医療・介護福祉機関における臨床研究支援体制構築のための実態調査

Survey of the actual conditions at healthcare and nursing care welfare institutions aiming for the construction of a support system for clinical research

　【目的】高齢者医療や介護分野のリハビリテーション（リハ）における臨床研究の教育・支援体制の構築を目的として，教育・支援対象として想定している地域の医療・介護福祉機関のリハ分野の臨床研究の実態を調査した．【方法】日本言語聴覚士協会公式ホームページの施設一覧に掲載されている愛知県内の主に成人を対象とする医療・介護福祉施設208施設のリハ担当者宛に郵送にて無記名アンケート調査を実施．【結果】回収された67通（回収率32.2％）のうち，成人を対象にリハを提供している66施設を分析対象とした．教育や支援を希望する施設割合は，研究実施施設で74.1％，研究未実施施設においても59.0％であった．また，研究実施施設であっても倫理指針の認知度は77.8％にとどまった．【考察】人を対象とする臨床研究を実施するうえで倫理指針の遵守は必要不可欠であるが，倫理指針を知らずに研究を実施している施設がある可能性が示された．臨床研究の教育や支援に対するニーズが明らかとなった．

　As a first step toward the goal of establishing an education and support system for clinical research on rehabilitation in the fields of healthcare and nursing care for the elderly, we investigated the actual conditions of clinical research on rehabilitation at healthcare and nursing care welfare institutions in Aichi Prefecture where the provision of research education and support was planned. An anonymous questionnaire for rehabilitation staff was sent by mail to 208 healthcare and nursing care facilities. These facilities were selected from those listed on the official website of the Japanese Association of Speech-Language-Hearing Therapists. The response rate was 32.2%, and from the 67 responses that were received, 66 facilities that provided rehabilitation for adults were selected for further analysis. The percentage of facilities requesting education and support was 74.1% among those involved in research and 59.0% among those not involved in research. The awareness of ethical guidelines was low (77.8%) even for those conducting research. Although adherence to ethical guidelines is essential for clinical studies involving human subjects, our results indicated that some institutions are conducting such research without being aware of these ethical guidelines. These results indicated a clear need for clinical research education and support.