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.
2.
M.H.Zawati, “Introduction to the Country Reports,”Journal of Law, Medicine & Ethics47, no. 4 (2019): 581.
3.
M.T.Nguyenet al., “Model Consent Clauses for Rare Disease Research,”BMC Medical Ethics20, no. 55 (2019): 1-7, 2, available at <https://doi.org/10.1186/s12910-019-0390-x> (last visited November 6, 2019).
4.
N.Boutinet al., “Implementation of Electronic Consent at a Biobank: An Opportunity for Precision Medicine Research.”Journal of Personalized Medicine6, no. 2, (2016): 17, available at <https://doi.org/10.3390/jpm6020017> (last visited November 6, 2019).
5.
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.
6.
M.Doerret 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).
C.Painteret 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).
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.
14.
A.K.Manraiet al., “Genetic Misdiagnoses and the Potential for Health Disparities,”New England Journal of Medicine375, no. 7 (2016): 655-665.
See Rothstein, Zawati, and Knoppers, supra note 3.
19.
France, Greece, India, Israel, Italy, Japan, Nigeria, Poland, and Spain.
20.
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.
21.
Brazil, China, Denmark, Israel, Italy, Mexico, the Netherlands, Peru, Spain, Sweden, Switzerland, and Taiwan.
22.
Australia, Canada, Greece, India, Japan, Qatar, South Africa, Uganda, and the United Kingdom.
23.
Estonia, France, Jordan, Poland, and South Korea.
24.
Finland, Singapore, and the United States.
25.
Brazil, China, Denmark, India, Israel, Italy, Mexico, the Netherlands, Nigeria, Peru, Qatar, South Africa, Sweden, Switzerland, Taiwan, Uganda, and the United Kingdom.
26.
Brazil, China, Denmark, Israel, Italy, Mexico, the Netherlands, Nigeria, Peru, Sweden, Switzerland, and Taiwan.
27.
India, Qatar, South Africa, Uganda, and the United Kingdom.
28.
Australia, Canada, and Japan.
29.
Estonia, France, Greece, Finland, Jordan, Poland, Singapore, South Korea, and the United States.
30.
Germany, the Netherlands, Peru, and Taiwan.
31.
Australia, Canada, Greece, and Japan.
32.
Brazil, China, Israel, Italy, and Mexico.
33.
India, Qatar, South Africa, and Uganda.
34.
Denmark, Singapore, South Korea, and the United Kingdom.
35.
Finland and the United States.
36.
Nine responded “Yes,” 4 stated it would be practical, and 2 stated it would depend on the context of the research.
37.
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).
38.
Brazil, Denmark, Finland, Israel, Italy, Mexico, the Netherlands, Nigeria, Peru, Singapore, Sweden, Switzerland, and Taiwan.
39.
Australia, Canada, Japan, Greece, South Africa, Uganda, the United Kingdom, and the United States.
40.
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.
41.
China, India, Poland, and Qatar.
42.
France and Jordan.
43.
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.
44.
Canada, Mexico, the Netherlands, Nigeria, Peru, Poland, Singapore, Switzerland, Taiwan, Uganda, and the United States.
45.
India, Jordan, Qatar, South Africa, and South Korea.
46.
Canada, China, Nigeria, South Korea, Spain, Switzerland, Taiwan, Uganda, the United Kingdom, and the United States.
47.
See, for example, Canada, Spain, Switzerland, and Taiwan.
48.
Australia, Estonia, Finland, France, Germany, Greece, Israel, Italy, the Netherlands, and Sweden.
49.
Estonia, Finland, France, Germany, Greece, Italy, the Netherlands, and Sweden.
50.
See Finland, France, the Netherlands, and Sweden.
51.
Denmark, Mexico, Peru, and Singapore.
52.
Brazil, Japan, and Poland.
53.
India, Jordan, Qatar, and South Africa.
54.
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 Kingdom
55.
E.W.Claytonet al., “The Law of Genetic Privacy: Applications, Implications, and Limitations,”Journal of Law and the Biosciences (2019): 1-36, doi: 10.1093/jlb/lsz007.
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).
58.
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).
59.
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.
60.
See, e.g., Fla Stat. §7 60.40); Ky. Rev. Stat. §61.931 et seq.; Me. Stat. tit. 22, § 1711C.
