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Responsible Conduct of Human Subjects Research in Islamic Communities

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Abstract

In order to increase understanding of the ethical implications of biomedical, behavioral and clinical research, the Fogarty International Center, part of the United States National Institutes of Health, established an International Research Ethics Education and Curriculum Development Award (R25) to support programs in low- and middle-income countries. To develop research ethics expertise in Jordan, the University of California San Diego fellowship program in collaboration with Jordan University of Science and Technology provides courses that enable participants to develop skills in varied research ethics topics, including research with human subjects. The program provides a master’s level curriculum, including practicum experiences. In this article we describe a practicum project to modify an existing introduction to human subjects research for a US audience to be linguistically and culturally appropriate to Arabic-speaking-Islamic communities. We also highlight key differences that guided the conversion of an English version to one that is in Arabic. And finally, as Institutional Review Boards follow the ethical principles of the Belmont Report in evaluating and approving biomedical and behavioral human subjects research proposals, we provide observations on the conformity of the three ethical principles of the Belmont Report with Islam.

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Notes

  1. National Institutes of Health. a part of the U.S. Department of Health and Human Services. http://www.nih.gov/about-nih/who-we-are.

  2. https://grants.nih.gov/grants/guide/pa-files/PAR-16-081.html.

  3. https://jordanrcrprogram.com/.

  4. http://grants.nih.gov/grants/guide/historical/1989_12_22_Vol_18_No_45.pdf.

  5. http://grants.nih.gov/grants/guide/notice-files/not-od-10-019.html.

  6. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

  7. Belmont Report (1979)

    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.

  8. Declaration of Helsinki (2008). http://www.healthscience.net/resources/declaration-of-helsinki.

  9. http://research-ethics.net (R-E.net) Resources for Research Ethics Education.

  10. http://www.jfda.jo/.

  11. The Jordanian Law of Clinical Studies No. 2 (2011) requires insurance coverage for human subjects enrolled in clinical trials. http://www.jfda.jo/EchoBusV3.0/SystemAssets/PDF/AR/LawsAndRegulation/Drug/PharmaceuticalStudies/50_211.pdf.

  12. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html.

  13. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html.

  14. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html.

  15. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html.

  16. Sunnah is the second primary source of Islam; it supplements the Quran and interprets its rulings.

  17. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.

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Acknowledgement

Al-Khatib is a participant in the Research Ethics Education Program in Jordan supported by grant #5R25TW010026-02 from the Fogarty International Center of the U.S. National Institutes of Health. The project described was also partially supported by the National Institutes of Health Grant UL1TR001442. The content and opinions are solely the responsibility of the authors and do not necessarily represent the official views of the Fogarty International Center or the U.S. National Institutes of Health.

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Correspondence to Aceil Al-Khatib.

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Al-Khatib, A., Kalichman, M. Responsible Conduct of Human Subjects Research in Islamic Communities. Sci Eng Ethics 25, 463–476 (2019). https://doi.org/10.1007/s11948-017-9995-y

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  • DOI: https://doi.org/10.1007/s11948-017-9995-y

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