for comments or concerns about this web site please contact:
Steve Marroulis at tissueresources@imsweb.com
The CHTN requires researchers to agree to follow the provisions of the "Common Rule" (45CFR46) federal human subjects regulations and obtain Institutional Review Board (IRB) approval before receiving specimens for their research. While these regulations currently do not apply to institutions that do not receive federal support, the CHTN policy requires all researchers using CHTN tissue to follow the Common Rule. The CHTN does not provide patient identity or other identifiers to investigators. As described above, all specimens are either anonymized, de-identified, or are part of a limited data set. This ensures complete confidentiality regarding medical information of patients.
Researchers at academic institutions and commercial companies are required to obtain IRB approval of their projects before receiving specimens from the CHTN. This may be accomplished in several ways. A researcher can use the established IRB at their institution/commercial organization. If the researcher does not have an established IRB at their institution/organization, the researcher may request that an IRB at another organization (e.g. university, college, hospital, other company) review their research proposal; or, alternatively, a researcher may use the services of the AAHRPP. For an accredited list of IRBs see AAHRPP’s accredited organizations. Investigators at institutions that DO NOT have an institutional review board (IRB) may instead submit a fully executed copy of the CHTN Human Subjects Agreement with their application. This form is NOT intended to be utilized by investigators who do have access to a local IRB. Please contact your primary division to obtain a copy of the Human Subjects Agreement.
All researchers should be aware of how the federal human subjects’ regulations apply to the use of human specimens. For example, specifically, the OHRP has indicated that research using anonymized or de-identified specimens does not constitute human research and thus is not regulated by the Code of Federal Regulations (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
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Last updated: 02/01/07. for comments or concerns about this web site please contact: Steve Marroulis at tissueresources@imsweb.com |
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