Summary of US Pres. Commission for the study of bioethical issues.

From the recent issue of the Lancet.  Volume 379, Issue 9813, 28 January–3 February 2012, Pages e20–e21

Download Report of the Commission here.  Report

Comment

Moral science and the Presidential Commission for the Study of Bioethical Issues

• Amy Gutmann^a, , 
• James W Wagner^a

• ^a Presidential Commission for the Study of Bioethical Issues, Washington, DC 20005, USA

• Available online 15 December 2011.

• http://dx.doi.org/10.1016/S0140-6736(11)61884-9, How to Cite or Link Using DOI

• Permissions & Reprints

“O that moral science were in as fair a way of improvement, that men would cease to be wolves to one another, and that human beings would at length learn what they now improperly call humanity!”

Benjamin Franklin, 1780¹

Are human volunteers in research sponsored by the US Government treated safely and ethically? President Barack Obama posed this fundamental question to the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) in response to chilling accounts of unethical research undertaken by the US Public Health Service in Guatemala during the 1940s, in which vulnerable populations were deliberately exposed to sexually transmitted diseases without their knowledge or consent. ^{[2], [3] and [4]}

In a report released on Dec 15, 2011, the Bioethics Commission concluded that the current US system provides “substantial protections for the health, rights, and welfare of research subjects and protects them from harm or unethical treatment”.⁵ Although confident that the current system affords substantial protections to research volunteers, the Commission identified 14 specific changes to current policies that could further reduce the likelihood of harm or unethical treatment. These recommendations include development of a compensation system for research participants who are injured during research studies; respecting equivalent ethical standards in foreign countries where US-funded research is conducted; and more explicit justifications for site selection to prevent potential exploitation of foreign research volunteers.

As noted by the International Research Panel that advised the Bioethics Commission, the USA—unlike many countries—lacks a comprehensive system to address potential harms connected to research participation.⁶ Thus some research volunteers are left without any assurance of protection from personal financial and physical risk when they take part in research that benefits society as a whole. Although current US regulations require investigators to inform research participants about any medical care or compensation to be provided in the event of research-related injuries,⁷ no rule requires free medical care or compensation to be provided. In this regard, the US regulations differ from the research injury compensation systems that exist in most other industrialised nations.⁸ The Commission recommends that the US Government adopt a carefully designated set of standards for compensation.⁵

Research supported by the US Government is subject to the same regulatory requirements domestically and internationally. These requirements permit government agencies to recognise foreign procedures if they provide “protections that are at least equivalent” to federal rules.⁹ For example, procedures for informed consent in the UK might be deemed “equivalent protections” to those required by the US Government. However, US federal agencies have almost never exercised this authority and often insist that all US rules be met even in foreign countries where protections are equal to, or more stringent, than those in the USA.¹⁰ The Commission recommends that the federal government develop a process for evaluating requests from foreign governments and other non-US institutions to determine if local laws and procedures can be recognised as providing equivalent protections to research participants.

The increasingly globalised nature of medical research presents ethical challenges when study sites do not offer robust protections for volunteers or if the “research subjects [are]…being systematically selected because of their easy availability, their compromised position, or their manipulability”.¹¹ The Commission recognised the potential for exploitation in low-income communities and countries and recommends that researchers and the proposed research sites demonstrate the capacity—or the ability to achieve the capacity when the research is to be conducted—to protect all human participants.⁵ In addition, the Commission recommends that the US Government develop criteria for ethical selection of sites, taking into consideration the extent to which sites can benefit the broader community. The Commission found that many of the risks of exploitation can be mitigated, for example, when a study is designed specifically to respond to the health needs of the local community.⁵

Good science requires good ethics, and vice versa. To do good science, individual investigators, along with the institutions that support and sponsor them, must assume responsibility to protect participants from avoidable harm and unethical treatment and to respect their inherent dignity. Benjamin Franklin¹ reminds us of the long-standing ethical principles at the heart of modern laws, rules, and regulations that govern research involving human beings. The challenge of pursuing science in a morally justified way is one that every generation must take up. Without sufficient attention to ethics, we risk losing sight of what is owed to our fellow human beings who deserve special protection by virtue of their willingness to participate in experiments so as to benefit others. The US Government should respond swiftly to the recommendations of the Bioethics Commission's report, or offer compelling reasons for maintaining the status quo.

AG is Chair and JWW Vice Chair of the Presidential Commission for the Study of Bioethical Issues.

References

1. • 1
   • B Franklin, J Sparks
   • The works of Benjamin Franklin, vol VIIIHilliard, Gray, and Company, Boston (1839)
2. • 2
   • Presidential Commission for the Study of Bioethical Issues
   • “Ethically impossible” STD research in Guatemala from 1946 to 1948. Sept, 2011Presidential Commission for the Study of Bioethical Issues, Washington, DC (2011)
3. • 3
   • US Department of Health and Human Services
   • Information on the 1946–1948 United States Public Health Service STD Inoculation Study
   • http://www.hhs.gov/1946inoculationstudy (accessed Dec 12, 2011).
4. • 4
   • S Reverby
   • Normal exposure and inoculation syphilis: a PHS Tuskegee doctor in Guatemala, 1946–1948
   • J Policy History, 23 (2011), pp. 6–27
5. • 5
   • Presidential Commission for the Study of Bioethical Issues
   • Moral science: protecting participants in human subjects research. Dec 15, 2011Presidential Commission for the Study of Bioethical Issues, Washington, DC (2011)
6. • 6
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   • Research across borders: proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues. Sept, 2011, Presidential Commission for the Study of Bioethical Issues, Washington, DC (2011), p. 11
7. • 7
   • US Department of Health and Human Services
   • Code of Federal Regulations. Basic HHS Policy for Protection of Human Research Subjects. Revised Jan 15, 2009. Effective July 14, 2009. 45 CFR § 46.116
   • http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html (accessed Dec 12, 2011).
8. • 8
   • Institute of Medicine
   • Responsible research: a systems approach to protecting research participantsNational Academies Press, Washington, DC (2003)
9. • 9
   • US Department of Health and Human Services
   • Code of Federal Regulations. Basic HHS Policy for Protection of Human Research Subjects. Revised Jan 15, 2009. 45 CFR § 46.101(h)
   • http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 (accessed Dec 12, 2011).
10. • 10
    • Equivalent Protections Working Group
    • Report of the Equivalent Protections Working Group. July 17, 2003US Department of Health and Human Services, Washington, DC (2003) http://www.hhs.gov/ohrp/international/epwgreport2003.pdf (accessed Dec 12, 2011).
11. • 11
    • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
    • The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Department of Health, Education, and Welfare Publication OS 78-0012, Department of Health, Education, and Welfare, Washington, DC (1978), p. 10