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Ethical Issues
Ethical Issues
Research ethics
What are research ethics?
How do regulatory and ethical issues differ?
Are the ethical issues in repository tissue collection the same as clinical trials?
Are there unique ethical issues when the repository is commercial?
Informed consent
Why we need informed consent
Is informed consent always required for tissue collection?
Who should conduct informed consent discussions with potential donors?
Is pre-surgical consent preferable to post-surgical consent?
Disclosures for "informed consent"
Why would individuals refuse?
Is open-ended consent ethical?
What is tiered consent?
Consent for minors
Opting in/opting out
What is group consent?
Consent for postmortem donation
Withdrawing consent
Redirecting remaining samples
Risk/benefit analysis
Should researchers report results to tissue donors?
Privacy
Privacy issues and genetic information
Privacy mechanisms
De-identifying samples
Linked samples
Certificates of confidentiality
Institutional integrity issues
Mission of medical center
Would collaboration compromise patient trust?
Community perceptions
Assessing research protocols
Assessing repositories
Tissue banking steering committees
What are conflicts of interest?
Incentives
Stock options
Appropriate incentives
Handling profits
Paying physicians
This guide was funded through the generous support of the Greenwall Foundation (2002-2004)
© 2004 University of Southern Maine Bioethics Project
Last Revision: 27 Dec 2005