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Informed Consent

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 Research And Development (RAND) Corporation, National Institutes of Health (NIH), and the National Bioethics Advisory Commission (NBAC) dating back to 1999.

FDA Requires Specific Language for Clinical Trials

Current guidelines are posted at: ELECTRONIC CODE OF FEDERAL REGULATIONS Subpart B—Informed Consent of Human Subjects. The following statement is mandatory language to be included in all informed consent documents and processes, per 21 CFR § 50.25 (c).

“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.”

NIH Guidance on Consent for Future Use and Genomic Data Sharing Policy

Prepared by the Office of Science Policy on July 13, 2015, “NIH Guidance on Consent for Future Research Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the NIH Genomic Data Sharing Policy” is now available at:
https://gds.nih.gov/pdf/NIH_Guidance_on_Elements_of_Consent_under_the_GDS_Policy_07-13-2015.pdf

The NIH Genomic Data Sharing (GDS) Policy and new GDS Policy Overview are available at:
https://gds.nih.gov/03policy2.html and https://gds.nih.gov/pdf/NIH_GDS_Policy_Overview.pdf

NIH “Points to Consider in Developing Effective Data Use Limitation Statements” is available at:
https://gds.nih.gov/pdf/nih_ptc_in_developing_dul_statements.pdf.

Further information and resources can be found at the NIH GDS website at:
https://gds.nih.gov/index.html

Recommended Biobank Consent Templates

Patient Education Tools

Capture Participant Declarations in Electronic Format

The UTHealth CCTS Biobank strongly recommends that all patient declarations from consent forms be 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.