Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
Conditions: Aortic Stenosis
Sponsor: Yale University

 
 
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Yale University 
Human Investigation Committee 
                                          Request for Approval of Medical Record Review 
100 FR 7 (2016-2) 
 
Questions to determine if the study qualifies as a Medical Record Review:   
 
 
1.   Will the medical information to be accessed be limited to only records of decedents? 
 No   Yes        
(If yes, stop completing this form and complete the Request for Access to Protected Health 
Information for a Research Purpose located in the HIPAA website at 
http://www.yale.edu/ppdev/policy/5032/5032.pdf. When completed this form is to be given only 
to the holder of the records).  
 
For additional information consult the HIPAA website http://hipaa.yale.edu/  
 
 
 
 
2.   Will the information collected be used to create a data archive for future research?  
 No   Yes     
(If yes, stop completing this form and complete the HIC Repository Application). 
 
 
 
3.   Are there plans to contact subjects for follow-up or to collect any information using assessment   
tools or other means to complete the information that is not currently available in the chart?  
 No   Yes 
(If yes, stop completing this form and complete the HIC Protocol Application Form).  
 
 
 
If you answered “No” to all of the above questions, complete the following form: 
 
 
 
 
 
 
 
 
 
APPROVED BY THE YALE UNIVERSITY HIC ON 19APR2016 VALID THROUGH 18APR2017

 
 
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Yale University 
Human Investigation Committee 
                                          Request for Approval of Medical Record Review 
100 FR 7 (2016-2) 
 
Title of Research Project:  
Pilot analysis of the association between types of anesthetic and outcomes in transfemoral aortic valve 
replacement. 
Principal Investigator:  
Robert B. Schonberger 
Yale Academic Appointment: 
Assistant Professor 
Department: Anesthesiology 
Campus Address:  
TMP-3 Anesthesiology 
Campus Phone: 2037852802  Fax: 2037856664 
Pager: 
 
E-mail: 
robert.schonberger@yale.edu 
Protocol Correspondent Name & Address (if different than PI): same 
 
Campus Phone:  
Fax:     
E-mail:  
Yale Cancer Center CTO Protocol Correspondent Name & Address (if applicable): 
 
Campus Phone:  
Fax:     
E-mail:  
 
 
 
 
 
 
List all other investigators and study personnel: 
 
Name: Eric Chen       Role:  Co-Investigator     Affiliation: Yale     
 
Name: Feng Dai          Role: Co-Investigator     Affiliation: Yale     
 
Name: Adambeke Nwozuzu  Role: Co-Investigator     Affiliation: Yale     
 
Faculty Advisor:(required if PI is a student, 
resident, fellow or other trainee)             NA 
Yale Academic Appointment: 
Campus Address:  
Campus Phone:  
Fax:     
Pager:     
E-mail: 
  
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Name:               Role:               Affiliation:          NetID: 
Investigator Interests: 
Does the principal investigator, or do any research personnel who are responsible for the design, conduct 
or reporting of this project or any of their family members (spouse or dependent child) have an incentive 
or interest, financial or otherwise, that may affect the protection of the human subjects involved in this 
project, the scientific objectivity of the research or its integrity? Note: The Principal Investigator 
(Project Director), upon consideration of the individual’s role and degree of independence in carrying 
out the work, will determine who is responsible for the design, conduct, or reporting of the research.  
See Disclosures and Management of Personal Interests in Human Research 
http://www.yale.edu/hrpp/policies/index.html#COI  
Yes                             No   
 
Do you or does anyone on the research team who is determined by you to be responsible for the design, 
conduct or reporting of this research have any patent (sole right to make, use or sell an invention) or 
copyright (exclusive rights to an original work) interests related to this research protocol? 
Yes                No   
If yes to either question above, list names of the investigator or responsible person: 
 
The Yale University Principal Investigator, all Yale University co-investigators, and all Yale University 
individuals who are responsible for the design, conduct or reporting of research must have a current 
financial disclosure form on file with the University’s Conflict of Interest Office. Yale New Haven 
Hospital personnel who are listed as con-investigators on a protocol with a Yale University Principal 
Investigator must also have a current financial disclosure form on file with the University’s Conflict of 
Interest Office. If this has not been done, the individual(s) should follow this link to the COI Office 
Website to complete the form:  http://www.yale.edu/coi/   
 
NOTE: The requirement for maintaining a current disclosure form on file with the University’s Conflict 
of Interest Office extends primarily to Yale University and Yale-New Haven Hospital personnel.  All 
Yale faculty, graduate students, post-docs and fellows conducting research are required complete the 
annual disclosure. Whether or not they are required to maintain a disclosure form with the 
University’s Conflict of Interest Office, all investigators and individuals deemed otherwise 
responsible by the PI who are listed on the protocol are required to disclose to the PI any interests 
that are specific to this protocol. 
 
