Transcript Cultural Competency in Research

Cultural
Competency in
Research
Presented by:
Mary Ellen Lawless, MA, RN
Case Center for Reducing
Health Disparities
 Ash
Sehgal, MD, Director
 2004- Created by CWRU and MHMC
 2007- Funded through a P60 & CTSC
from the NIH
Objectives
 Define
cultural competency in research
 Recognize
that culture is multifaceted
and the importance of integrating cultural
considerations into the research process
 Describe
one action to begin the process
of integrating cultural considerations into
your research efforts
We don’t see things as THEY are,
we see things as WE are.
- Anaïs Nin
Quick Questions
Can
you think of 3 culturally
incompetent research studies?
Can you think of 3 culturally
competent research studies?

Why Cultural Competency in Research?

Understand the needs and perspectives of
different groups

Community Outreach and Engagement

Contextualization of research knowledge

Increase in the community relevance of
research findings
Culture
Pattern of learned beliefs,
values, and behavior that
are shared within a group

(Reich, et.al, 2006)
Culture
Shaped by:
 Race

 Ethnicity

 Religion/Spirituality
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 Language
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 Nationality

 Region

Gender
Sexual Orientation
SES
Affiliation
Education
Customs
Cultural Competency
No
uniform definition
The ability to work effectively with
individuals of different cultural
backgrounds
A process
Kosko-Lasaki, et.al, 2006, O’Brien, et.al, 2006, Betancourt,et.al, 2003.
Related Terms
 Cultural
Awareness
 Cultural Humility
 Cultural Knowledge
 Cultural Sensitivity
 Linguistic Competence
Cultural Competency and the
Research Process
Research
Question
Study
Design
Recruitment
Data
Collection
Analysis
Dissemination
of Findings
Case Example
You are recruiting for a study focused on health literacy and KoreanAmerican women with Breast Cancer. The study will include an in-depth, openended interview that will be conducted by a research assistant who is fluent in
Korean. The research assistant will also assist with the informed consent process
to ensure that all participants fully understand the details of the study and their
rights as a participant. It is anticipated that 50 women will be enrolled in the
study.
You attend a cultural event in a predominately Korean-American
neighborhood. You’re prepared with study flyers that are translated into English
and Korean. Some of the women take the flyer, place it in their purses and walk
away from the table. Others smile and engage in conversation. They appear
very interested in participating in the study, but state that they will discuss the
information with their spouses. Following the event, you have spoken to
approximately 75 women and believe that the event was a success.
You decide to continue using the same strategy and attend numerous
community events to recruit participants for the study. After three months of
speaking to over 150 women, you realize that only 8 women have enrolled in
the study.
The Iceberg Concept of Culture
Consequences
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Stereotyping
Tokenism
Mistrust
Inability to engage certain communities
Poor health and research outcomes
Cultural Competency:
What it IS
 An
ongoing process
 Value
A
and respect for others
willingness and openness to
change attitudes and behaviors
Cultural Competency:
What it is NOT
A
checklist of do’s and don'ts
Creating
Following
a “formula”
"The Golden Rule”
Cultural Competency:
A Closer Look

Attitudes
 Self-Awareness

Individual and Institutional Level
 Acknowledging
cultural differences
 Attitudes towards research (General
and Project Specific)
Cultural Competency:
A Closer Look

Knowledge
 Continuing Education
 Cross-Cultural Encounters
Cultural Competency:
A Closer Look

Skills
 Incorporate knowledge into
research efforts
 Be sensitive to cultural differences
 Take Action!
Final Thoughts
 Starts
with Awareness
 Grows
with Knowledge
 Enhanced
 Polished
with Specific Skills
through Cross-Cultural Encounters
Cultural Diversity and Health Care - UCLA
Moving Forward…What will
be your next steps?
Contact Information
Mary Ellen Lawless, MA, RN
Community Development & Programming
216-778-1304
[email protected]
www.ReduceDisparity.org
Protection of Human
Subjects in Research
Overview
 Historical
context of human subjects
research
 Principles and Regulations of ethical
research
 Institutional Review Boards (IRBs)
 HIPAA
 Cultural humility
 Things to Think About…
Historical Overview
 1946

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
Nuremberg Code
Resulted from the atrocities committed by
Nazi physicians who conducted medical
experiments on concentration camp
prisoners
Research done in WWII provided the
impetus for current rules and frameworks for
ethical conduct in research
Ten principles for medical experiments
emerged
Belmont Report
Ethical Principles and Guidelines for the Protection of Human
Subjects of Research (1979)
Belmont Principles
 Respect for Persons
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Beneficence
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Individual autonomy
Protection of individuals with reduced autonomy
Maximize benefits and minimize harms/risks
Justice
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Equitable distribution of research costs and benefits
Those who volunteer should represent the population who
would later benefit
Applying Belmont Principles

Respect for Persons
Informed Consent/Assent/Parental Permission
 Regularly discussing the voluntary nature of a research study
 Respecting and Honoring right to withdraw or refuse to participate
Beneficence
 No risk can ever exceed benefits; there must be equipoise or risks
must be less than any potential direct or indirect benefit
 Remember what might be risky for different
populations/cultures/countries/etc.
 Maximize benefits/reduce risks
Justice
 Cannot exclude a group because of time, language, poverty,
inconvenience, etc. Everyone should have a chance to be
represented.
 Are data generalizable?
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Ideas from Belmont
 Anonymity - No identifying information is collected; reporting in the
Respect for Persons
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Informed Consent is a process not just a form
Ensuring participants understand what is being
asked of them (or their children/wards/etc.) and
what exactly participation entails
Must include all federally required elements, such
as, voluntary nature of participation and right to
withdraw at any time
No data/information can be collected without
informed consent (unless the IRB has granted a
waiver/alteration of informed consent)
Beneficence
 Acting
with kindness – maximizing the
benefits while doing no harm
 Requires an assessment of the level of risk
posed by a study
 Example of high risk, deception and no
benefit:

