Luann Van Campen, Ph.D., M.A. Bioethics, and Don Therasse, M.D. are two of YourEncore's premier subject matter Experts on Bioethics, collaborating with clients to improve and innovate their methodology and best practices when it comes to their ethics/bioethics frameworks. In this Expert Q&A session, Luann and Don provide valuable insights into the application and implementation of modern bioethics best practices within life sciences organizations.
When people think about ethics in the context of life sciences, they define it in a variety of different ways. Help us understand - what are the different types of ethics?
It’s common for people to talk about “compliance” with laws and regulations as “ethics.” However, that is only one aspect of ethics. Another key aspect is “applied ethics,” such as bioethics.
Ethics, broadly speaking, encompasses fundamental concepts and principles that guide and evaluate decent human behavior, both individually and corporately. When these are applied to a specific context to answer specific questions it is called applied ethics. Some examples of applied ethics are business ethics, bioethics, and professional codes of conduct.
It’s important to acknowledge that, to the extent public or private policies and regulations incorporate ethics concepts and principles, they do not and cannot encompass the full scope of ethics. To comprehensively address ethics, compliance must be partnered with applied ethics judgment.
In the context of life sciences, bioethics is the relevant applied ethics field with which to partner. The word means “the ethics of life,” and the field addresses ethical issues encountered in biomedical research, clinical care, and public health. Bioethics provides guidance for the development of public and private policies while providing the background rationale and content for some policies and regulations, which can be helpful for comprehension and subsequent compliance. It also provides guidance when a policy is ambiguous or when no policy exists for a given issue. Some examples are embryonic stem cell research, continued access to investigational drugs and devices, drug development strategies for rare diseases, and genome editing. Within a company’s integrity strategy, bioethics can be considered a “sibling” to compliance, corporate responsibility, and professional codes of conduct, functioning alongside quality and risk management.
Why is it so important to apply a bioethics methodology or framework to drug and device Research & Development (R&D)?
The simple answer to that question is that it’s in the best interest of research participants who will be enrolled in clinical trials, as well as for future patients. Patient well-being is at the core of bioethics.
But to elaborate, without a consistent methodology or framework from which to plan, design and conduct clinical trials, there is a risk that enrolled patients (and healthy volunteers) could be treated inconsistently from study to study. Just as we expect quality standards and policy compliance to be applied consistently, we should expect bioethics concepts and principles to be applied consistently; to do that, relevant, consistent guidance is needed.
Research ethics guidance can be gleaned from a variety of sources, such as the Declaration of Helsinki, The U.S. Belmont Report, the Council for International Organization of Medical Sciences, and the Nuffield Council, to name a few. Although each of these explains and promotes important bioethics concepts and principles, they were written primarily to address ethical responsibilities of physicians/investigators. None of these documents were written specifically to address the ethical responsibilities of biopharmaceutical research and development sponsors. This situation puts the onus on busy study teams to sort through the various documents for relevant, consistent guidance. That is not efficient and likely will not result in consistency, which is the goal.
Therefore, a biomedical research framework, like we developed when working at Lilly (independent of YourEncore), or a clinical trial protocol framework, like what I (Luann) co-authored with the Harvard University’s Multi-regional Clinical Trials Center, is quite valuable. These types of frameworks utilize existing ethics guidance documents and pull out the concepts and principles that are relevant for biopharmaceutical sponsors. When there is an organizational commitment to consistently employ these types of bioethics tools, the overall ethics quality of clinical trials improves.
Based on your experiences working with clients to design and implement standardized tool sets and frameworks for bioethics, what are some key considerations or best practices you can share? What are the common practices of a successful organization?
Best practices can be broken down into two categories. The first is organizational, which we alluded to in the previous answer. The second is resources, and they really need to be developed in that order. You can have all the best tools available, but if there is no organizational commitment to bioethics, the tools will be employed in an ad hoc nature, undermining consistency. Therefore, best practice starts with an organizational commitment to bioethics excellence, with a subsequent commitment to allocate appropriate resources to the effort. What “excellence” will look like will vary by the mission, vision, and values of a given company, as well as the size of the company, but the commitment should be articulated nevertheless.
