目的：當研究人員邀請乳癌病人參與放射治療衛教成效問卷調查時，有些醫院的人體試驗委員 會、為了保護病人權益，會要求研究者必須先向病人說明研究內容並請病人簽署同意書之後，方 可進行研究調查。然而在實務上，感覺許多病人願意接受邀請、填寫問卷，但是對於簽署同意書 則不甚樂意。本研究將探討：一、究竟有多少比例的受訪者不願意簽署同意書。二、當問卷調查 以匿名方式進行、不涉及病人隱私及醫療權益時，可否免取得受訪者同意書。三、當受訪者將問 卷帶回家填寫、之後自行繳回，如此可否視為自願受訪。 材料與方法：本研究分四個階段將問卷發給病人，每個階段發放方式稍有不同，用以辨別不同知 情同意過程是否影響問卷回收率、未簽署同意書比率及無效問卷率。 結果：除了第一階段（請病人簽署同意書），其餘二、三、四階段（由病人自主決定）皆有 2~3 成受訪者未簽署同意書。第二階段知情同意過程簡略，故問卷回收率最低。第一、三階段雖然知 情同意過程詳細但無效問卷率高。第四階段知情同意過程最完善，故問卷回收率高且無效問卷率 最低。 結論：一、當病人在自主權的情況下，確有 2~3 成的受訪者不願意在同意書上簽名。二、當匿名 問卷不涉及病人隱私及醫療權益時，應可採用說明書告知( 不須簽名為證) 以免病人為難。三、 當受訪者將問卷帶回去填寫、之後自動繳回，即可視為自願受訪。

Objective : As patients with breast cancer are recruited to participate in a survey on the effectiveness of health education in radiotherapy, the IRB of some hospitals will, to protect the patient’s interest, ask the investigators to explain the survey to the patient and ask the patient to sign an informed consent form before the questionnaire can be distributed. In practice, however, some patients would like to participate in the survey and answer the questionnaire but may be unwilling to sign the consent form. This study was designed to investigate: (1) The proportion of participants unwilling to sign the consent form. (2) If the questionnaire was anonymous and didn't involve patient's privacy and medical interests, can the consent form be waived? (3) If the patient takes the questionnaire home, answers it, and returns to the investigators, can this be regarded as a voluntary response? Materials and Methods : The questionnaires were distributed to patients in four different groups consecutively. The informed consent process of these groups were designed to differ a little so as to identify their effects on the response rate, the rate of unsigned consent form, and the invalid questionnaire rate. Results : Except the first group (asking the patient to sign the consent form), the other groups (at the patient’s discretion) had about 20 to 30% of the respondents who declined to sign the consent form. In the second group, the informed consent process was too simplistic; hence it had the lowest response rate. In the first and the third groups, the informed consent process was more elaborate, but the invalid rate was high. In the fourth group, the informed consent process was the most complete, as a result, the response rate was high and the invalid rate was the lowest. Conclusion : (1) At the patient’s discretion, about 20 to 30 percent of the respondents declined to sign the consent form. (2) If an anonymous questionnaire does not involve patient's privacy and medical interests, instructions may be used instead (without requiring a signature as evidence) lest the patient feel uneasy. (3) If a participant takes the questionnaire home, answers it, and returns to the investigator, this may be regarded as a voluntary response.