Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material
Phase: NA
Conditions: Facial Injuries
Sponsor: University of Pittsburgh

Protocol Title: Structural Fat Grafting for Craniofacial Trauma using manual technique for processing fat graft 
material (BTI++) 
NCT02267187 
Study Protocol including statistical plan 
Approved 04/04/2017 
 
 

Date: Monday, March 27, 2017 10:04:38 PM 
View: T1.0 - 2.0 
Triage Section   
 
Provide a short title for this study (200 characters or less): 
BTI++  
 
 
 
T1.0 Select the type of application:New Research Study  
  
T2.0 Is the proposed research study limited to the inclusion of deceased individuals? * No  
 
The review and approval of proposed innovative practices are not subject to IRB review and 
approval.  The introduction of innovative procedures or therapies into clinical practice (i.e., 
independent of a research activity approved by the IRB) should be reviewed with the applicable 
department chairperson and the UPMC Technology Assessment Committee/Innovative Practices 
Sub-Committee prior to their implementation. The contact person is Mary Gardner at 412-647-
6883. 
 
 
T2.1 Are any research activities being conducted at the VA Pittsburgh Healthcare System or 
with VA funds? * No  
  
Respond to the following questions to determine the IRB-of-record: 
 Research is conducted using only VA records and/or subjects recruited thru the VA: 
 
 University or UPMC facilities are not engaged in research: 
 University or UPMC funds are not expended in direct support of research: 
 
If all true, then the VA is the IRB-of-record and UPitt IRB review is not required.If all false, 
only UPitt IRB review is required.Otherwise, dual review from both the VA and UPitt IRB is 
required. 
 
Read carefully- Studies are not eligible for NCI Central IRB review if any of the following are 
required: • review by the Institutional Biosafety Committee (IBC) • waiver of HIPAA 
authorization • conduct of any research procedures at a site outside of the Commonwealth of 
Pennsylvania • enrolling prisoners 
Please select the external IRB of record: 
 
Provide the name of the Central IRB: 
 
 
Quality assurance projects are not subject to IRB review and approval. UPMC has adopted an 
oversight process that requires the submission of all quality assurance projects for review. At 
UPMC, submissions are reviewed by the Quality Improvement Review Committee (QRC). You 
can contact the QRC at askqrc@upmc.edu. 
  
 
 
 
Research studies that are limited to the inclusion of deceased individuals are not subject to IRB 
review and approval. Research performed on individuals who have been declared legally dead 
 

and/or research involving the collection of tissues from deceased individuals is not subject prior 
review and approval by the University of Pittsburgh IRB.  
There are, however, ethical issues associated with research conducted on or involving deceased 
individuals. To address these ethical issues, all University faculty who desire to perform research 
on or involving deceased individuals must submit a project application for review and approval 
by the Committee for Oversight of Research and Clinical Training Involving the Dead Research 
Involving the Dead (CORID). Note that, as per UPMC policies, research involving the medical 
records of deceased individuals is subject to obtaining the written consent of the decedents’ next-
of-kin or the executors of the decedents’ estates.  
For studies that include BOTH living and deceased subjects, IRB review and approval is 
required. 
  
Emergency Use is the use of a test article on a human subject in a life-threatening situation in 
which no standard acceptable treatment is available, and in which there is not sufficient time to 
obtain IRB approval [21 CFR312.310]. Detailed information on the submission process is 
available on the IRB website under the A-Z Guidance, Emergency Use. 
  
  
 
 
  
All of the following conditions must exist to justify the emergency use of an unapproved 
investigational drug, biologic, or device. Check all the boxes that apply: 
Selections 
There are no items to display 
 
 
 
    
View: T3.0 
Triage Section 
T3.0 What is the anticipated risk to the research participants? 
   
Greater Than Minimal Risk  
  
T3.1  Why do you feel that all aspects of this research study, including screening and follow-up, 
involve no more than minimal risk to the research subjects? 
  
