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Original E-mail Notification dated August 31, 2004

Subject: Refinement of Legal Interpretation of Common Rule for the Protection of Human Subjects

Based on recent advice received from the Office for Human Research Protections (OHRP) of the Department of Health and Human Services (DHHS), we are refining a legal interpretation of what constitutes research involving human subjects under the Common Rule for the Protection of Human Subjects (Common Rule). Under the NIST legal interpretation in effect since May 1998, if any person in the chain of custody had access to identifiers that could link data or specimens to an individual, the research using the data or specimens was analyzed under the Common Rule and was either determined to be exempt from the requirement of IRB review under 15 CFR 27.101(b)(4) or was determined to require IRB review.

To be more consistent with the OHRP legal interpretation of what constitutes research involving human subjects, beginning immediately, only if the investigator who is conducting a research project that is either supported or conducted by NIST and/or their direct collaborator(s) on the research project (the "research team") has access to identifiers will the research be considered research involving human subjects under the Common Rule. This means that many activities previously requiring exemption documentation, such as purchases of cell lines from vendors, will no longer require exemption documentation. We are working on a process to document that certain research involving biological materials and/or data about human subjects that cannot be linked to personal identifiers by the research team has been determined not to fall within the scope of the Common Rule.

This refinement of legal interpretation will be reflected in a revised Administrative Manual subchapter, to be issued by the end of this calendar year, and will also be addressed in the required human subjects training sessions to be conducted beginning this fall. Until the new process has been implemented, the determination whether a research project involves human subjects for purposes of the Common Rule must be made by the appropriate Division Chief and documented in a memorandum to Alan Cookson, the NIST IRB Chair, with concurrence by Michael Rubin, the NIST Counsel. The memorandum must include a description of the project in detail sufficient to justify the determination and must be submitted in the attached format unless a procedure ensuring equivalent documentation of the determination is approved by the NIST Counsel.

Please forward this message to anyone on your staff who performs work that this change in legal interpretation might affect. If you have questions, please contact me on x4783.

Melissa J. Lieberman
Office of NIST Counsel
Ph: (301) 975-4783
Fax: (301) 926-6241

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Memo Documenting Research Not Involving HS.doc