For a variety of reasons, increasing numbers of institutions are developing research ethics consultation services to provide guidance to investigators, study teams, research subjects, and IRBs about ethical issues arising in particular research studies. The principal source of ethical review for human subjects research has traditionally been the IRB, and so the presence of an consultation service can raise questions about each entity’s role in the research review process.
On April 23, PRIM&R presented a webinar, IRBs and Research Ethics Consultation Services: An Emerging Resource and Opportunity for Collaboration to address such questions and more. Presenters Katie Porter, JD, MPH and Ben Wilfond, MD presented a case study to illustrate how a research ethics consultation service might approach particular ethical issues.
The webinar case study was based on the 2016 article Studying the Role of Financial Incentives to Promote Hepatitis B Vaccination in a Community Clinic, by Wilfond et. al. in The American Journal of Bioethics. The study goal was to determine whether education on the benefits of vaccination or financial incentive would be more effective in achieving HBV vaccine acceptance among an immigrant population.
After the webinar, the presenters answered some additional audience questions related to the case study. We’re happy to share their responses with the readers of Ampersand.
Regarding the HBV case, it seems concerning to offer money for clinical care, especially for a vaccine, and to an immigrant population. Could this be coercive?
Coercion is typically defined as a threat that can only be mitigated by giving up something that one is entitled to. Offering money for health care is not likely to be seen as a threat and therefore does not constitute coercion. Instead, the question should be reframed to consider whether the influence of money for obtaining health care is ethically inappropriate. We would note that offering financial incentives for health care is actually quite common (e.g. money for gym memberships or reduced insurance rates for non-smokers).
However, the issue gets a bit more complicated when the incentive comes from the clinician. In that case, there may be a potential impact on the clinician-patient relationship. Physicians often make recommendations that may intentionally attempt to influence behavior, but efforts will be made to demonstrate respect and to acknowledge that the patient’s values, not the physician’s values, should guide health care decisions. For example, it is not typical when discussing smoking for a physician to directly offer money to a patient to stop smoking. There has been little research on the impact of physicians directly offering money to influence decision-making so the harms and benefits are not well explored.
An incentive program for the HBV vaccine need not be directly communicated by a physician. Instead, it could be organized on the clinic level, as is sometimes done for other vaccines such as influenza. However, we don’t know whether such an incentive would have a net positive or net negative impact on health and on the relationship that exists between the community and the clinic. The ability to answer this question is why this study is important—investigators will have an answer to the question of whether incentives can increase vaccine uptake and, if done with community engagement, will have a better sense of what community members view as the harms and benefits.
Can you comment on the HBV study design? What are your concerns about the education being offered to the control group only?
The study is designed to evaluate the impact of different financial incentives on vaccine uptake. However, it is also likely that education would have an impact on vaccine uptake. If that’s the case, then the control isn’t functioning as a control and might confound the ability to detect the impact of the financial incentives, thereby lessening the scientific validity of the study. Also, an argument could be made that education about the vaccine is part of the provision of basic healthcare and should be provided to all participants, regardless of whether they are offered a financial incentive or not.
One option would be to offer education to everyone. This would allow investigators to control for education and examine the impact of varying financial incentives only. A second option would be to have both a standard and enhanced education approach. A two by two factorial design could compare the standard education with and without incentives and enhanced education with and without incentives. Both of these options may better answer the scientific question and are therefore ethically preferable study designs.
It seems that deception about the incentives is a major issue. Do you think that incentives should be disclosed?
In general, deception in research is not allowed, primarily because it undermines informed consent by keeping important information about the study from potential participants. However, there are situations in which deception can be justified for scientific reasons. This requires balancing the potential harms associated with the deception against the potential value of a deceptive study. Regardless, when a study involves deception it is important to develop a plan for debriefing participants when the deception is no longer required for scientific purposes.
There can be some ambiguity regarding what counts as deception. One pragmatic rule of thumb that can be used to determine if deception is involved is to consider if the information being withheld is likely to influence a person’s decision to join the study. In some cases, a degree of vagueness may be acceptable if there is reason to believe that it would not influence decisions. In this case, having discussions with community representatives may help the investigators and the IRB make this determination. Furthermore, community engagement would be essential if this was deemed deceptive as it would give the community a way to provide input on the issue, including thinking about the potential harms of deception and whether it is justified.
We cannot say what such a community consultation would eventually conclude about the use of deception. It is likely, however, that it would be determined that the incentive payment could not be kept secret since participants may talk to their peers. Thus, for pragmatic reasons, it seems important in this case to disclose that the design includes incentives.
PRIM&R thanks Ms. Porter and Dr. Wilfond for sharing their expertise!
The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to email@example.com.