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Legal and Ethical Challenges of International Direct-to-Participant Genomic Research: Conclusions and Recommendations

Published online by Cambridge University Press:  01 January 2021

Abstract

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Type
Symposium 2 Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

Institutional Review Board is used to refer to ethics review bodies in the United States; Research Ethics Committee is used to refer to ethics review bodies in all other countries.Google Scholar
Our research methodology is summarized in Rothstein, M.A. and Knoppers, B.M., “Regulation of International Direct-to-Participant Genomic Research: Symposium Introduction,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 579580 and Zawati, M.H., “Introduction to the Country Reports,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 581.Google Scholar
Nguyen, M.T. et al., “Model Consent Clauses for Rare Disease Research,” BMC Medical Ethics 20, no. 55 (2019): 17, 2, available at <https://doi.org/10.1186/s12910-019-0390-x> (last visited November 6, 2019).Google Scholar
Jongen, P. et al., “Adherence to Web-Based Self-Assessments in Long-Term Direct-to-Patient Research: Two-Year Study of Multiple Sclerosis Patients,” Journal of Medical Internet Research (2017): 19, 7 e249; Krischer, J. et al., “Experience with Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study,” Journal of Medical Internet Research (2017): 19,2 e50; All of Us Research Program Investigators, “The ‘All of Us’ Research Program,” New England Journal of Medicine 381, no. 7 (2019): 668-676; Boutin, N. et al., “Implementation of Electronic Consent at a Biobank: An Opportunity for Precision Medicine Research.” Journal of Personalized Medicine 6, no. 2, (2016): 17, available at <https://doi.org/10.3390/jpm6020017> (last visited November 6, 2019).CrossRefGoogle Scholar
Comprehension is a special concern in countries where consent documents must be translated. Other concerns include different cultural meanings attached to risk or the value of scientific research. For a further discussion, see Part VI infra.Google Scholar
Grady, C. et al., “The Changing Face of Informed Consent,” New England Journal of Medicine 376, no. 9 (2017): 856867; Doerr, M. et al., “Developing a Transparent, Participant-Navigated Electronic Informed Consent for Mobile-Mediated Research” (2016), available at <http://dx.doi.org/10.2139/ssrn.2769129> (last visited November 6, 2019).CrossRefGoogle Scholar
Count Me In, “About Us,” available at <https://joincountmein.org/About> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
Painter, C. et al., “The Angiosarcoma Project: Enabling Genomic and Clinical Discoveries in a Rare Cancer through Patient-Partnered Research,” bioRxiv preprint first posted online August 26, 2019; available at <http://dx.doi.org/10.1101/741744> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
All of Us, About the All of Us Research Program, available at <https://allofus.nih.gov/about/about-all-us-research-program> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
See All of Us, supra note 4.Google Scholar
See section VII-E, infra.Google Scholar
The societal benefits of any health research depend on socioeconomic and socio-cultural considerations related to the individual country. Individuals in low- and middle-income countries may not realize the same health benefits, and may have greater social risks, as individuals in high income countries.Google Scholar
Lek, M. et al., “Analysis of Protein-Coding Genetic Variation in 60,706 Humans, Nature 536, no. 7616 (2016): 285291; Manrai, A.K. et al., “Genetic Misdiagnoses and the Potential for Health Disparities,” New England Journal of Medicine 375, no. 7 (2016): 655-665.CrossRefGoogle Scholar
NIH, Genetic and Rare Diseases Information Center, FAQs about Rare Diseases, available at <https://rarediseases.info.nih.gov/diseases/pages/31/faqs-about-rare-diseases> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
WHO, Priority Medicines for Europe and the World 2013 (2013), available at <https://www.who.int/medicines/areas/priority_medicines/Ch6_19Rare.pdf> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
See Rothstein, Zawati, and Knoppers, supra note 3.Google Scholar
France, Greece, India, Israel, Italy, Japan, Nigeria, Poland, and Spain.Google Scholar
