What happens when a healthcare institution becomes a research subject?

By Jan Piasecki and Vilius Dranseika.

Consider a hospital manager who works in a large hospital employing hundreds of medical professionals and receiving thousands of patients every day. When she is approached by a group of researchers, she faces a difficult decision. On the one hand, she and the staff of her hospital are committed to providing the best possible healthcare to all patients, to improve overall quality of care and contribute to the development of biomedical sciences. On the other hand, the research project will require access to a vast scope of data: administrative data, information about hospital logistics and management, as well as patient medical information. Although researchers assure the manager that the data will be stripped of personal identifiers and securely stored, she has some doubts.

The hospital manager must resolve the following problem: if she meets the professional obligation to contribute to the development of healthcare and biomedical sciences, she exposes her organization to multiple and potentially serious risks.

What are these possible risks? Involving patients in biomedical research without their explicit and informed consent can undermine the relationship between physicians and patients, even though such a practice is legal and would be approved by a research ethics committee. Moreover, the research project also exposes the medical professionals to additional scrutiny and gives researchers access to the information about the accuracy of their diagnoses, potentially questionable decisions, prescription patterns, to name just a few. The manager could worry that the results of the research could be either misleading or communicated to the public in a misleading manner, undermining trust of the local community or exposing the hospital to legal claims.

The Suicide Prevention Outreach Trial is an illustrative example. This research project aimed at testing suicide prevention strategies against usual care. A hospital that applies the new strategy reaches out to a higher-risk population of patients who do not seek professional help. Therefore raw suicide attempt rates for that hospital would probably be higher than for a hospital that applies the standard approach to involve only those patients who come to mental professionals by themselves. Measurement of suicide attempt rates would then be a misleading and unjust indicator of hospital performance: the hospital that puts in extra effort by implementing the new strategy would have worse performance than institutions applying the standard approach.

The hospital manager might then consult her research ethics committee, who could refer to existing guidelines and literature. The ethical framework for learning healthcare systems that was developed by bioethicists from Georgetown University does not include interests of healthcare institutions. The Ottawa Statement is more informative in this respect, stating that physicians participating in research should give their informed consent, and that a research project should be consulted within the community. However, the Ottawa Statement does not refer to any specific ethical principles or reasoning that would guide such consultations.

In the present article, we attempt to formulate an ethical principle that could balance the current system. The existing principles place upon all healthcare professionals an obligation to contribute to the development of biomedical sciences, but do not consider the interests of their institution. We suggest such an additional principle with a hope of helping to resolve the dilemma the hospital manager is facing.

We suggest that all healthcare professionals have two kinds of professional interests that can sometimes collide: primary professional interests and instrumental interests that enable them to realize their primary interest. For example, the primary professional interest of a physician is to treat the sick. However, a physician has to first establish a relationship with a patient that is based on trust and confidence. In that sense having a trusting relationship is an instrumental interest of the physician. Every healthcare professional, including the hospital manager, has instrumental interests and they are a part of her professional identity. We describe this duty to take care of such instrumental interests as “a professional integrity obligation”. This concept helps to clarify the dilemma that is faced by the hospital manager. She faces an ethical dilemma because the two kinds of her professional duties are in conflict, namely an obligation to contribute to the development of healthcare sciences and the obligation of personal integrity.

In our article we do not offer any specific solution to this conflict. We distinguish, however, three different procedural models that can be applied in order to resolve it: The self-regulating model, where the balancing is managed by the healthcare institutions themselves. The problem with this model is that it can promote the interests of healthcare institutions at the expense of the development of biomedical sciences. The centralized model, where the process is governed by a state body that has a power to force healthcare institutions to release some types of information. The main problem with this model is that central bodies may neglect the interests and views of patients, physicians and institutions, and in consequence undermine trust in the system. Finally there is the mediating model, where providers, the state and the citizens negotiate the parameters for learning healthcare.

Acknowledgments

We thank Phyllis Budka for linguistic edits.

Paper title: Balancing professional obligations and risks to providers in learning healthcare systems

Author(s): Jan Piasecki, 1; Vilius Dranseika, 1, 2

Affiliations:

1: Department of Philosophy and Bioethics, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland

2: Institute of Philosophy, Vilnius University, Vilnius, Lithuania

Competing interests: None declared

Social media accounts of post author(s):

Twitter:

@JJPiasecki

@ViliusDranseika