guide for preparing and conducting clinical research study


In 1985, all aspects of the performance of the Clinical Center were investigated by a distinguished team of nongovernment scientists and administrators. The committee urged that all protocols take full advantage of the special resources available at the NIH, avoiding studies that could be done as well or better elsewhere. The review group recommended applying four criteria to all protocols:

  • Does the protocol use the unique patient population that the CC is able to recruit for short- or long-term protocols?
  • Does the protocol use specialized diagnostic, treatment, and service facilities not available at other institutions?
  • Does the protocol fully use the basic science base at the NIH to help develop protocols? Studies on AIDS, covering basic virology and immunology and extended to clinical research, were favorably cited.
  • Does the protocol help to maintain long-range research programs such as the distinguished lipoprotein and diabetes studies carried out in the CC?

These criteria have merit, and the PI should strive to make the protocol plan consistent with them. The ultimate goal, however, is conducting high-quality, ethical, human-subjects research – a tightly designed protocol that accrues the correct number of patients (no more and no less) to answer a scientifically important question.

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