Managing Research In The Nursing Home

Nursing homes are neither designed nor staffed for research purposes. Their mission, and primary ethical obligation, is to provide the health care personal services needed while offering residents maximum autonomy in a homelike atmosphere. The researcher who is given access to a nursing home must design and conduct research that does not interfere with the nursing home's own obligations, which are also the rights of its residents.

The Institutional Review Board, or IRB, is a federally mandated committee whose role is to review research proposals and monitor research so as to protect human subjects. In reviewing proposals to conduct research in nursing homes, IRBs may require the investigator to submit documentation from the facility's administrator agreeing to the research, identifying an onsite person who will attest to the study's appropriateness with that facility's population, and ascertaining the facility's capabilities to perform the research. If nursing home staff are to be involved in data collection, the administrator may also need to provide assurance that they have appropriate expertise and will follow IRB-approved procedures. Such a requirement can elicit the kind of understanding, communication, and agreement between the investigator and the nursing home that is needed for nursing home research to be ethical and successful.

IRBs are typically university-based and are most familiar with research sites such as laboratories and acute and primary care facilities. They may lack the knowledge to oversee research in nursing homes and sometimes use a consultant to assist in reviewing and monitoring such research. The researcher will need to be prepared to explain to an IRB how the protocol meets its ethical standards in an environment unfamiliar to that committee.

The nursing home must make a considered decision about permitting a research project to take place within its walls. Nursing homes may find it difficult to review research opportunities due to the lack of familiarity with research. They need to address questions related to the rights and welfare of their residents during the research. They may need also to address facility-wide issues such as disruption of routine, resource consumption, and potential benefits to the facility. A nursing home's participation in research is elective; producing new and generalizable knowledge is usually not at the core of its mission and must be weighed against competing priorities. One author tells of a facility in which 17 different research proposals were received in one year (Daly et al., 2000). It is unlikely that a facility would have the resources to accommodate that many requests; if it did, competition for enrollment could easily doom all studies. Research committees in nursing homes, as Daly describes, can analyze such issues. Such committees are still uncommon, but developing one is worth considering in a facility planning to be open to research. Nursing home ethics committees are somewhat more common and present another possible avenue for consideration of protocols (Cassel, 1988). Such committees function in ways analogous to hospital ethics committees, by consulting and sometimes educating on issues related to ethical decisions in the institution (Hoffman et al., 1995).

In summary, research in the nursing home is complex ethically. The presence of a subject in the nursing home raises initial concerns for that person's ability to consent that must be addressed in study design and execution. The facility itself has an ethical mandate different from that of the researcher, and honoring it may require adaptation of the protocol and persistent communication. Research in nursing homes should be guided by an interest in the specific characteristics of its residents and structure, and not by the apparent convenient access to older subjects.

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