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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)
Requirements
Scientific or scholarly review is required by regulation before a human research study can be approved. The regulatory criteria for approval of research 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.
Types of Reviews
- 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.
- By 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.
- By 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.
IMPORTANT NOTES: The CHR strongly recommends that scientific or scholarly review be conducted before an application is submitted to the CHR, particularly a full committee application. This review will help assure the quality of the CHR submission and reduce turnaround time for review and approval. It is especially important that Investigator-initiated studies receive scientific review before they are submitted to the CHR for review.
The PI will need to be able to answer the following question on the CHR Application forms:
C. Scientific or Scholarly Review: |
Is this an investigator-initiated study? [ ]Yes [ ]No |
This study has received scientific or scholarly review from (check all that apply):
The results of this review must be communicated to the CHR as part of the CHR review process. |
[ ]NIH* [ ]Cancer Center** [ ]CTSI CRC [ ]SFVAMC [ ] CHORI
[ ]Kaiser Oakland DOR [ ]GESCR [ ] ITN [ ] Department Review***
[ ]Other (identify by name): ___ |
*Specific to this study. |
**Required prior to final CHR approval for oncology studies. |
***Submit a copy of the signed Departmental Scientific Review form. |
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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.
- 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.
Departmental Scientific Review Form: The CHR recommends the use of the form to document scientific or scholarly review. While the form may be adapted for departmental use or to document other scientific or scholarly review, the CHR does need all of the information requested on the form, including signatures of the reviewers or the chair of the committee.
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