Tuskegee Syphilis experiment (1932-1972)
 Individuals
were not told they had syphilis in
order for physicians to study the progression
of the disease
 Even after treatment available (penicillin),
participants not informed or treated
Justice
 Fairness
of the distribution of benefits and
risk among all participants or potential
participants
 In community-based organizations, the
principle of justice is particularly at risk



Already serve a population which can
create opportunities for beneficial
interventions and programs
Population served are often underserved or
disenfranchised in some way
Problematic when interventions are risky
Regulations

45 CFR 46 – “The
Common Rule”
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
Informed Consent
 Waivers/Alterations
 some Vulnerable
Populations
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The current rules
accepted by over 16
Federal Agencies
 Public Law 93-348 The Common Rule
National Research
governs and defines:
Act of 1974
 Human Subject &
 Recognizes that
Research
research and
 IRBs and IRB
practice may occur
composition
together

Review categories
Definitions & Concepts

Human Subject - a living individual about whom an
investigator conducting research obtains
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data thru intervention or interaction with the individual, or
identifiable private information
Research - a systematic investigation designed to develop
or contribute to generalizable knowledge.
Other Concepts to Understand and Consider –
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Child – Depends on the country
Legally Authorized Representative/Surrogate
Risk/Minimal Risk
De-Identified Data/De-Identifiers
Anonymity vs. Confidentiality vs. Privacy
Informed Consent
Risk & Minimal Risk
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Risk:
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The probability of harm or injury (physical, psychological,
social, or economic) occurring as a result of
participation in a research study.
Both the probability and magnitude of possible harm
may vary from minimal to significant.
Federal regulations define only “minimal risk.”
Minimal Risk:

A risk is minimal where the probability and magnitude of
harm or discomfort anticipated in the proposed
research are not greater, in and of themselves, than
those ordinarily encountered in daily life or during the
performance of routine physical or psychological
examinations or tests.
Identifying Risk
 Only
risks resulting from the research
should be considered.
 Risks
from therapies or procedures
subjects would undergo if not in research
should not be considered.
Types of Risk:
 Physical Harms
 Psychological Harms
 Social and Economic Harms
Minimizing Risk
Three ways to minimize risk
 Alternatives
- other procedures that are
 Precautions
- procedures to decrease
 Safeguards
- procedures to deal with
less risky
the likelihood that harms will occur
harms if they occur
 Terminating and/or Withdrawing
Participation
Deception & Debriefing
 An
IRB protocol must include a request of
a waiver of informed consent and a
debriefing process.
 Few instances when deception is
necessary to perform the study.
 If there is deception, all participants must
be debriefed following the study.
 Debriefing – fully informing subjects about
the true intent of the study, how and why
deception occurred, and answer any
and all participant questions.
Vulnerable Populations
Individuals for whom additional protections are required
 Groups mentioned in the Common Rule
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Pregnant women, fetuses and neonates (Subpart B)
Prisoners (Subpart C)
Children (Subpart D)
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Children as Wards
Groups included by many IRB’s, including the CWRU
IRB
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Mentally/Decisionally-Impaired persons
Physically-Impaired persons
University Students and Employees
Illiterate persons/groups
Non-English Speaking persons/groups
Other Ethical
Considerations
 Inaccurate
findings and/or reporting
 Fabrication
 Falsifying
data
 Poor Record Keeping:


Inaccurate, Incomplete, or Missing data
Poor data storage/security
 Plagiarism
 No
permission to obtain or use data
IRB Purposes & Charges
 Federally
mandated to oversee the
protection of animal and human subjects
in research
 Institutions of higher education, hospitals,
research facilities, military branches, etc.
where research is conducted as a part of
business
 Approval required for any research
conducted for presentation, publication,
or generalizability.

Includes theses and dissertations
IRB Responsibilities

Identify Risks
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IRBs cannot rely solely on investigators to identify risks
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It is human nature to underestimate risks and
overestimate benefits
Biomedical researchers especially underestimate social &
psychological risks
The IRB must do an independent analysis of risk
Determine that risks are minimized
Determine that “risks to subjects are reasonable in
relation to anticipated benefits”
Determine that subjects are adequately informed
about “any reasonably foreseeable risks or
discomforts”
HIPAA

The Health Insurance Portability and Accountability
Act of 1996

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Title I of HIPAA protects health insurance coverage for
workers and their families when they change or lose their
jobs.
Title II of HIPAA, known as the Administrative
Simplification (AS) provisions, requires the establishment
of national standards for electronic health
care transactions and national identifiers for providers,
health insurance plans, and employers.
Enforce privacy and confidentiality of health-related
personal data
Limits ability to link health data to small geographic
units
Cultural Humility
 No
one can be fully competent in
another person’s culture
 Protecting the rights of communities is
important in all research
Things to Think About…
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There is an ethical and moral imperative to
identify risks to communities and individuals
An IRB-approved protocol incorporates a
framework that supports ethical principles.
Consult an IRB office before engaging in
human subjects research.
Determine administrative needs (i.e.,
signatures, letter of cooperation, etc.)
Determine time factor; IRBs cannot rush
review process.