Ethical and effectiveness considerations with primary care behavioral health research in the medical home

Integrated primary care research in the Patient-Centered Medical Home (PCMH) presents unique challenges not found in other behavioral health or medical care settings. The PCMH service delivery principles and supporting systems are designed to maximize quality and outcomes of care while controlling health care costs. Conducting ethical research in this setting requires following processes and procedures established by federal statutes that threaten to disrupt this delicate balance. In addition, clinical researchers must consider the ethical requirements and guidance from their respective professional organizations to ensure they adhere to guidelines for conducting ethical research and practice. Given the setting, there is a high likelihood researchers from various disciplines who may adhere to different ethical standards will be collaborating. We present a case example of an ethical concern to illustrate the tension between research and clinical care, discuss federal and professional research guidelines, and propose recommendations for balancing ethical and effective research and clinical care in integrated primary care research in the PCMH.