 
T4.0 Does the proposed study qualify for 'exempt' IRB review or for a determination of either 
'not research' or 'no human subject' involvement? 
*  
 
 
T5.0 Does the proposed research study qualify for 'expedited' IRB review status? 
*  
 

    
View: CS01.0 - 01.1.1 
Cover Sheet Section 
CS1.0 
What is the reason for this submission? 
   
New Research Protocol Submission  
 
CS1.1 
Has this research study been approved previously by the University of Pittsburgh IRB? 
*  No  
 
If the study expired, you are required to upload the completed Renewal Report Form and a 
Data and Safety Monitoring Report. 
 
Upload the Renewal Report Form and Data and Safety Monitoring Report: 
Name 
Modified Date 
 
 
Previous IRB #:  
 
  
CS1.1.1 Has this research study (or a substantially similar research study) been previously 
disapproved by the University of Pittsburgh IRB or, to your knowledge, by any other 
IRB? 
*  No  
 
If Yes, identify the IRB, IRB number if Pitt IRB disapproved, and the primary reasons 
for disapproval: 
 
    
View: CS02.0 - 02.1 
Cover Sheet Section 
CS2.0 
Title of Research Study: 
Structural Fat Grafting for Craniofacial Trauma using manual technique for processing 
fat graft material  
 
CS2.0.1 Use the textbox below to list any language or documents to be displayed in the approval 
letter.  List only those items submitted for review with this submission. 
Documents to be displayed may include items such as versions of investigator brochures, 
consent forms, and advertisements. 
If specific language is not required in the approval letter, leave the textbox blank (do not 
write 'None'). 
   Requested approval letter wording:Protocol Informed Consent  
 
CS2.1 
Research Protocol Abstract:Clinical use of autologous fat grafting in humans was described 
as early as 1893, when Neuber published his report of transferring multiple small particles of 
fat to fill a soft tissue depression (1). Over the past three decades, autologous fat grafting has 
 
 

become a common procedure in clinical plastic surgery, and is also employed by clinicians in 
other specialties. The refinement of liposuction techniques in the 1980’s made it possible to 
harvest the adipose grafts with low risk and without the need for a significant incision. The 
liposuction aspirate could simply be re-injected at a different site. Specialized equipment has 
been developed for fat grafting and is commercially available from a number of sources. The 
American Society of Plastic Surgeons 2007 procedural statistics show that over 65,000 fat 
grafting procedures were performed in the United States (www.plasticsurgery.org) during the 
previous year.Fat grafting may represent a superior method of facial reconstruction after 
severe trauma, but the results can be impacted by resorption of fat volume over time. The 
specific aims of the study are:1) Assess facial appearance and soft tissue volume before and 
after autologous fat grafting using CT scans and 3D photography.2) Assess cellular properties 
of the cells within the fat graft3) Comparison of cotton rolling to centrifugation method of 
autologous fat grafting4) Measure of quality of life in patients before and after autologous fat 
grafting using validated psychosocial measures. Ten (10) subjects 18 years of age and older 
will be enrolled to this trial. This study will examine the impact of the fat grafting procedure 
on facial appearance and quality of life over time by precisely measuring soft tissue volume 
with CT scans, assessing appearance with 2D and 3D photography and standard photography 
and evaluating quality of life through various validated psychosocial measures. This study will 
be a very important evaluation of the effectiveness of this therapy, and will help guide 
clinicians in applying this technique. Additionally, laboratory testing of the injected fat 
material will be performed so that the results may be correlated with clinical outcomes in the 
future.The study endpoints include the analysis of the graft site via study procedures at 
different time points, the comparison of cotton rolling to centrifugation method of autologous 
fat grafting, as well as the correlation of cell behavior of the laboratory assays with clinical 
outcomes.  
CS2.2 
Select the category that best describes your research: 
 
View: CS03.0 - 03.9 
 
Cover Sheet Section 
CS3.0 
Name of the Principal Investigator: 
 
J. Peter Rubin  
Note: Adjunct faculty of the University, including lecturers and instructors, are not 
permitted to serve as a PI or Faculty Mentor but may serve as co-investigators. Refer to 
Chapter 4 on the HRPO website for more information. 
 
