兩家精神科專科醫院之專科醫師與精神分裂症病人 對於人體試驗『知情同意』之經驗

The Experiences of Board Psychiatrists and Patients with Schizophrenia in Two Mental Hospitals about Informed Consent in Human Subject Trials

滕西華(Hsi-Hua Teng)

指導教授 ： 丁志音

共同指導教授 ： 吳建昌(Chien-Chang Wu)

國立臺灣大學/公共衛生學院/衛生政策與管理研究所/碩士(2008年)

https://doi.org/10.6342/NTU.2008.03142

摘要

背景：國內尚無探討關於人體試驗前知情同意過程之醫師與病患經驗，相關施行規定實行之情況亦未知，因此本研究旨在了解精神科專科醫院中精神科醫師與精神分裂症病人，在人體試驗進行前知情同意（informed consent）之經驗。
方法：研究選於東部及北部兩家精神科專科醫院進行，本研究為探索性研究，採質性研究方法進行，共計訪談九位精神科專科醫師，抽樣採最大變異量與關鍵性抽樣，而十七位精神分裂症病人之抽樣採典型個案抽樣。
結果：在精神科醫師組之發現為：醫師認為精神分裂症病人對資訊的的理解能力與意思能力，確實因其疾病而受損，且病人也不喜歡參與抽血或是藥物等人體試驗；也因此醫師在進行知情同意時，都會以輔助的方法進行研究資訊之說明，或輔以對家屬進行說明，部分醫師也會避免研究困擾或是因副作用、風險等降低病人受試意願，而選擇說明之方式與先說明好處、再說明風險或副作用等，降低病人疑慮，也會對受試之病人使用誘因（incentive），醫師亦表示誘因之使用對病人存在風險，因此使用之時機與方式必須謹慎；而醫師認為病人簽署同意書的理由為醫病信任或醫師權威；另，醫師們都反映出書寫中文同意書時，特別是專有名詞，有相當之困難，不知如何解決。在精神分裂症病人組之發現為：病人不清楚人體試驗之定義與內涵，且不喜歡參加需抽血或藥物的人體試驗，病人若不喜歡參加人體試驗時多會拒絕醫師；病人本身認為在理解醫師所提之資訊上，確有困難，且病人希望醫師能以口頭、中文化的文字表述等說明研究資訊；大多數簽署同意書的理由是因為信任醫師或參加研究對他人有好處等，相信誘因會促使病人增加受試動機；病人也認為自己同意簽名受試即可，不需要家屬也同意，但家屬知情無妨。
結論：病人對人體試驗與治療程序易生混淆，而醫師所選擇之知情同意的方式、程序與內容都可能使醫病雙方忽略風險，醫病信任固然是利器，但在知情同意的過程中過度仰賴，也是一種危害。在研究資訊或受試同意書的呈現上，醫師被要求或是病人所期望的口語化說明，目前醫師仍苦無標準可供參照，而IRB在這一方面，尚無統一標準，且IRB對誘因等使用規範與對研究的監測機制目前都略顯不足。故本研究建議：（一）主管機關加強對病人宣導其受試基本權利與提供醫師知情同意之執行技巧及同意書資料庫；（二）人體試驗法規位階應予提升，以確保醫病雙方權益；（三）病人之自主同意權與家屬等第三人之代理同意權之合法性應予釐清，並建立輔助措施；（四）IRB應加入更多外部代表，與建立更客觀、積極主動之研究監督機制。

關鍵字

知情同意 ； 人體試驗 ； IRB ； 精神分裂症病人

並列摘要

Background: In Taiwan there is no study about any physicians’ and pstients’ experiecences in informed consent in human subjects trials.Thus, this qualitative explorative study investigated experiences of psychiatrists and persons with schizophrenia in the informed consent process before conducting clinical trials. Methods:Two mental hospitals were selected, one in east of Taiwan and the other in the north. In total, 9 psychiatrists and 17 patients with schizophrenia completed the interview for the study. Sampling in psychiatrists is maximum variation and politically important cases. Sampling in patients is typicall cases intensity.
Results:As shown in the interviews, the psychiatrists recognized that the symptoms and signs of schizophrenia might have negative impacts on the patients’ capacities to understand and express. They also recognized that the patients disliked participating in any clinical research that mandates blood drawing or drug testing. Therefore, during the informed consent process, the psychiatrists would endeavor to aid the patients in understanding research-relevant information. They may also disclose the information to the patients’ families for the families to help the patients make decicions. In order to make subject recruitment smooth and reduce the patients’ overconcerns with side-effects and risks, some psychiatrists might choose to diminish the patients’ worries by adjusting the ways of information disclosure. For example, they might mention benefits of the research before addressing its risk or side-effects. Understanding the risk of unethical incentives that distort the patients’ willingness to participle in research, they also carefully use monetary compensations to reduce the patients’ burdens in research participation. For these psychiatrist, patients willingness to sign research consent form originated in their trust in physicians or their respect for expert authority. Finally, all the the psychiatrists thought it necessary to conquer the difficulties translating the jargons into Chinese words in the research consent form that are easy for the patients to understand. The patients interviewed often didn’t know the definition and connotations of clinical research. The patients also expressed that they didn’t like any clinical research with blood drawing or drug testing. They would reject the physicians’ recruitment of subjects if they disliked the trials. The patients recognized their difficulty following the physicians’ explanations about clinical trials. They hoped that physicians present the research information verbally in plain Chinese language. Most of the patients thought that they would sign research consent form based on their trust in their physicians or their belief that the research benefits others. They also believed that material or monetary incentives that compensate for their time and labor would motivate them to participate in clinical research. Finally, the patients thought that they could sign the research consent form by themselves. They thought it fine to notice their families about the research, but family’s consent should not be mandatory for research participation.
Conclusions:The thisis found that patients tend to not differentiate clearly between human experiment and clinical treatment. Both physicians and patients should beware of patients’ risk ignornance that originates in ways, procedures and information presentations of informed consent. Although the trust relationship between patients and physicians is good, it might not be that good and ethically acceptable for it to dominate the informed consent process. As regards resolving the difficulty translating
jargons in the disclosed information into plain verbal and written languages in the informed consent process, so far there is no universal IRB-adopted standard for physicians to follow. Also, there is room for improvement in IRBs’ mechanisms to regulate the use of incentives to patients and to audit the conduction of research.

The thesis suggests that (1) the competent authority should strengthen the patients’ understanding of the basic rights of research subjects and provide physicians with the databank of informend consent skills and consent forms;(2) in order to protect the rights and interests of both patients and physicians, the rank of of the clinical trial regulations in the legal hierarchy should be promoted to the level of law; (3) it is necessary to clarify the legality of the consents given by the patients, their families or their representatives; and (4) IRBs should increase the number of members from outside of the institutions and establish more objective and active mechanism of research audit.

並列關鍵字

informed consent ； clinical trial ； IRB ； schizophrenia

參考文獻

行政院衛生署：人體研究倫理政策指引。民96。

石耀堂：研究受試者保護：台灣之現況與政策改革建議。台灣衛誌，2005；

蔡甫昌：臨床試驗之倫理規範演講稿，2003。

蔡甫昌：研究倫理與赫爾辛基宣言（一）（二）。健康世界，2005；352:71-74；353：83-87。

邱琪雯：醫師告知義務法律責任之再研究。民94。碩士論文。