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1.2 Human Subject Information

Policy

Under Federal law all research at Harvard that includes human subjects must be approved by a Harvard Institutional Review Board (IRB). Personally identifiable data collected for, used in, or produced by research involving human subjects must be protected from inadvertent or inappropriate disclosure. Proposals for all research projects that involve such data must include an acceptable, effective, and documented procedure for the protection of such data before the project can be approved or granted continuing approval by the IRB.

Discussion

Federal law requires universities and research institutions to create Institutional Review Boards (IRBs) to review all human subject research. The law and Harvard policies also require that all researchers that work with human subjects obtain approval from an IRB before they start the research. The IRBs are responsible reviewing the research proposals to ensure that the research proposal meets Harvard's Policies and Procedures Governing the Use of Human Subjects in Research and for ensuring that any data collected in such research is properly protected.

Harvard has three IRBs. One covers research at the School of Public Health, another covers research at the Medical and Dental Schools and the third covers research at the rest of the University.

Surveys of Harvard persons or analysis of information already held by Harvard may or may not be covered under the federal IRB rules. Surveys of non-Harvard persons will often be covered. Anyone wanting to conduct such surveys or to analyze student or other records should check with an IRB to see if their proposed work would be considered human subject research.

Additional References: 

Office for Sponsored Programs Research Data Protection - Form

Office for Sponsored Programs Research Data Protection - Process

Statement of Policies and Procedures Governing the Use of Human Subjects in Research at Harvard University

Harvard IRBs
SPH, HMS/Dental, FAS/rest of the university

U.S. Government Office for Human Research Protections

Research with the Veterans Administration
Security Requirements for VA Research Information
Federal Information Security Management Act (FISMA)
NIST FISMA guideline

Agreements with external parties for the use of data sets should be reviewed and signed by the Harvard Office for Sponsored Projects rather than the PI, researcher, or lab director. This should be the case even if there is no fee for the use of the data set. Contact the Office for Sponsored Programs at 617.495.5501 or http://vpf-web.harvard.edu/osr/contacts.shtml

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