61.
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.
62.
See E.W. Clayton et al., supra note 55 (discussing the various federal statutes governing genetic information and research, including issues of preemption).
K.Pormeister, “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 Biosciences5, no. 3 (2018): 1-18.
72.
Regulation (EU) 2016/679, Article 9(4).
73.
Regulation (EU) 2016/679, Article 9(2)(g) and (j); Article 6(e).
74.
Regulation (EU) 2016/679, Article 89(2).
75.
SeeM.A.Rothsteinet al., “Broad Consent for Future Research: International Perspectives,”Hastings Center Report40, no. 6 (2018): 7-12.
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).
Protection of Personal Information Act, supra note 66.
85.
C.Stauntonet 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 Research2, no. 15 (2019): 1-11.
86.
M.S.Pepperet al., “ASSAf Consensus Study on the Ethical, Legal and Social Implications of Genetics and Genomics in South Africa,”South African Journal of Science14 no. 11/12 (2018): 1-3 at 2; C. Staunton et al., supra note 85, at 3-4.
M.Kay, “Indian Supreme Court Tells Government to Act on Illegal Clinical Trials,”British Medical Journal346, 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.
93.
S.Reardon, “NIH Makes Wary Return to India, “Nature News506, no. 7487 (2014): 143-144.
Id. at 2, 40-49; seeM.Barneset al., “The Evolving Regulatory Landscape for Clinical Trials in India,”Food and Drug Law Journal73, no. 601 (2018): 601-623, 611.
96.
Expert Committee Report, supra note 94, at 2-3, 76-77; see Barnes et al., supra note 95, at 611-614.
97.
Expert Committee Report, supra note 94, at 3, 78-89; see Barnes et al., supra note 95, at 606-610.
98.
Expert Committee Report, supra note 94, at 3, 78-89; see Barnes et al., supra note 95, at 611-614.
99.
R.R.Chaudhury and D.Mehta, “Regulatory Developments in the Conduct of Clinical Trials in India,”Global Health, Epidemiology and Genomics1, no. e4 (2016): 1-6.
100.
K.Mallath and T.Chawla, “Investigators' Viewpoint of Clinical Trials in India: Past, Present and Future,”Perspectives in Clinical Research8, no. 1 (2017): 31-36.
D.Resnik, “Consistency in IRB Review,”Journal of Clinical Research Best Practices10, no. 12 (2014): 1-8.
116.
A.A.Lemkeet al., “Broad Data Sharing in Genetic Research: View of Institutional Review Board Professionals,”IRB33, no. 3 (2011): 1-5.
117.
See section VI infra.
118.
E.S.Dove and C.Garattini, “Expert Perspectives on Ethics Review of International Data-Intensive Research: Working Towards Mutual Recognition,”Research Ethics14, no. 1 (2018): 1-25.
SeeE.S.Doveet al., “Ethics Review for International Data-Intensive Research,”Science351, no. 6280 (2016): 1398-1399.
124.
C.Smith-Morris, “Autonomous Individuals or Self-Determined Communities? The Changing Ethics of Research among Native Americans,”Human Organization66, no. 3 (2007): 327-336.
125.
M.Hudson, “Think Globally, Act Locally: Collective Consent and the Ethics of Knowledge Production,”International Social Science Journal60, no. 195 (2009): 125-133, 128.
126.
R.Gilbar and J.Miola, “One Size Fits All? On Patient Autonomy, Medical Decision-Making, and the Impact of Culture,”Medical Law Review23, no. 3 (2014): 375-399.
127.
N.A.Garrisonet al., “Genomic Research Through an Indigenous Lens: Understanding the Expectations,”Annual Review of Genomics and Human Genetics20, no. 1 (2019).
128.
L.Dawson and N.E.Kass, “Views of US Researchers About Informed Consent in International Collaborative Research,”Social Science and Medicine61, no.6 (1982): 1211-1222.
129.
R.E.McWhirteret al., “Ethical Genetic Research in Indigenous Communities: Challenges and Successful Approaches,”Trends in Molecular Medicine18, no. 12 (2012): 702-708.
130.
SeeE.S.Dove, “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 & Ethics47, no. 1 (2019): 264-282, 271 (stating that “the case for local IRB review rests more on the force of its rhetoric than the force of its logic”).
