On April 18, 1979, the Belmont Report was first published in the Federal Register. Thirty-six years isn’t that long in the grand scheme of things, but it is effectively the lifetime of the research ethics field, formally beginning as it did with the publication of the Belmont Report. We were curious how the application of the principles contained in the report has changed over that time, so we reached out to a few past PRIM&R Blog Squad members to get their thoughts.
We asked: How do you think people’s understanding of the concept of beneficence has changed since the Belmont Report was published? What has made this change possible? Secondarily, how do you interpret the concept of beneficence and apply it to your own work?
Wendy Tate, MS, CIP, PhD student at the University of Arizona: It’s interesting for me to comment on how the concept of beneficence has changed, as I was born after April, 1979. Also, I look at the issue from the perspective of someone whose work is focused in cancer research. An ever-changing landscape, cancer therapy is very different now than it was in 1979. With the knowledge of the entire human genome sequence and the advent of targeted therapy, immunotherapy, and our newest buzzword, precision medicine, many cancers are becoming chronic diseases rather than death sentences. It is estimated that there over 14 million cancer survivors, an increase from about 4 million people in 1979 (January 2014, NCI). With that shift, focus now is on minimizing toxicity while continuing to improve (or maintain) life expectancy for many cancers. This is highlighted by the creation of the Patient Centers Outcomes Research Institute (PCORI), a national, nonprofit, non-government entity mandated to, “improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions” (PCORI website). This approach leads to the involvement of patients and their advocates to help guide research. The definition of beneficence is no longer mandated by the researcher—”this is good for you and the public”—but by the public—”researcher, this is what we want you to focus on.”
Beneficence is a concept reaching farther than “do no harm.” In research, we must not just do no harm but “do good.” In and of itself, this concept has not changed over time. A related aspect to beneficence is the concept of what constitutes harm. For example, the federal regulations for human protections has always included that costs associated with participation in the research study be disclosed (45 CFR 46.116(b)(3)); however, in cancer, the term “financial toxicity” has been coined. With the enormous costs of some treatments, and the changing landscape of health care and health insurance, some patients must now weigh their chance at survival from cancer against the financial devastation that is associated with many therapies. Beneficence has to include a conversation of the economic risk associated with research and subsequent treatment, not just whether a person’s disease state will be improved, a newer concept to many physicians.
Susan Trinidad, MA, Research Scientist at the University of Washington: I think one of the biggest changes we’ve seen since the Belmont Report was originally released is a shift in how we define respect for persons (it’s now framed as autonomy, which I would argue is a different, less engaged, more hands-off principle) and beneficence. It’s my view that the pendulum has shifted too far, to the extent that what the Belmont Report conceptualized as beneficence is now often (mis)labeled as paternalism and viewed as a bad thing. I think the reality is that clinicians and researchers do have expertise in certain areas and that part of their professional responsibilities using that knowledge/power – while at the same time not imposing their own values on patients or research participants.
There are lots of social and historical contributors to this change, I think, including the patients’ rights movement, successful lobbying to regard access to clinical trials as a benefit rather than a risk to participants, and the still-growing tide of consumerism and choice in the healthcare marketplace.
Stephanie Pyle, manager, community and communications at Schulman Associates Institutional Review Board, Inc.: The concept of beneficence encourages and obliges us to ask the hard questions: Does the benefit outweigh the risk? Are we truly doing no harm? Should a drug that’s only been studied in adults be prescribed to a child? Should a study with negative findings be published?
The Belmont Report was born of an era when many of research’s wrongs were fresh and tender, and its writers sought to prevent such terrible damages in the future. In 1979, placebo-controlled research was still controversial, and the internet and HIPAA were decades away. Much time has passed since then, and some ask: in the 21st century, is the Belmont Report overprotective? Should more clinical trials involve children? Does social media make privacy less important?
We are still compelled to ask difficult questions like these. Beneficence doesn’t go out of date. We have learned much in the past three decades, and the learning must never end. Research misconduct still happens; injustices are still being brought to light.
Beneficence requires us to examine the fine line between clinical care and research. It demands that we question the ideas and people we’ve known for years. By asking the questions of beneficence, we remain open minded and alert. We honor the risks assumed by research participants, and we keep our promise to find solutions that benefit the greater good.
Thank you, Wendy, Susan, and Stephanie for sharing your thoughts on this topic. We’d love to hear from Ampersand readers as well – How do you think people’s understanding of the concept of beneficence has changed since the Belmont Report was published? How do you interpret the concept of beneficence and apply it to your own work? Let us know in the comments!