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Cultural Competency in Research Presented by: Mary Ellen Lawless, MA, RN
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Presented by: Mary Ellen Lawless, MA, RN

Jan 01, 2016

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Page 1: Presented by: Mary Ellen Lawless, MA, RN

Cultural Competency in Research

Presented by:

Mary Ellen Lawless, MA, RN

Page 2: 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

Page 3: Presented by: Mary Ellen Lawless, MA, RN

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

Page 4: Presented by: Mary Ellen Lawless, MA, RN

We don’t see things as THEY are,

we see things as WE are.

- Anaïs Nin

Page 5: Presented by: Mary Ellen Lawless, MA, RN

Quick QuestionsCan you think of 3 culturally incompetent research studies?

Can you think of 3 culturally competent research studies?

Page 6: Presented by: Mary Ellen Lawless, MA, RN

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

Page 7: Presented by: Mary Ellen Lawless, MA, RN

Culture Pattern of learned beliefs, values, and behavior that are shared within a group

(Reich, et.al, 2006)

Page 8: Presented by: Mary Ellen Lawless, MA, RN

Culture

RaceEthnicityReligion/

SpiritualityLanguageNationalityRegion

Gender Sexual

Orientation SES Affiliation Education Customs

Shaped by:

Page 9: Presented by: Mary Ellen Lawless, MA, RN

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 .

Page 10: Presented by: Mary Ellen Lawless, MA, RN

Related Terms

Cultural AwarenessCultural HumilityCultural KnowledgeCultural SensitivityLinguistic Competence

Page 11: Presented by: Mary Ellen Lawless, MA, RN

Cultural Competency and the Research Process

Page 12: Presented by: Mary Ellen Lawless, MA, RN

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.

Page 13: Presented by: Mary Ellen Lawless, MA, RN

The Iceberg Concept of Culture

Page 14: Presented by: Mary Ellen Lawless, MA, RN

Consequences

Stereotyping Tokenism Mistrust Inability to engage certain

communities Poor health and research outcomes

Page 15: Presented by: Mary Ellen Lawless, MA, RN

Cultural Competency: What it IS

An ongoing process

Value and respect for others

A willingness and openness to change attitudes and behaviors

Page 16: Presented by: Mary Ellen Lawless, MA, RN

Cultural Competency: What it is NOT

A checklist of do’s and don'ts Creating a “formula”

Following "The Golden Rule”

Page 17: Presented by: Mary Ellen Lawless, MA, RN

Cultural Competency: A Closer Look

Attitudes Self-Awareness

Individual and Institutional Level

Acknowledging cultural differencesAttitudes towards research (General

and Project Specific)

Page 18: Presented by: Mary Ellen Lawless, MA, RN

Cultural Competency: A Closer Look

Knowledge Continuing Education Cross-Cultural Encounters

Page 19: Presented by: Mary Ellen Lawless, MA, RN

Cultural Competency: A Closer Look

Skills Incorporate knowledge into

research efforts Be sensitive to cultural

differences Take Action!

Page 20: Presented by: Mary Ellen Lawless, MA, RN

Final Thoughts

Starts with Awareness

Grows with Knowledge

Enhanced with Specific Skills

Polished through Cross-Cultural Encounters

Cultural Diversity and Health Care - UCLA

Page 21: Presented by: Mary Ellen Lawless, MA, RN

Moving Forward…What will be your next steps?

Page 22: Presented by: Mary Ellen Lawless, MA, RN

Contact Information

Mary Ellen Lawless, MA, RNCommunity Development & [email protected]

www.ReduceDisparity.org

Page 23: Presented by: Mary Ellen Lawless, MA, RN
Page 24: Presented by: Mary Ellen Lawless, MA, RN

Protection of Human Subjects in Research

Page 25: Presented by: Mary Ellen Lawless, MA, RN

Overview Historical context of human subjects

research Principles and Regulations of ethical

research Institutional Review Boards (IRBs) HIPAA Cultural humility Things to Think About…

Page 26: Presented by: Mary Ellen Lawless, MA, RN

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

Page 27: Presented by: Mary Ellen Lawless, MA, RN

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

Page 28: Presented by: Mary Ellen Lawless, MA, RN

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

Page 29: Presented by: Mary Ellen Lawless, MA, RN

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)

Page 30: Presented by: Mary Ellen Lawless, MA, RN

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

Page 31: Presented by: Mary Ellen Lawless, MA, RN

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

Page 32: Presented by: Mary Ellen Lawless, MA, RN

Regulations

Page 33: Presented by: Mary Ellen Lawless, MA, RN

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

Page 34: Presented by: Mary Ellen Lawless, MA, RN

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.

Page 35: Presented by: Mary Ellen Lawless, MA, RN

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

Page 36: Presented by: Mary Ellen Lawless, MA, RN

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

Page 37: Presented by: Mary Ellen Lawless, MA, RN

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.

Page 38: Presented by: Mary Ellen Lawless, MA, RN

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

Page 39: Presented by: Mary Ellen Lawless, MA, RN

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

Page 40: Presented by: Mary Ellen Lawless, MA, RN

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

Page 41: Presented by: Mary Ellen Lawless, MA, RN

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”

Page 42: Presented by: Mary Ellen Lawless, MA, RN

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

Page 43: Presented by: Mary Ellen Lawless, MA, RN

Cultural Humility No one can be fully competent in

another person’s culture Protecting the rights of communities is

important in all research

Page 44: Presented by: Mary Ellen Lawless, MA, RN

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.