Day 2: Starting a Project and Protecting Human Subjects
Transcript of Day 2: Starting a Project and Protecting Human Subjects
Day 2: Starting a Project andProtecting Human Subjects
Daniel J. Mallinson
School of Public AffairsPenn State [email protected]
PADM-HADM 503
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Road map
Questions about course
Research process
Ethical research practices
Institutional Review Board
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Why do we research?
Figure: Research by Nick Youngson CC BY-SA 3.0
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What is research?
Inquiry and knowledge production
A process of discovering new knowledge
Elements of research:1 Theory development and testing
2 Empirical inquiry
3 Sharing your new knowledge!
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Philosophical Approaches
Positivism
A macro-level view of human behavior, focusing on institutions insociety; prefer a scientific (i.e., quantitative) approach to research
Interpretivism
A micro-level view of human behavior, focusing on individuals insociety (not equally responsive to social phenomena); humanbehavior can’t be explained through quantification
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Two (Three?) Purposes of Research
1. To find out basic truths, or understand better how societyworks; knowledge for knowledge’s sake (basic research)
Examples: understanding why some people vote and others do not
2. To answer practical questions and support informeddecisions (applied research)
Example: A study of different voting machines in order to identifyease of use and/or incorruptibility
3? Translating basic science into practical applications;explicit ties between basic science and application(translational research)
Example: Studying outreach campaigns designed to increase voterturnout
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Two (Three?) Purposes of Research
1. To find out basic truths, or understand better how societyworks; knowledge for knowledge’s sake (basic research)
Examples: understanding why some people vote and others do not
2. To answer practical questions and support informeddecisions (applied research)
Example: A study of different voting machines in order to identifyease of use and/or incorruptibility
3? Translating basic science into practical applications;explicit ties between basic science and application(translational research)
Example: Studying outreach campaigns designed to increase voterturnout
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Two (Three?) Purposes of Research
1. To find out basic truths, or understand better how societyworks; knowledge for knowledge’s sake (basic research)
Examples: understanding why some people vote and others do not
2. To answer practical questions and support informeddecisions (applied research)
Example: A study of different voting machines in order to identifyease of use and/or incorruptibility
3? Translating basic science into practical applications;explicit ties between basic science and application(translational research)
Example: Studying outreach campaigns designed to increase voterturnout
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Deductive and Inductive Strategies
Deductive: Theory comes first!
If we do not have a theory, how can we conduct research?
Inductive: Empirical investigation comes first!
First collect data and analyze it. Develop a theory based on findings.
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Deductive and Inductive Strategies
In real-life research, the two strategies may be mixed.
Science is an iterative process
In this course, we will follow primarily a deductive strategy
Why? Deductive strategy is more pedagogically sound
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Four Important Reminders for ConductingResearch
1 You must have a theory or model of the topic you want toinvestigate [deductive]
But, your model may change during the research process[inductive]
2 You must use procedures (rules, protocols) accepted by scientificacademic community [deductive]
3 You must conduct research in an ethical manner and take pridein doing quality work
4 You need to be creative and have tolerance for ambiguity anduncertainty [inductive?]
#2 (using procedures) and #4 (creativity) may be in conflict
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Four Important Reminders for ConductingResearch
1 You must have a theory or model of the topic you want toinvestigate [deductive]
But, your model may change during the research process[inductive]
2 You must use procedures (rules, protocols) accepted by scientificacademic community [deductive]
3 You must conduct research in an ethical manner and take pridein doing quality work
4 You need to be creative and have tolerance for ambiguity anduncertainty [inductive?]
#2 (using procedures) and #4 (creativity) may be in conflict
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Steps in a Simplified Process of Research
1 Select a research topic and determine the purpose of yourresearch
2 Design the research project
3 Measure (or observe) variables
4 Conduct analyses
5 Interpret and communicate your results (typically in a writtenreport)
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Steps in a Simplified Process of Research
1. Topic and purpose
How do you choose a topic and purpose for your research?
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Steps in a Simplified Process of Research
2. Design the research project
Formulate (a) research question(s)
Specific, feasible, guides project
Choose a research strategy: explanatory or descriptive
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Steps in a Simplified Process of Research
2. Design the research project (Explanatory)
1 Develop a model
2 Formulate hypotheses
3 Operationalize variables
4 Develop a strategy (procedure) for measuring (or observing)variables
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Steps in a Simplified Process of Research2. Design the research project: Models
Types of Models
1. Schematic models (figures)
Figure: From by Plutzer, Honaker, and Berkman
2. Symbolic models (equations, words, and algorithms)
Y = a + b1X1 + b2X2 + b3X3... + bnXn (1)
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Steps in a Simplified Process of Research
2. Design the research project: Models
How to build models:
Ideas
Peer interaction
Literature review
Manipulating a data set
Pilot testing a model
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Steps in a Simplified Process of Research
2. Design the research project: Models
Model components:
Elements: variables and constants
Independent and dependent variables
X–Y models and If–Then sequence
Control (intervening, confounding) variables
Hypothesized relationships: covariation (direct, inverse,nonlinear)
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Let’s Practice!
Consider car accidents in the United States. Get into groups of fourand do the following:
1 Identify four variables linked to car accidents
2 Create a preliminary model of automobile accidents. Sketch aschematic model that incorporates your variables.
3 State hypotheses to relate each independent variable in themodel to the dependent variable.
4 Consider how your model could results in a policy or policiesthat would reduce car accidents.
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Steps in a Simplified Process of Research
2. Design the research project: Hypotheses
They define the expected relationships between variables
They should be specific and measurable
We will discuss this in the coming weeks.
