Copyright Issues

A copyright gives the creator of the work the “right to copy” the work and be credited for its creation. Copyright law applies to both paper and electronic formats.

PIs should assume that copyright applies to all Works other than:

• Works of the United States Government;
• Works authored before the year 1900; and
• Works authored between the years 1900 and 1977 and known on the basis of specific evidence not to be copyrighted.

Yes. In order to approve research, 45 CFR 46.111(a)/21 CFR 56.111 mandates the IRB find the risks to participants are minimized and risks are reasonable in relation to benefits. This requires the submission of all instruments/documents essential to the Board’s assessment to approve, even if copyrighted.

If the IRB is unable to make required regulatory determinations without the copyrighted documents being produced, the IRB must disapprove the project.