131.
L.Arbour and D.Cook, “DNA on Loan: Issues to Consider when Carrying Out Genetic Research with Aboriginal Families and Communities,”Public Health Genomics9, no. 3 (2006): 153-160.
C.R.McCarthy, “The Origins and Policies that Govern Institutional Review Boards,” in E.Emanuelet al., eds., Oxford Textbook of Clinical Research Ethics (New York, NY: Oxford University Press, 2008): 541-551, 545.
135.
Id.
136.
Id. at 549.
137.
R.Klitzman, “How Local IRBs View Central IRBs in the U.S.,”BMC Medical Ethics12, no. 13 (2011): 13-26.
138.
R.Skloot, The Immortal Life of Henrietta Lacks (New York: Crown Publishing Group, 2010).
139.
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).
140.
M.E.Redshaw, A.Harris, and J.D.Baum, “Research Ethics Committee Audit: Differences between Committees,”Journal of Medical Ethics22, no. 2 (1996): 78-82, 79.
141.
K.B.Brotherset al., “A Belmont Reboot: Building a Normative Foundation for Human Research in the 21st Century,”Journal of Law, Medicine & Ethics47, no. 1 (2019): 165-172.
142.
Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (4th ed. 2007).
143.
A.H.Ahmed and K.G.Nicholson, “Delays in the Practice of Local Research Ethics Committees,”Journal of Medical Ethics22, no. 5 (1996): 263-266.
144.
W.Burmanet al., “The Effects of Local Review on Informed Consent Documents from a Multicenter Clinical Trials Consortium,”Controlled Clinical Trials24, no. 3 (2003): 245-255.
145.
M.Hotopf, S.Wessely, and N.Noah, “Are Ethical Committees Reliable?”Journal of the Royal Society of Medicine88, no. 1 (1995): 31-33.
146.
C.C.Vicket al., “Variation in Institutional Review Processes for a Multisite Observational Study,”American Journal of Surgery190, no. 5 (2005): 805-809.
147.
Stair et al., supra note 146.
148.
R.Al-Shahi, “Research Ethics Committees in the UK — The Pressure Is Now on Research and Development Departments,”Journal of the Royal Society of Medicine98, no. 10 (2000): 444-447.
149.
R.J.Levine and L.Lasagna, “Demystifying Central Review Boards: Current Options and Future Directions,”IRB22, no. 6 (2000): 1-6.
150.
45 C.F.R. § 46.114(b)(1).
151.
F.Goodyear-Smith, “International Variation in Ethics Committee Requirements: Comparisons across Five Westernised Nations,”BMC Medical Ethics19, no. 3 (E2) (2002).
152.
E.S.Doveet al., “Ethics Review for International Data-Intensive Research,”Science351, no. 6280 (2016) 1399-4001.
153.
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.
154.
SeeM.H.Zawati, ed., “31 Country Reports on International Direct-to-Participant Genomic Research,”Journal of Law, Medicine & Ethics47, no. 4 (2019): 582-704.
155.
SeeJ.E.Childerhoseet al., “Participant Engagement in Translational Genomics Research: Respect for Persons — and Then Some,”Ethics and Human Research41, no. 1 (2019): 2-15.
156.
Id.
157.
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.
158.
We do not reach the complicated legal issue of how a country would obtain jurisdiction over researchers who never entered the country.
159.
Researchers who perform research in other countries without approval by their own IRB, however, will likely be subject to sanctions.
160.
N.Hoppe, “Germany Country Report,”Journal of Law, Medicine & Ethics47, no. 4 (2019): 615-619 (answer to question 10).
161.
SeeJ.Wagner, “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 Law8, no. 4 (2018): 318-337, 319.
162.
Dir. 95/46/EC (1995).
163.
15 U.S.C. § 45.
164.
C-362/14, EU:2015:650 (Eur. Ct. Just. 2015). SeeM.A.Roth-stein, “International Health Research after Schrems v. Data Protection Commissioner,”Hastings Center Report46, no. 2 (2016): 5-6.
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).
J.Sugarman, “Should the Gold Rule? Assessing ‘Equivalent Protections’ for Research Participants across International Borders,”Hastings Center Report35, no. 5 (2005): 12-13.
176.
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).
177.
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.
178.
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.
179.
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).