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Steps in a Simplified Process of Research
2. Design the research project:
Operationalize variables
Develop a strategy (procedure) for measuring (or observing)variables
We will discuss these topics in the coming weeks.
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Steps in a Simplified Process of Research
4 Measure (or observe) variables
5 Conduct analyses
6 Interpret and communicate your findings (typically write areport)
We will discuss these topics in the coming weeks.
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Your Own Research Project
Any topic of your choosing
Need to find secondary data (discussed next week)
Need to pair your thinking of a topic and data
Worksheet to get you thinking due September 17
See Canvas for relevant instruction files
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Break!
Figure: Coffee Pause by Gerd Altmann CC0
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Ethics in Research
Issues to Discuss1 Protecting human participants of research against any harm
(physical, psychological, or reputational)
2 Being truthful in the conduct of research and whendisseminating its results
3 Giving credit to those who deserve it
4 Transparency and data sharing
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Why Discuss These Issues?
The principles we will discuss in this class are ethical issues, and
there are legal requirements about them:
They are being enforced by the Office of Research Protections(ORP) at Penn StateSee the following:http://www.research.psu.edu/orp/humans/policies
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Protecting Human Participants:Background
Unethical research practices in the past led to the creation of thecurrent rules:
The Tuskegee Syphilis Study (1932-1972)
Nazi war crimes revealed during the Nuremberg Trials
The Willowbrook Study (1963-1966)
Milgram, Stanford Prison, and others
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Protecting Human Participants:Background
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Let’s Talk About Milgram
Figure: History will repeat itself by Regine Debatty, CC BY-SA 2.0
https://www.youtube.com/watch?v=eTX42lVDwA4
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Study Ad
Figure: Milgram Advertisement by Olivier Hammam, Public Domain
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Deception
Is it wrong? (Question 4)
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Protecting Human Participants
What questions do you have after doing the reading andcompleting CITI training?
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Protecting Human Participants: Principles
Three Principles Formulated in the Belmont Report (1979):
Respect for persons
Beneficence
Justice
See the US DHSS website for the Belmont Report and the principles:http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
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Protecting Human Participants: Principles
Belmont Principle #1: Respect for Persons
There are two issues under this principle:
1 Informed consent
2 Protecting Privacy and Confidentiality
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Protecting Human Participants: Principles
Examples: What is included in these informed consent documents?
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Protecting Human Participants: Principles
Informed Consent
Participants should be informed about:
The general purpose of the study
Possible risks (known and unknown): discomfort, anxiety, careerrisks, loss of privacy, embarrassment, inconvenience
Probable benefits
Why they were selected
What will be done with the collected information
Voluntary nature of participation
The researcher should not be in a position to influence the subject(e.g., teacher-student relations)
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Protecting Human Participants: Principles
For more information on informed consent:
See the PSU ORP website: https:
//www.research.psu.edu/irb/faq/informed-consent
Particularly see the templates and samples at the CentralizedApplication Tracking System (CATS) of PSU:https://irb.psu.edu/
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Protecting Human Participants: Principles
Particularly important issues for informed consent:
All wording must be at the 8th grade reading level or below
In the form, you should clearly declare/include:
Purpose of the studyProcedures to be followedDiscomforts or risksStatement that participants may withdraw their participation atany timeStatement that participants can decline to answer specificquestionsInformation about how confidential information will be kept
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Protecting Human Participants: Principles
Protecting privacy and confidentiality
Pay attention to:
Deductive disclosure: Could information about an individualbe linked through revealing his/her characteristics?
Note that federal laws about confidentiality and privacy areequivocal:
Research records can be subpoenaedMarket researchers may disclose individual information
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Protecting Human Participants: Principles
Belmont Principle #2: Beneficence
What are the risks and benefits of research design?
What are the risks?To whom?Have they been minimized?
What are the benefits?
To whom?Have they been maximized?
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Protecting Human Participants: Principles
Belmont Principle #3: Justice
Does recruitment for the study target the population that willbenefit from the research?
Does the recruitment unfairly target a population?
Are the inclusion/exclusion criteria fair?
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Protecting Human Participants: Principles
Institutional Review Boards (IRB)
Required for the US federal agencies by the Federal Commonrule (1991)
A violation of the Common rule may result in the termination offederal funding
IRB’s check:
RisksSelection of subjectsInformed consent documentsAppropriate measures for safety of subjectsProvisions for confidentiality
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Protecting Human Participants: Principles
Institutional Review Boards (IRB)
Types of review:
Exempt: Human Research Participant Program (HRPP) expertsreview applications to determine if they are exemptExpedited: Reviewed by a member of IRBFull: Reviewed by the full IRB
Surveys, demonstration projects, and some observations may beexempt. Check with the ORP first!
Penn State Rule: Class projects are exempt, but remember therules!
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Ethics in Research
Three issues:
Research integrity
Integrity in disseminating research findings
Giving credit to those who deserve it
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Ethics in Research
Potential problems:
Trimming: smoothing of irregularities
Cooking: Keeping results that fit theory
Forging: Inventing data
Plagiarism: Misappropriation of others’ thoughts, ideas, orwritings
Recognizing contributions and authorship: contribution todesign, execution, and writing
See “Honor in Science” by Sigma Xi (1986)
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Ethics in Research
Transparency and Replication
Many disciplines facing replication crises
Public Administration Review developing Transparency andOpenness Guidelines
Growth of the dataverse (https://dataverse.harvard.edu/dataverse/djmallinson)
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CITI Training
Required for all PSU graduate students before graduation
http://citi.psu.edu
Complete and submit completion certificate to me and respectiveprogram support staff
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Questions?
Figure: Q&A by Libby Levi, CC BY-SA 2.0
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