Professional Documents
Culture Documents
Test Material and Project Material
Test Material and Project Material
For the test: Chapters 1, 2, 7, and 31…read the Google Docs, skim over the chapters, and
the PowerPoints and notes!
The three aspects of informed consent: autonomy and respect, justice, benevolence, and
beneficence,
**GO OVER THE CITI TRAINING MATERIAL BECAUSE THAT WILL BE ON
THE TEST**
Example: if I am telling you a bunch of information that is not relevant to the study, has
your consent been taken? NO because the participant doesn’t understand what is going
o They will not understand what they are consenting to be a part of
o They need to understand what their data is being used for and why they have been
chosen as a participant for a study
o Language needs to be in simple terms: “These are the things I am doing, this is
what I am studying, this is what your data will be used for, these are the steps I
will be using and what it will help.”
o Scientific explanation is NOT a part of informed consent
Justice is not beneficence
Justice a person or a group of people are chosen b/c they are at a disadvantage, that is
NOT justice; the investigators should make a complete effort to recruit people from all
sections of society, regardless of anyone with financial status, race, ethnicity, color; if a
person cannot afford to get to the testing site, the investigators should offer money or
financial means; basically you are leveling the playing field so that it is more diverse and
inclusive; you do not take advantage of the disadvantaged population; recruit participants
from all walk of life
What populations are covered under the FDA? people who are mentally challenged or
are mentally institutionalized
Resources to use for research: PubMed, Cochrane Library, Scopus
When working with patients, systematic reviews are a good place to start, but you must
be careful
Year of publication if it not very recent, it won’t have latest information; highly
subjective and dependent on the fields
Since it is not really data driven, it is driven through what others have done and the
investigators may or may not have gone into more or less detail, it is just dependent on
the investigator(s); generally have 100-200 articles cited
Research proposal: looking for a lot in terms of the experiment and presentation the
background, budgets, justification, personnel, space, timeline, how you are going to do
it,; how much brain goes into conducting research; how are you arranging for the
research; HAVE A KICK ASS METHODOLOGY NO MATTER WHICH ONE YOU
DO