we treat all participants (and the pool f potential participants) fairly
- occasionally, one may be tempted to sample from easily obtained samples (e.g. prison inmates)
discuss respect for persons; respecting people’s rights and dignity :
- individuals should be treated as autonomous agents, capable of deliberating about personal goals and acting under such deliberation
- individuals with diminishes autonomy (e.g. children, or individuals suffering from cognitive dysfunction) may need additional protections
discuss unavoidable ethical conflict :
- there will always be unavoidable ethical conflicts in research
- weighting risks vs benefits is a conflict
- sometimes deception is required as being truthful may make it impossible to conduct a scientifically valid study
- whenever ethical conflicts arise the mitigation f those conflicts is vitally important
what is informed consent ?
participants must have the capacity to understand verbal information, make decisions, and consentD
FILL IN THE BLANK
(in regards to informed consent) participants must be __________
free of coercion/influence
what must researchers provide in regards to informed consent ?
researchers must provide sufficient information to facilitate participant decision-making
in regards to informed consent, what are researchers ultimately responsible for ensuring ?
that the participant has consented to participated and consent should be written
what is deception ?
the action of deceiving someone
how many forms of deception are there ?
4
deception is acceptable as long as what ?
as long as the risk is mitigated post-study
what are the four forms of deception ?
1) misinforming participants about the purpose of a study
2) using confederates
3) using phone/sham equipment
4) presenting participants with false feedback about their performances
what is debriefing ?
is a report of a mission or project or the information so obtained. It is a structured process following an exercise or event that reviews the actions taken.
discuss debriefing in regards to participants :
- participants are quired to be informed as soon as possible regarding the actual purpose of the study and any deception or misinformation must be corrected
what does debriefing help minimize ?
helps minimizing any harm that may have occurred
describe a historical overview of moral principles to ethics codes :
- throughout history there have been cases on unethical and inhumane scientific studies
- many of these studies have resulted in the establishment of ethical codes which now form the foundation of modern research ethics
describe the medical experiments on the nazi medical war crimes :
- injecting people with gasoline and live viruses
- immersion in ice water
- forcing participants to ingest poison
what was December 1946 ?
- 23 physicians and administrators indicated for war crimes before the nuremberg tribunal
- 16/23 found guilty, 7 sentenced to death
- verdict formed the basis of the nuremberg code
- nazi medical war crimes
what was the Tuskegee syphilis study ?
initiated in 1930 as a study of the natural history of untreated syphilis
how long did the Tuskegee syphilis study continue until ?
from 1930 to 1972
when did the Tuskegee syphilis study begin ?
1930
when did the Tuskegee syphilis study end ?
1972
describe the Tuskegee syphilis study :
400 male patients with syphilis, 200 controls recruited without informed consent, “spinal taps” called “special free treatment”
what became clear in regards to the Tuskegee syphilis study in 1936 ?
that complications were more common among the infected … death rate among those with syphilis was twice as high as it was in controls
what happened in regards to the Tuskegee syphilis study in 1940 ?
penicillin found to be more effective in treating syphilis;
- participants were not informed, and were not treated
- study continued for almost 30 more years without administering treatment to participants
what served as part of the impetus for creating a publicly funded body for the protection of research participants ?
the Tuskegee syphilis study (1940s)
what year did the jewish chronic disease hospital study occur ?
1963
what Is the jewish chronic disease hospital study ?
1963, intended to determine whether body’s inability to reject cancer cells was due to cancer or debilitation ; previous research indicated that healthy individuals rejected cancerous cells
what did the jewish chronic disease hospital study involve ?
involved the injection of foreign, live cancer cells into patients that were hospitalized for variety of debilitating diseases
what are the three points of the jewish chronic disease hospital study ?
- oral consent only - no written consent
- no mention of “cancer cells” at all
- researchers were found guilty ion fraud
describe “oral consent only - no written” :
no mention of the potential consequences of th injections
describe “no mention of “cancer cells” at all :
researchers thought that this alarm participants, and thought that the cells would be rejected anyways
in the jewish chronic disease hospital study what were researchers found guilty of ?
fraud, deceit, and unprofessional conduct
what is the willowbrook study ?
intended to study the natural history of infectious hepatitis under controlled circumstances
what type of people did the willow brook study include ?
- included cognitively challenged children only, at a residential care facility (deliberately infected all newly-admitted children)
- parents were only able to enrol their children in the school if they consented to participation in the study
how many steps were there in the path to modern ethics codes ?
4
what were the 4 steps of the path to modern ethical codes ?
1) nuremberg code 1947
2) declaration of Helsinki 1964
3) Belmont report 1978
4) tri-council policy statement : ethical conduct for research involving humans (TCPS 2) 2018
discuss the nuremberg code :
- one of the earlier codes
- a set of 10 principles
- arose from the 1947 verdict of the nuremberg tribunal
- unnecessary suffering should be avoided
- degree of risk should not be exceed humanitarian importance
- participants must always always be at liberty to withdraw
in the nuremberg code what is absolutely essential ?
voluntary consent
how many steps are there in the nuremberg code ?
10
what is step 1 of the nuremberg code ?
the voluntary consent of the human subject is absolutely essential
what is step 2 of the nuremberg code ?
the experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature
what is step 3 of the nuremberg code ?
the experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under the study that the anticipated results will justify the performance of the experiment
what is step 4 of the nuremberg code ?
the experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury
what is step 5 of the nuremberg code ?
no experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects
what is step 6 of the nuremberg code ?
the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment
what is step 7 of the nuremberg code ?
proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death
what is step 8 of the nuremberg code ?
the experiment should be conducted only by scientifically qualified persons. the highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment
what is step 9 of the nuremberg code ?
during the course of the experiment the human subject should be at liberty to bring the experiment to an end id he has reached the physical or mental state where continuation of the experiment seems to hum to be impossible
what is the declaration of Helsinki :
code developed by the world medical association, in response to the nuremberg code
what does the declaration of Helsinki allow ?
for surrogate consent when the research participant is incompetent, physically or mentally incapable, or a minor (assent should be obtained wherever possible)
what does the most recent version of the declaration of Helsinki include ?
a statement about comparing novel treatments against current best practice
what does the WMA stand for ?
world medical association
what did the WMA do ?
the world medical association (WMA) has developed the declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research no identifiable human material and data
what is the declaration of Helsinki general principal :
” a physician shall act in the patients best interest when providing medical care “
discuss vulnerable groups and individuals in regards to the declaration of Helsinki :
some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm (all vulnerable groups and individuals should receive specifically considered protection)
discuss the declaration of Helsinki privacy and confidentiality :
every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information
what is the Belmont report ?
- (ethical principles and guidelines for the protection of human subjects of research)
- the “common rule” on the united states
- canada has the tri-council policy statement
what are the three modern guiding principles of the Belmont report ?
- respect for persons
- beneficence
- justice
describe the TCPS 2 :
- joint policy of Canadas three federal research agencies
- expresses the continuing commitment to the people of Canada to promote the ethical conduct of research involving humans
- based on internal ethics norms
what are the three point policy of Canadas there federal research agencies o the (TCPS 2) ?
- canadian institutes of health research (CIHR)
- natural sciences and engineering research council of canada (NSERC)
- social sciences and humanities research council of canada
