Total number of subjects to be enrolled in the study. Include justification:
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
In assessing the risk/benefit to potential participants the DOH IRB must be informed as to the total number of participants to be enrolled.
INVESTIGATOR HELP:
This refers to the total number of participants to be enrolled at all sites over the life of the study. A potential participant is entitled to consider the risk to participate and confidentiality issues if 1000 participants will be recruited versus enrolling in a trial in which 10 will be enrolled. This is an additional element of consent and should be included in the consent form when appropriate.
FEDERAL REGULATIONS/GUIDANCE:
45 CFR 46.116 – Additional elements of informed consent
(b) additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
(2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(3) any additional costs to the subject that may result from participation in the research;
(4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
(6) the approximate number of subjects involved in the study.