Vulnerability And Research Consent In The Nursing Home

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Informed consent for research in the nursing home is ethically complex. The same health problems that result in nursing home admissions can also affect the capacity to consent. Ordinarily, we assume persons have the capacity to consent and then watch and check for exceptions during and after the recruitment and consent processes. In the nursing home, there is a higher probability that each individual is incapable of consent or requires some additional assistance. Consequently, potential subjects should be screened for capacity by a knowledgeable and disinterested party before recruitment or consent. Making this initial determination of capacity ensures that the appropriate approach is then taken to the consent process itself. Some advocate the use of an ethics or research committee for screening (Cassel, 1988). Others recommend using knowledgeable nursing home staff, such as nurses or social workers (Ouslander et al., 1993). In either case, the researcher must still ensure that the consent process itself is monitored, that proxies are used as appropriate, and that the research is monitored for ongoing consent or assent.

Nursing home residents have significant health care needs and are accustomed to the continual presence of professionals charged with meeting those needs. They (and their families) do not typically regard the nursing home as a research site; teaching and research nursing homes are uncommon. When research is conducted in the same environment as the one in which persons typically receive health care, they may assume that the research is related to their care and that it is in their best interests to participate (Lidz et al., 2002). This assumption, the therapeutic misconception, can result in a consent based on misunderstanding. Ethical researchers take steps to prevent such mistaken assumptions. To prevent such misconceptions, it may be important to have someone not identified as a regular caregiver to discuss consent with the subject and proxy and to conduct any interventions that are related to the study protocol.

Understanding the consent process for treatment can be helpful for those who seek research consent in the nursing home. That process can become complex. Staff may have an interest in providing correct health care and in an orderly routine to benefit the residents as a group. Family members of residents may vacillate between wanting the best health care and wanting them to be as free as possible to continue their preferred living patterns. Residents may experience the same ambivalence, complicated occasionally by confusion and forgetfulness.

Residents, family members and staff as a group must make decisions that direct health care, respect the autonomy of the resident, and maintain the orderly operation of the nursing home. This is frequently done in care planning meetings in which all groups and interests are represented. Afterwards, it may be difficult to identify a point in this process at which consent actually takes place. In some respects, it is more like a negotiation process (Moody, 1996). Still, it is highly adapted to the vulnerability and possible incapacity of the resident.

Researchers in nursing homes may find a similar process taking place with research consent. Multiple parties may participate, and they may bring various considerations to bear on the decision. It can be challenging to avoid deviating from the protocol during such a process. The researcher needs to view this unfamiliar and complex process as responsive to the unusual situation of a vulnerable population. To ignore it is to disregard the imperfect supports in place to protect persons in an ethically ambiguous situation.

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