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1 02/09/ :49 AM To b Eligible to be exempt from IRB Review: Marker Chromosome The KPSC IRB Vice Chair reviewed your summary listed in your dated 2/8/2012 at 2:57pm and agreed that the publication is now eligible to be exempt from IRB review. The statement, "5 of ten sequential marker chromosomes studied were found to be complex intra chromosomal rearrangements or derived from an acrocentric with non acrocentric euchromatin, is a permissible description and interpretation of actual findings. It is permissible for authors to include such conclusions in their publications. Please keep this in your record. 02/08/ :57 PM To Re: Determination of Your Exempt Request - Marker Chromosome We will be using a total of 5 cases with marker chromosomes. All 5, will be anonymous. The authorship per journal guidelines will be limited to the physicians within KP who provided the clinical information and two authors from an outside lab (Genedx) who performed array comparitive genomic hybridization (acgh).

2 3) Describe the genetic findings per test type and clinical outcome. 4. I will collate and write this paper and the clinicians who provided the clinical information are included along with an outside testing lab involved in performing one test (acgh) in the panel for all cases 5. Is one statement like " 5 of ten sequential marker chromosomes studied were found to be complex intra chromosomal rearrangements or derived from an acrocentric with non acrocentric euchromatin",permissable? ---02/08/ :48:53 PM--- Please revise your summary and submit to m 02/08/ :48 PM Subject Re: Determination of Your Exempt Request - Marker Chromosome Please revise your summary and submit to me. I will obtain the approval from our Vice Chair.

3 02/08/ :45 PM To Re: Determination of Your Exempt Request - Marker Chromosome Yes, that is what we will do /08/ :39:31 PM--- Both our IRB Chair and Vice Chair think that 02/08/ :39 PM Subject Re: Determination of Your Exempt Request - Marker Chromosome Both our IRB Chair and Vice Chair think that your project is a research project since two or three of the five individuals can be identified, thus needs an IRB application for IRB review. Are you willing to make all 5 cases anonymous so you don't have to go through the IRB application process? Please let me know your decision. Please

4 02/06/ :59 PM To Re: Determination of Your Exempt Request - Marker Chromosome We will be using a total of 5 cases with marker chromosomes. Among the 5, 3 or 2 will be anonymous and 2-3 will have clinical pictures, full clinical h/o and patient consent. The authorship per journal guidelines will be limited to the physicians within KP who provided the clinical information and two authors from an outside lab (Genedx) who performed array comparitive genomic hybridization (acgh). 3) Describe the genetic findings per test type and clinical outcome. 4. I will collate and write this paper and the clinicians who provided the clinical information are included along with an outside testing lab involved in performing one test (acgh) in the panel for all cases 5. Is one statement like " 5 of ten sequential marker chromosomes studied were found to be complex intra chromosomal rearrangements or derived from an acrocentric with non acrocentric euchromatin" permissable? ---02/06/ :20:06 PM--- With the information you provided below, ou 02/06/ :20 PM Isabel M Sanchez/CA/KAIPERM@Kaiperm Subject Determination of Your Exempt Request - Marker Chromosome With the information you provided below, our IRB Chair determined that your project is more than a series of case study of five or less patients. You are required to complete and submit an IRB application to review existing clinical data for publication. Please refer to the instruction I sent you in the chain below on 1/16/11 at 3:23 pm to submit an IRB

5 application to Marcela Sanchez who is copied on this . 02/06/ :14 AM Subject Re: Please revise the case description: Exempt Request - Marker Chromosome We will be using a total of 10 cases with marker chromosomes. Out of the 10 we will be utilizing clinical information from 5. Among the 5, 3 or 2 will be anonymous and 2-3 will have clinical pictures, full clinical h/o and patient consent. The rest of the cases will have indication for study and genetic findings i.e. we will only present without identifiers the reason given on the genetic form for performing the test and the results of the tests run. The authorship per journal guidelines will be limited to the physicians within KP who provided the clinical information and two authors from an outside lab (Genedx) who performed acgh test on all 10 cases. 3) Describe the genetic findings per test type and clinical outcome in some of the unique cases. 4. I will collate and write this paper and every clinician who provided the clinical information is included along with an outside testing lab involved in performing one test in the panel for all cases

