B4.025 - Research Ethics Flashcards
what is a phase 0 clinical trial
pre trial
what are phase 1 trials
try on small # of people and see if its safe
Figuring out doses
what are phase 2 trials
its not poison, were gonna see if theres any benefit. Larger group
what is a phase 3 trial
what you need to do to display it should be sold on market
larger population looking for statistically signifiant evidence that it helps
what are phase 4 trials
after a drug is available on market, are there problems?
what is the plan part of PDSA
questions and predictions, plan to carry out the cycle, plan for data collection
what is the do part of PDSA
carry out plan
document problems and unexpected observations
begin analysis of data
what is the study part of PDSA
Complete the analysis of data
compare data predictions
summarize what was learned
what is the act part of PDSA
what changes are to be made
next cycle?
what is buy-in?
the PDSA cycle promotes buy-in, the idea that people who are more invested in the cycle will be more aligned with the mission
what are ethical considerations in common in quality and public health research and clinical research
Non maleficence
beneficence
proportionality
what is a key factor for determining who needs to consent for a public health research study
level of risk
do QI projects undergo IRB review?
QI studies have to be reviewed by the IRB to determine if they also qualify as research, unless they are clearly being used locally to analyze and improve practice, using accepted methods, for the benefit of the local patient population.
Public health research has specific challenges that differ from those in conventional clinical research trials. What represents a major challenge specific to public health research at the population level.
If an intervention is directed at a population, it is not always possible to identify all potentially affected individuals, much less have all of them provide meaningful informed consent. The question about whether consent can be waived, then, rests on the risk to those individuals, the potential benefits to them, and whether the research presents risks greater than they would otherwise face in the ordinary course of their lives. All of the other issues are routine in public health research, and have established protocols for addressing them.
Participants in research are promised privacy in order to reveal information that they would normally not provide, and because breach of privacy can cause a number of harms from personal embarrassment to identity theft to financial repercussions such as loss of insurance or loss of a job. What method provides the most security to assure participants’ privacy:
Anonymous data collection
If researchers don’t record the participants’ names or other identifiers, they cannot lose them, accidentally release them, or breach privacy in most ways. This may not be completely true in if the research data itself could be used to identify participants. This is particularly true in small groups, whether studies of small communities (rural, indigenous) or of small professional networks (a sociologist was asked to change the gender of a genetic counselor in an reports from an interview study because a pseudonym that matched her ethnicity, along with her words, made it easy for other genetic counselors to identify her).