Australia, Brazil, Canada, China, Denmark, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Nigeria, Peru, Qatar, South Africa, Spain, Sweden, Switzerland, Taiwan, Uganda, and the United Kingdom. Note: We include Peru within these 22 countries despite an “unsure” response in its report as it was stated, based on existing legislation, that HREC approval was a prerequisite for all forms of scientific research in the country. Finland answered both “yes” and “no,” therefore we categorized the response as “unsure/other.” Similarly, we categorized South Korea's response as “unsure/other” as the explanation did not state that DTP genomic research would be unlawful without external or local REB approval.Google Scholar
Brazil, China, Denmark, Israel, Italy, Mexico, the Netherlands, Peru, Spain, Sweden, Switzerland, and Taiwan.Google Scholar
Australia, Canada, Greece, India, Japan, Qatar, South Africa, Uganda, and the United Kingdom.Google Scholar
Estonia, France, Jordan, Poland, and South Korea.Google Scholar
Finland, Singapore, and the United States.Google Scholar
Brazil, China, Denmark, India, Israel, Italy, Mexico, the Netherlands, Nigeria, Peru, Qatar, South Africa, Sweden, Switzerland, Taiwan, Uganda, and the United Kingdom.Google Scholar
Brazil, China, Denmark, Israel, Italy, Mexico, the Netherlands, Nigeria, Peru, Sweden, Switzerland, and Taiwan.Google Scholar
India, Qatar, South Africa, Uganda, and the United Kingdom.Google Scholar
Australia, Canada, and Japan.Google Scholar
Estonia, France, Greece, Finland, Jordan, Poland, Singapore, South Korea, and the United States.Google Scholar
Germany, the Netherlands, Peru, and Taiwan.Google Scholar
Australia, Canada, Greece, and Japan.Google Scholar
Brazil, China, Israel, Italy, and Mexico.Google Scholar
India, Qatar, South Africa, and Uganda.Google Scholar
Denmark, Singapore, South Korea, and the United Kingdom.Google Scholar
Finland and the United States.Google Scholar
Nine responded “Yes,” 4 stated it would be practical, and 2 stated it would depend on the context of the research.Google Scholar
We included Germany and South Korea in this grouping, despite their uncertainty as to their responses because their legislation does not explicitly preclude commercial entities from conducting research. Rather, in certain circumstances, commercial entities may be subject to additional scrutiny during HREC approval (South Korea) or stricter regulation in the conduct of their research (Germany).Google Scholar
Brazil, Denmark, Finland, Israel, Italy, Mexico, the Netherlands, Nigeria, Peru, Singapore, Sweden, Switzerland, and Taiwan.Google Scholar
Australia, Canada, Japan, Greece, South Africa, Uganda, the United Kingdom, and the United States.Google Scholar
We were not able to categorize Estonia, Nigeria, and Spain as there were insufficient indications as to the types of normative documents relied on to provide their responses.Google Scholar
China, India, Poland, and Qatar.Google Scholar
France and Jordan.Google Scholar
Australia, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Israel, Italy, Japan, Spain, Sweden, the United Kingdom. Note: we include countries which listed the GDPR within this list as it contains provisions regarding the protection of genetic data.Google Scholar
Canada, Mexico, the Netherlands, Nigeria, Peru, Poland, Singapore, Switzerland, Taiwan, Uganda, and the United States.Google Scholar
India, Jordan, Qatar, South Africa, and South Korea.Google Scholar
Canada, China, Nigeria, South Korea, Spain, Switzerland, Taiwan, Uganda, the United Kingdom, and the United States.Google Scholar
See, for example, Canada, Spain, Switzerland, and Taiwan.Google Scholar
Australia, Estonia, Finland, France, Germany, Greece, Israel, Italy, the Netherlands, and Sweden.Google Scholar
Estonia, Finland, France, Germany, Greece, Italy, the Netherlands, and Sweden.Google Scholar
See Finland, France, the Netherlands, and Sweden.Google Scholar
Denmark, Mexico, Peru, and Singapore.Google Scholar
Brazil, Japan, and Poland.Google Scholar
India, Jordan, Qatar, and South Africa.Google Scholar
See Question 10 of the Country Reports: Brazil, Denmark, Finland, France, Greece, Israel, Italy, Jordan, Mexico, the Netherlands, Nigeria, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Uganda, and the United KingdomGoogle Scholar
Clayton, E.W. et al., “The Law of Genetic Privacy: Applications, Implications, and Limitations,” Journal of Law and the Biosciences (2019): 136, doi: 10.1093/jlb/lsz007.CrossRefGoogle Scholar
National Human Genome Research Institute, Genome Statute and Legislation Database, NHGRI website, available at <https://www.genome.gov/about-genomics/policy-issues/Genome-Statute-Legislation-Database> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
See, e.g., Alaska Stat. § 18.13.010(a)(2); Colo. Rev. Stat. § 10-3-1104.7(1)(a); Fla. Stat. § 760.40(2)(a); Ga. Code Ann. § 33-54-1(1); La. Rev. Stat. Ann. § 22:213.7(E).Google Scholar