CS3.1 
Affiliation of Principal Investigator: 
   
UPitt faculty member  
  
If your answer was Other, fill in the Principal Investigator's affiliation:  
 
If you chose any of the Pitt options, please indicate the specific campus:Main Campus - 
Pittsburgh  
 If you chose the UPitt faculty member option, provide the PI’s University Faculty Title:Professor of 
Plastic Surgery    
 

CS3.1.1 Indicate below the name of the qualified University faculty member or UPP or UPMC 
staff member who will serve as a mentor and provide supervision or guidance regarding 
the conduct of this research study. 
 
CS3.2 
Address of Principal Investigator:UPMC Center for Innovation in Restorative Medicine6B 
Scaife Hall, Room 690 3550 Terrace StreetPittsburgh, PA 15213 
 
CS3.3 
Recorded Primary Affiliation of the Principal Investigator: 
 
 
U of Pgh | School of Medicine | Plastic Surgery  
   
CS3.4 
Identify the School, Department, Division or Center which is responsible for oversight of 
this research study: 
 
 
U of Pgh | School of Medicine | Plastic Surgery   
 
  
CS3.5 
Telephone Number of Principal Investigator: 
 
412-383-8080  
 
CS3.6 
Recorded Current E-mail Address of Principal Investigator to which all notifications 
will be sent:rubinjp@upmc.edu  
 
CS3.7 
Fax Number: 
 
 
412-383-9053  
   
CS3.8 
Does this study include any personnel from Carnegie Mellon University, and/or use any 
CMU resources or facilities (e.g., Scientific Imaging and Brain Research Center (SIBR)? 
 
 
*  No  
   
CS3.9 
Is this your first submission, as PI, to the Pitt IRB?   
 
*  No  
 
    
View: CS04.0 
Cover Sheet Section 
CS4.0 
List of Co-Investigators:  
Last 
First 
Organization 
Acarturk 
Tahsin Oguz U of Pgh | School of Medicine | Plastic Surgery 
Amar 
Dalit 
UPMC | Physician Services Division | UPP | Surgery 
Bliley 
Jacqueline Other 
Bourne 
Debra 
UPMC | Other 
Branstetter Barton 
U of Pgh | School of Medicine | Radiology 
Bykowski 
Michael 
UPMC | Physician Services Division 
Coleman 
Sydney 
U of Pgh | School of Medicine | Plastic Surgery 
czerniak 
sharona 
Other 
DiBernardo Gabriella 
U of Pgh | School of Medicine | Plastic Surgery 
Donnenberg Albert 
U of Pgh | School of Medicine | Medicine 
Donnenberg Vera 
U of Pgh | School of Medicine | Surgery | Thoracic Surgery 
 
 
 
 

Fishman 
Jordan 
UPMC | Physician Services Division | UPP | Medicine 
Foley 
Karen 
U of Pgh | School of Medicine | Plastic Surgery 
Grybowski Damian 
U of Pgh | School of Medicine | Plastic Surgery 
Gusenoff 
Jeffrey 
U of Pgh | School of Medicine | Plastic Surgery 
Haas 
Gretchen 
U of Pgh | School of Medicine | Psychiatry 
James 
Isaac 
U of Pgh | School of Medicine | Surgery | Plastic Surgery 
Lee 
Jessica 
U of Pgh | School of Medicine | Surgery | Plastic Surgery 
Ma 
Irene 
U of Pgh | School of Medicine | Plastic Surgery 
Marra 
Kacey 
U of Pgh | School of Medicine | Plastic Surgery 
Mermon 
Diana 
U of Pgh 
Minteer 
Danielle 
U of Pgh | School of Medicine | Plastic Surgery 
Pang 
John Henry U of Pgh | School of Medicine | Plastic Surgery 
Radomsky Elizabeth 
UPMC | Hospital Divisions 
Ruane 
Edward 
U of Pgh | School of Medicine | Plastic Surgery 
Schusterman Mark 
U of Pgh | School of Medicine | Plastic Surgery 
Simon 
Patsy 
U of Pgh | School of Medicine | Plastic Surgery 
Steele 
Amy 
U of Pgh | School of Medicine | Plastic Surgery 
  
