Other Related Resources
Below you will find links to federal regulations, best practices, informed consent
models, protocols, and other related resources.
- Global Rare Disease Registry-Related Conferences
- National Institutes
of Health Biospecimen Interest Group (BIG)
Cancer Institute (NCI) Best Practices
- International Society for Biological
and Environmental Repositories (ISBER)
- Federal Regulations
- Office for Human Research Protections
- Genetics Home Reference
- Genetic and
Rare Diseases Information Center (GARD)
- National Organization of Rare Disorders (NORD)
- Genetic Testing Registry
- Informed Consent Models
- Ethical and Legal Issues
Mongoven, AM, Solomon S. Biobanking: shifting the analogy from consent to surrogacy. Genetics in Medicine 2011; 14, 183-188.
- Proposed revisions to the EU data protection regulation pages are available at: http://ec.europa.eu/justice/data-protection/document/review2012/com_2012_11_en.pdf
- Anderson N. “Anonymized” data really isn’t-and here’s why not.” Ars Technica,
n.d. Thurs. 9 June 2011.
- Caplan AL. “What No One Knows Cannot Hurt You: The Limits of Informed Consent in
the Emerging World of Biobanking .” The Ethics of Research Biobanking. Solbakk,
JH. et al. Philadelphia: Springer, 2009.
- Caplan AL, Moreno JD. The Havasu ‘Baaja tribe and informed consent.
Lancet. 2011 Feb 19;377(9766):621-2. Epub 2010 Jul 12.
- Elger BS., Caplan AL: Consent and anonymization in research involving biobanks. EMBO
Rep. 7(7), 661–666 (2006).
- McBride R. “Study: EMRs could aid in disease research.” FierceBiotechIT,
25 Apr. 2011. Thurs. 9 June 2011.
- Nietfeld JJ, Sugarman J, Litton JE. The Bio-PIN: a concept to improve biobanking Nat Rev Cancer.
2011 Apr;11(4):303-8. Epub 2011 Mar 17.
- Neff MJ.
Informed Consent: What Is It? Who Can Give It? How Do We Improve It? Respir
- Petrini C. Informed consent in experimentation involving mentally impaired
persons: ethical issues. Ann. Ist. Super. Sanità vol.46 no.4 Roma Oct./Dec.
Common consent. Nature. 2009 Aug 20;460(7258):933.
- List of topics on informed consent
- Universal use of short and readable informed consent documents:
How de we get there? Summary of Strategic Planning Meeting May 30, 2007. Division
of Biomedical and Health Sciences Research. Association of American Medical Colleges.
- OHRP has posted a new item of correspondence on its website regarding "nonengaged"
scenarios and can also be viewed at http://www.hhs.gov/ohrp/policy/Correspondence/index.html
- Emanuel EJ, Menikoff J. Reforming the Regulations Governing Research with Human Subjects.
N Engl J Med 2011; 365:1145-1150.
- NCI Informed consent
- NIH's Bioethics Resources
on the Web
- Tissue Microarrays and Other Biological Material
- States and federal regulations
2013 Edition of the International Compilation of Human Research Standards, available at: http://www.hhs.gov/ohrp/international/index.html