Study your flashcards anywhere!

Download the official Cram app for free >

  • Shuffle
    Toggle On
    Toggle Off
  • Alphabetize
    Toggle On
    Toggle Off
  • Front First
    Toggle On
    Toggle Off
  • Both Sides
    Toggle On
    Toggle Off
  • Read
    Toggle On
    Toggle Off
Reading...
Front

How to study your flashcards.

Right/Left arrow keys: Navigate between flashcards.right arrow keyleft arrow key

Up/Down arrow keys: Flip the card between the front and back.down keyup key

H key: Show hint (3rd side).h key

A key: Read text to speech.a key

image

Play button

image

Play button

image

Progress

1/86

Click to flip

86 Cards in this Set

  • Front
  • Back
Views on quality depend on ___________of the patients who use treatments
perspective
Qual Res gives us a variety of methods to help us
1)identify patient and provider _________,
2) identify _________to changing practice,
3) Offers ___________to the development of “ contextually grounded, culturally sensitive” res projects that inform our clinical practice
preferences

obstacles

“unique” contributions
Qualitative
Historically, qual methods have been views as a way to enhance the quality of __________
Now, qual methods are seen as ends in themselves, providing info to ______________.
Qual res philosophy diff than Quant (_____________)…Differs in purpose of research, use of lit review, level of investigator involvement
Quant projects
impact treatment process
single objective reality
________philosophy is one that supports the idea that:
_________meaning and interpretations are what decisions are based upon
It is generative…meant to offer __________and explanation
Qual res
subjective
description
Indications for Qual Research
*The level of knowledge uncovered in your lit search often establish ________for your study design
*____________for the background of your study may be indicative of the need for qual res
*Qual methods are often used as the “_________” in a new area of inquiry
*How so? Example, focus groups and observ, may uncover variables and their roles …________can then be based on these existing variables
*Used to “_________” when used in conjunction with other methods..mixed methodology
*See top of page 101- Indications for Qual Res…
rationale
Lack of literature
first steps
exper design
augment or enhance study
Qual Research Techniques
Three data collection techniques
Observation
Interviews
Document Review
Qualitative Res Techniques
Observation is central to _____________
Observe what they do…describe and interpret what has been observed
Often ____________ responses are diff than what people actually do…
understanding behavior

questionnaire or interview
Observational Methods Vary in distinct ways
1) __________- Participant Observer
2) based on the ____________the researcher is involved
3) conducted with or w/o subj awareness/permission..________
4) may be limited to specific area of _________
Classic Fieldwork

length of time

hawthorne eff

inquiry
Interview
Different interview strategies are avail
__________- Highly structured and directed vs unstructured and non directed
__________, probes for content, recall strategy will effect quality and quantity of information received.
Unstructured in _________ stage, structured during later stages
__________ interview is popular
6-10, open, agenda set, richer (more depth ) in exploration
Remember, this (interview) method is also a good way to identify __________that may be used to study a particular topic
Indiv

Active listening

exploratory

Focus groups

variables
Qual Research Techniques
_________
Involves organizing and evaluation of a body of existing information for combination with other data; or as a stand alone data source.
____________can range from formal to informal
_________- objective reports, patient records
_________- info from personal notes or calendars
Some comments found in documentation are less formal (or not directly related to the research question) MAY require conceptual translation
Document Review
Documents
Formal
Informal
Qualitative Research
_____________
Qual Research requires constant __________..Field notes and trigger notes are used,
Recording on subjective experiences during data collection also impt
___________means to capture interview or observation are ok
____________are equally impt
Audio can’t capture nonverbal
____________is expensive/hard to analysis
Data Management
recording
Electronic
Nonverbal and verbal
Transcription
Qualitative Research
____________
Do not have to have all data collection completed prior to beginning
___________..coding for initial categories and themes
Develop concepts/categories
Sort and re categorize, will have themes evolve to support theory
____________, how categories may link to one another
____________used…generation of new theory or understanding is the goal of qualitative inquiry
The use of literature MAY become heavier at the end of the project
Keep working until you feel the theory that has been developed fits the data and conceptual framework.
Data Analysis
Segment data
Contextualizing process
Inductive theory
Qualitative Research
_________is subject of debate in qual research
Strategies:
___________is a safeguard- Multistrategy approach
(Ex. Open ended interviewing WITH observation)
Need to work out issues of logistics and resources
___________- Informant review (they review researchers conclusions)
_____________- systematically test theories and look for alternative explanation…monitor your data for cases that don’t fit their theory…
Uses of __________(outside opinion) is not unusual..can they find fit with the raw data and your categories? Inter-rater reliability
____________researches must describe (in detail) their methods/process.
Validity

