The path from the atrocities of Nuremberg and Tuskegee to today’s robust ethics of medical research has not been easy.
In response to these horrific events, a remarkable global consensus emerged, across countries in very different parts of the world and with very different types of governments: Medical researchers, and the institutions and companies who fund their work, are bound by a series of ethical obligations. These obligations are designed to protect and respect the interests of people who participate in their research. They include minimizing foreseeable harms to participants and keeping the promises that researchers make to study volunteers.
While the fate of USAID remains murky, one thing absolutely is clear. The abrupt termination of critical USAID-funded clinical trials, with insufficient time to safeguard the welfare of people who are participating, is profoundly unethical and utterly inexcusable. Such actions threaten the health and lives of thousands of patients.
The stop-work orders affect research designed to answer important questions about HIV or TB treatments, where immediate withdrawal of drugs not only takes away what may be lifesaving treatments but also risks exacerbating or creating drug-resistant strains, leaving participants potentially worse off than if they had never joined the study and creating additional, unacceptable risks for others in the community.
The “pause” has also ensnared studies of experimental devices that, in accordance with scientific and ethics principles, require regular monitoring of participant well-being and opportunities to remove the device at an appropriate time. Telling a medical researcher they must abruptly abandon study participants is akin to telling a surgeon they cannot treat a patient who has a post-operative infection that resulted from a surgery they performed the week before. All medical ethics codes forbid this. And for obvious reason.
Experienced researchers understand this. Glenda Gray, a South African researcher about to initiate a long-planned HIV vaccine trial in three countries has the vaccine in hand, and regulatory approvals are in place. But the trial will not begin. “It would be unethical to start a study that you cannot continue,” she told the American Association for the Advancement of Science. A policy from the NIH, drafted years ago, is clear about this. Any early stoppage of a clinical trial requires that “participants receive adequate follow-up and alternate therapy/treatments for their condition.”
Two things, at minimum, need to happen immediately.
First, while the fate of USAID makes its way through the courts, funding must continue for clinical research sites to ensure that current participants are not put in medical danger, and to ensure that the most basic of professional ethical codes may be followed. If a study must be stopped, the closeout must be safe, gradual, and responsible. This means removing experimental medical devices from the bodies of participants where safe monitoring can no longer continue. It means identifying a way to continue providing a reasonable supply of research treatments or identifying alternative treatment options for participants who have been receiving needed medical care through the study. And it means explaining to participants that the research project for which they graciously volunteered their time and bodies is abruptly coming to an end.
Second, medical professionals who honored their ethical obligations to research participants, as required by U.S. federal regulations as well as professional and international ethics codes, should be assured that there will be no repercussions to them or their institutions for following these rules and norms while programs wind down, even if such behavior appears to be in conflict with the stop-work order.
The Declaration of Helsinki was drafted in 1964 to counter concerns that the welfare of research participants might not be put first. Signed now by 115 constituent members, the declaration has been revised eight times since 1964 to strengthen that commitment. Participant welfare in medical research always must be primary.
The moral progress that today’s worldwide standard of research ethics represents is always on shaky ground. It is why international codes, and professional societies in the United States and around the globe, assert these commitments strongly and repeatedly. The welfare of people, and the moral commitments we make when we ask them to join medical research, is too important to disregard.
Ruth Faden is the founder of the Berman Institute of Bioethics and the Philip Franklin Wagley Professor of Biomedical Ethics at Johns Hopkins University’s Bloomberg School of Public Health. Nancy Kass is the Berman Institute’s deputy director for public health and the Phoebe R. Berman Professor of Bioethics and Public Health at the Bloomberg School.
The opinions expressed in this commentary are those of the authors and do not represent the opinions of any organization or other entity they may be associated with.