View: CS05.0 - CS06.3 
 
Cover Sheet Section 
CS5.0 Name of Primary Research Coordinator:Amy Steele  
 
CS5.1 Address of Primary Research Coordinator: 
UPMC Center for Innovation in Restorative MedicineDepartment of Plastic Surgery University 
of PittsburghIsaly Building 3380 Blvd. of the Allies, Suite 158Pittsburgh, Pa. 15213 
 
CS5.2 Telephone Number of Primary Research Coordinator: 
412-641-3728  
 
 
 
CS6.0 Name of Secondary Research Coordinator: 
Karen Foley  
 
CS6.1 Address of Secondary Research Coordinator:  3380 Blvd. of the AlliesSuite 158Pittsburgh, 
PA 15213  
 
CS6.2 Telephone Number of Secondary Research Coordinator: 412-641-3726  
 
CS6.3 Key Personnel/Support Staff (Only list those individuals who require access to OSIRIS):  
Last First Organization 
Simon Patsy U of Pgh | School of Medicine | Plastic Surgery 
 
 
View: CS07.0 
Cover Sheet Section 
CS7.0 Will this research study use any Pediatric PittNet or Clinical and Translational Research 
Center (CTRC) resources? 
 

No  
 
CS7.1 Please select the sites you intend to use: 
There are no items to display 
 
 
  
  
 
    
View: CS08.0 
Cover Sheet Section 
CS8.0 Select the entity responsible for scientific review. 
  
Department Review - (a dean, department chair, division chief, or center head) Note: DoD 
funded studies require departmental review   
 
CS8.1 Select the school, department or division which is responsible for scientific review of this 
submission. 
U of Pgh | School of Medicine | Plastic Surgery  
 
 
CS8.1 Select the CTRC which is responsible for scientific review of this submission 
  
    
View: CS09.0 - 10.0 
Cover Sheet Section 
CS9.0 
Does this research study involve the administration of an investigational drug or an FDA-
approved drug that will be used for research purposes?  
* No   
 
CS9.1 
Do you plan to utilize the Investigational Drug Service (IDS) to dispense the drug?  
*  
  
 
CS10.0 Is this research study being conducted under a University of Pittsburgh-based, sponsor-
investigator IND or IDE application? 
  
 
*  No If YES, you are required to submit the IND or IDE application and all subsequent FDA 
correspondence through the Office for Investigator-Sponsored IND and IDE Support 
(O3IS).  Refer to applicable University policies posted on the O3IS 
website  (www.O3IS.pitt.edu). 
  
 
CS10.1 Append to this application: 
 
(1) Copy of the current version of the clinical protocol submitted with the IND or IDE 
application which corresponds to this IRB submission:  
Name Modified Date 
 
 

(2) Copy of the FDA’s letter which acknowledges receipt of the application and assignment of 
the IND or IDE number:    
Name Modified Date 
 
    
View: CS11.0 
 
Cover Sheet Section 
CS11.0 Use the 'Add' button to upload one or more of the following: 
• 
the sponsor protocol (including investigator initiated studies) and/or 
other brochures  
• 
the multi-center protocol and consent form template, if applicable 
Name Modified Date 
Is this research study supported in whole or in part by industry?  This includes the 
provision of products (drugs or devices).   *  No  
Is this a multi-centered study?*  No  
 
 
View: CS12.0 - 14.0 
 
Cover Sheet Section 
CS12.0 Does your research protocol involve the evaluation or use of procedures that emit 
ionizing radiation?*  Yes  
 