Triangulation

Validity Check

Researchers’ critical appraisal skills

colleagues

Qualitative
Community Based Participatory Research (CBPR)
An approach to RESEARCH designed to “___________”.
How? Through the establishment (*and ________) of community partnerships
Not the “___________” clinician researcher coming into the community, but a partnership approach to benefit community partners, community based organizations etc.
promote community

maintenance

all knowing
Why does this WORK?
The __________approach creates a well needed “________” between communities and researchers
Incorporates local knowledge and local theory
Culturally relevant measurement design and instrumentation
Partnerships ultimately ENHANCE _________and _________of Findings/interpretation
partnership
BRIDGE
quality of data
VALIDITY
CBPR
CBPR is
Designed to be
-____________
-emphasize co-learning/reciprocal transfer of ___________, and ownership of process and product
-ensure and structure ___________ by those being affected
-increase the _______ of studies for community and researchers
- ask impt ?s to _________, not just clinician
-use reasonable and authentic __________

ALL of this will require strong partnerships (lay community members, health dept reps, researches, CBO reps)…must all participate and ___________control over all __________of the research process
collaborative
expertise
participation
value
community
methods

SHARE
PHASES
CBPR PHASES
*Identifying ________
*Assessing _________ strengths, assets and challenges
*Defining __________
*Developing research and _________
*______________data
*______________findings
(Disseminating of findings
*Applying the results- to address ______________thru action/intervention;(Can be individual-level change interventions, community-level and policy advocacy)

The Hallmark of CBPR is the “ _______________”…must improve the health status of ___________, not just gain knowledge for knowledge sake

See ADVANTAGES page107 Table 8-1
research questions
community
priorities
data collection methodologies
Collecting and analyzing
Interpreting
community concerns

Transformation of findings into action
community members
RESEARCH PARADIGMS
____________- Set of basic beliefs about the nature of reality which can be studied and understood.
______________- A single reality on how things work exists to be studied and understood
_______________- single reality can be fully captured, reflects in experimental research designs, used in science
_____________-single reality can only be approximated, reflected in quasi experimental design, used in social and behavioral health
_____________(betw res and participants) are impt to validity
Paradigm
Positivist and Postpositivist
Positivist
Postpositivist
Objective detachment
Research Paradogms
CBPR is aligned with ______________(multiple realities, intangible construction and rooted in everyday experience)
_______________– indiv constructions of reality “informed rather than true” and are alterable…
Researchers and Participants must be interactively “__________”, so consensus construction [of reality] is created as the study happens…
If you are a researcher using CBPR, you are in a dual role……Participant and Facilitator
constructivist research paradigms

Consensus construction

linked
Common Research Methods
There are basic partnership principles and values that CBPR rely on
*Form and informal __________and structures
*Build and maintain _______
*Agree on values, ________and obj of research
*Balancing _______and sharing resources
*Sharing __________
partnership networks
trust
goals
power
credit
Clinician is armed with ___________but can’t forget that community members and reps from CBO’s have perspectives that are also useful for inclusion during the research process
CBPR can be infused into any __________. Your text demonstrates its use in at least 4 methods
intellectual resources

research methodology
Common Research Methods
AOCD- ____________
It’s purpose-To understand the health status, dynamics and relationships with the community.
To understand the interaction between community members and “_____________” which impede or promote the conditions and skills required to assist those members in making decisions
AOCD may serve as a critical first step in program planning, intervention and evaluation…it may serve as a process for ____________- but goes beyond traditional needs assessment
Looks into the assets and strengths within a community or a ___________approach….(deficits based approach does NOT do this)
Action Oriented Community Diagnosis

