IRB Review of Informed Consent - New Hanover Regional Medical 新汉诺威地区医疗IRB审查知情同意——.pptVIP

IRB Review of Informed Consent The purpose of this presentation is to provide instruction, tips and techniques about how to review the consent process and the consent document. The Belmont Report Belmont Principle #1: Respect for Persons Individuals are treated as autonomous agents. Persons with diminished autonomy are given protection. There are 4 conditions that follow directly from this principle and are thus requirements for IRB approval of research: Voluntary consent to participate in research Informed consent to participate in research Protection of privacy and confidentiality The right to withdraw from research participation without penalty The Consent Process An Investigator shall seek legally effective informed consent of the subject or the subject’s legally authorized representative. This consent must be obtained only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor the institution or its agents from liability for negligence. The Consent Process Investigators presenting a research study to a potential research participant should: Pause during consent process, ask potential participant to paraphrase essential information Evaluate understanding Re-explain missed info Re-evaluate understanding Re-explain again Re-evaluate Simple but effective: Investigators should talk with patients or potential research participants. Investigators should evaluate subject understanding of the 5 ess