(Page 69 of 80) - Changing Teaching Practice in a Research Methods Course Utilizing a Student-Centered Approach authored by Shingles, Richard., Becerra, Raquel. and Pencek, Bruce.

Shingles, Becerra & Pencek
Virginia Tech

February, 2006

APSA Teaching & Learning Conference

investigators (ACHRE 1995, 108), and at the NIH Clinical Center, procedures for
independent review were rarely invoked (Rothman 1991, 56).

Moreover, both the DOD and NIH policies were limited by confusion over the definition
of research. It is not clear whether the Nuremberg Code was meant to apply to research

with patients as participants or only to research with healthy individuals. As a result,
until 1961, the NIH Clinical Center policy did not require independent review for most
research with patients. In part, policymakers were concerned about intruding into the

doctor-patient relationship. More generally, though, until the late 1960s, concern about
human protections seemed unnecessary to many observers. The development of
penicillin, the conquest of polio, and the emergence of new medical devices and
procedures, all apparently unmarked by inappropriate conduct bolstered the public
prestige of and trust in the biomedical research community. In 1962, fetal abnormalities
linked to maternal use of thalidomide shook public confidence in the regulation of drug-
related research. In response, Congress passed the Kefauver-Harris amendments to the
Federal Food, Drug, and Cosmetic Act, requiring the Food and Drug Administration
(FDA) to evaluate new drugs for efficacy in addition to safety. The amendments also

specifically required the informed consent of participants in the testing of
investigational drugs, but this requirement was weakened by vague language outlining
permissible exceptions. Nonetheless, the Kefauver-Harris amendments gave FDA broad

authority to regulate drug-related research.

Other events soon influenced NIH policy. A 1962 NIH-commissioned study found that
few institutions had their own policies for the protection of research participants
(ACHRE 1995, 174; Faden and Beauchamp 1986, 158). The potential for problems was
borne out when, in early 1964, newspapers began to describe an NIH-funded study at
the Brooklyn Jewish Chronic Disease Hospital in which investigators had injected
cancerous cells into elderly patients. The investigators claimed to have obtained
informed consent, but many of the patients were incapacitated or did not speak English,
and those able to give consent were not told that the cells to be injected were cancerous
(Faden and Beauchamp 1986, 161; Jonsen 1998, 143).

In response (and against the recommendations of a committee appointed to examine

the issue), NIH Director James Shannon argued that the institutes should take more
responsibility for research ethics (Faden and Beauchamp 1986, 208). At Shannon's
request, the Public Health Service (PHS) issued a policy for extramural projects (PHS
1966). The initiative was important, but the policy was primarily procedural. It required
independent review of research by a committee of the investigator's institutional
associates', but offered little guidance about the content of that review (PHS 1966, 475).
The policy did not originally specify the composition of the review committee, but an

accompanying memo stated that a group of people from different disciplines, familiar
with the investigator but 'free to assess his judgment without placing in jeopardy their
own goals,' would be required (Stewart 1966, 474). Importantly, it marked a shift away
from sole 'reliance on the judgment and virtue of the individual researcher' in the
assessment of the ethics of research. At NIH, the PHS policy was implemented through
the Institutional Relations Branch of the Division of Research Grants. The branch
addressed this policy in the way it handled other matters of institutional relations, by