broader structures

needs assessment

strengths-based
CBPR within AOCD
Like ALL methods that adhere to CBPR, AOCD begins with a working collaborative relationship with _________
*Community data review and windshield tour of community
*After tour (and throughout AOCD), researchers document experiences using _________
*Field notes are multi purpose- Track perspectives, impressions, frustrations..record names and places etc…notes of research efforts
*Since researchers tend to be so diff from the communities they research (___________) they need to gain an emic (an insider’s perspective on how they live and what their issues are)
*All kinds of information (esp secondary) must be explored and analzed…requires use of insiders and outsiders
*AS with CBPR, must reach the hallmark, to move twds change through some kind of ____________
community members
field notes
fish bowl scenario
action or intervention
CBPR with in AOCD
More about AOCD
AOCD will rely on a community forum to present to “_________” the findings of a research process
*__________is meant to encourage dialogue
Often emic and etic perspectives are explored and done so via ___________
Some qualitative methods are:
__________
Photovoice
In Depth Interviews
*Data analysis software may be used (____________)
influential advocates
Forum
qualitative methods

Focus Group
ethnograph
CBPR
How to get started?
To be able to establish partnerships, values and principals…you must ____________first
Networking is essential. Identify _________, investigate issues from various perspectives, build trust
Stakeholders are often __________to comm members.
Try multiple points of ______…local school system, boys and girls clubs/service agencies, etc..
NETWORK
stakeholders
gatekeepers
entry
How do start a CBPR?
Build _______
They have been “________” before as living laboratories
You, the researcher, may want to put in some volunteer time
Serving on local health coalitions are good ideas too
You build community trust by ________
Don’t forget..building trust includes building relationships
Maintain ___________
Do not take partnership for granted
Keep them informed
Explain steps processes (i.e. IRB) and delays
Negotiate ____________
Explore community priorities and perspectives. Don‘t fix without asking
You may have to provide data to increase awareness
Be careful with agendas…whose are they and what do they say?
May have to begin with health coalition
Trust
burnt
association

Relationships

Partnerships
Things you need to know about Data Analysis
You must make decisions about data analysis ________to data collection
Data analysis planning is part of ____________
Pay careful attention to the type of research being conducted and the type of data produced by the investigation
As a PA, ____________is a KEY part of your interpretation of medical literature
You may not see the relevance now, but you will later if you do not learn basic statistics and data analysis methods
PRIOR
research methodology
understanding data analysis
Objectives when evaluating data analysis of a research study
Be familiar with the ___________ in the study
Be familiar with the most common __________
Understand the rationale behind the selection of _________
Understand how specific analyses test the study’s hypotheses


Do NOT be afraid to consult a statistician, in fact, it is recommended (pg. 125)
types of data produced
statistics
statistical analyses
What test do I use
The first step in deciding on the type of statistical analysis is determining the ___________
The higher the level of measurement, the ________info that can be ascertained from the data
See figure 9-1 page 121 AND see handout
______- Only descriptive summary
_______- Des or non parametric i.e. Likert scale
There is a real debate over whether these numbers can be analyzed using tests traditionally designed for ratio and interval
__________- Des or parametric
Lets look at page 127…
level of measurement
more

Nominal
Ordinal
Interval/ratio
What test do I use?
The second step- Is your data _______________?
* parametric(normal) and non parametric describe the distribution of the ________ or variables. _________ data are always considered to have a normal distribution.

The third step is to consider the _________of your data. Are results paired or matched?

The Fourth step the ________ of variables. How many do you have. The number of IV and DV also impact test you chose

The Fifth step…What are you trying to explain?
____________or difference
parametric or non parametric
subjects
Continuous

relationship

number

Relationship
Statistics
___________- measures of central tendency, measures of variability (range, std dev and std error of the mean)
_____________-Start with the basic, “What is the hypothesis? 1) A relationship or 2) a difference between variables
There are HUNDREDS of statistical tests
What test to use is the Big Question!
See decision tree Figure 9-12 and review handout chp
Descriptive

