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Biobank and Genomic Research in Uganda: Are Extant Privacy and Confidentiality Regimes Adequate?

Published online by Cambridge University Press:  01 January 2021

Obiajulu Nnamuchi
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Abstract

Not many African countries have been able to develop a robust system for regulating health research within their respective jurisdictions, particularly in the realm of biobanking and genomics. This is not without reason. Aside from underdevelopment and all that it entails or perhaps in consequence thereof, countries in the region have been unable to make significant strides in medical research. But there are exceptions. Amongst the few seeming success stories is Uganda. Nonetheless, although the country has developed what appears to be a functional framework to govern genomic research and biobanking, the consistency of key provisions with international standards, especially those pertaining to privacy of research participants and confidentiality of their health information, is not at all clear. Yet, making this determination – the main objective of this article – is critical in determining the adequacy of protection available to human research subjects in the country.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 44 , Issue 1: Part II: Harmonizing Privacy Laws to Enable International Biobank Research , Spring 2016 , pp. 85 - 95
Copyright
Copyright © American Society of Law, Medicine & Ethics 2016

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References

World Bank, Data: Poverty, available at <http://data.world-bank.org/topic/poverty> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
World Health Organization (WHO), World Health Statistics 2015 (Geneva: WHO, 2015): at 74-75, 86–87.Google Scholar
Id., at 98–99.Google Scholar
Id., at 122-123. See also WHO, The World Health Report 2006: Working Together for Health (Geneva: WHO, 2006): at xviii – xix.Google Scholar
SciDev.net, New Centre Launched to Aid Medical Data Sharing, available at <http://www.scidev.net/sub-saharan-africa/data/news/centre-launched-aid-medical-data-sharing.html> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id.Google Scholar
Id.Google Scholar
See generally, National Human Genome Research Institute, Human Genome Project Produces Many Benefits, November 17, 2011, available at <https://www.genome.gov/27549135>(last visited February 16, 2016).(last+visited+February+16,+2016).>Google Scholar
World Medical Association (WMA), Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 64th WMA General Assembly, Fortaleza, Brazil, October 2013, 8, available at <http://www.wma.net/en/30publications/10policies/b3/> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
UNFPA, News: Census Provisional Results Released; Uganda’s Population at 34.9 Million, November 18, 2014, available at <http://countryoffice.unfpa.org/uganda/2014/12/23/11171/census_provisional_results_released_uganda_rsquo_s_population_at_34_9_million/> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Faye, M. L., Mcarthur, J. W. and Sachs, J. D., et al., “The Challenges Facing Landlocked Developing Countries,” Journal of Human Development 5, no. 1 (2004): 31–68.Google Scholar
The African Center, University of Pennsylvania, Uganda: Ethnic Groups, available at <http://www.africa.upenn.edu/NEH/u-ethn.html> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
African Studies Center, University of Pennsylvania, East Africa Living Encyclopedia, Uganda: A Profile, available at <http://www.africa.upenn.edu/NEH/uhome.htm> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Biryabarema, E., Reuters, UPDATE 2-Uganda Ups Oil Reserves Estimate by 85 pct, Finds Natural Gas, August 29, 2014, available at <http://www.reuters.com/article/2014/08/29/uganda-oil-idUSL5N0QZ1EW20140829>(last visited February 16, 2016).(last+visited+February+16,+2016).>Google Scholar
