 |
|
| THE HUMAN RESEARCH PROTECTION PROGRAM | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
THE COMMITTEE ON HUMAN RESEARCH UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES OVERVIEW OF THE APPLICATION PROCESS (Revised October 2007, Revised February 2008)
• Determine Whether CHR Review is
Required Top Tips to Speed up the Approval Process and Prevent Problems Determine whether CHR Review is Required The first step in the CHR application process is for the investigator to determine whether a study requires CHR review:
then the study requires CHR review. Before initiating, modifying, or extending any research project involving human subjects, principal investigators must submit an application to the Committee on Human Research for review and approval. Reapproval is necessary at least annually. No activity, including patient follow-up or data analysis, is allowed to continue if approval has expired. Determine the Type of CHR Review Required The next step is to identify the appropriate application type, that is, Exempt, Expedited or Full Committee. The appropriate type of application reflects the level of risk to the subject. The risk level is compared to “minimal risk” as defined by the federal regulations:
If you cannot determine or are unsure about which type of review is needed, please call the CHR Analyst of the Day at 476-1814. For a full description of the different requirements and the forms please see the CHR website Applying to the CHR page. Full Committee Review is required for all studies involving greater than minimal risk. Examples include randomized studies, phase I, II, III and IV trials, studies using investigational drugs and/or devices, and some behavioral interventions. Expedited Review, is appropriate when studies involve no greater than minimal risk and fit into one of nine specific categories, as defined by the federal government. Examples include blood sampling by finger stick, heel stick, ear stick, or venipuncture from healthy individuals, collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, and low risk behavioral research. Exempt Certification may be allowed if the research involves the lowest level of risk and if it fits into one of four federally defined categories, for example, research conducted in established or commonly accepted educational settings, and the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Emergency Use of an Investigational Drug or Device may be approved in very limited circumstances under very specific conditions. The conditions are the following:
Specific information is required before the Chair can sign off on this type of study. PLEASE NOTE: Emergency Use should not be confused with “Compassionate Use.” The latter requires review by the full committee. Fill out the Appropriate Application Full Committee Review requires 1 copy of the submission to the CHR for initial screening. If revisions or additions are needed, the Screener will contact the PI and Contact and ask them to submit 18 identical sets of the CHR’s revised application and accompanying materials (e.g., appendices, supplements, recruitment materials, consent documents, questionnaires, letters of support, etc), as indicated in the Submission Checklist. Expedited Review requires 6 identical sets of the CHR Cover Page, protocol written according to the Initial Subcommittee Review Application Format, consent form or information sheet, and any special requirements or attachments, as indicated in the Submission Checklist. Exempt Certification requires three copies of the completed and signed Exempt Certification Form. There are two versions of form, depending on the type of study. The directions for completing the forms are embedded within the text of the forms itself and should be self-explanatory. General Submission Requirements and Information Submitting the Paperwork
Principal Investigator: The individual listed as the Principal Investigator (PI) for the project must be a UCSF faculty member who meets the eligibility requirements for PI status on grant applications. For studies conducted under the auspices of an affiliated institution (e.g., SFVAMC, UCSF-Fresno, SFDPH) the individual listed as the PI must meet eligibility criteria defined by that institution. PI Signature: All CHR application forms require the signature of the PI of the study. Key Personnel: All key personnel involved in the conduct of the study should be listed on the CHR Application. This is especially important if a grant application for the work is being submitted under a different name from that of the PI listed on the CHR Application, since there must be a cross-reference. Also, if a study is being done wholly at the Veterans Affairs Medical Center (VAMC), San Francisco General Hospital (SFGH), or Mount Zion (MZ), a VAMC, SFGH or MZ physician or otherwise qualified person must be listed on the CHR Application as an investigator. Incorrect Applications May be Returned: All submissions are reviewed for completeness by the CHR staff before distribution to the Committee members. Submissions must meet all requirements (e.g., forms completed, consent forms and all attachments included), or they may be returned to the investigator for correction or completion prior to Committee review. Studies are placed on the agenda in order of receipt of a fully completed application. There are a number of factors that affect turnaround time including type of application, quality of application, expertise of members available for review, quality of other applications at meeting, staffing levels, and holiday schedules. The average turnaround times for the following applications are:
If you have an emergency situation or an unanticipated urgent deadline, please contact the CHR office at 476-1814. At each full committee meeting, the full committee reviews initial full committee format applications, full committee renewals, applications returned to the full committee for rereview, major modifications, some expedited applications, and adverse and incident reports as well as reports and studies involving problems with compliance. A subcommittee in the office reviews studies that qualify for expedited review. These studies include initial expedited applications, renewals of expedited applications, minor modifications and some adverse event reports. Exempt applications are certified as exempt by one member of the committee. One of two possible outcomes are possible following review. Either the investigators can begin the study without submitting additional information to the CHR, or the investigators may not begin the study until additional information is provided.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||