Inferential statistics
What do we remember about Inferential statistics?
Tools we use to draw ________ about the results (the test of hypothesis)
It is based on the testing of a _____________
___________ testing is key
All the steps of hyp testing are important. Remember the steps (5)?_____________
Hypothesis testing on nominal data uses __________
Chi Square test (Determine whether an event has occurred more frequently than it would be expected to occur by chance).
___________studies used nominal data to produce incidence and prevalence rates
inferences
null hypothesis
Hypothesis

(est hyp, alpha, test, conclusion, p values)

Chi Square
Epidemiological
Measures of Association
Can only be used to determine relationship between two continuous (interval or ratio) variables
__________, interpret it and test of significance
____________ techniques also allow for relationships among variables to be examined
IF you recall, regression is based on the concept of ___________
Remember your other tests, one sample and two sample tests, as well as multi sample or multi group tests (ANOVA) and post hoc tests)
Remember.. The results of your analysis will allow you to extrapolate your finding to a population or groups within a population
Pearson R
Multivariate Regression
prediction
What do you do next?
After selecting design and data analysis method…you run the test
Then you need to report and interpret your results
Results of a study are presented in the _______ of the text, tables, figures and charts
Extensive results are BEST presented in _________ form, least comprehended in written form in the body
________ provide the middle ground and should be able to stand alone. You must describe them in the body of the text.
body
graphical
Tables
Results
One of the more impt parts of the research report.The “_______” of the report
Key ________ must be presented clearly in logical fashion
Author indicates whether the _________ was supported or rejected
Previous sections of report build up the anticipation
________and only the facts
meat
findings
hypothesis
Facts
Interpretations and conclusions need to go elsewhere
Opinions need to go elsewhere- Discussion section
_______ section should be neutral in every aspect, free from conclusions
The use of _________ is advised
The ______ part of the research report
Needs to be written clearly and succinctly
Needs to be written in _____ tense for experimental or quasi-experimental,
Needs to be written in _____ tense for descriptive studies
Results
Graphs and Charts
shortest
past
present
Results
For ethical purposes, all _________ should be reported, not just those supporting the hypothesis
Information or description of what was done go in Materials and Methods section and NOT in the Results Section
Do not make the mistake of reporting ______ data, rather than to summarize and present findings,,,you are to provide a picture of the data for the reader.
Results that are ambiguous or which leaves the reader to determine the ______ of the data are not what you want to display.
Remember, your results should offer up evidence that supports or doesn’t support the research hypothesis….the reader should not have to wade through this.
key findings
raw
meaning
Results
How do you start
Begins with description or profile of subjects..include _________
Use #s % and central tendency measures to describe the study sample
After you describe the sample used in study, you need to report the results of the statistical analysis
Make sure you do so with ________ so the reader can assess what you did
For _________ Research- use freq, range, and measures of cent tendency
For _____________- use associational or inferential stats, include the test statistic, the direction and level of probability..some now advocating to include confidence interval info
demographics
detail
Descriptive
Experimental (or Quasi)
Results
Be careful using the word _________.
Significant can mean statistically significant or clinically significant
Only significant if statistics support that judgment
Include ________ for why you chose the statistical procedure, best to include in _________
Assume that readers have knowledge in stats, don’t insult them
Indicate which hyp were supported…the null or the alt
Do not explain or interpret why the hyp were or were not supported, let the data speak for itself
Your conclusions regarding these results should be described in the “_______” section of your work
significant
rationale
methodology
discussion
Results
Tables and figures as essential for ________ and brevity..exp when numerical data needs to be presented.
Software programs are great, excel and spss
Don’t start off with topic sentence “Tables 1 presents…”
Tables useful to describe study sample, show ________and compare groups
Tables should be clear enough to stand alone without text
Include all relevant info for the type of tat you are reporting (test statistic, p value, df)
Seek page 135 for additional guidelines (Box 10-1) for tables, (Box 10-2 for graphs, p 136)
Advantage of ______ is that a large amount of data can be presented in a small print space
clarity
correlations
tables and figures
Results
Variety of choices, line graphs, scatter graphs, histograms, pie charts
_______graphs to show relationships (between to quan variables)
_______and histograms, used to plot freq distributions
Remember the difference in bar graph and histogram
Know where to put the dep and the indep, the x and the y
Use color to contract between bars or other graph or table features
Check your font type and size
Make sure your axis is well labeled
Double and triple check your numbers
Do your tables and graphs present your results accurately and clearly?
Line
Freq polygons
Discussion
This is where you state your:
__________
You can have subsections in the discussion paper for _______, conclusions, implications, interpretations, _________ and a closing
interpretations,
Conclusions and
Opinions