A.   Principal Investigator Assurance 
 
As the Principal Investigator of this research project, I certify the following: 
    The information provided in this application is complete and accurate. 
    I assume full responsibility for the protection of human subjects and the proper conduct of the  
            research. 
    Subject confidentiality will be of paramount concern, and every effort will be made to protect  
            subjects’ rights and welfare. 
    The research will be performed according to ethical principles and in compliance with all  
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            federal, state and local laws, as well as institutional regulations and policies regarding the   
            protection of human subjects. 
    All members of the research team will be kept apprised of research goals. 
    I will obtain approval for this research study and any subsequent revisions prior to initiation. 
    I am in compliance with the requirements set forth in the Yale University Faculty Handbook and  
           qualify to serve as the Principal Investigator of the project or have acquired the appropriate  
           approval from the Dean’s office or Office of the Provost, or Yale New Haven Hospital general   
           counsel. 
    My signature below provides written assurance that subjects’ Protected Health Information   
            (PHI) will not be used or disclosed except as required by law, for authorized oversight of  
            research or for conducting secondary research only if that research has been reviewed and   
            approved by the HIC. 
 
____________________________________     4/14/2016                              
Signature of PI                                                                                                                            Date 
 
 
 
B.   Faculty Advisor Assurance 
 
As the faculty advisor of this research project, I certify that: 
    The information provided in this application is complete and accurate. 
    This project has scientific value and merit and that the student or trainee investigator has the  
            necessary resources to complete the project and achieve the aims. 
    I will train the student investigator in matters of appropriate research compliance, protection of                
            human subjects and proper conduct of research. 
    The research will be performed according to ethical principles and in compliance with all   
            federal, state  and local laws, as well as institutional regulations and policies regarding the   
            protection of  human subjects. 
    The student investigator will obtain approval for this research study and any subsequent   
            revisions prior to initiating the study or revision and will obtain continuing approval prior to the   
            expiration of any approval period. 
    The student investigator will report to the HIC any serious injuries and/or other unanticipated    
            problems involving risk to participants.  
    I am in compliance with the requirements set forth by the University and qualify to serve as the  
            faculty advisor of this project. 
 
 
__________________________________       ________________________           
Signature of Faculty Advisor  (If Applicable)            (Print or Type Name)                                                  
 
___________________________ 
Date         
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C.   YNHH Human Subject Protection Administrator Assurance Statement 
Required when the study is conducted solely at YNHH by YNHH Health Care Providers 
 
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that:  
      * I have read a copy of the protocol and approve its being conducted at YNHH 
      * I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest 
      * The Principal Investigator of this study is qualified to serve as PI, and has the support of the  
         Hospital for this research project. 
 
__________________________________________                       ___________________ 
YNHH HSPA Name (PRINT) and Signature                                    Date 
 
 
 
D.  Project Information 
 
1.   Funding Source: (Specify Federal, Private, Industry or Department source, etc. If grant 
funded, provide the “M” number from the ProSum, and the grant number, if known.) 
-Summer research fellowship from the Office of Student Research (Yale School of Medicine) 
 
2.   Purpose of the study: (describe briefly, including hypothesis, research plan and possible 
risks and benefits). 
This study proposes to perform a descriptive analysis and pilot observational study looking at the  
types and quantity of anesthetic agents used and their associations with outcomes among patients 
scheduled to receive transfemoral aortic valve replacements (TAVR) at YNHH. 
Hypothesis 1: TAVR surgery done under monitored anesthesia care are performed using some 
combination of the following anesthetics: dexmedetomidine, propofol, fentanyl, and midazolam. 
Hypothesis  2: Age-adjusted dosing of these agents will be insufficient to account for extreme 
age after controlling for preoperative comorbid status. 
Hypothesis 3: The rate of conversion to general anesthesia will be unrelated to the type of 
conscious sedation used. 
Hypothesis 4: ICU length of stay, delirium, hospital length of stay, and length of hospital stay 
will be shorter for patients who were sedated using dexmedetomidine vs those without. 
 
Research Plan: The research will be done via chart review and analysis of data already contained 
in the Multicenter Perioperative Outcomes Group databases at Yale (the latter is a research 
database approved under HIC# 1206010438). 
 
The possible risks are primarily the risk to privacy that is inherent in any retrospective chart 
review. The benefit may be to suggest areas of future study to improve sedation practices for 
TAVR at Yale and elsewhere. 
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a.    What information will be collected and recorded?  
Information recorded will include demographic and preoperative medical assessment from prior 
to the TAVR, the anesthetic record, and the post-operative course of recovery for patients 
undergoing TAVR.  These data will include age, gender, comorbidities, laboratory values, vital 
signs, and the results of imaging studies as well as other records potentially related to the above 
hospitalization. 
 
