암환자의 임상연구에 대한 인식도 분석: 피험자 보호 관점에서 = Analysis of the Degree of Cancer Patients’ Awareness on Clinical Trials: A View of Subject’s Protection

다국어 초록 (Multilingual Abstract)

This study was designed to assess the degree of cancer patients’ awareness of the nature of clinical trials (CT) and to provide basic information for further research in developing systems of protection for vulnerable patients. Patients diagnosed with cancer and admitted for chemotherapy or receiving outpatient treatment were surveyed. The survey consisted of three parts to gather information on (1) patients’ awareness of the nature of CT in general, (2) patients’ awareness of CT from medical perspectives, and (3) the relationship between intent to participate in CT and financial compensation. Eighty-five patients participated in the survey. In the first part, many patients answered that they would participate in the study lest they be put at a disadvantage for not participating, while others said they would participate because they felt they would receive special treatment. In the second part, scores were lowest in men, the elderly, the unemployed, and those who participated as a result of decisions made by their spouses. In the third part, rewards influenced women more than men, and patients in their 60s expected a greater reward than those in other groups. Most cancer patients may not be sufficiently aware of the nature of CT and may be vulnerable when making decisions by themselves. Therefore, it is necessary for patients to receive more information on CT and for the information to be presented in terms that patients can easily understand. A system for the protection of vulnerable patients may also be needed.

참고문헌 (Reference)

1 김해진, "항암제 임상시험에 참여 중인 암환자의 불안, 우울과 불확실성" 서울대학교 대학원 2012

2 김민우, "임상시험에서 취약한 피험자의 권리" 동아대학교 대학원 2013

3 이연진, "임상시험 동의과정에서 피험자 보호 방안" 동아대학교 대학원 2013

4 오지은, "일개병원 간암환자를 대상으로 임상시험에 대한 인식조사" 연세대학교 보건대학원 2010

5 권은진, "유방암 환자 배우자의 돌봄 경험" 대한종양간호학회 13 (13): 18-27, 2013

6 김현영, "암환자의 신약개발 임상시험 참여 경험" 대한종양간호학회 6 (6): 121-132, 2006

7 문한림, "암환자의 그 가족을 대상으로 임상시험과 피험자 동의서에 대한 인식조사" 3 (3): 143-153, 1995

8 김양희, "암 임상연구에 참여하는 환자들의 피험자 동의서에 관한 인식조사" 연세대학교 보건대학원 2008

9 홍소연, "미성년자의 의사결정능력과 동의" 한국의료윤리학회 8 (8): 155-170, 2005

10 Platonov P, "Why do patients participate in trials?" 9 (9): 11-14, 2002

11 Bankert EA, "IRB란 무엇인가" 지코사이언스 576-577, 2011

12 Ellis PM, "Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature" 11 : 939-945, 2000

13 Rusell F, "An exploratory study of patient perception, memories and experience of an intensive care unit" 29 (29): 783-891, 1999