Browse > Article

Assessing the Old Participants' Capacity of Consent to Oriental Clinical Research  

Yoo, Jong-Hyang (Korea Institute of Oriental Medicine)
Kim, Yun-Young (Korea Institute of Oriental Medicine)
Kwon, Ji-Hye (Korea Institute of Oriental Medicine)
Kim, Ho-Suk (Korea Institute of Oriental Medicine)
Lee, Si-Woo (Korea Institute of Oriental Medicine)
Publication Information
Journal of Physiology & Pathology in Korean Medicine / v.25, no.6, 2011 , pp. 1089-1094 More about this Journal
Abstract
We examined the decision-making capacity of seniors of consent to oriental clinical research. This study was performed in order to improve the quality of ethical aspects before obtaining informed consent. Oriental investigators interviewed 251 seniors who participated in Sasang clinical research. The questionnaire was about the capacity of consent and the subjective awareness of informed consent. Two hundred fifteen out of 250 questionnaires were collected. One hundred thirty four(62.3%) seniors had the capacity of consent to research and 81(37.7%) seniors did not pass. The subjective awareness of informed consent in having the capacity group is $78.02{\pm}12.92$ and not having group is $72.17{\pm}9.17$. The investigation of senior capacity of consent was aimed at protecting seniors' interests and completing investigators' ethical responsibilities. This study found that only 62.3% of senior participants had the capacity of consent. This investigation will be expected to raise the importance of seniors' capacity of consent. Also we expect methods and procedures for capacity assessment of informed consent to be followed for increasing quality of clinical research.
Keywords
elderly participants; ethical issue; capacity to consent for clinical research;
Citations & Related Records
Times Cited By KSCI : 4  (Citation Analysis)
연도 인용수 순위
1 약사법 시행규칙 별표 3의 2. 의약품 임상시험 관리기준(제32조 관련). 2011.5.6.
2 Roberts, L.W. Informed consent and the capacityy for voluntarism. American Journal of psychiatry. 159: 705-712, 2002.   DOI   ScienceOn
3 Moye, J., M.J. Karel. A, R Azar. 2004. Capacity to consent to treatment:empirical comparison of three instruments in older adults with and without dementia. The Gerontologist 44(2):166-175, 2004.   DOI   ScienceOn
4 김지혜, 고선규, 이인수, 김도관. 기억력 저하를 호소하는 노인들을 대상으로 INM176를 3개월간 임상시험한 후의 치료 성적 및 부작용 평가. 신경정신의학회지 42(2):254-262, 2003.
5 이화영, 함병주, 이민수. 한국의 노인우울증 환자에서 조발성 우울증과 만발성 우울증의 임상증상의 비교. 생물정신의학회지 17(3):145-152, 2010.
6 Boyle PA, Cohen RA, Paul R, Moser D, Gordon N. Cognitive and motor impairments predict functional declines in patients with vascular dementia. Int. J Geristr Psychiatry 17: 164-169, 2002.   DOI   ScienceOn
7 Palmer, B.W., Jeste, V. D. Relationship of individual cognitive abilities to specific components of decisional capacity among middle-age and older patients with schizophrenia. schizophrenia bulletin. 32(1):98-106, 2006.
8 문한림, 김훈교, 이경식, 강봉규, 송혜향. 임상시험과 피험자 동의서에 대한 인식조사-암환자 가족을 대상으로- 임상약리학회지 3(2):141-150, 1995.
9 Stuman, E.D. The capacity to consent ot treatment and research: A review of standardized assessment tools. Clinical psychology review. 25: 954-974, 2005.   DOI   ScienceOn
10 Resnik, R. AlL. Gruber-Baldini, I. Pretzer-Aboff, E. Galik, V. C. Reliability and validity of the evaluation to sign consent measure. The Gerontologist. 47(1):69-77, 2007.   DOI   ScienceOn
11 Palmer, B. L.B. Dunn, P.s. Appelbaum, S. Assessment of capacity to consent to research among older persons with schizophrenia, alzheimer disease, or diabetes mellitus. Arch Gen Psychiatry 62: 726-733, 2004.
12 Jefferson, A. Lambe, S. Decisional capacity for research participation in individuals with mild cognivtive impairment. J of the American Geriatric Society. 56(7):1236-1243, 2008.   DOI   ScienceOn
13 이성희, 최병인, 김철민, 김경수. 의약품 임상시험 및 피험자 동의서에 대한 인식도. 임상약리학회지 17(1):72-92, 2009.
14 정인숙, 손지홍, 신재국. 임상연구에서 피험자 서면동의의 질 평가. 한국의료윤리학회 13(1):43-58, 2010.
15 심명진, 임영채. 임상연구 동의과정의 새로운 분류와 각 단계별 개선방안. 임상약리학회지 17(1):5-26, 2009.
16 구인회. 동의능력이 없는 어린이 피험자를 중심으로 살펴본 임상시험의 운리적, 법적 문제. 법철학연구 6(2):179-204, 2003.
17 이민홍. 시설거주노인의 연구참여 동의능력 유무에 영향을 미치는 요인에 대한 연구. 노인복지연구 46: 173-192, 2009.
18 Zayas, L. H., L, J. Cabassa, M.C. Perez. Capacity-to-consent in psychiatric research: Development and preliminary testing of a screening test. Research on social work practice. 15(6):545-556, 2005.   DOI   ScienceOn
19 이민홍. 한국노인의 연구참여를 위한 동의능력평가척도의 타당성 연구. 한국사회복지학 61(3):55-76, 2009.
20 Joffe S. Cook E. Jeffrey W. Quality of informed consent: a new measure of understanding among research subjects. J of National cancer institute. 93(2):139-147, 2011.
21 Royall D.R. Cordes, J. Poli M. Executive control and the comprehension of medical information by elderly retires. Experimental aging research. 23: 301-313, 1997.   DOI   ScienceOn