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86 Cards in this Set
- Front
- Back
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Views on quality depend on ___________of the patients who use treatments
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perspective
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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 |
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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 |
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________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 |
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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 |
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Qual Research Techniques
Three data collection techniques |
Observation
Interviews Document Review |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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__________
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 |
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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 |
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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 |
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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 |
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________
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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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________– 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 |
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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 |
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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 |
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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 |
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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
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___________
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 |
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____________
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 |
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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 |
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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 |
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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
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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 |
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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 |
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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 |
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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 |
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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 |
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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
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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
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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 |
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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 |
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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 |
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Obligation of the Respondent
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Honesty
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