See, e.g., Alaska Stat. Ann. § 18.13.010(a)(2); Ariz. Rev. Stat. § 20-448.02; Del. Code tit. 16, §1201 et seq.; Fla. Stat. Ann. § 760.40(2)(a).Google Scholar
See, e.g., Del. Code tit. 16, §1201 et seq.; Nev. Rev. Stat. §629.101 et seq.; N.J. Rev. Stat. §10:5-43 et seq.; Tex. Bus. & Com. Code § 546.001 et seq.; Wyo. Stat. § 35-31-101 et seq.Google Scholar
See, e.g., Fla Stat. §7 60.40); Ky. Rev. Stat. §61.931 et seq.; Me. Stat. tit. 22, § 1711C.Google Scholar
See, e.g., Cal. Health and Safety Code § 24170 et seq.; Md. Health Code §13-2001 et seq.; N.Y. Public Health Code §2440 et seq.; Code of Va. § 32.1-162.16.Google Scholar
See E.W. Clayton et al., supra note 55 (discussing the various federal statutes governing genetic information and research, including issues of preemption).Google Scholar
California Consumer Privacy Act of 2018, available at <https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201720180SB1121> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
See Rothstein, M.A. and Tovino, S.A., “California Takes the Lead on Data Privacy Law,” Hastings Center Report 49, no. 5 (2019): 45.CrossRefGoogle Scholar
General Data Protection Regulation, Regulation (EU) 2016/679.Google Scholar
See, e.g., Protection of Personal Information Act, 2013 (South Africa), available at <http://www.justice.gov.za/inforeg/docs/InfoRegSA-POPIA-act2013-004.pdf> (last visited November 6, 2019); California Consumer Privacy Act of 2018, supra note 63.+(last+visited+November+6,+2019);+California+Consumer+Privacy+Act+of+2018,+supra+note+63.>Google Scholar
Regulation (EU) 2016/679, Article 9(2).Google Scholar
Regulation (EU) 2016/679, Article 9(2)(a).Google Scholar
Regulation (EU) 2016/679, Article 9(2)(j).Google Scholar
Regulation (EU) 2016/679, Article 5(1)(e).Google Scholar
Pormeister, K., “Genetic Research and Applicable Law: The Intra-EU Conflict of Laws as a Regulatory Challenge to Cross-Border Genetic Research,” Journal of Law and the Biosciences 5, no. 3 (2018): 118.CrossRefGoogle Scholar
Regulation (EU) 2016/679, Article 9(4).Google Scholar
Regulation (EU) 2016/679, Article 9(2)(g) and (j); Article 6(e).Google Scholar
Regulation (EU) 2016/679, Article 89(2).Google Scholar
See Rothstein, M.A. et al., “Broad Consent for Future Research: International Perspectives,” Hastings Center Report 40, no. 6 (2018): 712.Google Scholar
Regulation (EU) 2016/679, Recital 33.Google Scholar
Senger, A. and Schonhofen, S., “German DPAs Publish Resolution on Concept of ‘Broad Consent’ and the Interpretation of ‘Certain Areas of Scientific Research,’” Technology Law Dispatch (April 25, 2019), available at <https://www.technologylawdispatch.com/2019/04/privacy-data-protection/german-dpas-publish-resolution-on-concept-of-broad-consent-and-the-interpretation-of-certain-areas-of-scientific-research/> (last visited November 6, 2019); the full text of the resolution (in German) is available at <https://www.datenschutzkonferenz-online.de/media/dskb/20190405_auslegung_bestimmte_bereiche_wiss_forschung.pdf> (last visited November 6, 2019).+(last+visited+November+6,+2019);+the+full+text+of+the+resolution+(in+German)+is+available+at++(last+visited+November+6,+2019).>Google Scholar
K. Pormeister, supra note 71.Google Scholar
European Commission, “Declaration of Cooperation: Towards Access to at least 1 Million Sequenced Genomes in the European Union by 2022,” available at <https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=50964> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
European Commission, “13 European Countries Have Signed a Declaration for Delivering Cross-border Access to Their Genomic Information,” available at <https://ec.europa.eu/digital-single-market/en/news/eu-countries-will-cooperate-linking-genomic-databases-across-borders> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
Protection of Personal Information Act, supra note 66.Google Scholar
Staunton, C. et al., “Ethical and Practical Issues to Consider in the Governance of Genomic and Human Research Data and Data Sharing in South Africa: a Meeting Report,” AAS Open Research 2, no. 15 (2019): 111.CrossRefGoogle Scholar
Pepper, M.S. et al., “ASSAf Consensus Study on the Ethical, Legal and Social Implications of Genetics and Genomics in South Africa,” South African Journal of Science 14 no. 11/12 (2018): 13 at 2; C. Staunton et al., supra note 85, at 3-4.Google Scholar
M.S. Pepper et al., supra note 86.Google Scholar
L. Nordling, supra note 83.Google Scholar
