Ethical Guidelines for Human Subjects Research in Least Developed Countries: How do they compare to the Council for International Organizations of Medical Sciences International Ethical Guidelines?

Abstract

Background: The most vulnerable populations for human subjects research are those living in the most resource poor settings. As technology has progressed to support convenient long-distance travel, international communication, and data sharing via the internet, international research has become a more manageable task. While some dismiss the ethical guidelines for human subjects research as necessary only for the most barbaric researchers, history demonstrates the need for ethical guidelines as well as oversight of adherence to such guidelines. Methods: Forty-eight countries designated as least developed countries (LDCs) were identified and selected for analysis. An internet search was utilized to identify research guidelines for LDCs available online or primary research studies conducted in such countries to determine to what extent authors noted ethical considerations. Council for the International Organizations of Medical Sciences (CIOMS) guidelines were distilled into keywords by the authors and compared to guidelines for LDCs. Frequencies and percentages of comparison to CIOMS guidelines were tabulated across the 48 LDCs. Findings: Of the 48 LDCs identified, 22 did not have published research guidelines or mention of a Research Ethics Committee (REC). An additional 10 countries had documentation of some sort of REC, 3 countries had at least one ethical guideline in addition to a REC, and 13 countries had no mention of a REC but did have established ethical guidelines available online. Overall, the average number of guidelines per country was 5 with a SD of 4.11. Conclusion: Over half of countries had online documentation of limited ethics oversight for research, indicating a clear lack of thoroughness in the available guidelines as compared to the international gold standard guidelines from CIOMS. The majority of primary research articles reviewed showed no mention of ethical considerations despite some of the articles using chart review or engaging in patient care interventions. Based on the findings of this study, authors recommend the adoption of existing ethical guidelines by countries still lacking individualized guidelines, as well as a movement toward journals requiring documentation of ethical approval or ethical considerations as a requirement prior to approving articles for publication.