Od-041893 MedStar Georgetown Clinical Research Policies and Procedures, Fundamentals in the Conduct of Research: Protection of Human Subjects - Informed Consent Process and Documentation

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Research Team Responsibilities to Ensure Compliance for Human Subjects Protection show details
Outlines roles, fostering collaboration, managing resources, and maintaining compliance with regulations to achieve the project goals.
  • : Candice Vance
  • : Pr-041866
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Informed Consent Process and Documentation show details
The informed consent is more than just a form and training explains the process that takes place between researchers and subjects, forming the basis of ethical research and formally recording this process in accordance with Good Clinical Practice (GCP) and relevant regulations.
  • : Candice Vance
  • : Pr-041867
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Informed Consent Process and Documentation Quiz show details
Informed Consent Process and Documentation quiz
  • : Candice Vance
  • : Qu-041876
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Consenting English-Speaking Illiterate and Legally Blind Research Subjects show details
This specialized consent process focuses on oral communication, visual aids, and simplified methods to confirm subjects’ comprehension rather than relying on written materials.
  • : Candice Vance
  • : Pr-041869
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Consenting English-Speaking Illiterate and Legally Blind Research Subjects Quiz show details
Consenting English-Speaking Illiterate and Legally Blind Research Subjects Quiz
  • : Candice Vance
  • : Qu-041879
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Consenting Non-English Speaking Research Subjects show details
This specialized consent process involves using qualified interpreters and accurately translated consent forms to guarantee the subject fully understands the risks, benefits, and alternatives, allowing for a truly voluntary decision.
  • : Candice Vance
  • : Pr-041871
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Consenting Non-English-Speaking Research Subjects Quiz show details
Consenting Non-English Speaking Research Subjects quiz
  • : Candice Vance
  • : Qu-041884
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Re-Consenting Research Subjects show details
Covers how to identify when re-consent is needed (e.g., new risks), how to obtain IRB-approved consent forms, methods for contacting subjects, and the requirement for documenting the re-consent process and securing the subject’s updated signature.
  • : Candice Vance
  • : Pr-041872
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Re-Consenting Research Subjects Quiz show details
Re-Consenting Research Subjects quiz
  • : Candice Vance
  • : Qu-041881
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Obtaining Consent for Research from a Surrogate show details
Provides direction on obtaining and conducting from a legally authorized representative (LAR) the valid informed consent process to participate in research for an adult subject who is cognitively impaired, lacks capacity, or suffers a serious or life-threatening disease.
  • : Candice Vance
  • : Pr-041873
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Obtaining Consent for Research from a Surrogate Quiz show details
Obtaining Consent for Research from a Surrogate quiz
  • : Candice Vance
  • : Qu-041890
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Remote Informed Consent Process and Documentation show details
Outlines how to conduct the informed consent process with a subject and study team physically separated using technologies like video conferencing or telephone.
  • : Candice Vance
  • : Pr-041874
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Remote Informed Consent Process and Documentation Quiz show details
Remote Informed Consent Process and Documentation quiz
  • : Candice Vance
  • : Qu-041891
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Obtaining Electronic Consent (eConsent) show details
Covers navigating eConsent platforms, electronically signing forms, automatic archiving, and understanding remove vs. in-person procedures.
  • : Candice Vance
  • : Pr-041875
Main task
Title
Obtaining Electronic Consent (eConsent) Quiz show details
Obtaining Electronic Consent (eConsent) quiz
  • : Candice Vance
  • : Qu-041974