de Vries, J. et al., “Regulation of Genomic and Biobanking Research in Africa: A Content Analysis of Ethics Guidelines, Policies and Procedures from 22 African Countries,” BMC Medical Ethics 18, no. 8 (2017): 19; Rich, C., “Privacy Laws around the World,” Bloomberg Law (2016), available at <http://garnerhealth.com/wp-content/uploads/2014/02/privacy-laws-around-the-world-report.pdf> (last visited November 6, 2019).CrossRefGoogle Scholar
Kay, M., “Indian Supreme Court Tells Government to Act on Illegal Clinical Trials,” British Medical Journal 346, no. f51 (2013), available at <https://doi.org/10.1136/bmj.f51> (last visited November 6, 2019). See Swasthya Adhikar Manch v. Union of India, Writ Petition (Civil) No. 33 of 2012.CrossRefGoogle Scholar
Reardon, S., “NIH Makes Wary Return to India, “ Nature News 506, no. 7487 (2014): 143144.Google Scholar
Report of the Prof. Ranjit Roy Chaudhury Expert Committee to Formulate Policy and Guidelines for Approval of New drugs, Clinical Trials and Banning of Drugs (July 2013), available at <http://www.indiaenvironmentportal.org.in/files/file/clinical%20trials1.pdf> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
Id. at 2, 40-49; see Barnes, M. et al., “The Evolving Regulatory Landscape for Clinical Trials in India,” Food and Drug Law Journal 73, no. 601 (2018): 601623, 611.Google Scholar
Expert Committee Report, supra note 94, at 2-3, 76-77; see Barnes et al., supra note 95, at 611-614.Google Scholar
Expert Committee Report, supra note 94, at 3, 78-89; see Barnes et al., supra note 95, at 606-610.Google Scholar
Expert Committee Report, supra note 94, at 3, 78-89; see Barnes et al., supra note 95, at 611-614.Google Scholar
Chaudhury, R.R. and Mehta, D., “Regulatory Developments in the Conduct of Clinical Trials in India,” Global Health, Epidemiology and Genomics 1, no. e4 (2016): 16.Google Scholar
Mallath, K. and Chawla, T., “Investigators' Viewpoint of Clinical Trials in India: Past, Present and Future,” Perspectives in Clinical Research 8, no. 1 (2017): 3136.CrossRefGoogle Scholar
Barnes et al., supra note 95, at 618-622.Google Scholar
Normile, D., “China Asserts Firm Grip on Research Data,” (April 9, 2018), available at <https://www.sciencemag.org/news/2018/04/china-asserts-firm-grip-research-data> (last visited November 6, 2019).CrossRef+(last+visited+November+6,+2019).>Google Scholar
Lovells, H., “New Human Genetic Resources Regulations in China (July 2019),” available at <https://f.datasrvr.com/fr1/319/56529/New_human_genetic_resources_regulations_in_China_-_July_8_2019.pdf> (last visited November 6, 2019); the full text of the resolution (in Chinese) is available at <http://www.gov.cn/zhengce/content/2018-04/02/content_5279272.htm> (last visited November 6, 2019).+(last+visited+November+6,+2019);+the+full+text+of+the+resolution+(in+Chinese)+is+available+at++(last+visited+November+6,+2019).>Google Scholar
Id. at 1-2.Google Scholar
Id. at 2-3.Google Scholar
Id. at 3-4.Google Scholar
Guarino, B., Rauhala, E., and Wan, W., “China Increasingly Challenges American Dominance of Science,” Washington Post (June 3, 2019), available at <https://www.washington-post.com/national/health-science/china-challenges-american-dominance-of-science/2018/06/03/c1e0cfe4-48d5-11e8-827e-190efaf1f1ee_story.html> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
See, e.g., J. de Vries et al., supra note 90.Google Scholar
Resnik, D., “Consistency in IRB Review,” Journal of Clinical Research Best Practices 10, no. 12 (2014): 18.Google Scholar
Lemke, A.A. et al., “Broad Data Sharing in Genetic Research: View of Institutional Review Board Professionals,” IRB 33, no. 3 (2011): 15.Google Scholar
See section VI infra.Google Scholar
Dove, E.S. and Garattini, C., “Expert Perspectives on Ethics Review of International Data-Intensive Research: Working Towards Mutual Recognition,” Research Ethics 14, no. 1 (2018): 125.CrossRefGoogle Scholar
Global Alliance for Genomics and Health, Ethics Review Recognition Policy (2017), available at <https://www.ga4gh.org/wp-content/uploads/GA4GH-Ethics-Review-Recognition-Policy.pdf> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
UNESCO, Universal Declaration of Bioethics and Human Rights (2005), available at <http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
See Dove, E.S. et al., “Ethics Review for International Data-Intensive Research,” Science 351, no. 6280 (2016): 13981399.CrossRefGoogle Scholar
Kleinman, A., “Culture, Health Care, and Clinical Reality,” in: Kleinman, A., ed., Patients and Healers in the Context of Culture: An Exploration of the Borderland Between Anthropology, Medicine, and Psychiatry (Berkeley: University of California Press, 1980): 2470; Marshall, P.A., “Informed Consent in International Health Research,” Journal of Empirical Research on Human Research Ethics 1, no. 1 (2006): 25-42; Smith-Morris, C., “Autonomous Individuals or Self-Determined Communities? The Changing Ethics of Research among Native Americans,” Human Organization 66, no. 3 (2007): 327-336.CrossRefGoogle Scholar
