Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.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) that are currently unforeseeable.When appropriate, one or more of the following elements of information shall also be provided to each subject: 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.Īdditional elements of informed consent.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.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.A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, including the possibility that the Food and Drug Administration (FDA) may inspect the records if applicable.A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.A description of any benefits to the subject or to others that may reasonably be expected from the research.A description of any reasonably foreseeable risks or discomforts to the subject.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 that are experimental. ![]() The following basic elements of informed consent are required to be disclosed in all research consent forms pursuant to 45 CFR 46(a-b): * As a free service to all UMB faculty, researchers are strongly encouraged to use this service.Ĭlick Here To Request a Research Consent Form Review Library staff will review your consent form and suggest changes that will help simplify the language, lower the reading grade level, and make the consent form more understandable to potential participants. ![]() The Health Sciences and Human Services Library offers a Research Consent Form Review service to improve consent form readability. The HSHSL Health Literacy guide contains a list of Plain Language resources. Informed consent is required to be presented in language understandable to potential participants.
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