Ethics

“Reading about ethics is about as likely to improve one’s behavior as reading about sports is to make one into an athlete.” -- Mason Cooley, U.S. aphorist

Summarizing research ethics succinctly is a challenging task. Most hospice agencies are already well versed in the principles of ethics from their daily work with patients and families, but a review of these ethical principles as they pertain to research may prove helpful. Ethics is about balancing the rights of one individual with the needs of others, and is an invaluable component of a hospice research program.

THE ETHICAL PRINCIPLES OF THE BELMONT REPORT

1. Respect for Persons acknowledges the dignity and autonomy of individuals, and requires that people with diminished autonomy be provided special protection.
2. Beneficence requires us to protect individuals by maximizing anticipated benefits and minimizing possible harms.
3. Justice requires that we treat subjects fairly.

Each of these principles carries strong moral force, and difficult ethical dilemmas arise when they conflict. A careful and thoughtful application of the principles of The Belmont Report will not always achieve clear resolution of ethical problems. However, it is important to understand and apply the principles, because doing so helps to assure that people who agree to be experimental subjects will be treated in a respectful and ethical manner
(Taken from Guidelines for the Conduct of Research Involving Human Subjects at The National Institutes of Health, 3/1995).

Note: Some bioethicists add “non-maleficence” (as a subset of beneficence) to their ethical principles, although non-maleficence is not expressly listed as part of the Belmont Report. Non-maleficence means not doing evil in Latin.

Roles
There are many ways in which hospice agencies can participate in or support end-of-life research. Before becoming involved in research, hospice agencies should decide what role they would like to play in the research process. Few hospice agencies have a full-time researcher on staff so for many hospice agencies, collaborative research or the use of external research consultants may prove to be the easiest way to begin conducting research. The roles hospice agencies can play in conducting research include:

• Data collection site: As a data collection site, a hospice agency provides researchers access to their population of staff, patients, and families (depending on the study being conducted.) Typically, a data collection site has little control over the study, and minimal input into analysis and reporting of results, although this can often be negotiated ahead of time with the researchers. A hospice agency may be a data collection site in a single- or multi-site study.
• Partner/collaborator: As a partner/collaborator in a research study, a hospice agency works together with another hospice agency, a student, a college/university faculty member, or other researcher to design and implement a research study. As a partner/collaborator, a hospice agency has more control over the focus of the study and can help shape how, where and when results of the research are disseminated.
• Principal Investigator: As principal investigator, a hospice agency leads the research by identifying a topic, designing the study, collecting the data, analyzing the data and disseminating results. The actual principal investigator role is usually assumed by one individual at a hospice agency, and in the case of federal grants, the principal investigator is typically someone with an advanced degree (usually a Ph.D. or M.D). While the role of principal investigator carries with it increased autonomy and control over the research process and products, it also carries with it tremendous responsibility.  The principal investigator is responsible for ensuring the rigor of the research, the integrity of the data collection process, and the accuracy of conclusions drawn.  The principal investigator may be a contracted researcher to the hospice agency.
• Consultant: As a consultant, a hospice agency provides input and feedback to another researcher, usually on a paid basis under a grant. The role of consultant is to provide expertise in a particular area to the researchers. Consultants typically have little control over analysis and dissemination of results, although hospice agencies may be called upon to provide consultative services in the interpretation of results within the context of the field of end-of-life care.

Hospice agencies have the opportunity to decide which role(s) the agency will play in conducting research and this may vary, depending on the project. Hospice agencies should assess their goals, skills, and organizational capabilities before deciding which role fits their needs sufficiently.  Many hospice agencies participating in research have found that assuming the role of principal investigator works best for small internal projects (rather than large-scale federally-funded projects) as the hospice agency begins to develop its research program. Federal funding agencies (like the National Institutes of Health) are unlikely to fund hospice agencies with little or no experience conducting research, so if securing federal funding is an agency goal, it may be wise to consider partnering with a college- or university-based researcher or other end-of-life researcher with an established track-record in conducting research. 

For hospice agencies new to research, partnering with a researcher with experience may prove to be beneficial, but it is also important to recognize the expertise that the hospice agency brings to that partnership. While an individual may be a luminary in the field of academic end-of-life research, they do not necessarily have experience with end-of-life care or settings. Thus, the experience and perspective the hospice agency brings to the collaboration is essential.

In collaborative research projects, hospice agencies may want to consider negotiating the terms of the partnership, in writing, before commencing the research so that there is clarity regarding roles and responsibilities of the parties involved.  While this may seem to be a formality, putting the partners’ mutual understandings of the collaborative relationship on paper helps to facilitate a smooth working relationship with fewer misunderstandings.

Hospice agencies may want to clarify the following before agreeing to participate/collaborate in a research project:

• If the project will be grant-funded, who will write the grant proposal? Who will manage the funds? Who will be responsible for oversight and reporting of results to the funding agency?
• Who will manage the data collection activities of the research project? Will an external researcher handle this, or is the hospice agency expected to oversee data collection on site? How much time is anticipated to be required for data collection?
• What is the researcher’s goal in conducting this study? (e.g. If the goal is to change or influence public policy, how might this impact patient/family access to quality hospice services?)
• Which hospice agency personnel are expected to work on the project, and for how many hours?
• What funding does the researcher currently have for this research project? What funds are available for the hospice agency to offset the cost of supporting the research being conducted?
• If the research requires Institutional Review Board (IRB) approval, who will complete the IRB application and reports/updates? (See page 35 for detailed information about IRB’s.)
• Will the hospice agency have the right to review any and all publications and presentations before dissemination?
• Is there an option for the hospice agency to co-author articles and other publications jointly? If so, whose names go on the publications?