summary
recommendations
The discussion should center on the importance of the results AND their _________ to patient care, as well as society, education or the profession
The _________ discussion section of a research report covers the following area:
Implications, ___________, discussion, __________, recommendations and conclusions
The order of SUBsections can vary
APPLICATION

TRADITIONAL
limitations
bias considerations
Discussion
__________
This is where you explore the meaning of research results
Think critically about the research results and draw/make ____________
Remember, even with out statistical significant findings, there is still meaning to the research effort. ---Why and what does this mean?
Implications
inferences
Discussion
Implications in a study may point out the ________ values of a finding or the need for replication of the study or ________
Your arguments should be ________ if you are contradicting accepted dogma or theory
Be __________in listing implications and recommendations in some cases (i.e. r=.70, but r2 is .49)
Think about (and write about) your implications with regard to the literature reviewed, current theory /practice and the framework of your research study.
Implications should have ________significance and be clearly supported by the research findings
potential
modifications
rational
conservative
practice and clinical
Discussion
_____________
Impt bec it gives a picture of the study’s defects or weaknesses
Limitations should be considered in light of the overall ________of the study.
________ in the methodology..such as the sample size limited by a variable unforeseen
Best to put the limitations in front of the reader to give your conclusions credence
You need to be able to state clearly whom and in what situation your findings can be applied.
Is the sample representative?
Limitations
worth
Flaws
Discussion
Limitations…other things to discuss
Discuss the _________ if the sample selection
Can the data be generalized to the entire population
Discussion of errors in data _______
The level of data quality
Any intervening variables or _______?
Level of statistical significance….practical or clinical implications of this?
This section must be honest and forthright about all the shortcomings or weaknesses
randomness
entry
hawthorne effect
Discussion
___________
To avoid bias, make sure you write out your hyp before hand
Maintain your ___________
Concentrate on the process and methodology of the study
If the process is sound, results will be sound
Be careful not to give too much _________ to the subjects, they may want to please you (hawthorne)
When collecting data, be careful NOT to influence the study’s outcome
Ways to prevent bias are random selection/ assignment, control groups, ________ studies etc.
Bias Consideration
objectivity
attention
double blind
Discussion
_________
States your ideas on what future research is needed based on the outcomes of the current study
New data collection technique? New instrument, larger sample, etc
Purpose is to alert the reader that more?s need to be asked or answered
Don’t put too many recommendations so that you ________ the lead one
Strive for “(3)” (blessing, 2006)
Recommendations
obscure
****
1.relevance,
2.clarity and
3.brevity
__________
Last section of the paper
It is brief
Begins with brief restatement of the aim of the study and major res ?s
Then state the major ________ of the study (bullets or numbers to separate each)
Point out same findings as other research or not
Restate the strong and weak points of the research…becareful with redundancy.
Much like a _________, but with more detail.
Avoid Pitfalls, page 143 11-2
Conclusions
findings
closing abstract
Bibli and Ref
Most places have a technical style manual requirement for papers
Publishers require manuscripts that follow a style, found under “________”
APA, MLA and CHI (Chicago Manual of Style)
Differences between these styles are vast, ie. box 12-1 page 146
____style is often used for medical publications
Once you have identified the style you are to use, follow it exactly
Invest in a style guide
___styles is widely used in the social sciences and it is what you will need to use in this course
___is used by teachers of English, or in the humanities (parenthetical notes)
_______ style is popular for newspapers and magazine but also many scholarly and non scholarly publications (uses footnotes)
information for authors
AMA
APA
MLA
Chicago
Bibli and Ref
Buy the manual or an abridged handbook
The ______ Handbook
The ______ Writers Handbook
Adv are compact and handy
Disadv limited _____ and amount of info limited
There are lots of different writing style manuals
http://www.library.fordham.edu/researchguides/guides.html
Ask your university, mentor etc about the appropriate author guidelines and style requirements BEFORE you do your research and writing.
Brief Holt
Thesis
scope
Documenting Sources Using Ref and Bibli
Since much of the info gleaned in a lit search uses backgrd materials representing other people’s work, you must ________
Whether direct quote or paraphrased, you must ______
If it is not ________ knowledge, you must document
The way you document each citation is determined by the editorial style you are using
Two ways to document
1) At the end of each page or chapter, by the use of citations in the form of __________
2 )Listing the source of info used by a bibliography. The bibliography is at the ___of the manuscript
cite it and give credit.
document
general
footnote or endnotes
end
________
End notes and footnotes seem to be giving way to the bibliographic format in many scientific writings
All works used as ________ material in the construction of the paper need to be properly documented
The bibliography (also referred to by some as references or selected bibliography) is arranged ________ by first-author names.
There will be slight differences in format, depending on the style being used
Again, CONSULT the specific style guidelines to determine the proper format
The bibliography should contain enough info in each citations for readers to be able to locate the source if need be
Bibliographies
reference
alphabetically
Text mentions two variations of bibli 1) _______(authors comments to be appended to any of the entries in the list) and 2_ ______entries by source, primary, secondary, published and unpublished ..
Remember, ________ sources are those which are original first hand work…book or video
Secondary sources are derived from primary sources and contain “________” comments from others who are knowledgeable about the subject..secondary sources can be in many forms, such as ____________.
For this paper, you will use APA referencing per manual’s instruction
Remember that bibliographies are useful in getting background info…or topic searches will lead to authors in that area
Annotated
Grouping
Primary
critical
article,case studies or books
General bibliographies are available, such as ________- can be a starting place to locate other sources of info. Not a good tool for graduate work and above (too generic written for layman)
_________ direct reader to more in-depth sources in particular subject areas that you might use. A valuable resource for clinicians in clinical research
Books in Print and the Bibliographic Index

