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THE COMMITTEE ON HUMAN RESEARCH
UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES
SCIENTIFIC OR SCHOLARLY REVIEW OF HUMAN RESEARCH PROTOCOLS
(March 2008, Revised May 2008)
Introduction and Background
Scientific or scholarly review is required (by regulation 45CFR46.111) before an Institutional Review Board can approve a human research study. For the majority of studies being reviewed and approved by the CHR, the CHR itself has over the years performed this review, with a few exceptions. This requirement is not new. The purpose of this guidance is to provide the investigator with other options for scientific or scholarly review, particularly for full committee studies. The regulatory criteria and the other options are described below.
The regulatory criteria for approval of research (45CFR46.111) are the following:
- Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk.
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.
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Options for Reviews
There are several options for scientific or scholarly review. This review may take place by:
- An external funding agency that is on the List of Agencies that Conduct Acceptable Scientific Merit Review posted on the Office of Research website.
If you wish to add another agency, please send an e-mail to chr@ucsf.edu and provide the name and address of the agency so that it can contact agency to inquire about its review process. If acceptable, the agency will be added to the list.
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An internal scientific review committee. The latter includes but is not limited to the Comprehensive Cancer Center Protocol Review Committee (CCPRC), the Clinical Research Center (CRC) Advisory Committees, the Immune Tolerance Network (ITN) and the VAMC Clinical Research Subcommittee, all of which have developed and shared their guidelines for conducting scientific review with the CHR. See below for details about how to establish an internal scientific review committee. Other internal review committees may be added to this list. The results of these reviews need to be communicated to the CHR.
IMPORTANT NOTE: The UCSF Comprehensive Cancer Center may require prior review and approval by its Protocol Review Committee before final approval can be given by the CHR. If a study is being conducted at the VAMC, scientific review will also take place at the VA.
- The members of the CHR panel reviewing the study. If the CHR panel does not believe it has the appropriate expertise to review a particular study, then it will call upon the help of an outside consultant who does have the appropriate expertise.
The CHR will continue as it has in the past to provide scientific or scholarly review of expedited and exempt studies. With rare exceptions, the CHR may request an outside review of an expedited study.
IMPORTANT NOTE: The CHR strongly recommends that scientific or scholarly review be conducted before a full committee investigator-initiated study without external funding is submitted to the CHR. This review will help assure the quality of the CHR submission and reduce turnaround time for review and approval.
NOTE: Researchers may also wish to contact the Clinical and Translational Science Institute (CTSI) Consultation Services (formerly BREAD) at UCSF for questions about study design and implementation, data management, biostatistics, although this group does not currently provide scientific review.
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Internal Scientific Review Committee
An internal scientific review committee may be established within or among the department(s), division(s), organized research unit(s), or other appropriate groups. The following guidelines provide questions to consider when reviewing for scientific or scholarly merit. Please note that not all questions are relevant for every study and there may be additional questions to ask for any given study. The following are suggestions of what to consider.
- Sound Scientific Basis and Rationale: Is the protocol scientifically sound and based on well-established scientific principles? Is there convincing clinical and/or preclinical evidence that the trial will have valuable results? Do preclinical studies demonstrate promising results regarding safety and potential efficacy? Is the technology/ understanding sufficiently advanced to warrant detailed clinical investigation?
- Appropriateness of the Proposed Study Design: Are the primary and secondary objectives scientifically sound? Is the study designed to meet the objectives? Has an appropriate study configuration been chosen? Does the protocol distinguish between standard and/or routine care and research? Are patient populations and associated criteria for inclusion/exclusion well defined? Are the sample sizes appropriate? Is the statistical design appropriate? Are the endpoints clearly defined?
- Competency of Personnel and Adequacy of Proposed Resources: Does the principal investigator have the appropriate expertise and experience to conduct this study? Does the investigative team bring sufficient expertise to the project? Is there sufficient access to resources (e.g., appropriate personnel, equipment, facilities) for the successful and safe conduct of this study?
These guidelines do not address administrative matters (i.e., how many people on a committee, who chairs, how to convey information to the researcher) for the Scientific Review Committee. Top of Page
Departmental Scientific or Scholarly Review Form
Because the results of the scientific or scholarly review need to be communicated to the CHR, the CHR recommends the use of the Departmental Scientific Review Form or a form adapted for departmental use to document other scientific or scholarly review. One copy of this documentation should be included with the CHR application.
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