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Informed consent forms are crucial for ensuring that individuals understand and voluntarily agree to participate in a research study. Writing a clear…
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There are other ways beyond a face-to-face conversation that can be used to obtain informed consent. Before consent can be obtained using a remote pr…
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This page provides answers to frequently asked questions about the consent process.
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The requirement to obtain assent from minors is described in the regulations under Subpart D of 45 CFR 46 and 21 CFR 50. The rules at 45 CFR 46.408 …
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Guidance for obtaining consent to participate in research from non-English speaking participants
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Short Form Consent Documents Including Certificates of Translation are listed below. NOTE there is only one version now of the short form which is…
Policies
Related documents
The Belmont Report outlines three main parts of the consent process.
Information: You need to give potential participants enough details so they can decide if they want to join the research. The updated Common Rule states that you must provide information that a reasonable person would need to make an informed decision and give them a chance to discuss it.
Comprehension: You need to make sure the person can understand the information you give them. There are many things that can make it hard for them to understand.
Voluntariness: You must ensure that the decision to participate is made freely. If there is any pressure or influence, people might make choices that don't really match their true goals and values. Their decisions might be different if there was no such pressure.
It's important for people taking part in research to fully understand the study to ensure their safety. Many of the drugs being tested and procedures being done can have serious side effects and risks. Participants need to know about these possible risks so they can take the right actions and report any issues to the researcher. The written informed consent document is the starting point for discussions between you and the researcher. It gives you information about what to expect, what to do, and who to contact in certain situations. Many people use this document as an important guide throughout the study.
Related Resources
Important Changes to Informed Consent: The Regs, the Policies, the Procedures and Forms, Oh My!
Presented by Heather Bridge
The Informed Consent Process-The Good, the Bad & the Ugly
Presented by Katherine W. Todman and Carol Squires
Re-consent and Subject Notification: Expectations and Flexibilities for Complying with the Common Rule
Presented by Julie Eiserman and Tiffany Gommel
Considerations for Modernizing the Informed Consent Process
Presented by Nichelle Cobb and Christine Suver
Consent Forms and Processes: What Investigators Need to Know
Presented by Peg Sanders, RN, MSN, MA, CIP
Considerations for Informed Consent in Gene Therapy Trials
Presented by Daniel Kavanagh, PhD, RAC
An Overview of IRB Expectations When Non-English Speaking Persons Enroll in Research: The Importance of Ensuring Comprehension
Presented by Jonathan Green, Nancy Muir and Brenda Robles
Research Enrolling Vulnerable Individuals - What Investigators Need to Know
Presented by Peg Sanders, RN, MSN, MA, CIP
Using and Sharing Existing Specimens and Data for Secondary Research: Expectations for Consent and IRB Approval
Presented by Julie Eiserman