This section should describe the process for supplying researchers with tissue samples that will not have any information that could identify the tissue donor, (i.e. identifiers as defined by the HIPAA regulations governing protected health information (for additional information see: www.med.upenn.edu/pennmanual/sp/hipaa/index.html) The following is an example of some wording that could be used in this subsection:
Researchers may request de-identified tissue samples for proposed human research studies. To quality as de-identified (anonymous) tissue, samples must not contain any information that can be used to trace the identity of the donor of the tissue. Consistent with the Healthcare Information Portability and Accountability Act (HIPAA), such tissue samples cannot contain any of the following identifiers:
· Names · Street address · Postal or street address information (some exclusions apply here) · All elements of dates (except year) related to an individual (including hospital admission and discharge dates) · Ages of individuals over 89 · Telephone and fax numbers · Email addresses · Social security numbers | · Medical record, health plan, or other account numbers · Certificate/license numbers · Vehicle identifiers · Device identifiers · &nbs, p; Web (URLs) and Internet (IP) addresses · Biometric identifiers · Full face photos · And any other unique identifying number specific to the donor |
Samples provided for such research will have identifiers removed and replaced with appropriately designed, non-traceable serial numbers.
[Add further information as appropriate]
This section should describe the process for handling requests outside of the scope of the main purposes of the Tissue Bank or the originally intended research goals of the Tissue Bank.
Typically this section might begin with the following wording:
In cases where an investigator proposes research that does not fall under the guidelines set forth in the “Use of Tissue Bank Samples” section above, the proposal will be …
This section should describe the specific non-identifying information that is expected to be stored with the sample, for example tissue type, classification (e.g. standard tumor classification system), medical disease of the donor, etc. Also, if there is a standard data set of this information that is to be routinely supplied with samples released to investigators, that can be included in this section as well.
[This section must include the following]:
The intended use for the Tissue Bank samples is to facilitate research projects. The Tissue Bank will remind all investigators receiving Tissue Bank samples of their ethical and regulatory responsibilities concerning the use of such samples by providing them the following statement:
"The recipient of this tissue sample acknowledges that the conditions for use of this research material are governed by the Penn IRB in accordance with Department of Health and Human Services regulations noted in 45 CFR 46. The recipient agrees to comply fully with all such conditions and to report promptly to the Penn IRB any proposed changes in the research project and any unanticipated problems involving risks to subjects or others. The recipient remains subject to applicable State or local laws or regulations and institutional policies that provide additional protections for human subjects. This research material may only be used in accordance with the conditions stipulated by the Penn IRB. Any additional use of this material requires prior review and approval by the Penn IRB and, where appropriate for recipients that are not faculty or staff of the University of Pennsylvania, by an IRB at the recipient’s site, which must be convened under an applicable OHRP-approved Assurance."
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