Ojambo, F., “Uganda Resumption of Copper Mining Seen Delayed by Looming Rains,” Bloomberg News, Feb. 9 2015, available at <http://www.bloomberg.com/news/articles/2015-02-09/uganda-resumption-of-copper-mining-seen-delayed-by-looming-rains>(last visited February 16, 2016).(last+visited+February+16,+2016).>Google Scholar
Infoplease, Uganda: Government, available at <http://www.infoplease.com/encyclopedia/world/uganda-government.html> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Uganda, Ministry of Local Government, List of Current Local Government Districts in Uganda, available at <https://molg.go.ug/local-governments/> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id.Google Scholar
WHO, World Health Report 2000: Health Systems: Improving Performance (Geneva: WHO, 2000): at 155.Google Scholar
See WHO, supra note 2, at 50.Google Scholar
Id., at 51.Google Scholar
Id.Google Scholar
Id., at 70.Google Scholar
Kasyaba, R. M., “Uganda: Fast-Track National Health Insurance Bill,” The Monitor, Sept. 12, 2015, available at <http://allafrica.com/stories/201509130178.html> (last visited February 16, 2016) [hereinafter cited as Kasyaba].+(last+visited+February+16,+2016)+[hereinafter+cited+as+Kasyaba].>Google Scholar
See WHO, supra note 2, at 157.Google Scholar
Golooba-Mutebi, F., Background: Governance in Uganda, The Guardian (U.K.), March 6 2008, available at <http://www.theguardian.com/katine/2008/mar/06/katinegoalback-ground.background3> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See Kasyaba, supra note 24.Google Scholar
The Guidelines are a revised version of the National Guidelines for Research Involving Humans as Research Participants 2007.Google Scholar
Uganda National Council for Science and Technology (UNCST), National Guidelines for Research Involving Humans as Research Participants 2014, at v, available at <https://www.swarthmore.edu/sites/default/files/assets/documents/institutional-review-board/Human_Subjects_Protection_Guidelines_July_2014.pdf>(last visited February 16, 2016) [hereinafter cited as Guidelines].(last+visited+February+16,+2016)+[hereinafter+cited+as+Guidelines].>Google Scholar
Id., at 1.Google Scholar
National Human Genome Research Institute, NIH and Well-come Trust Announce Partnership to Support Population-based Genome Studies in Africa, available at <https://www.genome.gov/27540084> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
IBRH3AU, Welcome to IBRH3AU Biorepository, available at http://www.ibru.mak.ac.ug/>(last visited February 16, 2016) [[hereinafter cited as IBRH3AU Biorepository].(last+visited+February+16,+2016)+[[hereinafter+cited+as+IBRH3AU+Biorepository].>Google Scholar
IBRH3AU, IBRH3AU Biorepository Specimen Inventory, available at <http://www.ibru.mak.ac.ug/services/samples.php>(last visited February 16, 2016).(last+visited+February+16,+2016).>Google Scholar
See IBRH3AU Biorepository, supra note 32.Google Scholar
H3Africa, Integrated Biorepository of H3Africa Uganda – IBRH3AU, available at <http://h3africa.org/consortium/projects/16-projects/79-integrated-biorepository-of-h3africa-uganda-ibrh3au> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Guidelines, supra note 29, at 1.Google Scholar
Ministry of Health, The Second National Health Policy: Promoting People’s Health to Enhance Socio-economic Development, July 2010, 19–20, available at <http://apps.who.int/medicinedocs/documents/s18426en/s18426en.pdf> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Guidelines, supra note 29, at 1.Google Scholar
Id., at 2.Google Scholar
Id.Google Scholar
Id., at 4.Google Scholar
Id.Google Scholar
Id.Google Scholar
Sections 4 and 5 of the UNCST Act (CAP 209), Laws of Uganda. See also Guidelines, id.Google Scholar
Guidelines, supra note 29, at 4.Google Scholar
Id.Google Scholar
Id.Google Scholar
Section 6(e) of the UNHRO Act, Laws of Uganda. See also Guidelines, supra note 29, at 5.Google Scholar
