Presented by: Mary Ellen Lawless, MA, RN

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

2. 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

3. Objectives • Define cultural competency in research • Recognizethat 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

4. We don’t see things as THEY are, we see things as WE are. - Anaïs Nin

5. Quick Questions • Can you think of 3 culturally incompetent research studies? • Can you think of 3 culturally competent research studies?

6. 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

7. Culture • Pattern of learned beliefs, values, and behavior that are shared within a group (Reich, et.al, 2006)

8. Culture Shaped by: • Race • Ethnicity • Religion/Spirituality • Language • Nationality • Region • Gender • Sexual Orientation • SES • Affiliation • Education • Customs

9. 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.

10. Related Terms • Cultural Awareness • Cultural Humility • Cultural Knowledge • Cultural Sensitivity • Linguistic Competence

11. Cultural Competency and the Research Process

12. 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.

13. The Iceberg Concept of Culture

14. Consequences • Stereotyping • Tokenism • Mistrust • Inability to engage certain communities • Poor health and research outcomes

15. Cultural Competency:What it IS • An ongoing process • Value and respect for others • A willingness and openness to change attitudes and behaviors

16. Cultural Competency: What it is NOT • A checklist of do’s and don'ts • Creating a “formula” • Following "The Golden Rule”

17. Cultural Competency: A Closer Look • Attitudes • Self-Awareness • Individual and Institutional Level • Acknowledging cultural differences • Attitudes towards research (General and Project Specific)

18. Cultural Competency: A Closer Look • Knowledge • Continuing Education • Cross-Cultural Encounters

19. Cultural Competency: A Closer Look • Skills • Incorporate knowledge into research efforts • Be sensitive to cultural differences • Take Action!

20. Final Thoughts • Starts with Awareness • Grows with Knowledge • Enhanced with Specific Skills • Polished through Cross-Cultural Encounters Cultural Diversity and Health Care - UCLA

21. Moving Forward…What will be your next steps?

22. Contact Information Mary Ellen Lawless, MA, RN Community Development & Programming 216-778-1304 mel15@case.edu www.ReduceDisparity.org

24. Protection of Human Subjects in Research

25. Overview • Historical context of human subjects research • Principles and Regulations of ethical research • Institutional Review Boards (IRBs) • HIPAA • Cultural humility • Things to Think About…

26. 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

27. Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979) Belmont Principles • Respect 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

28. 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

29. 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)

30. 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

31. 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

32. Regulations • 45 CFR 46 – “The Common Rule” • The current rules accepted by over 16 Federal Agencies • The Common Rule governs and defines: • Human Subject & Research • IRBs and IRB composition • Review categories • Informed Consent • Waivers/Alterations • some Vulnerable Populations • Public Law 93-348 - National Research Act of 1974 • Recognizes that research and practice may occur together

33. 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

34. Risk & Minimal 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: • 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.

35. 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

36. Minimizing Risk Three ways to minimize risk • Alternatives - other procedures that are less risky • Precautions - procedures to decrease the likelihood that harms will occur • Safeguards - procedures to deal with harms if they occur • Terminating and/or Withdrawing Participation

37. 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.

38. Vulnerable Populations Individuals for whom additional protections are required • Groups mentioned in the Common Rule • Pregnant women, fetuses and neonates (Subpart B) • Prisoners (Subpart C) • Children (Subpart D) • Children as Wards • Groups 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

39. 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

40. 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

41. 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”

42. 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

43. Cultural Humility • No one can be fully competent in another person’s culture • Protecting the rights of communities is important in all research

44. 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.