Abstract
Health leaders manage many types of risk. One type of risk that may be underrecognized is the ethical risk in the many projects and activities that are done regularly besides research (eg, program evaluation, quality improvement, and health innovation). Applying clinical, personal, professional, and organizational ethics can help address the risks but are insufficient by themselves or in combination. Each different type of project or activity requires an ethics review that is appropriate for that activity. Health leaders must first acknowledge that ethical risks exist in many of the activities occurring in their organization and then support the different types of ethics review required to adequately protect and respect people and their information.
Introduction
Health leaders play an important role in ensuring that risks to patients, clients, and employees are assessed and mitigated. They rely on lawyers to advise about legal risks, they rely on healthcare providers to advise on clinical risks, and they rely on human resource professionals to advise on organizational risk.
Another type of risk that needs similar attention is the ethical risk that exists in projects whenever data or information is used from patients, clients, families, or communities. Organizations probably have processes for ethics review of research, but other types of activities can have equal amount of risk. For example, quality improvement or program evaluation departments regularly use surveys, yet there may be no formal process for assessing the ethical risks of those projects. Without an ethics review that is appropriate for the type of activity being conducted, organizations simply cannot adequately assess and address the ethical risks.
Four types of ethics: Necessary but insufficient for ethics review of activities
People may assume that ethical risks in projects are adequately addressed because four types of ethics already help a healthcare organization function. While these can contribute, they are insufficient by themselves—and even in combination—to appropriately address the ethical risks in all activities.
Clinical ethics support clinicians, patients, and families when difficult decisions arise about healthcare. Clinical ethicists might refer to the ethical principle of beneficence when considering whether to commence or cease an extraordinary life-support. Ethicists might refer to the principle of justice when helping clinicians understand why they are feeling moral distress when unable to offer the care they would like to provide.
Personal ethics focus on the decisions made by individuals based on their own ethical framework or moral code. A practitioner may choose to treat people fairly based on her personal beliefs that the principle of justice is an important one. Or, if a practitioner values autonomy, he will not try and persuade a patient to engage in a certain therapy that the patient has already refused.
Professional ethics help individual professionals to determine right actions based on values inherent in a particular profession. Professional organizations publish codes of ethics that guide behaviour and are used as a standard against which an individual’s action is judged. When nurses provide care and interact with other healthcare professionals, they are informed by the Canadian Nurses' Association code of ethics. 1 The Canadian College of Health Leaders’ code of ethics, 2 and the accompanying ethics self-assessment tool 3 are other examples of a professional organization offering ethics support to its members.
Organizational ethics enhance the overall mission of the organization, provide advocacy avenues for employees and the recipients of care, and develop values for the organization. Based on the ethical principle of respect for persons, organizations develop processes to ensure confidentiality of patient or employee information. Autonomy might be the principle underlying consent forms, or the principle of justice might guide policies regarding the fair treatment of employees. An example of operationalizing organizational ethics is the Alberta Health Services (AHS) code of conduct 4 that outlines the values and principles and expected conduct for anyone who is involved in that organization.
All these four different types of ethics play an important and necessary role in an organization, but clinical ethics cannot address all the questions regarding ethical recruitment of participants. Organizational ethics cannot address all the questions regarding ethical collection of data. Personal ethics cannot address all the questions regarding the appropriate type of consent. Professional ethics cannot address all the questions regarding the reporting of findings. Even when taken together, their collective power is insufficient for a comprehensive and robust ethics review of projects. Therefore, to adequately assess, minimize, and mitigate ethical risks, projects and activities that use data from or about people must undergo an ethics review. However, not just any kind of ethics review, but one that is appropriate for the specific type of activity.
The type of ethics review depends on the type of activity
Just as organizations require several types of ethics to operate well, several types of ethics reviews are required to adequately address the different types of activities occurring in healthcare organizations.
Ethics review of research
Research ethics review is the most well-known type of ethics review and, as stated before, organizations probably already have processes for this. Researchers submit protocols to duly constituted Research Ethics Boards (REBs) for assessment and concomitant risk mitigation strategies. If the REB members are satisfied that the benefits outweigh the risks, then they will approve the study. If not, they may conditionally approve, may ask for further clarification, or even reject the study. Healthcare organizations may sponsor research themselves or may allow outside investigators to access their population or data sets, but the appropriate review is done by an REB. Once submitted, investigators are subject to the policies and procedures of that particular REB.