Hudson, M., “Think Globally, Act Locally: Collective Consent and the Ethics of Knowledge Production,” International Social Science Journal 60, no. 195 (2009): 125133, 128.CrossRefGoogle Scholar
Marshall, supra note 124; Smith-Morris, supra note 124; De Craemer, W., “A Cross-Cultural Perspective on Personhood,” Milbank Memorial Fund Quarterly Health and Society 61, no. 1 (1983): 1934; Marshall, P. and Koenig, B., “Accounting for Culture in a Globalized Bioethics,” Journal of Law, Medicine and Ethics 32, no. 2 (2004): 252-266; Levine, R.J., “Informed Consent: Some Challenges to the Universal Validity of the Western Model,” Law, Medicine and Health Care 19, no. 3-4 (1991): 207-213; Marshall, P.A., “‘Cultural Competence’ and Informed Consent in International Health Research,” Cambridge Quarterly of Healthcare Ethics 17, no. 2 (2008): 206-215; Gilbar, R. and Miola, J., “One Size Fits All? On Patient Autonomy, Medical Decision-Making, and the Impact of Culture,” Medical Law Review 23, no. 3 (2014): 375-399.Google Scholar
Foster, M.W. and Sharp, R.R., “Genetic Research and Culturally Specific Risks: One Size Does Not Fit All,” Trends in Genetics 16, no. 2 (2000): 9395; de Vries, J. et al., “Ethical Issues in Human Genomics Research in Developing Countries,” BMC Medical Ethics 12 (2011); Garrison, N.A. et al., “Genomic Research Through an Indigenous Lens: Understanding the Expectations,” Annual Review of Genomics and Human Genetics 20, no. 1 (2019).Google Scholar
Hudson, supra note 125; Clark, M.J., “Cross-Cultural Research: Challenge and Competence,” International Journal of Nursing Practice 18, no. s2 (2012): 2837; Foster and Sharp, supra note 127; Hyder, A.A. and Wali, S.A., “Informed Consent and Collaborative Research: Perspectives from the Developing World,” Developing World Bioethics 6, no. 1 (2006): 33-40; Krogstad, D.J. et al., “Informed Consent in International Research: The Rationale for Different Approaches,” American Journal of Tropical Medicine and Hygiene 83, no. 4 (2010): 743-747; Marshall, P.A., “Human Subjects Protections, Institutional Review Boards, and Cultural Anthropological Research,” Anthropological Quarterly 76, no.2 (2003): 269-285; Marshall, P.A., “The Individual and the Community in International Genetic Research,” Journal of Clinical Ethics 15, no. 1 (2004): 76-86; Dawson, L. and Kass, N.E., “Views of US Researchers About Informed Consent in International Collaborative Research,” Social Science and Medicine 61, no.6 (1982): 1211-1222.CrossRefGoogle Scholar
Claw, K.G. et al., “A Framework for Enhancing Ethical Genomic Research with Indigenous Communities,” Nature Communications 9 (2018): 2957; Tsosie, K.S., Yracheta, J.M., and Dickenson, D., “Overvaluing Individual Consent Ignores Risks to Tribal Participants,” Nature Reviews Genetics 20, no. 9 (2019): 747-798; Hudson, supra note 125; Garrison, supra note 127; Henare, K.L. et al., “Mapping a Route to Indigenous Engagement in Cancer Genomic Research,” The Lancet Oncology 20, no. 6 (2019): e327-e335; Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, “Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans” (2010); Indigenous People Council of Biocolonialism, “Indigenous Research Protection Act,” A Model Tribal Ordinance for the Protection of Indigenous Knowledge and Biological Resources (2000); Sharp, R.R. and Foster, M.W., “Community Involvement in the Ethical Review of Genetic Research: Lessons from American Indian and Alaska Native Populations,” Environmental Health Perspectives 110 (Supp. 2) (2002): 145-148; Bhutta, Z.A., “Ethics in International Health Research: A Perspective from the Developing World,” Bulletin of the World Health Organization 80, no. 2 (2002): 114-120; McWhirter, R.E. et al., “Ethical Genetic Research in Indigenous Communities: Challenges and Successful Approaches,” Trends in Molecular Medicine 18, no. 12 (2012): 702-708.CrossRefGoogle Scholar
See Dove, E.S., “Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 264282, 271 (stating that “the case for local IRB review rests more on the force of its rhetoric than the force of its logic”).CrossRefGoogle Scholar
