BRAINSTORMING SESSION (continued)
Topic Area 4: What are the Potential Barriers—Legal, Ethical, and Practical—to the Participation of Older Persons in Studies of Medication Use and Driving?
- Several OT/CDRSs voiced that participating in a research protocol where subjects with severe impairments do not get reported to the driver licensing agency would violate their ethical standards. One CDRS stated that she absolutely could not send a research participant back out on the road who she had observed to be severely impaired; it is a requirement that people coming in for (clinical and driving) evaluations come with another licensed driver, who can drive them home if the evaluation outcome is poor. In contrast, a panelist who has conducted research for the National Institute on Aging (NIA) stated that it is standard agency protocol to let a person with a poor evaluation continue to drive. Another approach to this potential ethical dilemma was described by a panelist who is a Medical Advisory Board physician as well as a university researcher: as per informed consent procedures, researchers may report impairment in driving ability to the driver’s family and primary physician—but not to the DMV—if there is not a mandatory reporting requirement in the State in which the research is being conducted. More generally, researchers may be guided by the reporting requirement for those in clinical practice in a given State. For example, if reporting is mandatory, then the research team would be required to report negative results to the licensing agency. If reporting is voluntary, then the research team would do whatever clinicians in that environment would do if a research subject’s driving performance is impaired.
- Several panelists thought that the Health Insurance Portability and Accountability Act (HIPAA) regulations for the privacy of health information would not be an issue if informed consent was obtained from the participants, for specified research activities. These would include sending letters to participants’ physicians to obtain reports of prescribed medications; and, linking databases with identifiers to determine the relationship between medication use and (retrospective) crashes. However, it was pointed out that there are different interpretations of HIPAA as a function of what type of site is conducting the research, e.g., a university versus a Veteran’s Administration site. It was further stated that different Institutional Review Boards (IRBs) may view the same study, performed under the same circumstances, quite differently; and these subjective bodies impose their own restrictions.
- The informed consent process should be consistent with HIPAA’s rules for privacy of health information. For example, if the research team finds signs of severe cognitive, visual, or physical impairment or uncovers an ultra-high-risk medication that a person is taking, there should be some method for notifying the primary physician. This may discourage potential research participants, however; and in a mandatory-reporting jurisdiction, it is likely that few would voluntarily participate. In this way, HIPAA provisions could reduce the likelihood of participation in research where driving privileges may be affected.
- It was agreed that as long as a researcher is not manipulating a person’s drug regime and a subject regularly drives while taking the medications being studied, that individual does not pose any more risk to public safety or to him/herself by participating in a research study on driving and drugs than he or she would if not a participant in the study.
- A physician and researcher underscored the inadvisability of performing future research that introduces medications or combinations of medications to individuals, or withdraws existing medications.
- An OT perspective is that anytime a study requires people to drive in an unfamiliar area, they may be a public safety risk. This risk would increase if they were driving their own car, because there is no dual control; this would be a particular concern for people with cognitive impairments.
- Discussants raised the concern that somehow a research participant’s auto insurance company could learn about a poor driving performance evaluation, and raise that person’s premiums. This will be another potential barrier to research participation, unless research protocols can offer a protection of confidentiality/anonymity in this regard. Experts agreed that in this kind of research, the perceived risk (of loss of license) significantly outweighs the benefit (gadgets, payments, insurance reductions for good performance).
- A potential barrier to research participation may be raised, if poor performance on a driving evaluation is to be reported to the subject’s family. An older driver may be reluctant to participate in a study if he or she thinks the results could lead to efforts by others to try to restrict driving.
- Some populations of interest (e.g., ethnic or cultural or socioeconomic) may be unwilling to participate in research on drugs and driving, because they try hard to always be “below the Government’s radar screen.” They don’t want to be noticed or singled out, because they don’t trust the system. This may be true particularly for non-native English speakers or Medicaid recipients.
- An incentive to encourage research participation could include giving away some type of gadget to help people keep track of what medications to take and when to take them (e.g., pill organizer, counter, etc.). Also, a “driving report card” may be looked upon positively by some older drivers, to show their adult children that their driving capabilities are intact in the various areas assessed.
- Recruiting research participants through physicians’ contacts was suggested. If a physician encourages a patient to do something that involves health care, the patient often complies because of the physician’s support for the activity—it makes it worthwhile in the patient’s eyes.
- Another possibility for recruiting drivers is through “safe driving courses” (e.g., AAA, AARP) that explicitly address the effects of aging and medications on driving performance. This may be less threatening than recruiting through—for example—physicians; but it is likely that this recruitment strategy would yield a more fit population than the general population of licensed (older) drivers.
- Another recruiting tool could be a “pharmacy review” of prescription and OTC medicines a person is taking. This could identify medications that do not need to be continued. Many people view the need to take multiple medicines as a negative thing, and they may be encouraged to participate in a study if they thought it might somehow reduce the number of drugs they are taking.