HUSC GUIDANCE REQUIREMENTS FOR THE REVIEW OF HUMAN SUBJECT 
RESEARCH PROTOCOLS BY THE HUMAN USE SUBCOMMITTEE (HUSC), 
RADIATION SAFETY COMMITTEE 
For Research Protocols Involving the Evaluation of Use of Diagnostic Procedures that Emit 
Ionizing Radiation: Formal HUSC review/approval is required if the research protocol involves 
any of the following: 
1. The use or evaluation of a radioactive agent or procedure that is not currently approved 
(i.e., for any clinical indication) by the FDA  
2. The evaluation (i.e., for safety and/or effectiveness) of a FDA-approved 
radiopharmaceutical or procedure for an “off label” indication1; or    the use of a FDA-
approved radiopharmaceutical or procedure for an “off label” indication if such use is 
experimental (i.e., not routinely performed in clinical practice).   
3. Individuals (e.g., healthy volunteers) who would not be undergoing the procedure in 
association with the diagnosis or treatment of a disease or condition 
Formal HUSC review/approval is not required if the diagnostic procedure is being performed, 
in a standard clinical manner and frequency, for screening or to evaluate the outcome of a 
treatment regimen.  This would include diagnostic procedures for off- label uses that are 
routinely performed in clinical practice. 2,3 
 

For Research Studies Involving the Use or Evaluation of Therapeutic Procedures that Emit 
Ionizing Radiation: 
Formal HUSC review/approval is required if parameters (e.g., total radiation dose, dose 
fractionation scheme, etc.) of the radiation therapy procedure(s) are defined by the research 
protocol. 
1An “off-label” indication is a clinical indication which is not currently specified in the FDA-
approved product labeling.2The risks of radiation exposure associated with the diagnostic 
procedure must continue to be addressed in the protocol and consent form using the HUSC-
accepted wording.3The University of Pittsburgh IRB, at its discretion, may request formal 
HUSC review of the research protocol. 
For any questions related to these requirements or their application, contact the Chair of 
the HUSC (412-383-1399) or the University’s Radiation Safety Office (412-624-2728) 
CS12.1 After reviewing the HUSC guidance above, does your research protocol require HUSC 
review? (Note: University of Pittsburgh’s Radiation Safety Committee oversight is limited 
UPMC Presbyterian-Shadyside, Magee Women’s Hospital of UPMC, Children’s Hospital of 
Pittsburgh-UPMC, and Hillman Cancer Center.  If other sites, you will be required to obtain 
approval from your radiation safety officer.  Please contact askirb@pitt.edu for more 
information.) 
Yes  
Upload Radiation Forms: 
Name 
Modified Date 
 
 
CS13.0 Does this research study involve the deliberate transfer of recombinant or synthetic 
nucleic acid molecules into human subjects?  
  
*  No  
 
 
Upload Appendix M of NIH Guidelines: 
Name 
Modified Date 
  
  
 
CS14.0 Are you using UPMC facilities and/or UPMC patients during the conduct of your 
research study?  
  
*  Yes If Yes, upload completed Research Fiscal Review Form: 
Name 
Modified Date 
BTI++ Initial FRIAR Draft Mod 3 
7/24/2015 10:31 AM 
 
    
View: CS15.0 - CS15.0.1(a) 
Cover Sheet Section 
CS15.0 Indicate the sites where research activities will be performed and/or 
private information will be obtained. 
 

Choose all sites that apply and/or use Other to include sites not listed: 
Sites: 
UPMC 
 
 
University of Pittsburgh 
Campus: 
There are no items to display 
List university owned off-campus research sites if applicable: 
 
  
 
 
 
 
UPMC  
Sites: 
UPMC Presbyterian 
UPMC Magee Women's Hospital 
UPMC Montefiore 
UPMC Shadyside 
Other UPMC Site- Specify below: 
UPMC Aesthetic Plastic Surgery Center 3380 BLVD of the Allies suite 
158Pittsburgh, PA. 15213 
 
 
 
UPMC Cancer Network Sites: 
Site 
There are no items to display 
 
 
 
  
 
 
 
 
If you selected School, International or Other, list the sites:UPMC 
Aesthetic Plastic Surgery Center3380 Boulevard of the Allies, Suite 158  
 
