Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc
Journal website http://www.jocmr.org

Short Communication

Volume 6, Number 3, June 2014, pages 205-208

Informed Consent for Phase I Oncology Trials: Form, Substance and Signature

Tables

Table 1. Federally Required Elements of Informed Consent [21]
 
1.A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed and identification of any procedures which are experimental;
2.A description of any reasonably foreseeable risks or discomforts to the subject;
3.A description of any benefits to the subject or to others which may reasonably be expected from the research;
4.A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5.A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6.For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7.An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
8.A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

 

Table 2. Potentially Helpful Information Missing From ICFs of Phase I Studies
 
Type of informationMissing in this review (%)
Mechanism of action of investigational agent77.8
Study scheme and design75.0
Loss of time/energy59.3
Dose escalation and possibility of receiving sub- therapeutic dose37.0
Expected duration of each visit25.0