As patients, we like to believe that our personal health information does not leave the doctor’s office. We divulge our medical secrets to our healthcare providers, and by mere virtue of the fact that they took the Hippocratic Oath, we trust that the burden of our calamities remains on their shoulders. We trust that our healthcare providers are not discussing our medical issues with their spouses over dinner, and we trust that they are not sharing our interesting story to diffuse an awkward silence in the physician’s lounge.
We also trust that our blood work is carried straight to the lab solely for our personal diagnostic testing. We trust that researchers are not using our blood or tissue unless we are notified, briefed, and consented; only if we sign the dotted line.
But for some, after the recent scandal with Planned Parenthood, the pedestal of trust upon which we place our healthcare professionals has begun to crumble.
In July, a pro-life group leaked two videos which show physicians from Planned Parenthood, a reproductive health, not-for-profit organization known most for its abortion services, negotiating a sale of fetal body parts with a tissue procurement company. Such companies act as an intermediary between clinics and researchers. They pass tissue or individual cells on to researchers, who then take advantage of the pluripotency of the fetal cells, meaning their unique ability to be transformed into any cell type. This paves the way for breakthrough biomedical discoveries such as deeper understanding of diseases or the creation of new vaccines.
What caused such an uproar surrounding Planned Parenthood were the legal and ethical issues entangled in the scenario exposed by the video. As noted by the undercover video, it is illegal to sell human tissue for money. However, small reimbursements to the involved parties are permitted. Donated human organs or tissue, such as those used for transplants or research, are allowed as per the Anatomical Gift Act. However, before fetal tissue can be used in research, written consent first and foremost must be obtained from the mother.
Robert Klitzman of Columbia University told the New York Times the ethical issues with selling human tissue. “The concern most of us have ethically is that poor people would be selling their kidneys to rich people, and rich people [would] get kidneys and poor people end up without kidney.” With the selling of fetal tissue in specific, another “concern is abortion, and particularly I would say the large national debate of ‘What is the moral status of a fetus?’”Many of us who are pro-choice believe that a fetus is not a full human being … [But] there’s a certain level of respect because it’s like us. And so we don’t want to be buying and selling fetuses or buying and selling parts of fetuses.’”
Many have rallied for the defunding of Planned Parenthood. But as of yet, there is no clear evidence indicating that Planned Parenthood violated the law.
From the perspective of medical research, the controversy has opened a reevaluation of the regulations of clinical research. The scandal was one of the impetuses for the HHS proposal of changes to the Common Rule, also known as the Federal Policy for Protection of Human Subjects. Published in 1991, the Common Rule provides guidelines for institutions conducting human subjects research.
Currently, de-identified human blood or tissue that is left over from previous research is permitted to be used for other research studies without consent of the subject. But that “tak[es] the human out of human subjects research,” asserted Kathy Hudson of the NIH. Moreover, Nature revealed that modern technology such as DNA sequencing can trace the sample back to the participant. At the NIH, a 90-day public comment period will commence before reforms to the rule can be finalized.
As a result, the plan is to now require informed consent for research with such specimens for all clinical trials. When a patient consents to one research trial, they will be asked if they would be willing to consent to allow the use of any extra samples of their blood or tissue for other research studies. “The people who are participating in research and providing pieces of themselves should be providing permission as well,” commented Hudson.
Some are unhappy with this change. There is great value in specimens that are left over from previous trials. Cutting-edge research is being conducted with those samples, and “requiring explicit consent is going to throw a wrench in that,” lamented Barbara Koenig of University of California, San Francisco.
Another change to the Common Rule has also been proposed. Institutional review boards, or IRBs, established within each institution, are currently required to convene to discuss the risks of a proposed clinical trial and to approve its implementation, even if multiple institutions are participating in the trial. With the reformed Common Rule, only one IRB will be designated to approve the trial.
Moreover, an IRB review will only be obligatory for research that poses greater than minimal risk to its human subjects, and not for low-risk or survey research. With this, clinical trials can be implemented more quickly and easily and IRBs can focus their energy on optimizing higher risk trials for the participants.
Additionally, the HHS would like to restructure the informed consent forms. The main section of the form will include the basic aspects of the study, such as its purpose, scope, and participant responsibilities, as well as any additional important information. Details will be moved to an appendix. In a research study done last year through the NIH, which assessed the amount of oxygen necessary for a premature baby, parents of babies harmed in the study claimed that they did not have a clear understanding of the risks of the study. The potential risks included death for babies given insufficient amounts of oxygen, and blindness for those with too much. The Office for Human Research Protections criticized the NIH for the oversight. The revised forms will clarify and simplify the details and risks associated with research studies and will prevent similar situations from occurring.
Though the proposal to revise the Common Rule stemmed from a sticky legal and ethical controversy, it has also shed light on the value of clinical research and the astounding advances in healthcare and biomedical research. A new wave of technology known as precision medicine is gaining publicity. It focuses on the individual, on the biological scale as well as on the lifestyle behavioral scale, and works to find causes of and treatments for diseases that are not widely understood.
President Obama has spearheaded the Precision Medicine Initiative, which will help advance precision medicine, thereby exploring and making discoveries for more diseases, and integrating the technology into healthcare systems.