 
*For research being conducted at non Pitt or UPMC sites, upload a 
site permission letter granting the researcher permission to conduct 
their research at each external site: 
Name Modified Date 
  
 
 
CS15.1 Have you, J. Peter Rubin , verified that all members of the research 
team have the appropriate expertise, credentials, and if applicable, 
hospital privileges to perform those research procedures that are 
their responsibility as outlined in the IRB protocol? 
*  Yes  
 
 
CS15.2 Describe the availability of resources and the adequacy of the 
facilities to conduct this study: 
*  UPMC Facilities have the resources necessary to perform this clinical 
trial. UPMC Operative suites and clinics provide the support necessary to 
 
 

see and perform surgical procedures to meet the collection of data to 
assess the objectives of the study.  
    
View: CS16.0 
Cover Sheet Section 
CS16.0 
Special Research Subject Populations:  
 
Categories 
None 
 
View: CS17.0 
Cover Sheet Section 
CS17.0 Does your research involve the experimental use of any type of human stem cell?*  No  
  
View: Clinical Trial Study 
  
NIH Definition of a Clinical Trial  
A research study1 in which one or more human subjects2 are prospectively assigned3 to one or 
more interventions4 (which may include placebo or other control) to evaluate the effects of 
those interventions on health related biomedical or behavioral outcomes.5 
1 See Common Rule definition of research at 45 CFR 46.102(d) . 
2 See Common Rule definition of human subject at 45 CFR 46.102(f) . 
3 The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) 
specified in an approved protocol that stipulates the assignment of research subjects 
(individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of 
a clinical trial. 
4 An intervention is defined as a manipulation of the subject or subject’s environment for the 
purpose of modifying one or more health-related biomedical or behavioral processes and/or 
endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; 
procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face 
interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, 
development of new habits); treatment strategies; prevention strategies; and, diagnostic 
strategies. 
5 Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or 
condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical 
or behavioral status or quality of life.  Examples include:  positive or negative changes to 
physiological or biological parameters (e.g., improvement of lung capacity, gene expression); 
positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood 
management intervention for smokers; reading comprehension and /or information retention); 
positive or negative changes to disease processes; positive or negative changes to health-related 
behaviors; and, positive or negative changes to quality of life.  

CS18.0 * Based on the above information, does this study meet the NIH definition of a clinical 
trial?  
Yes 
No   
  
If Yes, click Save and then Click Here For Study Team's CITI Training Records .  Please 
ensure all personnel's training is up to date 
View: 1.1 - 1.4 
Section 1 - Study Objective, Specific Aims, Background and Significance 
1.1 Objective: What is the overall purpose of this research study?  (Limit response to 1-2 
sentences.)The Objective of this study is to evaluate the changes in facial appearance over time in 
craniofacial deformity subjects who are post injury and/or post surgery (e.g. tx of aneurism, 
intercranial bleed, and tumor resections that do not involve radiation and would be analogous to 
trauma population requiring craniotomy) following autologous fat graft procedure.   
 
 
1.2 Specific Aims: List the goals of the proposed study (e.g., describe the relevant hypotheses or 
the specific problems or issues that will be addressed by the study).Facial trauma injuries, 
especially those sustained in military combat and severe automobile crashes, are characterized by 
destruction of bone and soft tissue anatomy. While the bony skeleton can often be reconstructed, 
the overlying soft tissue is difficult to restore. Similar deformities typically seen after treatment of 
facial trauma.Importantly, it is the structure of the soft tissue that imparts the normal human form, 
and adequate reconstruction of soft tissue defects allows trauma victims to reintegrate into society. 
Accepted procedures for soft tissue reconstruction of the face involve tissue flap reconstruction 
procedures and autologous fat grafting. Tissue flap operations are extensive, often including 
microvascular surgery, and do not precisely correct the deformities. Fat grafting is a less invasive 
technique that allows for more precise shaping of the reconstructed tissues. However, autologous 
fat grafts may undergo resorption that can affect the appearance of the reconstruction over time. 
The degree of change in appearance after fat grafting has not been well studied for facial trauma 
patients. We hypothesize that initial results from fat grafting for facial trauma will show good 
restoration of tissue volume, and that a majority of the fat tissue will remain in place over time. 
Additionally, we hypothesize that the cellular properties of the fat precursor cells (preadipocytes) 
may correlate with fat graft retention.The specific aims of the study are:1) Assess facial appearance 
and soft tissue volume before and after autologous fat grafting using CT scans, standard 
photography and 3D photography.2) Assess cellular properties of the cells within the fat graft3) 
Measure of quality of life in patients before and after autologous fat grafting using validated 
psychosocial measures. 4) Compare the cotton rolling to centrifugation method of autologous fat 
grafting. This will be accomplished by analyzing outcomes of facial appearance and soft tissue 
volume in subjects in this study compared to those subjects enrolled in protocol PRO09060101.  
 
