Complete your consent form, which is needed for those participating in your scholarly project and submitted with your IRB proposal. The informed consent process must be delivered in â⦠language that is understandable to the subject (Links to an external site.) â¦â (45 CFR 46.116). Note: HHS regulations (45 CFR 46.116(a) (Links to an external site.)) require that researchers disclose:
The purpose of the study;
Any reasonably foreseeable risks to the individual;
Potential benefits to the individual or others;
Alternatives to the research protocol;
The extent of confidentiality protections for the individual;
Compensation (Links to an external site.) in case of injury due to the protocol;
Contact information for questions regarding the study, participantsâ rights, and in case of injury and;
The conditions of participation, including right to refuse or withdraw without penalty.
Complete your consent form, which is needed for those participating in your scho
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