de Vries, J. et al., supra note 90; Moodley, K. et al., “‘It's My Blood’: Ethical Complexities in the Use, Storage and Export of Biological Samples: Perspectives from South African Research Participants,” BMC Medical Ethics 15 (2014); Chokshi, D.A. et al., “Valid Consent for Genomic Epidemiology in Developing Countries,” PLoS Medicine 4 (2007): e95-e95; Garrison, N.A., “Considerations for Returning Research Results to Culturally Diverse Participants and Families of Decedents,” Journal of Law, Medicine and Ethics 43, no. 3 (2015): 569-575; Brief, E., Mackie, J., and Illes, J., “Incidental Findings in Genetic Research: A Vexing Challenge for Community Consent,” Minnesota Journal of Law, Science & Technology 13, no. 2 (2012): 541-558; Arbour, L. and Cook, D., “DNA on Loan: Issues to Consider when Carrying Out Genetic Research with Aboriginal Families and Communities,” Public Health Genomics 9, no. 3 (2006): 153-160.Google Scholar
World Medical Association, Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects (2013), available at <https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
McCarthy, C.R., “The Origins and Policies that Govern Institutional Review Boards,” in Emanuel, E. et al., eds., Oxford Textbook of Clinical Research Ethics (New York, NY: Oxford University Press, 2008): 541551, 545.Google Scholar
Id. at 549.Google Scholar
Klitzman, R., “How Local IRBs View Central IRBs in the U.S.,” BMC Medical Ethics 12, no. 13 (2011): 1326.CrossRefGoogle Scholar
Skloot, R., The Immortal Life of Henrietta Lacks (New York: Crown Publishing Group, 2010).Google Scholar
The possibility that ethics review of research protocols might need to account for local concerns has been offered as a justification for local review since at least 1978. In that year, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the U.S. published recommendations for regulations on Institutional Review Boards. The Commission stated that local ethics review might be desirable because it provides an opportunity to consider values or needs that are specific to a particular community: “In its deliberations, it is desirable that the IRB show awareness and appreciation of the various qualities, values and needs of the diverse elements of the community served by the institution or in which it is located.” National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978).Google Scholar
Redshaw, M.E., Harris, A., and Baum, J.D., “Research Ethics Committee Audit: Differences between Committees,” Journal of Medical Ethics 22, no. 2 (1996): 7882, 79.CrossRefGoogle Scholar
Brothers, K.B. et al., “A Belmont Reboot: Building a Normative Foundation for Human Research in the 21st Century,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 165172.Google Scholar
Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (4th ed. 2007).Google Scholar
Ahmed, A.H. and Nicholson, K.G., “Delays in the Practice of Local Research Ethics Committees,” Journal of Medical Ethics 22, no. 5 (1996): 263266.CrossRefGoogle Scholar
Burman, W. et al., “The Effects of Local Review on Informed Consent Documents from a Multicenter Clinical Trials Consortium,” Controlled Clinical Trials 24, no. 3 (2003): 245255.CrossRefGoogle Scholar
Ahmed and Nicholson, supra note 143; Berry, T.J., Ades, T.E., and Peckham, C.S., “Too Many Ethical Committees,” British Medical Journal 301, no. 6763 (1990): 1274; Garfield, P., “Cross District Comparison of Applications to Research Ethics Committees,” British Medical Journal 311 (1995): available at <https://doi.org/10.1136/bmj.311.7006.660> (last visited September 5, 2019); Gilbert, C., Fulford, K.W., and Parker, C., “Diversity in the Practice of District Ethics Committees,” British Medical Journal 299, no. 6713 (1989): 1437- 1439; Hotopf, M., Wessely, S., and Noah, N., “Are Ethical Committees Reliable?” Journal of the Royal Society of Medicine 88, no. 1 (1995): 31-33.CrossRefGoogle Scholar
Dziak, K. et al., “Variations among Institutional Review Board Reviews in a Multisite Health Services Research Study,” Health Services Research 40, no. 1 (2005): 279290; Mansbach, J. et al., “Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research Protocol,” Academic Emergency Medicine 14, no. 4 (2007): 377-380; McWilliams, R., Hoover-Fong, J., and Hamosh, A., “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” Journal of the American Medical Association 290, no. 3 (2003): 360-366; Ravina, B. et al., “Local Institutional Review Board Review of a Multicenter Trial: Local Costs without Local Context,” Annals of Neurology 67, no. 2 (2010): 258-260; Silverman, H., Hull, S.C., and Sugarman, J., “Variability among Institutional Review Boards' Decisions within the Context of a Multicenter Trial,” Critical Care Medicine 292, no. 2 (2001): 235-241; Stair, T.O. et al., “Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial,” Academic Emergency Medicine 8, no. 6 (2001): 636-641; Stark, A.R., Tyson, J.E., and Hibberd, P.L., “Variation among Institutional Review Boards in Evaluating the Design of a Multicenter Randomized Trial,” Journal of Perinatology 30, no. 3 (2010): 163-169; Vick, C.C. et al., “Variation in Institutional Review Processes for a Multisite Observational Study,” American Journal of Surgery 190, no. 5 (2005): 805-809.CrossRefGoogle Scholar
