I was recently at a technology for health event, during which a number of designers showcased their inventions. One such project plans to use biometric data as a means of accessing patient medical records through mobile phone technology. The project has designed a biometric scanner that can link patients to their medical records. Health workers scan the fingerprints of the patient, which can then create a new unique ID for that patient, or allow the health records of existing patients to be downloaded to a phone, improving medical treatment and support. It is one of a number of similar initiatives seeking to make accessing of patient records, and identification of individual patients in remote rural areas especially, easier for health care workers.
It all looked good: a nice scanner, the (very now) linking in to mobile technology, and the understanding that difficulties in identifying patients, and in knowing their health histories, is a major problem in providing decent healthcare. But in the otherwise solid presentation, one comment stuck out. Kenya had been chosen as one area to pilot the project: in part because of the extensive use of mobile technologies in the country, in areas such as mobile banking for example; but also because Kenya’s regulations on the encryption of data are not as strict as in other countries.
Offshoring of clinical trials for new drugs, vaccines, etc, to low- and middle-income countries has long been a concern of global health governance. Pharmaceutical companies, keen to take advantage of laxer regulatory regimes, or work in areas where it is easier (quicker and cheaper) to recruit participants, have an obvious incentive to do this. In recognition of this fact, the global ethical rules governing such clinical trials attempt to set and enforce minimum standards, no matter where those trials take place.
Clinical trials must be run in accordance with the Declaration of Helsinki principles governing such trials. Physicians, pharmaceutical companies, and all those engaged in medical research involving human subjects must place “the well-being of the human subject” above “the interests of science and society.” In practical terms, research must be underpinned by basic principles designed to “protect the life, health, privacy, and dignity of the human subject”, principles that include:
- The research must conform to accepted scientific principles.
- All aspects of the research must have received approval from an independent ethical review committee (which has the right to monitor on-going trials).
- Only properly qualified people must carry out the research; and only a medically qualified individual can have responsibility for the people.
- All those involved should have been through a careful evaluation of the risk and burden from participation, as well as the potential benefit.
- Volunteers must be informed participants, and only under very controlled circumstances can those deemed legally incapable of giving informed consent be engaged as participants (and assent must be granted by the legal representative of that individual).
- And one principle that has relevance to the discussion of testing out biometric technology: “Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient’s information and to minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject”.
The existence of global ethical guidelines means that, in theory, participants in a low- or middle-income country should be just as protected from unethical clinical trials as those from high-income countries. Within the European Union, for example, “Regardless of where they are conducted, all clinical trials included in applications for marketing authorisation for human medicines in the European Economic Area” must comply with EU directives on clinical trials:
Clinic trials conducted outside the EEA have to comply with ethical principles equivalent to those set out in the EEA, including adhering to international good clinical practice and the Declaration of Helsinki
So whether the participant is in Nairobi, Accra, Mumbai or Manchester, the trial should conform to the same ethical and rigorous standards.
Of course, there are a widely acknowledged failures in translating theory to practice. There are questions about whether EU regulators pay sufficient attention to the ethical underpinning of trials undertaken outside the area in their deliberations (see the report ‘Ethics for Drug Testing in Low and Middle Income Countries’, published by the Centre for Research on Multinational Corporations, for example). And there are serious concerns over the transparency of trials conducted in low- and middle-income countries.
Nonetheless, and it is an important caveat, there are global standards underpinning clinical research trials against which such trials can (and should more rigorously) be judged. What about trials for technology? Certainly there are many working on issues of ethnics in the design and use of technology. But what global ethical guidelines apply to pilot projects that test out a particular type of technology?
To return to the project that started off these thoughts: it seemed to me that the reason the project was piloting in Kenya was largely because it would be cheaper due to the more relaxed regulatory regime. Now, one obvious response is provided that the pilot accords with national laws in the country in which it is based, that should be sufficient to make it ethical.
But is that sufficient? As we have learnt over the past few months, data privacy is a real concern, and encryption of data containing personal details is tremendously important. Of course, one could argue it is for Kenyans to demand their government tighten up regulations. But is there any responsibility on those undertaking such pilot projects to conform not just to national standards, but to best practice in the countries in which they are themselves based? Would they be happy if their personal details (identification details such as fingerprints, sensitive material such as personal health records, etc) were sent between servers and devices with the same level of encryption and privacy as those taking part in the trial? Will those be taking part be informed of the potential risks of this technology (however small the designers believe those risks to be)? Would this accord with the Helsinki Declaration principle that “every precaution should be taken to respect … the confidentiality of the patient’s information”?
There is always a danger that regulatory burdens can stifle creative responses to particular needs, or make the price of testing and piloting new ideas too expensive. But for the same reason global regulations seek to protect the most vulnerable from exploitation through clinical trials (even where those participants may be the ultimate beneficiaries), so too must we take more seriously the ethical implications of pilot projects of all sorts. Doing something because it is cheap is not an ethical decision, no matter how useful or potentially ground-breaking the technology might be.