1.3 Background: Briefly describe previous findings or observations that provide the background 
leading to this proposal. Autologous fat grafting is a common procedure in clinical plastic 
surgery. Clinical use of autologous fat grafting in humans was described as early as 1893, when 
Neuber published his report of transferring multiple small particles of fat to fill a soft tissue 
depression (1). Over the past three decades, autologous fat grafting has become a common 
procedure in clinical plastic surgery, and is also employed by clinicians in other specialties. The 
refinement of liposuction techniques in the 1980’s made it possible to harvest the adipose grafts 
with low risk and without the need for a significant incision. The liposuction aspirate could simply 
be re-injected at a different site. Specialized equipment has been developed for fat grafting and is 
commercially available from a number of sources. The American Society of Plastic Surgeons 2007 
procedural statistics show that over 65,000 fat grafting procedures were performed in the United 
States (www.plasticsurgery.org)Autologous fat grafting has often been used in the craniofacial 
regionOf the anatomic sites that autologous fat grafting can be applied to, a significant experience 
 
 

has been accrued in the craniofacial region. Indications include post-traumatic reconstruction, 
congenital deformities, post-surgical deformities (e.g. cancer resection), facial atrophy associated 
with HIV treatment, acne scars, and cosmetic correction of facial aging (2-25). Adipose tissue is 
injected into the subcutaneous planes and into deep fat pads. Volumes of adipose tissue injection in 
the facial region tend to range from several ml to over 100 ml. Procedures are often performed in a 
single stage, but staged fat injections are not uncommon.Advantages of autologous fat grafting for 
craniofacial reconstructionAutologous fat grafting has many advantages for craniofacial 
reconstruction compared with alternative treatments. Other standard methods of restoring soft 
tissue volume involve the surgical transfer of tissue flaps, either on a vascular pedicle or by 
microvascular technique. These flap procedures are much more invasive, carry a risk of donor site 
morbidity, and do not allow for precise. We have had significant and successful improvement in all 
subjects, with retention of volume in the range of 65%. Our basic science team recently published a 
paper in Plastic and Reconstructive Surgery Journal demonstrating in an animal model that a 
manual processing technique for separating the aqueous layer from the fat graft material without 
centrifugation provides superior volume retention after healing. This manual separation method 
requires less equipment in the operating room, making it more applicable for a variety of clinical 
settings in the military health system. Craniofacial Injuries Have Serious Psychosocial Sequele and 
Affect Quality of LifeMany individuals who suffer significant facial disfigurement from injury 
experience psychological distress and impairment in functioning not limited to the acute phase of 
injury but over a longer term period of treatment, recovery and adjustment (26, 27). Symptoms of 
anxiety and depression and post-traumatic stress disorder are common—both before and after 
surgery (28, 29). In their study of individuals with severe facial lacerations and disfigurement, 
Levine and colleagues (30) noted the “powerful [influence] of facial appearance and body image 
on the quality of life” of these individuals. Clinical studies of facial trauma victims, using 
structured interview and self-report instruments, also document the common experience of social 
anxiety and social withdrawal—problems that can significantly compromise social and 
occupational functioning and engagement in social and leisure time activities--ultimately impacting 
the overall quality of life (31, 32). Facial burn victims report that interactions with strangers and 
with children and adolescents can be particularly discomfiting in response to visible non-verbal 
communications of negative affect (e.g. surprise, disgust) (27). Results of outcome studies of burn 
patients suggest that personal adjustment and quality of life are better predicted by psychosocial 
factors than site of injury (33). Pre- and post-surgical psychosocial factors such as social support, 
coping skills, and satisfaction with surgical outcomes are significant predictors of personal and 
social adjustment and quality of life outcomes, in addition to the physical outcomes of surgical 
intervention for disfigurement (34-36). Significant is the fact that there are few studies of the 
psychosocial impact of complex CMF battle injuries and post-surgical changes in psychosocial 
well-being and quality of life.  
1.4 Significance: Why is it important that this research be conducted? What gaps in existing 
information or knowledge is this research intended to fill? Fat grafting may represent a superior 
method of facial reconstruction after severe facial deformity, but the results can be impacted by 
resorption of fat volume over time. This study will examine the impact of the fat grafting procedure 
on facial appearance and quality of life over time by precisely measuring soft tissue volume with 
CT scans, assessing appearance with 2D and 3D photography and standard photography and 
evaluating quality of life through various validated psychosocial measures. This study will be a 
very important evaluation of the effectiveness of this procedure, and will help guide clinicians in 
applying the technique. Additionally, laboratory testing of the injected fat material will be 
performed so that the results may be correlated with clinical outcomes in the future.The study is 
also demonstrating the application of a minimally invasive injectable technique to a very difficult 
reconstructive problem. The concentration of the cotton roll technique for autologous fat 
processing has the potential to further improve clinical outcomes while simplifying the procedure.  
 

