Certificate of Approval

Transcription

1 Colorado Multiple Institutional Review Board, CB F490 University of Colorado, Anschutz Medical Campus E. 17th Place, Building 500, Room N3214 Aurora, Colorado [Phone] [Fax] COMIRB Home Page [Web] [ ] FWA [FWA] University of Colorado Hospital Denver Health Medical Center Veteran's Administration Medical Center The Children's Hospital University of Colorado Denver Colorado Prevention Center Certificate of Approval 13-Jan-2015 Investigator: Sponsor(s): Subject: Effective Date: Expiration Date: Title: Expedited Category: Ellen Burnham National Institute of Healthcare Research~ COMIRB Protocol Continuing Review 07-Jan Jan-2016 CPARC: Colorado Pulmonary Alcohol Research Consortium N/A Submission ID: CRV003-1 SUBMISSION DESCRIPTION: Status: Enrolling Your COMIRB Continuing Review submission CRV003-1 has been APPROVED until the expiration date listed above. The investigator will need to submit this research for Continuing Review at least 45 days prior to the expiration date. Study personnel are approved to conduct the research as described in the documents approved by COMIRB, which are listed below the REVIEW DETAILS section. Please carefully review the REVIEW DETAILS section because COMIRB may have made red-line changes (i.e. revisions) to the submitted documents prior to approving them. The investigator can submit an amendment to revise the documents if the investigator does not agree with the red-line changes. The REVIEW DETAILS section may also include important information from the reviewer(s) and COMIRB staff. COMIRB stamps the approved versions of documents in the top right hand corner. Stamped copies of documents are available for download through COMIRB s electronic submission website, era(infoed). Click here for instructions on how to retrieve stamped documents. REVIEW DETAILS:

2 Continuing Review: All information required for continuing review and re-approval of the protocol and consent form was included and found to be satisfactory with the exception of the requested itemized changes below. The committee determination was: APPROVED THE COMMITTEE REQUESTED THAT THE INVESTIGATOR MAKE REQUESTED CHANGES AND PROVIDE ADDITIONAL INFORMATION BY THE NEXT CONTINUING REVIEW. PLEASE READ AND MAKE NOTE OF THESE REQUESTS TO ADDRESS WITH OR PRIOR TO THE NEXT CONTINUING REVIEW TO AVOID DELAYS IN PROCESSING Protocol and application form: The committee reviewed all the documents provided for the continuing review. Previous changes: All previous changes have been reviewed and determined to be appropriate and incorporated into the submitted documents. Requested changes from last review: All changes previously requested have been reviewed and determined to be appropriate and incorporated into the submitted documents except as detailed below. Status: Enrollment of participants continues. Number approved locally: 510 Number signed consent: 147 Number of screen failures: 4 Number of withdrawals: 0 Sites: University of Colorado Hospital UCD Anschutz Medical Campus Denver Health CTRC (University of Colorado Hospital) This study does not involve the VA. Consent process: The committee agreed that informed consent will be sought and documented from each prospective subject. Subject enrollment: The committee determined that the selection of subjects is equitable. Vulnerable populations: None. FDA Regulated Research (Drugs/Devices) This research study is subject to FDA regulations. Drugs: The following drugs are being used in this study: Midazolam, Chlorazepate, Fentanyl, and Lidocaine. The committee determined that an IND is not required for this study because the drugs are being used in accordance with current FDA approved labeling indications, the results will not be submitted to the FDA for a new labeling indication or marketing, and the study complies with informed consent and product promotion requirements.

3 Devices: No safety or effectiveness data are being collected on devices in this study. Conflict of Interest: No conflict declared. Safety information: The committee reviewed all the safety information provided and requested no changes to the protocol or consent form at this time. The committee reviewed the Safety Officer Report dated 12/17/14, which noted no concerning adverse events and recommended the study continue as planned. The committee reviewed the previously noted unanticipated problem reports (UAP003) and had no concerns. Risks: The committee determined that the risks were appropriately minimized as outlined. The committee made the following risk assessment for the populations to be enrolled: Adults: The committee determined that this research involves greater than minimal risk due to risks associated with the bronchoscopy procedure. The risks are minimized by using procedures that are consistent with sound research design, using procedures already being performed on subjects for diagnostic or treatment purpose, qualified investigators, appropriate inclusion / exclusion criteria, close monitoring of subjects, oversight by a Safety Officer, appropriate withdrawal criteria, and no unnecessary procedures. Benefits: The potential benefits of this research are generalizable knowledge, improvement of treatment or system, and close monitoring. Risk / Benefit Ratio: The committee has determined that the potential benefits of the study continue to outweigh the known risks. Continuing Review Frequency: The committee determined that the continuing review frequency is 12 months. The reason for this frequency is due to the specific experience of the PI and other members of the research team, structured stopping criteria, close monitoring of subjects, and oversight by a Safety Officer. All submitted documents were reviewed and approved except as detailed below. The application form with attachments was reviewed but was not stamped approved due to the amendment (PAM008) that was concurrently submitted with this continuing review submission. The new versions of these documents are approved and stamped approved with the associated amendment. It is noted that the stamped version of the previously approved document is already on file with COMIRB. COMMITTEE ISSUES AND CONCERNS: 1) It is the committee s understanding that a total of 510 subjects (250 control and 260 alcohol) will be enrolled in the study. However, the enrollment numbers appear to be inconsistent in several study documents. To ensure consistency across all study documents, please see the requested changes below for each item. As these inconsistencies do not affect subject risk or study procedures, the committee determined that no immediate action is required, and these changes can be made at the time of the next continuing review. 2) The committee requested changes to the revised version of application form with attachments (12/18/14) that was submitted under PAM008. These changes are listed under the feedback letter for PAM008 that was concurrently

