The preparation of a written research protocol (''Clinical Research Protocol") according to existing guidelines prior to commencing studies is almost always required. By virtue of its various sections governing background; patient eligibility and confidentiality; data to be collected; mechanism of data storage, retrieval, statistical analysis and reporting; and identification of the principal and associate investigators, the Clinical Research Protocol provides a highly codified mechanism covering most of the topics covered elsewhere in the Guidelines. The Clinical Research Protocol is generally widely circulated for comment, review and approval. It should be scrupulously adhered to in the conduct of the research. The ideas of the investigators who prepared the protocol should be protected by all who review the document.

Clinical investigators are responsible for assuring that the proposed clinical research will be conducted only if the Clinical Center, or other clinical facilities, has the appropriate capability and support structure to insure that the research can be done safely and efficiently. The principal investigator should be familiar with the functioning of the clinical unit and should allow the investigation to continue only if the unit can provide adequate clinical care.

Investigators who are neither clinicians nor trained in clinical research may perform laboratory research on material derived from humans. To conform to the requirement of working under approved human experimentation guidelines, they should ordinarily be advised by or collaborate with trained clinical investigators.

The supervision of trainees in the conduct of clinical investigation is complex. Often the trainees are in fellowship training programs leading to specialty or subspeciality certifications as well as in research training programs. Thus, they should be educated in general and specific medical management issues as well as in the conduct of research. The process of data gathering, storage, and retention can also be complex in clinical research and sometimes not easily subject to repetition. The principal investigator is responsible for the quality and maintenance of the records and for the training and oversight of all personnel involved in data collection.

Concluding Statement

These Guidelines are not intended to address issues of misconduct, i.e., fabrication, falsification, plagiarism or other practices motivated by intent to deceive. Rather, their purpose is to provide a framework for the fair and open conduct of research without inhibiting scientific freedom and creativity.

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