This approach provides “ key information ” essential to decision making that must appear at the beginning of the consent form and presented first in the consent discussion. Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to participants.The benefits to the participant or others that may reasonably be expected from the research.An explanation of the purposes of the research, expected duration of participation, and procedures to follow in the study.A description of the reasonably foreseeable risks or discomforts to the prospective participant.Consent is being sought for research and that participation is voluntary.The informed consent process and consent form must encompass key information, be well organized, and presented in a way that facilitates comprehension and include a concise explanation of the following (excerpted from ): Answer questions to improve a subject’s understandingįor certain types of research (e.g., research for which there is reason to believe some subjects will find the research controversial or objectionable), a robust description of the research will be required.Make sufficient time and opportunity to discuss the research.Provide more information when requested by subjects.The responsibility for the investigator in the consent process is to: The goal of the consent process is to facilitate a prospective participant’s or legally authorized representative’s understanding of the reasons why an individual might or might not want to participate in a research study.
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