Stair et al., supra note 146.Google Scholar
Al-Shahi, R., “Research Ethics Committees in the UK — The Pressure Is Now on Research and Development Departments,” Journal of the Royal Society of Medicine 98, no. 10 (2000): 444447.Google Scholar
Levine, R.J. and Lasagna, L., “Demystifying Central Review Boards: Current Options and Future Directions,” IRB 22, no. 6 (2000): 16.CrossRefGoogle Scholar
45 C.F.R. § 46.114(b)(1).Google Scholar
Goodyear-Smith, F., “International Variation in Ethics Committee Requirements: Comparisons across Five Westernised Nations,” BMC Medical Ethics 19, no. 3 (E2) (2002).Google Scholar
Dove, E.S. et al., “Ethics Review for International Data-Intensive Research,” Science 351, no. 6280 (2016) 13994001.CrossRefGoogle Scholar
In some cultures, any analysis of human biospecimens may be viewed with great skepticisim or at least as raising very important issues. The possible use of information derived from specimens may raise other important issues. On a global basis, these issues arising from international DTP genomic research deserve further study, as we recommend. On a study-by-study basis, the investigators and their ethics review bodies ought to consider the issues in the context of the range of countries from which participants will be recruited or accepted.Google Scholar
Thorogood, A., Dalpe, G., and Knoppers, B.M., “Return of Individual Genomic Research Results: Are Laws and Policies Keeping Step?” European Journal of Human Genetics (2019): available at <https://doi.org/10.1038/s41431-018-0311-3> (review of laws and policies in 20 countries found discrepancies on return of results). The questionnaire results from this study had a similar finding. See Zawati, M.H., ed., “31 Country Reports on International Direct-to-Participant Genomic Research,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 582704.Google Scholar
See Childerhose, J.E. et al., “Participant Engagement in Translational Genomics Research: Respect for Persons — and Then Some,” Ethics and Human Research 41, no. 1 (2019): 215.CrossRefGoogle Scholar
Even in countries where direct-to-consumer genetic testing is illegal, there have been no reported cases of legal actions being brought against consumers who obtain these services.Google Scholar
We do not reach the complicated legal issue of how a country would obtain jurisdiction over researchers who never entered the country.Google Scholar
Researchers who perform research in other countries without approval by their own IRB, however, will likely be subject to sanctions.Google Scholar
Hoppe, N., “Germany Country Report,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 615619 (answer to question 10).Google Scholar
See Wagner, J., “The Transfer of Personal Data to Third Countries under the GDPR: When Does a Recipient Country Provide an Adequate Level of Protection?” International Data Privacy Law 8, no. 4 (2018): 318337, 319.CrossRefGoogle Scholar
Dir. 95/46/EC (1995).CrossRefGoogle Scholar
15 U.S.C. § 45.Google Scholar
C-362/14, EU:2015:650 (Eur. Ct. Just. 2015). See Roth-stein, M.A., “International Health Research after Schrems v. Data Protection Commissioner,” Hastings Center Report 46, no. 2 (2016): 56.CrossRefGoogle Scholar
See Schwartz, P.M., “Global Data Privacy: The EU Way,” New York University Law Review 94, no. 4 (2019): 771818, at 802.Google Scholar
Regulation (EU) 2016/679 of the European Parliament.Google Scholar
“Adequacy Decisions.” European Commission - European Commission, available at <https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/adequacy-decisions_en> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
“ARTICLE29 Newsroom - Working Document on Adequacy Referential (Wp254rev.01) - European Commission,” available at <https://ec.europa.eu/newsroom/article29/item-detail.cfm?item_id=614108> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
See Privacy Shield Framework, available at <https://www.privacyshield.gov/Individuals-in-Europe> (last visited November 6, 2019). Another example is the Asia-Pacific Economic Cooperation agreement involving 21 countries. See Asia-Pacific Economic Cooperation, “What Is the Cross-Border Privacy Rules System?” available at <https://www.apec.org/About-Us/About-APEC/Fact-Sheets/What-is-the-Cross-Border-Privacy-Rules-System> (last visited November 6, 2019).+(last+visited+November+6,+2019).+Another+example+is+the+Asia-Pacific+Economic+Cooperation+agreement+involving+21+countries.+See+Asia-Pacific+Economic+Cooperation,+“What+Is+the+Cross-Border+Privacy+Rules+System?”+available+at++(last+visited+November+6,+2019).>Google Scholar