6 ---02/06/ :46:59 AM--- Please clarify if the case study that you plan 02/06/ :46 AM Subject Re: Please revise the case description: Exempt Request - Marker Chromosome Please clarify if the case study that you plan to publish is based on only 5 KP cases or if you will review any data from the other 5 cases with marker chromosomes for the publication. You included a statement about "the rest of the cases will have indication for study and genetic findings". Please clarify what this statement means. Is the data on indication and genetic findings for all 10 patients going to be used for the publication? 02/03/ :11 AM Subject Re: Please revise the case description: Exempt Request - Marker Chromosome We will be using a total of 10 cases with marker chromosomes. Out of the 10 we will be utilizing clinical information from 5. Among the 5, 3 or 2 will be anonymous and 2-3 will have clinical pictures, full clinical h/o and patient consent. The rest of the cases will have indication for study and genetic findings. The authorship per journal guidelines will be limited to the physicians within KP who provided the clinical information and two authors from an outside lab (Genedx) who performed acgh test on all 10 cases.

7 3) Describe the genetic findings per test type and clinical outcome in some of the unique cases. 4. I will collate and write this paper and every clinician who provided the clinical information is included along with an outside testing lab involved in performing one test in the panel for all cases ---02/03/ :35:42 AM--- You mentioned that you will be using 10 cas 02/03/ :35 AM Subject Re: Please revise the case description: Exempt Request - Marker Chromosome You mentioned that you will be using 10 cases with markers. Out of the 10, 5 cases will utilize clinical information. Please advise what information the remaining 5 cases will utilize.

8 02/02/ :31 PM Subject Re: Please revise the case description: Exempt Request - Marker Chromosome We will be using a total of 10 cases with markers. Out of the 10 we will be utilizing clinical information from 5. Among the 5, 3 or 2 will be anonymous and 2-3 will have clinical pictures, full clinical h/o and patient consent. The authorship per journal guidelines will be limited to the physicians within KP who provided the clinical information and two authors from an outside lab (Genedx) who performed acgh test on all 10 cases. 3) Describe the genetic findings per test type and clinical outcome in some of the unique cases. 4. I will collate and write this paper and every clinician who provided the clinical information is included along with an outside testing lab involved in performing one test in the panel for all cases ---02/02/ :08:05 PM--- I want to assist you to present precise inform 02/02/ :08 PM Subject Please revise the case description: Exempt Request - Marker Chromosome I want to assist you to present precise information to our Privacy Rule Officer for his review. I extracted the information from your dated 1/16/12 at 2:24 pm. Please revise the text below to reflect that it is 5 cases and send it back to me. We will be using a total of 10 cases with markers. Out of the 10 we will be utilizing clinical information from 6. Among the 6, 4 will be anonymous and two will have clinical pictures, full clinical h/o and patient consent. The authorship per journal guidelines will be limited to the physicians within KP who provided the clinical information and two authors from an outside lab (Genedx) who performed acgh test on all 10 cases. 3) Describe the genetic findings per test type and clinical outcome in some of the unique cases.

9 4. I will collate and write this paper and every clinician who provided the clinical information is included along with an outside testing lab involved in performing one test in the panel for all cases Forwarded by on 02/02/ :56 PM /02/ :55 PM Subject Re: Please clarify: Exempt Request - Marker Chromosome Then I will restrict clinical case reports to 5. Kindly send the request to the Privacy Rule Officer to get clearance on privacy rule requirement. Thx ---02/02/ :48:17 PM--- Please note that six or more case studies ar 02/02/ :48 PM Subject Please clarify: Exempt Request - Marker Chromosome

10 Please note that six or more case studies are considered research as they may lead to generalizable knowledge. If you want your project to qualify for IRB exempt status, it has to be five (5) or less globally (including KP and non-kp patients). Once I receive your confirmation, I will send your request to our Privacy Rule Officer to get clearance on privacy rule requirement. 02/02/ :35 PM To Re: Fw: Exempt Request - Marker Chromosome I am inclined to present clinical identifiers on only 6 cases so that it qualify under for IRB exempt status. Thank you ---01/16/ :23:05 PM---Hi Thank you for providing additional informa 01/16/ :23 PM Isabel M Sanchez/CA/KAIPERM@Kaiperm Subject Fw: Exempt Request - Marker Chromosome