4 submitted with this continuing review. 3) The PI is reminded that the amendment to the protocol that is concurrently submitted with this continuing review should be submitted to SARC for review and approval if it has not been already submitted. Any changes requested by SARC (e.g., change to study procedures, resource utilization, etc.) should be incorporated. The revised documents should also be reviewed by COMIRB; please submit an amendment if changes are requested by SARC after approval by COMIRB. For information on the SARC amendment process, please visit the following website: Resources/CTRCs/AmendmentSubmission/Pages/AmendmentSubmission.aspx The continuing review form was submitted and the following changes were requested: 1. Pg 2, table 1, please delete the national enrollment number as there are no external sites. 2. Pg 2, item 2b, please check yes and uncheck no. Note: Since the committee's requested changes were very minor, COMIRB administration will make the changes. Protocol submitted: CPARC: Colorado Pulmonary Alcohol Research Consortium, 1/13/14 Protocol changes by the next continuing review: 1. Pg 6, Subjects with AUDs, line 5: Please replace 360 subjects with 260 subjects. Application form with Attachments submitted: Application form with Attachments A, C, D, M, O, Q, R, S, Section C - Personnel, 1/13/14 Application form with Attachment changes: Changes are requested to the new version of the application form. Please see the feedback letter for PAM008. Other material submitted: 1. Safety Officer Report, 12/17/14 Other material changes: None. Consent forms submitted: 1. Consent and HIPAA Authorization Form, Controls, 9/4/14 2. COMIRB Subject Consent Form, Subjects (Alcohol), 2/5/14 The consent forms were reviewed and approved. Waiver of Documentation of Consent was reviewed and approved for pre-screening only because the pre-screening procedures present no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. HIPAA Compliance: The COMIRB committee, acting as the COMIRB Privacy Board, noted the submitted combined consent and HIPAA Authorization B form, and the information in the application form. HIPAA Waiver: The committee concurred with the waiver of HIPAA Authorization (Attachment O) that was reviewed and approved previously for this protocol for pre-screening.

5 For the duration of this research the investigator must: Submit any change in the research design, personnel, and any new or changed study documents (including new/changed consent forms, questionnaires, advertisements, ect.) to COMIRB and receive approval before implementing the changes. Use only a copy of the COMIRB-approved, stamped Consent and/or Assent Form. The investigator bears the responsibility for obtaining from all subjects "Informed Consent" as required by COMIRB. COMIRB REQUIRES that the subject be given a copy of the consent and/or assent form after it is signed. Provide non-english speaking subjects with a certified translation of the approved Consent and/or Assent Form in the subject's first language or use a Consent Short Form, as approved for the study. Inform COMIRB immediately of any Unanticipated Problems that are unexpected and related to the study in accordance with COMIRB Policies and Procedures. Maintain approval for the research. COMIRB approval is generally given in one year increments, but the period may be shorter. Research is required to be submitted for continuing review and re-approval at least 45 days prior to the expiration date. If a study's approval expires, investigators must stop all research activities immediately (including data analysis) and contact the COMIRB office for guidance. Remain actively engaged in the conduct of the research. The investigator must ensure that all enrolled participants are appropriate for the study prior to study procedures beginning. For FDA-regulated research the investigator must sign the investigator line on the consent form prior to participants receiving study-related interventions. Information on how to submit changes (amendments) to your study, requests for continuing review, and reports of unanticipated problems to COMIRB can be found on the COMIRB website Contact COMIRB with questions at or COMIRB@ucdenver.edu. Sincerely, UCD Panel B Please provide your feedback on IRB processes and support