There will be constant discussion among researchers and ethicists regarding the perfect informed consent template. The great difficulty lies in consenting human subjects today for the unknown future.
The biobanking industry has followed best practice recommendations for access to data and samples by investigators from the National Cancer Institute (NCI), the International Society for Biological and Environmental Repositories (ISBER), the Rand Corporation, National Institutes of Health (NIH), and the National Bioethics Advisory Commission dating back to 1999.
FDA Requires Specific Language for Clinical Trials:
Guidelines are posted at: http://edocket.access.gpo.gov/2011/2010-33193.htm. The new mandatory language for all ICFs (per amended 21 C.F.R. § 50.25) is as follows:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Website will include a summary of the results. You can search this Web site at anytime.”
Recommended Biobank Consent Templates:
- CCTS Biobank Standard Consent.doc (single study)
- CCTS Biobank Genetic Consent.doc
- CCTS Biobank Banking Samples Consent.doc
Patient Education Tools:
Capture Participant Declarations in Electronic Format
The biobank strongly recommends all patient declarations from consent forms are captured in electronic format (MS Excel, CSV files). Secondary sharing and biobanking require automated processing of searchable documents to determine patient permissions and restrictions for use and storage of samples and data. For further discussion on automated data collection, contact the Biomedical Informatics Component at www.uthouston.edu/uth-big/contact+us.htm.