Index Medicus
Material in _______ domain can be used without permission, but should be acknowledged as a source..PD- Material that has not been copyrighted or for which the copy right has expired.
Public Domain works are those “Creative works that are ____________”
Anything before Dec 31, 1992 are in PD..complex after this!
Copyrighted materials requires permission of the copyright holder be obtained PRIOR to use in the material..one exception to this statement is a provision called “______”
public

not protected by copyright and may be freely used by anyone

fair use
The __________ Act is a comprehensive law that deals with the legalities of using copyrighted material. Material may be used without permission of the holder for certain specific uses. These uses are referred to collectively as fair use. …
$_______ for copyright violations
The specific outlines of circumstances that constitute fair use are vague. However, research, teaching and new reporting are mentioned and included in the “fair use” application
Good faith fair use
Fairuse doctrine found at
http:// www.utsystem,edu/ogc/intelelctualproperty/copypol2.htm
Tutorial on FAIR USE
For more info on copyright http://www.copyright.gov
1976 Copyright
$150,000
Evaluating Sources
Remember, its not quantity but _______
Is your source authorative? Credible author
Current trends or theories? Don’t forget _________
Where and when was article published? Peer reviewed?
Prestigious Journals?
Not everything on the internet has values
Question its purpose on the net
Be compulsive in the area of bibliography and reference…it has to be accurate.
Always cite only ______ sources that you have checked and read
quality
classic works
original
________– a discipline which seeks to understand the moral duties and obligations that associate with any action
Ethics in medicine a factor- _____ medical experiments
Do no Harm
Respect Human Rights
Have you thought about what it means to be ethical in the practice of research?
The ethics of RESEARCH is to “consider the ______ of science alongside its ________”
Ethics and research- Consider your _______ action as you search for knowledge
Ethics
WW II
affective dimension
intellectual rigor
moral
The values that surface as impt to researchers are: ________, ________, ________, altruism, respect, prudence, justice, equality, and fidelity…intra or interpersonal aspects of personal functioning..
Other good values that shape good practice, page 177….
There is an __________ dimension of science
Honesty
beneficence
intergrity

