1. NIH has set forth guidelines on the inclusion of women and members of minority groups and their subpopulations in biomedical and behavioral human subject research. This inclusion is to ensure that:

– Investigators examine and understand of historical contexts for study populations before initiating research study design.
– Early-phase study design should take into account race, ethnicity and cultural factors.
– IRB membership should include representatives of large communities and cultural groups as representatives.
Question In 1979, the National Commission for the Protection of Humans Subjects of Biomedical and Behavioral Research developed ethical principles and guidelines for the protection of human subjects for research. The purpose of these guidelines was to:
Your Answer Provide a framework for use in the resolution of ethical problems arising from research involving human subjects.
Result Correct
Comment The three principles, as outlined in the Belmont Report, require culturally competent research-related interactions with study participants: First, respect for persons requires researchers to assure autonomy and protect those with diminished autonomy. Second, beneficence requires favorably balancing physical, emotional, economic, stigmatization, and confidentiality risks and potential benefits of research participation. Risks and benefits differ according to multiple factors and circumstances that vary widely across diverse communities, and minority populations may be more vulnerable to risks. Third, justice for the individual requires fair recruitment practices. Disadvantaged groups should be protected from being asked to participate in research for convenience or socioeconomic status.

Question 2

Question NIH has set forth guidelines on the inclusion of women and members of minority groups and their subpopulations in biomedical and behavioral human subject research. This inclusion is to ensure that:
Your Answer Valid analyses of differences in intervention effects can be accomplished.
Result Correct
Comment In 1994, the National Institutes of Health (NIH) established policy for the inclusion of women, children, and members of minority groups and their subpopulations in biomedical and behavioral clinical studies. Public Law 103-43 requires that women and minority subjects “be included in all clinical research studies, as appropriate for the scientific goals of the work proposed.” The goal is to ensure that minority individuals are included in clinical trials “in numbers adequate to allow for valid analyses of gender and/or racial/ethnic differences in intervention effects.”

Question 3

Question Overcoming challenges to cultural competence in research requires that: (Check ALL that apply)
Your Answers – Investigators examine and understand historical contexts for study populations before initiating research study design.
– Early-phase study design should take into account race, ethnicity and cultural factors.
– IRB membership should include representatives of large communities and cultural groups as representatives.
Result Correct
Comment Some research may not hold immediate clinical relevance or application to practice, but such studies lay the scientific foundation for research that develops treatments or directly influences health interventions. It is important that early-phase studies build an understanding of, and take into account, differences that can be attributed to race, gender, age, and other cultural factors. Engaging diverse communities in research requires building trust and, as importantly, understanding, that can only be developed over time. Inclusion of diverse study participants should occur early in the study development process to increase cultural congruence of study methods and likelihood of success in study recruitment and retention.

Question 4

Question Trust and transparency are critical to successful and culturally competent research. In the research setting, establishing trust in diverse communities does NOT require:
Your Answer Limiting public transparency and accountability
Result Correct
Comment When conducting research with diverse communities, involving community members in decisions about key aspects of the research, promoting feelings of ownership within the community, maintaining public accountability and transparency, and assuring appropriate ethics oversight creates trust in study participants. Diverse populations more easily adopt interventions that were developed in research in which they may have participated, developed trust through transparency and was aligned as closely as possible to prevailing cultural factors.

Question 5

Question Cultural competence in research is defined as the ability of researchers to provide high quality research that takes into account:
Your Answer The diversity of population’s values, beliefs and behaviors when developing research ideas, conducting research and exploring applicability of their findings.
Result Correct
Comment Cultural competence in research is the ability of researchers to provide high quality research that takes into account the culture and diversity of a population when developing, conducting and interpreting research findings. Cultural competence in research plays a critical role in study design and implementation processes, including the development of research questions and hypotheses, outreach and recruitment strategies, consent activities, data collection protocols, analyzing and interpreting research findings, and drawing conclusions. Altogether, cultural congruence in these research processes helps to ensure the research is applicable to diverse populations and if necessary can be adapted to meet the target population’s social, cultural and linguistic needs.