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THE COMMITTEE ON HUMAN RESEARCH

CHR GUIDELINES - PART I

INTRODUCTION

These University of California, San Francisco campus guidelines for research on human subjects are published for three reasons. First, they define the obligations and responsibilities incumbent upon any investigator at UCSF who uses human subjects in his or her research. Second, they set forth for the members of the UCSF research community a comprehensive description of the manner in which the CHR currently implements its mandate from the University to safeguard the rights and welfare of research subjects. Third, they provide investigators with current, specific guidance concerning the submission of research projects for review by the Committee on Human Research (CHR). They supersede guidelines originally published in 1975, and last updated in 1985.

Over two decades have passed since the first human research review committees were established by the University of California in response to federal regulation requiring prior review and approval of research involving human subjects. During this time, UCSF has developed a comprehensive program for implementing the regulations regarding research on human subjects and honoring the ethical principles mandated by these regulations.

This program at UCSF includes three major elements. One of these is the Committee on Human Research, whose mandate it is to implement the federal regulations on human research. A second element is the skilled and dedicated staff, which facilitates the work of the Committee at an operational level. Underlying the entire program is the crucial third element, that of every investigator's assumption of his or her responsibilities in conducting research on human subjects.

The Committee and the CHR staff provide information to the investigator as to appropriate means by which the rights of the subjects are protected, free and informed consent on the part of the subject is encouraged, and federal and local requirements regarding human research are satisfied. The Committee can only approve projects in which these issues have been adequately addressed by the investigator. However, approval for any human research project to proceed is always based on a presumption of the investigator's integrity. It is ultimately the investigator's responsibility to adhere to the protocol as it has been approved, and to optimize the consent process, not only by using the approved contact method and consent document, but through the manner in which the prospective subjects are approached and consent is discussed. It is the investigator's obligation to report any adverse reactions which may be experienced by his or her subjects, and to use completely accurate data in publishing results of a study. The University of California indemnifies its investigators based on the premise that these personal obligations have been met during the conduct of any research endeavor.

Other than annual review of protocols, the Committee on Human Research does not carry out any type of formal monitoring of human research activities at UCSF. However, if the Committee is informed of improper or questionable conduct in a research activity, an appropriate inquiry is conducted. Depending upon the circumstances and potential seriousness of the incident, this may be done by the Committee or its staff, or by the Academic Vice Chancellor. Reports of misconduct may come to the Committee from subjects themselves, from personnel involved in the conduct of the study, or from concerned faculty, staff or students who have become aware of questionable recruiting methods or other study activities, or significant deviations from approved procedures.

Clearly, in order to provide the most complete protection to human subjects who volunteer to participate in research at UCSF, the institution must depend on investigators and others knowledgeable about research activities to assume the important responsibility of alerting the Committee of any possible misconduct involving human subjects of which they may become aware.

The responsibilities of being an investigator conducting human research necessarily raise a number of important ethical issues. It is hoped that these Guidelines will aid in clarifying these issues, and provide useful information as to the appropriate conduct of research involving human subjects at UCSF. The Committee on Human Research recognizes that the ethics of human research rest on long-honored moral traditions of civilization. In accord with these traditions, the concept "research on human beings" is based on the premise that researcher and subject are always fellow human beings, equal in dignity and rights. The researcher's quest for knowledge must always be balanced with respect for the person and rights of subjects and of the social groups to which they may belong. Thus, the elements of protection discussed here are intended to be guides by which the legitimate impulse for scientific inquiry may be kept in proper relation to other human values.