A best practice approach is an intentional systematic approach, and a systematic approach has four components: governance, organization, framework, and activities. For each of these areas, there needs to be proactive discussion as to how bioethics will be governed within an organization, how it will be programmatically structured, what type(s) of framework will be employed, and what types of activities will be resourced (e.g. development of company positions on a given topic, consulting on specific team-based issues, education & training, etc). As we said, the approach likely will look different for each company; some may choose to do this all in-house, while others may choose to outsource some or part of the components. However, the objective of consistent application of bioethics concepts and principles should be the same, regardless of tactics.
How does establishing a standard bioethics framework benefit the patients?
For patients who will be or are already enrolled in a study, there should be assurance that significant thought was given to whether this type of research should be conducted, and if so, how it should be conducted. A real example is whether additional studies can be conducted based on biological samples or data obtained in another unrelated clinical trial. What are the risks to study participants in this scenario? Are the study participants being respected? Would this breech the original agreement (i.e. informed consent)?
For future patients who will take an innovative medicine, there should be assurance that the medicine was developed within ethical boundaries. The end does not always justify the means. Questionably ethical scientific methodology will have a downstream effect and likely will be a factor for prescribing decisions made by healthcare practitioners, patients, and payors. This can be avoided by having bioethics discussions early in the drug development process.
Whether with clinical research or clinical care, patients benefit from thoughtful consideration of the impact of the research and development endeavor on individuals and society more broadly. Ethics should be one of the “non-negotiables” of drug R&D, just like efficacy, safety, quality, and data integrity. Just as there is increasing appreciation of “quality by design,” there should be an increasing appreciation of “bioethics by design.” When bioethics is “baked in” throughout the drug R&D and commercialization process, patients can trust that their rights, interests, and well-being were appropriately considered.
What is the business impact? What are the business-related benefits to implementing such a practice?
Efficiency is the first business impact. Early and often is the best way to approach bioethics. Why? Because if you don’t consider it, someone else will, and likely, that will introduce a speed bump or even a stop sign to development plans. Investigators, business partners, regulators, institutional review boards (IRBs), health authorities, patient advocates, and investors are just a few of the stakeholders who are impacted by the ethics of the R&D and commercialization process and are likely to speak up and question plans and conduct. It makes good business sense to proactively address bioethics rather than wait and react to an inquiry. One real example is the questions a study team can receive from IRBs about the procurement, use, and storage of biological samples and how this is described in the informed consent document. Another example is questions regulators may have about clinical trial designs, such as the ethics of the choice of comparator, rescue arms, and outcome adaptive designs.
Sustainability is the second business impact. A commitment to ethics is good business practice because of the irreplaceable business commodity of trust. Trust is something that takes years to build but can be dismantled in minutes – often resulting in business calamity. It’s well known that stakeholder trust depends on both the expertise and character of the individual/organization to be trusted. You can’t be considered trustworthy with just one or the other, so an intentional bioethics plan is requisite to business sustainability.
At what point should a company consider a bioethics committee? Does this just apply to large pharma companies?
A bioethics committee is a wonderful resource to have because it engages people with different areas of expertise and perspectives. It allows a company to have robust discussion on a variety of bioethics topics in order to set direction and provide guidance.
However, as we said previously, the organizational structure for bioethics will vary from company to company depending on a number of factors. Therefore, a bioethics committee may be a great starting point for a company, or it may come later in their bioethics development. Likewise, a company may decide to establish a standing committee or an ad hoc committee, and the membership could be all internal members, all external members, or a mix. These are organizational details that need to be fleshed out as a company delineates its current and future needs.
About the Authors: Luann Van Campen, Ph.D., M.A. Bioethics has clinical, academic, government, and industry experience as a certified audiologist, hearing scientist, scientific communicator, and bioethicist; she is also a peer-reviewed published author in each area. She is an internationally recognized leader in biopharmaceutical bioethics. Dr. Van Campen was Eli Lilly and Company’s first full-time bioethicist, serving as Senior Advisor and Head of the Bioethics Program for 10 years.
About the Authors: Don Therasse, M.D. has been a consultant to the biopharmaceutical industry in the areas of clinical development, medical affairs, pharmacovigilance, and bioethics since 2014. During that time, he has also served as a consultant and strategic advisor with YourEncore. Prior to that, he spent 26 years in the pharmaceutical industry, all with Eli Lilly and Company.