11 Hi Thank you for providing additional information on the project. Unfortunately, the described project does not meet the exempt requirement listed in our SOP-013 ((Notes 2 and 3 on P.8). In additional, six or more case studies are considered research as they may lead to generalizable knowledge. Attached for your use is a copy of the SCPMG IRB application and next steps to submit the study to the KPSC IRB. Please submit the attached Research Application along with the supporting documents listed below electronically to Isabel.M.Sanchez@kp.org 1) Copy of the Coversheet with signatures for the PI and Co-Investigators submitted as a pdf. document. 2) Area Research Chair, Chief of Service and Department Administrator approvals via (see page 2 of application for details). 3) CV(s) or Biographical Sketch (es) for all investigators. 4) Signed KPSC Programwide Conflict of Interest Attestations for all Investigators submitted as pdf documents (see page 13 of application). 5) Signed Investigator Assurance of Responsibility, required for PI only submitted as a pdf document (see pages of application). 6) Signed Policies and Regulations Agreement form, required for the PI only submitted as a pdf document (see page 14 of application). 7) Copy of your & other investigator(s)' NIH human subjects training and SOP-502 training certificates. 8) Electronic copy of the study consent form (if applicable). Please let me know if study subjects will be contacted prospectively and I will provide you a current template of the informed consent form. 9) RAMP PI Attestation and Risk Assessment Form is only required when KPSC data is shared with research collaborators outside of KP. A collaborator is an individual or entity who is not a KP workforce or physician and who participates in research with KPSC investigators. A collaborator is also a collaborator s contractors or vendors who provide data storage or services involving KP PHI such as a pharmaceutical or other research sponsor (see pages 23 & 24 of application for RAMP document). 10) Electronic copies of study supporting documentation as applicable to your study (i.e. Study

12 Protocol, Investigator's Brochure, Data Abstraction form, web internet questionnaire, study questionnaires, telephone script, etc). Please contact Marcela Sanchez at who is copied on the if you have any questions regarding the application process and she will gladly assist you Forwarded by on 01/16/ :01 PM /16/ :24 PM Subject Fw: Exempt Request - Marker Chromosome Thank you for your feedback. We will be using a total of 10 cases with markers. Out of the 10 we will be utilizing clinical information from 6. Among the 6, 4 will be anonymous and two will have clinical pictures, full clinical h/o and patient consent. The authorship per journal guidelines will be limited to the physicians within KP who provided the clinical information and two authors from an outside lab (Genedx) who performed acgh test on all 10 cases. 3) Describe the genetic findings per test type and clinical outcome in some of the unique cases. 4. I will collate and write this paper and every clinician who provided the clinical information is included along with an outside testing lab involved in performing one test in the panel for all cases Hope this provides the outline for assessment of IRB waiver.

13 ----- Forwarded by on 01/16/ :17 PM To 01/16/ :09 PM Subject Re: Fw: Exempt Request - Marker Chromosome Thank you for your feedback. 3) Describe the genetic findings per test type and clinical outcome in some of the unique cases. 4. I will collate and write this paper and every clinician who provided the clinical information is included along with an outside testing lab involved in performing one test in the panel for all cases Hope this provides the outline for assessment of IRB waiver /16/ :26:00 PM--- Thank you for sending us the exempt reques 01/16/ :26 PM Isabel M Sanchez/CA/KAIPERM@Kaiperm Subject Fw: Exempt Request - Marker Chromosome Thank you for sending us the exempt request titled " Marker Chromosome". Our Vice Chair reviewed your request and we need you to provide additional information to answer the following questions: 1) provide a description of the proposed project in sufficient detail to understand the questions you are addressing, 2) describe the outcome measures and the methods you will use, 3) describe who are the participants and the number of participants that will be included in this project 4) describe the manner in which the participants will be chosen, and

14 5) provide any additional information necessary to understand your project. Please spell out all the abbreviations included in your exempt form. Once we receive your additional information, we will forward your responses to our Vice Chair to determine whether your project meets the exempt requirements or requires further IRB review Forwarded by on 01/16/ :03 PM IRB KPSC 01/16/ :34 AM To VONEE SO/CA/KAIPERM Please respond to IRB KPSC Subject Re: Reddy---01/13/ :42:32 PM---Kindly expedite the processing of the exemption. I Reddy 01/13/ :42 PM To: KPSC.IRB@Kp.org : Subject: Kindly expedite the processing of the exemption. I will be on vacation between 17Jan - 2Feb.

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