Rapid Bioethical Assessment for Mycobacterium tuberculosis and Host Genetic Study in Amhara Regional State, Ethiopia: Towards a Context-Specific Ethical Approach

Background Rapid Ethical Assessment (REA) is a rapid qualitative study anticipated to understand the ethical sphere of the research setting prior to recruiting study subjects. This study assessed the communities' knowledge about tuberculosis (TB) and research, understand the social arrangements advisable for recruiting research participant and appraised the information provision and consent process. Methods The study was conducted in Amhara region, Ethiopia from 5th-30th January 2021. Google-based survey, face-to-face in-depth interview and focus group discussion were carried out to collect the data from researchers, data collectors, health professionals, TB program officers. A structured questionnaire was administered to assess the knowledge of TB patients and healthy controls about TB, research, gene, (co)evolution and consent process. Results Over 71% of researchers were not satisfied with the current consent process, and 82.7% of researchers agreed that the best interest of the research participants was not adequately addressed in the current research practices in ANRS. TB patients and healthy controls misunderstood research and its goals. Participants advised the researchers to approach the community with the assistance of health extension workers (HEW) or religious/local leaders. Combined use of verbal and written based information provision at individual participant level is the preferred way for information provision. Conclusions The adherence of researchers to standard information provision and consent process was very low. Healthy controls and TB patients have low level of knowledge and awareness about research, ethics and genomic research-related common terms. Hence, public education is required to strengthen the research ethics in the region.

[1]  Richard Milne,et al.  Ethical Challenges Associated with Pathogen and Host Genetics in Infectious Disease , 2022, The New bioethics : a multidisciplinary journal of biotechnology and the body.

[2]  T. Heupink,et al.  Whole-genome sequencing for TB source investigations: principles of ethical precision public health. , 2021, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease.

[3]  Burak Yelmen,et al.  West Asian sources of the Eurasian component in Ethiopians: a reassessment , 2019, Scientific Reports.

[4]  J. Gardy,et al.  Trust and the ethical challenges in the use of whole genome sequencing for tuberculosis surveillance: a qualitative study of stakeholder perspectives , 2019, BMC Medical Ethics.

[5]  M. Zastrow Japanese hospital uncovers flood of research ethics violations , 2019, Nature.

[6]  H. Tilley Medicine, Empires, and Ethics in Colonial Africa. , 2016, AMA journal of ethics.

[7]  R. G. Hewinson,et al.  Population Genomics of Mycobacterium tuberculosis in Ethiopia Contradicts the Virgin Soil Hypothesis for Human Tuberculosis in Sub-Saharan Africa , 2015, Current Biology.

[8]  R. Durbin,et al.  Tracing the Route of Modern Humans out of Africa by Using 225 Human Genome Sequences from Ethiopians and Egyptians , 2015, American journal of human genetics.

[9]  Osman Elbek,et al.  Ethical Issues in Tuberculosis Control. , 2015, Turkish thoracic journal.

[10]  M. Newport,et al.  A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting , 2014, BMC Medical Ethics.

[11]  M. Newport,et al.  A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting , 2014, BMC medical ethics.

[12]  J. Porter,et al.  Ethical aspects of directly observed treatment for tuberculosis: a cross-cultural comparison , 2013, BMC medical ethics.

[13]  R. Rawbone The Oxford Textbook of Clinical Research Ethics , 2013 .

[14]  E. Koch Tuberculosis Is a Threshold: The Making of a Social Disease in Post-Soviet Georgia , 2013, Medical anthropology.

[15]  B. Moreno,et al.  Violation of ethical principles in clinical research. Influences and possible solutions for Latin America , 2012, BMC Medical Ethics.

[16]  S. Bull,et al.  Tailoring Information Provision and Consent Processes to Research Contexts: The Value of Rapid Assessments , 2012, Journal of empirical research on human research ethics : JERHRE.

[17]  R. Ghooi The Nuremberg Code–A critique , 2011, Perspectives in clinical research.

[18]  Y. Touré,et al.  Informed consent in international research: the rationale for different approaches. , 2010, The American journal of tropical medicine and hygiene.

[19]  C. Rotimi,et al.  Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study , 2009, BMC medical ethics.

[20]  C. Rotimi,et al.  Tailoring Consent to Context: Designing an Appropriate Consent Process for a Biomedical Study in a Low Income Setting , 2009, PLoS neglected tropical diseases.

[21]  M. Selgelid Ethics, Tuberculosis and Globalization , 2008 .

[22]  A A Hyder,et al.  Ethical review of health research: a perspective from developing country researchers , 2004, Journal of Medical Ethics.

[23]  W. Stevens Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. , 2003, Quality assurance.

[24]  R. White The Tuskegee syphilis study. , 2002, The Hastings Center report.

[25]  R. M. White Unraveling the Tuskegee Study of Untreated Syphilis. , 2000, Archives of internal medicine.

[26]  James R. Dixon,et al.  The International Conference on Harmonization Good Clinical Practice guideline. , 1999, Quality assurance.

[27]  Darryl Macer,et al.  Universal Declaration On The Human Genome and Human Rights , 1997, Nursing ethics.

[28]  S. Krugman,et al.  Infectious hepatitis; studies of its natural history and prevention. , 1958, The New England journal of medicine.

[29]  A. Vickers,et al.  San Code of Research Ethics , 2017 .

[30]  W. Robinson,et al.  The Hepatitis Experiments at the Willowbrook State School , 2008 .

[31]  K. Matsuura,et al.  Universal Declaration on Bioethics and Human Rights , 2006 .

[32]  F. Gray The Tuskegee Syphilis Study : the real story and beyond , 1998 .

[33]  J. Legemaate The CIOMS guidelines for biomedical research involving human subjects. , 1994, European journal of health law.

[34]  E. Langer Human Experimentation: Cancer Studies at Sloan-Kettering Stir Public Debate on Medical Ethics. , 1964, Science.

[35]  P. P. Rickham HUMAN EXPERIMENTATION. CODE OF ETHICS OF THE WORLD MEDICAL ASSOCIATION. DECLARATION OF HELSINKI. , 1964, British medical journal.