Guidelines, supra note 29, at 5.Google Scholar
Id., at 5, 9.Google Scholar
Id., at 5–6.Google Scholar
Id., at 6, 9.Google Scholar
Id., at 9.Google Scholar
Id.Google Scholar
Id., at 11.Google Scholar
Id., at 13.Google Scholar
Id.Google Scholar
Id., at 14.Google Scholar
Id., at 16.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 16–17.Google Scholar
Id., at 18.Google Scholar
Id.Google Scholar
Id., at 18–19.Google Scholar
Id., at 19.Google Scholar
Id., at 14.Google Scholar
Id., at 32.Google Scholar
Id., at 28.Google Scholar
Id. Note that there are other bodies with oversight functions over research in Uganda such as Scientific Committees, Data and Safety Monitoring Boards, Community Advisory Boards and Institutional Biosafety Committees. See id., at 6–8.Google Scholar
Guidelines, supra note 29, at 28.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Guidelines, supra note 29, at 28–29.Google Scholar
Id. at 29.Google Scholar
Id.Google Scholar
Id.Google Scholar
Guidelines, supra note 29, at 29–31.Google Scholar
Id., at 4.Google Scholar
Id., at 1.Google Scholar
Id.Google Scholar
Guidelines, supra note 29, at 16.Google Scholar
H3Africa Working Group on Ethics and Regulatory Issues, H3Africa Guidelines for Informed Consent, 8 August 2013, available at <http://www.h3africa.org/images/PDF/H3A%20WG%20Guidelines%20Informed%20Consent_FINAL_01082013.pdf> (last visited February 16, 2016) [hereinafter cited as H3Africa Working Group].+(last+visited+February+16,+2016)+[hereinafter+cited+as+H3Africa+Working+Group].>Google Scholar
Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002, at 33, Guideline 4 (Commentary), available at <http://www.cioms.ch/publications/layout_guide2002.pdf> (last visited February 16, 2016) [hereinafter cited as CIOMS].+(last+visited+February+16,+2016)+[hereinafter+cited+as+CIOMS].>Google Scholar
Guidelines, supra note 29, at, 16–18.Google Scholar
See CIOMS, supra note 90, at 33–34, Guideline 4 (Commentary).Google Scholar
Guidelines, supra note 29, at 17.Google Scholar
Guidelines, supra note 29, at 18.Google Scholar
The H3Africa framework posits thumbprinting as an alternative to signature. See H3AfricaWorking Group, supra note 89, at 21.Google Scholar
Guidelines, supra note 29, at 18.Google Scholar
See Uganda Bureau of Statistics, Uganda National Household Survey Findings 2009/2010, available at <http://www.ubos.org/UNHS0910/chapter3_literacy.html> (last visited February 16, 2016) (reporting that 31 percent of rural dwellers in Ugandans (10 years and above) are illiterate).+(last+visited+February+16,+2016)+(reporting+that+31+percent+of+rural+dwellers+in+Ugandans+(10+years+and+above)+are+illiterate).>Google Scholar
Guidelines, supra note 29, at 16.Google Scholar
See CIOMS, supra note 90, 34, Guideline 4 (Commentary).Google Scholar
de Vries, J., Abayomi, A. and Littler, K., et al., “Addressing Ethical Issues in H3Africa Research – The Views of Research Ethics Committee Members,” The Hugo Journal 9, no. 1 (2015): 1–4.Google Scholar
Guidelines, supra note 29, at 28.Google Scholar
Igbe, M. A. and Adebamowo, C. A., “Qualitative Study of Knowledge and Attitudes to Biobanking among Lay Persons in Nigeria,” BMC Medical Ethics, 13, no. 27 (2012), available at <http://www.biomedcentral.com/1472-6939/13/27> (last visited February 16, 2016).Google Scholar
Guidelines, supra note 29, at 32.Google Scholar
Id., at 14.Google Scholar
Id., at 17.Google Scholar
Id., at 28.Google Scholar
Id., at 32.Google Scholar
Id., at 2.Google Scholar
Id., at 6–10.Google Scholar
Matimba, A., Oluka, M. N., Ebeshi, B. U., et al., “Establishment of a Biobank and Pharmacogenetics Database of African Populations,” European Journal of Human Genetics 16 (2008): 781.Google Scholar
See CIOMS, supra note 90, at 77, Guideline 18 (Commentary).Google Scholar
See IBRH3AU Biorepository, supra note 32.Google Scholar
Guidelines, supra note 29, at 1.Google Scholar
Id.Google Scholar