Affective
Research Ethics
Ultimately, the goal of ethics in research is to ensure that no one is _________ from research activities.
As research is designed, several ethical considerations must be balanced:
Protect the ______ of the participant or subject.
Ensure the ________ receives ethically conducted and reported research.
Follow ethical standards when designing research.
Protect the safety of the researcher and the team.
Ensure the research team follows the design.
harmed or suffers adverse consequences

rights

sponsor
Ethical Principles
Three Ethical Principles Guide Research with Human Participants


There are MORE we will discuss, p 177
1) Respect for Persons
2) Beneficence
3) Justice
Respect for Persons
Requires investigators to obtain _________ from research participants, to protect participants with impaired decision making capacity, and to maintain confidentiality
Research participants are not passive sources of data, but individuals whose rights and welfare must be respected.
informed consent
___________
Requires that the research design be scientifically sound and that the risks of research be acceptable in relation to the likely benefits
Risks to participants include (not only physical harm from tests or treatments) but also _______harm, such as breeches of _________, stigma and discrimination
The risks of participating in the study can be reduced for adverse effects, using data from procedures that are carried out in the course of clinical care, and monitoring participants for adverse effects
Beneficence
psychosocial
confidentiality
____________
Requires that the benefits and burdens of research be distributed fairly
Requires equitable access to the benefits of research
_________ populations, such as people with poor access to health care, those with impaired decision making capacity and the residents of nursing homes, may lack the capacity to make informed or free choices about participating in research
No matter how attractive they seem, vulnerable populations should not be targeted for research if other populations would also be suitable.
Justice
Vulnerable
So what is the problem?
Historically, Clinical Research has been thought of as ________and potential subjects have been thought of as “_________” needing protection…
Now, it is regarded as providing access to potentially life saving new therapies and patients seek out promising new drugs and to participate in research asking for increased access to clinical research and certainly not _________
risky
guniea pigs
PROTECTION
Obligations of the Client
Protect rights of ____________ of the subjects
Follow medical ethics in their relationship with the researcher
Provide full information to the researcher about the objectives or problems to be studied
Encourage the researcher to objectively seek the _______
Do not overstate or _________ the results
confidentiality
truth
misrepresent
Affect vs Cognition
Science demands affect and cognition from its ________…often in equal measures.
Examples of situations that may involve value conflicts are endless.
Lets go over some of the scenarios we MIGHT encounter….Page 176
practioners
Federal Regulations for Research on Human Subjects
_________ regulations are intended to ensure that clinical research is conducted in an ethically acceptable manner
Federal regulations provide 2 main protections for human subjects, _________and __________.
Regulations apply to all federally funded research and that submitted to the FDA in support of a new drug or device.
Many universities require that all research on human subjects comply with these guidelines
Federal
IRB approval
informed consent
Federal guidelines distinguish ________(that to contribute to generalizable knowledge) from unproven clinical care that is directed toward benefiting the individual patient and not toward publication
Research is also distinguished from ______ that will not be applied in other settings
If YOU have questions about fed regs, check with your institutional review board (IRB) to or go to the web of the Office of Health Research Protection (OHRP ) within the Department of Health and Human Services
research
program evaluation
IRB
Fed regulations require that research on _______subjects be approved by an IRB. IRB systems are decentralized
The IRB mission is to “ensure that the research is _________ and that the welfare and rights of research participants are ________”.
Most of the members of the IRV are researchers, they also include community member and those knowledgeable about legal and ethical issues concerning research, esp medical research
human
ethically acceptable
protected
Ok, but what does the IRB actually Do?
It has the authority to approve (or deny) research study and the IRB must determine the following for EACH study
1) ______ to participants are minimized
2) Risks are reasonable in relation to anticipated ______ and the importance of the knowledge that may be expected to result
3) Selection of ________is equitable
4) ____________ will be sought from participants or their legally authorized representatives
5) __________is adequately maintained
Risks
benefits
participants
Informed consent
Confidentiality
The Cons of IRB
Some criticize them for focusing too much on ________, like consent forms rather tha research design
A common criticism is that the fail to scrutinize the research design and review of scientific merit is usually beyond the expertise of IRBs (in some places) and is often left to the _________
They (IRBs) also do not check to see that the research was actually carried out in accordance with the approved protocols.
Many IRBS (not all) seem to lack the resources and the expertise to protect __________).
For these reasons, federal regs and IRB approval should be regarded only a minimal ethical standard for research.
procedure
funding agency
research participants
Character? Does it have its place in Medicine?
Many feel that it is ultimately about the judgment and character of the _________(researchers) which is the most essential element for ensuring that the research is ethically acceptable.
WHAT DO YOU THINK? AGREE OR DISAGREE?
investigator
Exceptions to the IRB Review
What Research is EXEMPT from IRB Review
(See pg 191)