One potential difficulty is ascertaining whether a particular project is research or not, and therefore, whether a REB should review the project. Definitions and conceptualizations of “research” can be vague and do not discriminate well among different types of projects. For example, a commonly accepted definition of research is “…an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.” 5 However, many non-research projects that extend knowledge are disciplined and systematic. Consequently, clarifying the most appropriate type of review can be difficult.
Ethics review of non-research projects
A pRoject Ethics Community Consensus Initiative (ARECCI) 6 is an example of a second type of ethics review that is appropriate for non-research projects. The ARECCI framework incorporates two open-access on-line tools to help practitioners make appropriate decisions about the ethical conduct of program evaluations, quality improvement initiatives, need assessments, and knowledge translation projects. The tools help determine whether the project is a research or not, help identify the ethical risks, and then suggest the appropriate type of ethics review. Over the past decade, these tools have had more than 14,000 views. The ARECCI also offers training in Project Ethics, and during the past decade, approximately 1,700 professionals and practitioners have attended the three types of training provided. The final offering in the ARECCI framework is an ethics consultation service called Second Opinion Review. Second opinion reviewers have conversations with project leads and their teams to help identify and mitigate ethical risks.
Here is an excerpt from a letter that illustrates the kind of feedback provided in a second opinion review: A few main areas we discussed include: 1) The email introduction where you may want to include details about participant anonymity, only aggregate data being shared, and the ability to withdraw at any time. 2) After thanking the participants, we discussed [that you] either including a disclaimer sentence to let the participants know that if they gave their name/contact information it would not be linked to the study questions or providing the name/contact information of the project leads who could be contacted. As no [patients] are to be contacted in any manner, and the data are obtained from established information sources and health databases, and the information to be utilized…are to be aggregate and anonymized, [you are correct that] no informed consent is deemed to be required for this project.
Ethics review of innovations
A third type of ethics review is an “Ethics Impact Assessment” (EIA). Health innovations are necessary 7 and may actually involve several types of activities. For example, if research is required for the innovation, then the project should be reviewed by a REB. If a program evaluation or a quality improvement initiative is best, then an ARECCI-like ethics review should be used. However, if the project is neither, then the EIA could be the appropriate review.
Many innovations have happened in technology and so most literature regarding an EIA is from that field. The principles, however, are easily transferable to any innovation. Ethical technology assessment is discussed in a general way, 8 while others describe an explicit framework for ethics review of information technology. 9 Wright’s EIA framework is a series of questions that innovators ask themselves based on the widely used ethical principles of autonomy, non-maleficence, beneficence, and justice. He also makes special mention of privacy and data protection. For example, under autonomy, a question specific to informed consent is, “Will the person be informed of the nature, significance, implications, and risks of the project or technology?” Under beneficence, he asks, “Who benefits from the project and in what way?” There is a limitation in the framework described by Wright: he requires only a self-assessment. The REB and ARECCI reviews are effective because someone unrelated to the project offers an objective assessment. Adding some type of ethics consultation to an EIA would result in a more robust review.
Organizations may already do Health Technology Assessments (HTAs), and assessing the ethical risks has been encouraged when making these types of decisions. 10 However, requiring an ethics review is not always made explicit. For example, in the HTA form required by Alberta Health, 11 while there is nothing precluding submitters from discussing ethical aspects of the technology, they are not required to do so.
Examples
Organizations will likely have adopted processes for ethics review of research because this may be mandated by legislation 12 or required by funding agencies. 5 However, because ethics review for non-research projects and innovations is voluntary, organizations may not have processes in place. Two organizations that could be models for implementing an organizational review for non-research projects are AHS and Interior Health (IH) in British Columbia. While AHS has collaborated with ARECCI for a decade, an agreement over the past 2 years resulted in many more of their employees being trained. The ARECCI has a prominent place on their web site related to training and education and to research ethics. There is also work being done on integrating the ARECCI framework in all projects happening within that organization. The IH has integrated ARECCI in their organization and requires practitioners to use the framework for all quality improvement projects in their organization. 13
Recommendations
Considering that there are different types of ethics review, five recommendations for health leaders are as follows: Acknowledge that there are ethical risks in most, if not all, projects and activities when people and their information are used. Acknowledge that there are different types of ethics review for different types of projects. Spend resources in ethics risk management to support appropriate ethics review, just as resources are spent in financial and reputational risk management. Support educational activities regarding ethics review for all levels of employees. Seek out existing models of ethics review; others have already done foundational work.
Conclusion
Although health leaders probably know that many projects happen in their organization, they may not fully appreciate that most of them have ethical risks. They may also not realize that different ethics review processes exist for different types of projects. However, a comprehensive, robust ethics review program is essential to ensure that people and their information are always respected and protected.