Day 2: Starting a Project andProtecting Human Subjects

Daniel J. Mallinson

School of Public AffairsPenn State Harrisburgmallinson@psu.edu

PADM-HADM 503

Mallinson Day 2 September 3, 2019 1 / 46

Road map

Questions about course

Research process

Ethical research practices

Institutional Review Board

Mallinson Day 2 September 3, 2019 2 / 46

Why do we research?

Figure: Research by Nick Youngson CC BY-SA 3.0

Mallinson Day 2 September 3, 2019 3 / 46

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!

Mallinson Day 2 September 3, 2019 4 / 46

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

Mallinson Day 2 September 3, 2019 5 / 46

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

Mallinson Day 2 September 3, 2019 6 / 46

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

Mallinson Day 2 September 3, 2019 6 / 46

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

Mallinson Day 2 September 3, 2019 6 / 46

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.

Mallinson Day 2 September 3, 2019 7 / 46

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

Mallinson Day 2 September 3, 2019 8 / 46

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

Mallinson Day 2 September 3, 2019 9 / 46

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

Mallinson Day 2 September 3, 2019 9 / 46

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)

Mallinson Day 2 September 3, 2019 10 / 46

Steps in a Simplified Process of Research

1. Topic and purpose

How do you choose a topic and purpose for your research?

Mallinson Day 2 September 3, 2019 11 / 46

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

Mallinson Day 2 September 3, 2019 12 / 46

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

Mallinson Day 2 September 3, 2019 13 / 46

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)

Mallinson Day 2 September 3, 2019 14 / 46

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

Mallinson Day 2 September 3, 2019 15 / 46

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)

Mallinson Day 2 September 3, 2019 16 / 46

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.

Mallinson Day 2 September 3, 2019 17 / 46

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.

Mallinson Day 2 September 3, 2019 18 / 46

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.

Mallinson Day 2 September 3, 2019 19 / 46

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.

Mallinson Day 2 September 3, 2019 20 / 46

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

Mallinson Day 2 September 3, 2019 21 / 46

Break!

Figure: Coffee Pause by Gerd Altmann CC0

Mallinson Day 2 September 3, 2019 22 / 46

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

Mallinson Day 2 September 3, 2019 23 / 46

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

Mallinson Day 2 September 3, 2019 24 / 46

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

Mallinson Day 2 September 3, 2019 25 / 46

Protecting Human Participants:Background

Mallinson Day 2 September 3, 2019 26 / 46

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

https://www.youtube.com/watch?v=8g1MJeHYlE0&t=181sMallinson Day 2 September 3, 2019 27 / 46

Study Ad

Figure: Milgram Advertisement by Olivier Hammam, Public Domain

Mallinson Day 2 September 3, 2019 28 / 46

Deception

Is it wrong? (Question 4)

Mallinson Day 2 September 3, 2019 29 / 46

Protecting Human Participants

What questions do you have after doing the reading andcompleting CITI training?

Mallinson Day 2 September 3, 2019 30 / 46

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

Mallinson Day 2 September 3, 2019 31 / 46

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

Mallinson Day 2 September 3, 2019 32 / 46

Protecting Human Participants: Principles

Examples: What is included in these informed consent documents?

Mallinson Day 2 September 3, 2019 33 / 46

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)

Mallinson Day 2 September 3, 2019 34 / 46

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/

Mallinson Day 2 September 3, 2019 35 / 46

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

Mallinson Day 2 September 3, 2019 36 / 46

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

Mallinson Day 2 September 3, 2019 37 / 46

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?

Mallinson Day 2 September 3, 2019 38 / 46

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?

Mallinson Day 2 September 3, 2019 39 / 46

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

Mallinson Day 2 September 3, 2019 40 / 46

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!

Mallinson Day 2 September 3, 2019 41 / 46

Ethics in Research

Three issues:

Research integrity

Integrity in disseminating research findings

Giving credit to those who deserve it

Mallinson Day 2 September 3, 2019 42 / 46

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)

Mallinson Day 2 September 3, 2019 43 / 46

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)

Mallinson Day 2 September 3, 2019 44 / 46

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

Mallinson Day 2 September 3, 2019 45 / 46

Questions?

Figure: Q&A by Libby Levi, CC BY-SA 2.0

Mallinson Day 2 September 3, 2019 46 / 46