About this guide

I. Research on Human Tissue

1. What is human tissue research?
2. Is there a need for human tissue?
3. What are the sources of human tissue?
4. Do surgical tissue remnants have commercial value?
5. Is there a need for clinical data to be associated with a tissue sample?
6. What kinds of data are needed?

II. Research Tissue Repositories

1. What are research tissue repositories?
2. What materials do research repositories collect and provide?
3. What donor information do research repositories collect?
4. How do they store tissue/info?
5. Who are the users of repository tissue?
6. Are individuals who donate tissue patients, donors, or human subjects?

III. Medical Centers as Suppliers of Human Tissue for Research

1. How do medical centers provide tissue for research?
2. Typical kinds of collaboration
3. Why would medical centers collaborate?
4. Are there risks?
5. Should health care institutions consider ethical issues in collaborating with tissue repositories?
6. What are the ethical issues in tissue collection?

IV. Legal Issues

1. Who owns excised tissue?
2. Who owns associated clinical data?
3. Who owns genetic information?
4. Can donors profit from donating tissue?
5. Are there legal cases?
6. Who has intellectual property rights?
7. Who is liable for tissue use?
8. What is a tissue use agreement?

V. Regulatory Issues

1. Repository regulations
   1. Are there regulations for research repositories?
   2. How does the Privacy Rule apply to repositories?
2. Human subject research regulations
   1. International codes
   2. Federal regulations for human subject research
   3. Federal commissions for human subject research
   4. Federal guidance for HHS-supported repositories
   5. State laws for human subject research
   6. Who must comply with federal research regulations?
   7. Are there degrees of identifiability?
   8. Is there federal guidance on research using repository tissue?

VI. Ethical Issues

1. Research ethics
   1. What are research ethics?
   2. How do regulatory and ethical issues differ?
   3. Are the ethical issues in repository tissue collection the same as clinical trials?
   4. Are there unique ethical issues when the repository is commercial?
2. Informed consent
   1. Why we need informed consent
   2. Is informed consent always required for tissue collection?
   3. Who should conduct informed consent discussions with potential donors?
   4. Is pre-surgical consent preferable to post-surgical consent?
   5. Disclosures for "informed consent"
   6. Why would individuals refuse?

VI. Ethical Issues, continued

2. Informed consent, continued
   7. Is open-ended consent ethical?
   8. What is tiered consent?
   9. Consent for minors
   10. Opting in/opting out
   11. What is group consent?
   12. Consent for postmortem donation
   13. Withdrawing consent
   14. Redirecting remaining samples
   15. Risk/benefit analysis
   16. Should researchers report results to tissue donors?
3. Privacy
   1. Privacy issues and genetic information
   2. Privacy mechanisms
   3. De-identifying samples
   4. Linked samples
   5. Certificates of confidentiality
4. Institutional integrity
1. Mission of medical center
2. Would collaboration compromise patient trust?
3. Community perceptions
4. Assessing research protocols
5. Assessing repositories
6. Tissue banking steering committees
7. What are conflicts of interest?
8. Incentives
9. Stock options
10. Appropriate incentives
11. Handling profits
12. Paying physicians

VII. Best practices

1. Rand Report
2. ISBER
3. Our recommendations for best practices

VIII. Future issues

IX. Resources

X. Contact Us