45 C.F.R. § 46.101(h).Google Scholar
Another provision of the Common Rule, setting forth the applicability of the Common Rule, provides in pertinent part: “It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.” 45 C.F.R. § 46.101(a).Google Scholar
See Dove, E.S., Knoppers, B.M., and Zawati, M.H., “Towards an Ethics Safe Harbor for Global Biomedical Research,” Journal of Law and the Biosciences 3-51 (2014), available at <doi: 10.1093/jlb/lst002>; Lavery, J.V., McDonald, M., and Meslin, E.M., “Research Ethics Across the 49th Parallel: The Potential Value of Pilot Testing ‘Equivalent Protections’ in Canadian Research Institutions,” Health Law Review 13, no. 2-3 (2005): 86-96; Sugarman, J., “Should the Gold Rule? Assessing ‘Equivalent Protections’ for Research Participants across International Borders,” Hastings Center Report 35, no. 5 (2005): 12-13.Google Scholar
The OHRP International Program “works to ensure that human subjects outside of the United States who participate in research projects conducted or funded by HHS receive an equal level of protection as research participants inside the United States.” HHS Office for Human Research Protections, International, available at <https://www.hhs.gov/ohrp/international/index.html> (last visited September 2, 2019). It also publishes a list of international laws, regulations, and guidelines relevant to research with human subjects. HHS Office for Human Research Protections, International Compilation of Human Research Standards, available at <https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html> (last visited November 6, 2019).+(last+visited+September+2,+2019).+It+also+publishes+a+list+of+international+laws,+regulations,+and+guidelines+relevant+to+research+with+human+subjects.+HHS+Office+for+Human+Research+Protections,+International+Compilation+of+Human+Research+Standards,+available+at++(last+visited+November+6,+2019).>Google Scholar
Another possibility is to establish international ethics review entities to approve international studies, but the proposal has not received any favorable response. See E.S. Dove, B.M. Knoppers, and M.H. Zawati, supra note 175.Google Scholar
Arguably, such a determination is not necessary under current U.S. law, but it would be necessary for a country that currently requires local ethics review for a researcher outside of the country.Google Scholar
As discussed in section V, there is considerable alignment of the criteria and procedures for research ethics review around the world, but we do not reach the issue of what specific standards ought to be developed or applied to satisfy equivalency and adequacy. An example of proposed guidelines is Global Alliance for Genomics and Health, Ethics Review Recognition Policy, available at <https://www.ga4gh.org/wp-content/uploads/GA4GH-Ethics-Review-Recognition-Policy.pdf> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
CIOMS/WHO, International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002), available at <https://cioms.ch/wp-content/uploads/2016/08/International_Ethical_Guidelines_for_Biomedical_Research_Involving_Human_Subjects.pdf> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
UNESCO, Universal Declaration of Bioethics and Human Rights (2005), available at <http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
UNESCO, Draft Recommendation on Privacy and Protection of Health-Related Data (2019)), available at <https://www.ohchr.org/EN/Issues/Privacy/SR/Pages/HealthRelatedData.aspx> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
Council of Europe, Recommendation of the Committee of Ministers to Member States on the Protection of Health-Related Data (2019), available at <https://search.coe.int/cm/pages/result_details.aspx?objectid=090000168093b26e> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
H3Africa Guidelines for Informed Consent, available at <http:/h3africa.org/ethics/17-ethics/71-informedconsent> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
World Medical Association, supra note 133.Google Scholar
Wellcome Trust, available at <https://wellcome.ac.uk/> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar
Bill and Melinda Gates Foundation, available at <https://www.gatesfoundation.org/> (last visited August 23, 2019).+(last+visited+August+23,+2019).>Google Scholar
Global Alliance for Genomics and Health, available at <https://www.ga4gh.org/> (last visited November 6, 2019).+(last+visited+November+6,+2019).>Google Scholar