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Oregon Health & Sciences University

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment Sponsored by OHSU Cancer Institute and Oregon Health & Science University, Oregon Clinical & Translational Research Institute (OCTRI);
Bashi Ratterree, RN, BSN, CCRP, CRM Director and Phyllis Carello, BS, CCRC, Research Study Coordinator Manager
Contacts Kathryn G. Schuff, MD, Associate Professor, Endocrinology; Director, Research Support and Services
Format PowerPoint?
URL Download
Materials Provided PowerPoint Presentation (65 Slides)
Title Informed Consent Process for Research Coordinators
Topics Description This is (65 slides) PowerPoint? presentation covers the elements of Informed Consent (i.e., is the study research, description of foreseeable risks or discomforts, confidentiality of research records, contact information.) / Common Consent Problems (i.e., language is too complex, failure to describe procedures completely.) / Issue with writing Informed Consent, (i.e., tips on writing in Lay Language, Formatting, grammar and translating consents.) / Obtaining Informed Consent (e.g., Adults, Impaired Adults, Adults with limited English proficiency (LEP), Assent for Children, Mental Illness, Alzheimer’s, decisional impairment, unconsciousness due to trauma.) / Two specific regulations covering the Informed Consent: 45 CFR (Code of Federal Regulations) 46.115 (Applies to all Consent Forms) and 21 CFR 50.25 (FDA Regulations).

Comments: Very good presentation covering the Informed Consent Process for Research Coordinators. The information provided is really something everyone involved should know.
Keywords Advertising; Child Assent; Child Dissent; Commercial Development; Confidentiality; Cost benefit ratio; Documenting Informed Consent; HIPAA; Genetic materials; Industry Sponsored Research; Informed Consent Video; Interpreter; IRB approved/stamped consent form; Limited English Proficiency (LEP); Minors; Non-English speakers; Obtaining Consent; Personal Health Information (PHI); Phone screening; Procedures; Progress Notes; Representative for Research (ARR); Risks and benefits; Signatures; Signed & dated by subject and person obtaining informed consent at the time of consent; Sponsored Research; Study aims; Tissue banking; Waiver of Consent; Witness
See Also

Topic Data Acquisition Management Sharing and Ownership, Human Subjects, Research Misconduct, Collaborative Science, Other
Topic revision: r5 - 12 Jun 2009 - 16:47:56 - NancyHills
ResearchEthics.Informed_Consent_Process_for_Research_Coordinators moved from ResearchEthics.InformedConsentProcessforResearchCoordinators on 02 Apr 2009 - 22:46 by CTSpediaAdmin - put it back
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