The requirement for obtaining informed consent stems from one of the ethical principles listed in the Belmont Report. Respect for persons states first “that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.” This means that potential participants should enter into the research voluntarily and with adequate information. Informed consent is one of key protections listed in the regulations 45 CFR 46 from the Department of Health and Human Services. Show
What is Informed Consent?Informed consent is a process that includes providing accurate information about a research study and the purpose of the study. The process involves exchanging information between the investigator and the potential participant, and the communication should continue throughout the study. The amount of information that is presented in the consent form will vary based on the risks and complexity of the study. Please note that obtaining a signature or verbal consent does not complete the consent process. You must provide participants with any new information throughout the study that may impact their participation and their decision to remain or not in the study. What can the researcher do to make the Informed Consent process effective?
What are key considerations for obtaining Informed Consent?
How does the researcher assess participant comprehension?
What are instances when participants should be “Reconsented”?
What are the different types of Informed Consent?
Regardless of the format, participants should always receive a copy of the consent document. What must be included in a consent form?The basic requirements for the informed consent can be found in the HHS regulations at 45 CFR 46.116(b). The regulations require that the following be included in the consent form:
What do I do if my participants do not speak English?The consent form must be translated into the language that the participant understands. The translated document must be submitted to the IRB. Documents should be provided to the UMaine IRB along with a translation certification document. The translator must be certified and the certification must be attached with the translation. Exceptions to this requirement can be made on a case by case basis. Where can I find sample UMaine consent form templates?Go to the Forms and Samples page on the IRB website. You will find sample consent forms under “Sample Documents.” Please do not use old templates that you have saved on your computer. Do I need to obtain Informed Consent if my study is exempt?Yes. Documentation of informed consent (a signature) is not required, but the participants still need to be presented with a consent form. Even though the study is exempt from Federal regulations, this does not mean that it is exempt from the ethical principles of the Belmont Report. References:University of California San Francisco: Obtaining and Documenting Informed Consent Guidance Northwestern University: Informed Consent Guidance Duke Health: Consent Guidance University of Wisconsin: IRB Guidance: Informed Consent What must be included in an informed consent form?Description of Clinical Investigation. ... . Risks and Discomforts. ... . Benefits. ... . Alternative Procedures or Treatments. ... . Confidentiality. ... . Compensation and Medical Treatment in Event of Injury. ... . Contacts. ... . Voluntary Participation.. Which of the following is a requirement of an informed consent form quizlet?A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence.
What are the 3 components of informed consent quizlet?Terms in this set (3)
Case law and statutory regulations concurred that the three key elements of informed consent are that it must be knowing, competent, and voluntary.
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