Requests for medical records should be made through JDAT as described at 
http://medicine.yale.edu/ycci/oncore/availableservices/datarequests/datarequests.aspx 
 
Note: Medical record data for extraction will occur via the Multicenter Perioperative Outcomes 
Group database and the associated EPIC record as described above and as approved under HIC# 
1206010438. 
 
List all data to be recorded from the chart (i.e., MRN, name, diagnosis). Only those items listed 
on this application may be requested from JDAT.  Note that only the minimum information 
necessary to conduct the research should be used. 
 
MRN, demographic and preoperative medical assessment from prior to the TAVR,  the 
anesthetic record,  and the  post operative course of recovery for patients undergoing TAVR.  
These data will include age, gender, comorbidities, laboratory values, vital signs, and the results 
of imaging studies as well as other records potentially related to the above hospitalization. 
 
o    Identify the type of medium that will be used to record the information and the plans for 
maintaining confidentiality and security of the data.   
 
Only Yale / YNHH approved computers with appropriate HIPAA compliant encryption will be 
used for data storage and analysis. 
 
o    Also indicate who will have access to the data, and how access to the data storage 
(whether paper-based or electronic) will be monitored.  
 
Only the investigators will have access to the data which will be monitored by the PI. 
 
Note: Investigators are reminded that subject identifiers and the means to link subject names and codes 
with research data should not be stored on unencrypted moveable media.  Identifiers and code keys must 
be stored in a secure manner, e.g., Yale network servers.  If identifiers are stored on moveable media then 
investigators must use encryption methods to protect access to these files or other methods as appropriate 
for the types of information stored on these devices.    
 
b.   How will the data and/or identifiers be destroyed when no longer needed for research 
purposes?        
 
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Data on the Multicenter Perioperative Outcomes Group database are maintained by YNHH IT, 
and there are no plans to destroy those records. 
 
If it will not please explain why data must be retained, for how long and how it will be kept 
secured. 
 
The data are contained in an ongoing perioperative data repository already approved by the HIC. 
 
c.    Waiver of Consent/Waiver of HIPAA Authorization:  Complete the following: 
 
a)   Does the research pose greater than minimal risk to subjects? 
No 
 
b)   Will the waiver adversely affect subjects’ rights and welfare? 
 
No 
c)   Explain why the research could not practicably be carried out without the waiver. 
The number and types of patients in the MPOG database are too numerous to be possible without 
a waiver.  
 
d)   Are there any plans to provide subjects with additional pertinent information after their 
records have been reviewed?    No    Yes  
       If yes,  
 
e)   How will pertinent information be returned to subjects, if appropriate at a later date? 
 
NA 
 
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale                        
HIPAA-Covered entity must be accounted for in the “accounting for disclosures log”, by subject 
name, purpose, date, recipients, and a description of information provided.  Logs are to be 
forwarded to the Deputy HIPAA Privacy Officer. 
 
By signing this protocol application, the investigator assures that the protected health 
information for which a Waiver of Authorization has been requested will not be reused or 
disclosed to any person or entity other than those listed in this application, except as 
required by law, for authorized oversight of this research study, or as specifically approved 
for use in another study by an IRB. 
 
 
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APPENDIX I 
Waiver of signed consent: (Verbal consent from subjects will be obtained. Note that an information 
sheet may be required.)  
 
          If requesting a waiver of signed consent, please choose one of the following criteria: 
a. Would the signed consent form be the only record linking the subject and the research? 
 Yes    No 
b. Does a breach of confidentiality constitute the principal risk to subjects?  
 Yes    No 
 
 
OR 
 
a. Does the research pose greater than minimal risk?   Yes    No 
If you answered yes, stop. A waiver cannot be granted.     
b. Does the research include any activities that would require signed consent in a non-
research context?   Yes    No 
   
 
If consent will be obtained (verbal or written), please address the following: 
 
1. Consent Personnel: List the names of all members of the research team who will be obtaining 
consent/assent.  
 
 
2. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will 
be obtained, including parental permission or surrogate permission and the steps taken to ensure 
subjects’ independent decision-making.  
 
 
3. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the 
personnel obtaining consent will assess the potential subject’s ability and capacity to consent to the 
research being proposed. 
 
 
4. Documentation of Consent/Assent: List the documents that will be used during the 
consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given to subjects.  
 
 
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5. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for 
research involving non-English speaking subjects. Translated copies of all consent materials must 
be submitted for approval prior to use.  
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