Submission Guidelines for Written Informed Consent Form
Certain basic elements are required in the Information Sheet & Consent Form:
- (a) Study title should be put at the top and consistent with the one stated in the Application form
- (b) Traditional Chinese version is mandatory, and English version is optional; if reason for only English version is justified, Chinese version can be exempted
- (c) The subject should receive a written explanation of the procedures involved in simple language
- (d) The discomforts and any risks involved should be included in the written explanation, as should be benefits likely to accrue from the research
- (e) There should be an acknowledgement by the subject:
- that he or she was offered the opportunity to ask any questions they wished;
- that he or she was made aware of their right to withdraw their consent at any time without prejudice to any other relationship that might exist between the subject and the research workers
- (f) In the case of subjects who are minors or who are mentally handicapped or psychiatrically disabled, voluntary informed consent from parents, guardians or relatives should be obtained
- (g) A statement regarding confidentiality and anonymity of subject data should be included
- (h) The full name of PI should be shown in the consent form so that the patients are informed of whose study they are participated in
- (i) Contact details should be indicated i.e. full name of contact person and contact number. The contact person should be the clinical person who manages patients’ safety (e.g. PI, Co-I or research nurse)
- (j) For Student Projects; Supervisor’s full name & contact number in the consent form should be included so that the subjects can reach the responsible personnel to answer their enquiry in case any problems arise
- (k) Unit / Hospital in which the study is to be conducted
- (l) Contact details of the Joint CUHK-NTEC CREC should be mentioned in the consent form, please quote as follows:
The Joint Chinese University of Hong Kong
– New Territories East Cluster Clinical Research Ethics Committee
香港中文大學－新界東醫院聯網 臨床研究倫理聯席委員會
Tel. no.: 3505 3935