In considering the issues raised by research involving elder abuse and neglect, one should keep in mind certain characteristics of U.S. policy governing research involving human subjects. Ethical principles and federal regulations establish a general framework for analyzing research proposals. In the current system, local IRBs, as well as funding agencies, interpret and apply the general principles and regulations to specific studies. The oversight system is based on the judgment that studies are sufficiently different and complex that it would be difficult (and probably futile) to set rules for every possible situation. Moreover, the current system reflects the government’s desire to avoid a centralized approach in which federal officials are responsible for reviewing study proposals. Instead, the system is designed to allow staff at the local institution and people from the local community to decide how the general principles should apply to individual studies. One inevitable consequence of this system is variation in IRB decisions addressing matters not definitively resolved by the federal regulations.

WHICH PROJECTS ARE GOVERNED BY RESEARCH ETHICS PRINCIPLES AND FEDERAL POLICY?

An initial task is to determine which projects qualify as research and which research projects are covered by the Common Rule. Not all information gathering and interventions related to elder abuse and neglect involve research. Moreover, some research is exempt from federal oversight. The Belmont Report and the Common Rule address, but do not fully resolve, these classification issues.

Distinguishing Research from Other Information Gathering Activities

Underlying the research oversight system is the judgment that research presents particular ethical concerns. Past incidents illustrate that the rights and interests of participants may be compromised in research. As a result, individuals are owed certain special protections in research that may not be required in other data-collection contexts. The Common Rule and its underlying principles are intended to cover the process of producing generalizable knowledge, an activity that society labels desirable but not so important that people should be compelled to participate (Pritchard, 2000). A project’s classification as research determines the nature of ethical and policy scrutiny it receives.

Data collection can occur in numerous contexts, including patient care, social services, public health, and program evaluation contexts. These activities fall under the general heading of practice and are not covered by the research oversight system. At the same time, these activities may be



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