What is __________? There is a list of types of research that are eligible for expedited review (review by a ________ rather then the full committee) published by the Department of Health and Human Services
expedited review
single reviewer
Obligations of the Researcher
Protect the ___________of the subjects and client
Provide subjects informed choice to participate (________)
Follow medical ________ in their relationship with the client
Do not appropriate ideas from other researchers’ proposals
Do not misrepresent sales tactics as marketing research (illegal as well as unethical)
Use deception only when necessary
Maintain high research standards to ensure data are accurate
Do not overstate the significance of the results
rights of confidentiality
INFORMED CONSENT
ethics
Scientific Misconduct- Other Responsibilities of the Researcher
There are many levels of __________ and many behaviors considered worthy of this labels (ie. Enrolling ineligible patients in clinical trials, making up research data, altering research data to produce favorable results)
However, the Federal Gov’t has proposed to define research misconduct narrowly as _________, ________and plagiarism
misconduct
fabrication, falsification
SCIENTIFIC MISCONDUCT
__________- MAKING UP RESULTS AND RECORDING OR REPORTING THEM
_________- MANIPULATING RESSEARCH MATERIALS, EQUIPMENT OR PROCEDURES OR CHANING OR OMITTING DATA OR RESULTS SO THAT THE RESEARCH RECORD MISREPRESENTS THE ACTUAL FINDINGS
__________-APPROPRIATING ANOTHER PERSON’S IDEAS, RESULTS, OR WORDS WITHOUT GIVING APPORPRIATE CREDIT
FABRICATION
FALSIFICATION
PLAGIARISM
Conflicts of interest
RESEARCHERS MAY HAVE CONFLICTING INTERESTS THAT MIGHT IMPAIR THEIR ___________
Some potential types of conflict of interest are:
1) ________for clinician-investigators
2) ________conflicts of interest
Researchers can chose to respond by eliminating the potential for bias, or just avoiding the situation entirely because the potential for conflict is so great.
OBJECTIVITY AND UNDERMINE PUBLIC TRUST IN RESEARCH

Dual roles
Financial
Deception is sometimes used in research. It is allowed if the information is critical, and there is no other way to gather the necessary data.
If deception is used,
1. The researcher must ensure that _________will result from the deception, and
2. The researcher must take personal responsibility for informing the respondent of the _________ after the research project ends.
no physical danger or psychological harm

concealment or deception
Informed Consent
Researchers must disclose information that will be relevant to the potential participant’s decision about whether or not to participate
Some crucial questions are?
Why is the research being done?
What will participants do in the course of the research?
What are the risks and benefits of participating? (Concept of _________ is in play)
minimal risk
Minimal risk?
Plays a key role in _________
Minimal Risk is defined as that “__________” encountered in daily life or during the performance of routine physical or psychological tests.
The ________ and probability of risk must be considered
federal regulations
ordinarily
magnitude
Informed Consent
You must address these areas with potential participants
1) The _______ of the research project
2) The ________ of the study
3) The _______and potential benefits of the study…and the alternatives to participating in the study
4) Procedures to maintain ________
5) Assurances that participation in the research is ________
6) Consent Form
7) Subjects who Lack decision-making capacity
nature
procedures
risks
confidentiality
voluntary
Vulnerable Populations
The following should be subjected to additional scrutiny
1) ________
2) Prisoners
3) _________, fetuses and embryos
4) People with impaired decision making capacity
Children
Pregnant women
Obligation of the Respondent
Honesty