Roles & Responsibilities. Melody Lin, Ph.D. December, 2012. Objectives. Research Suspensions Roles & Responsibilities Writing the informative consent form. Government Shutdowns. Massachusetts Eye and Ear Infirmary UCLA VA Health Sys. Greater Los Angeles
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Melody Lin, Ph.D.
“The Integrity of Research
Public Confidence in Research”
HHS Secretary, Donna Shalala, May 2000
“Each institution engaged in research which is covered by this policy and which is conducted or supported by a Federal Department or Agency shall provide written assurance ... that it will comply with the requirements set forth in this policy.” §46.103(a)
See OHRP guidance on engagement in research:
eg: Oversight and Monitoring of Research
Design and implement ethical research, consistent with ethical principles
Three Basic Ethical Principles:
RESPECT FOR PERSONS
Privacy & ConfidentialityProtection of subjects (especially vulnerable populations)
AssentIRB Decision Matrix
Qualifications of PI
J. Cooper, Albany Medical Center
Beyond the Consent Form
Informed consent is not a single event or just a form to be signed -- it is an educational process that takes place between the investigator and the subject.
The basic elements of the consent process include:
An IRB shall conduct continuing review at intervals appropriate to the degree of risk, but not less than once per year…
21 CFR 56.109(e) 45 CFR 46.109(e)
Involving risks to subjects or others
At least 3 years after completion of the research activities
ICH-GCP & applicable regulations
Training must be documented!
What PI need to:
Unforeseen risks to subject (fetus)
Anticipated reasons for termination from the study by PI
Consequences of withdrawal by participant
Number of subjects
Write in 2nd person
Not valid unless the subject understands the information that has been provided
The PI must consider subject population, type of information, and circumstances under which the consent will be obtained
Avoid technical terms
Translation is required when English is not participants’ primary language
ALL changes to the consent form must be submitted to the IRB for review and approval, no matter how small!
Update version date when submitting for amendments
Qualified PI and their Responsibilities
Writing the informative Consent Form