National Commission for the Protection of Humans Subjects was the first body to shape policies in the United States for Biomedical and Behavioral research. In 1979 they have established ethical principles and guidelines for protecting the human subjects in Biomedical and Behavioral Research. According to those guidelines and Belmont report, cultural competence is one of the essential requirements for conducting research. Cultural competence means that researcher should adhere to the following there principles: respect for persons, beneficence and justice.
Belmont report have explained these three principles for conducting research with human subjects in detail. The first principle, ‘Respect for Person’, that the researcher should assure autonomy and also protecting those who have diminished autonomy. Under this, researcher have two obligations, one is making sure people are making informed choices for taking part in research and secondly by instituting added protections for those who do not have the capacity to decide. The researcher need to ensure that information to the participants of the research is tailored in their local language, comprehensible and passes on to them in culturally acceptable manner.
Second principle, beneficence are the circumstances for the communities, that are favorable in terms of physically, emotionally and economically when the research is conducted. The research design need to take care of stigmatic and confidentiality risks and informing the communities about potential benefits of their participation in the research. Risk and benefit analysis of the individual community is essential because they vary from community to community. The researchers need to ensure that the vulnerable groups for example like minorities, poor households, female and old headed households, are not at risk during or after the research is completed, because the research might have long-term consequences for them. The social standing of the these vulnerable groups can put them under more pressure from the community members in the same vicinity. In order to understand and estimating the risks associated to human subjects, community leaders must be involved.
Third principle, Justice is referred as fair recruitment practices of the human subjects in the research process. Impartiality towards the recruitment of humans is the first step, meanwhile researcher should ensure that community is not involved in riskier interventions due to their circumstances. Vulnerable and marginalized groups should be protected and their participation should not be solely due to the reason that they are easily accessible. Social justice also requires that research should be conducted with those communities or people who can bear the economic and social burden of the research without having long term impacts on their wellbeing. Vulnerable groups or communities should only be asked to accept the risks involved in the research, if the research is related directly to conditions specific to them.
When conducting research with diverse communities it is essential to involve community members in decisions regarding key aspects of the research, promoting feelings of ownership within the community, maintaining public accountability and transparency, and assuring appropriate ethics oversight
It is important for the researchers in middle and lower income countries to adhere to these above three principles and adopt best practices from the developed countries. It is highly recommended for all the researchers, either from biomedical sciences or behavioral sciences, to have an understanding of the concepts and principles in Belmont Report. Adhering to these standards will certainly help the researchers and communities.
For those who are interested in Belmont Report, here is the link to the report: https://science.education.nih.gov/supplements/nih9/bioethics/guide/teacher/Mod5_Belmont.pdf