Barbara,

The situation you describe is probably repeated hundreds of times across
the country each academic term.  And, you are correct that men and women of
good will may likely disagree about the preferred course of action once
something like this has happened.

Assuming that the College of Charleston has an approved assurance with DHHS
and that your institution has agreed to bring all human subjects research
under the aegis of your IRB, i.e., whether funded or not, the rules that
were broken were BOTH local institutional rules and federal rules.  I
mention this in case someone tries to tell you that you're making a federal
case out of it.  It is by definition, if no other reason.

Most institutions, however, do not bring undergraduate research assignments
under the aegis of their IRBs because most believe that assignments to
undergraduates like senior theses fail the essential test of 45 CFR
456.101.d that is: "Research means a systematic investigation, including
research development, testing and evaluation, designed to develop or
contribute to generalizable knowledge...."

CofC is entitled to its opinion and policy, of course, but the present
situation seems to weigh heavily on the side of "undergraduate instruction
and experience in formal research processes," rather than "ordinary
protection of human subjects of research."  If this had been masters
student research or doctoral-level original research where research is an
integral and substantive part of the definition of the graduate degree, the
matter would be a lot clearer.

In a case like yours, where the student has acknowledged the aegis of the
IRB, but subsequently deceived it, the question is certainly more
substantive that writing a bad check to the Bursar, but is it entirely the
student's fault?  The range of response is broad: the degree could be
withdrawn, the honors revoked, a letter of reprimand issued, a letter of
concern sent, but in any case the faculty member in charge should be
brought to account for the situation.  If you don't make a point with the
faculty, this will happen again and again.

At my former institution we discovered that a Masters student, having
submitted a protocol application, decided that time was wasting and went
ahead with the research before approval was given.  Believing that the IRB
is not a court and not particularly well-equipped to deal with student
behavior problems, we referred the matter to the Chair of the department,
who, after conducting a quick but thorough investigation, provided the
student and the supervising faculty member with letters of reprimand.  The
IRB was informed of the event and of the outcome.

Be reasonable, but be firm.

Jim Brett
Director of Research Emeritus

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