Cultural Competency in Research
Presented by:
Mary Ellen Lawless, MA, RN
Ash Sehgal, MD, Director2004- Created by CWRU and MHMC2007- Funded through a P60 & CTSC
from the NIH
Case Center for Reducing Health Disparities
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 QuestionsCan 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
RaceEthnicityReligion/
SpiritualityLanguageNationalityRegion
Gender Sexual
Orientation SES Affiliation Education Customs
Shaped by:
No uniform definitionThe ability to work effectively with
individuals of different cultural backgrounds
A process
Cultural Competency
Kosko-Lasaki, et.al, 2006, O’Brien, et.al, 2006, Betancourt,et.al, 2003 .
Related Terms
Cultural AwarenessCultural HumilityCultural KnowledgeCultural SensitivityLinguistic Competence
Cultural Competency and the Research Process
Case Example You are recruiting for a study focused on health literacy and Korean-American
women with Breast Cancer. The study will include an in-depth, open-ended 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
Stereotyping Tokenism Mistrust Inability to engage certain
communities Poor health and research outcomes
Cultural Competency: What it IS
An ongoing process
Value and respect for others
A willingness and openness to change attitudes and behaviors
Cultural Competency: What it is NOT
A checklist of do’s and don'ts Creating a “formula”
Following "The Golden Rule”
Cultural Competency: A Closer Look
Attitudes Self-Awareness
Individual and Institutional Level
Acknowledging cultural differencesAttitudes 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 with Specific Skills
Polished through Cross-Cultural Encounters
Cultural Diversity and Health Care - UCLA
Moving Forward…What will be your next steps?
Contact Information
Mary Ellen Lawless, MA, RNCommunity Development & [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 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 ReportEthical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
Belmont PrinciplesBelmont PrinciplesRespect for Persons
Individual autonomy Protection of individuals with reduced autonomy
Beneficence Maximize benefits and minimize harms/risks
Justice 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?
Ideas from Belmont Anonymity - No identifying information is collected; reporting in the aggregate Confidentiality - All information remains with the researcher; limited access Privacy
Respect for Persons 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
Definitions & Concepts Human Subject - a living individual about whom an
investigator conducting research obtains 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 – 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 Risk: Risk:
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: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 RiskThree ways to minimize riskAlternatives - other procedures that are
less riskyPrecautions - procedures to decrease the
likelihood that harms will occurSafeguards - procedures to deal with
harms if they occur Terminating and/or Withdrawing
Participation
Deception & Debriefing An IRB protocol must include a request of a An IRB protocol must include a request of a
waiver of informed consent waiver of informed consent andand a debriefing a debriefing process.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 PopulationsIndividuals for whom additional protections are requiredGroups mentioned in the Common Rule
Pregnant women, fetuses and neonates (Subpart B) Prisoners (Subpart C) Children (Subpart D)
Children as WardsGroups included by many IRB’s, including the CWRU IRB
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
IRBs cannot rely solely on investigators to identify risks 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 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… 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.