    
View: 2.01 
Section 2 - Research and Design Methods 
2.1 
Does this research study involve the use or evaluation of a drug, biological, or nutritional 
(e.g., herbal or dietary) supplement? 
 
*  No  
 
2.1.1 
Does this research study involve an evaluation of the safety and/or effectiveness of one or 
more marketed nutritional (e.g., herbal or dietary) supplements for the diagnosis, 
prevention, mitigation or treatment of a specific disease  or condition or symptoms 
characteristic of a specfic disease or condition? 
*  
 
2.1.1.1 List each of the marketed nutritional supplements being evaluated in this research 
study.  Specify for each supplement the corresponding IND number or attach FDA 
correspondence specifying that an IND is not required. 
  Marketed nutritional supplement 
IND number 
 There are no items to display 
Upload FDA correspondence specifying that an IND is not required, if applicable: 
Name Modified Date Version 
 
 
    
View: 2.02 
Section 2 - Research Design and Methods 
2.2 
Will this research use or evaluate the safety and/or effectiveness of one or more devices? 
 
  
*  No   
 
2.2.1 
Does this research study involve an evaluation of the safety and/or effectiveness of one or 
more devices not currently approved by the FDA for general marketing?*  
  
If YES, describe your plan to prevent unauthorized use of the investigational device: 
 
2.2.1.1 List each of the unapproved devices being evaluated in this research study.  Specify for 
each listed device the corresponding Investigational Device Exemption (IDE) number or 
provide a justification for why you feel that this device and its use, as proposed in this research 
study constitute a non-significant risk (i.e., to include potential failure of the device) to 
the research subjects: 
  Unapproved device 
IDE # 
Non-significant risk justification 
 There are no items to display 
 
 
    
View: 2.03 - Summarize general classification 

Section 2 - Research Design and Methods 
2.3 
Summarize the general classification (e.g., descriptive, experimental) and methodological 
design (e.g., observational, cross-sectional, longitudinal, randomized, open-label single-
blind, double-blind, placebo-controlled, active treatment controlled, parallel arm, cross-
over arm) of the proposed research study, as applicable. 
 
This is an experimental intervention study with an observational component assessing clinical 
outcomes following the fat graft reconstructive surgery procedure using a manual separation 
process of the fat grafting material.  
 
2.3.1 Does this research study involve a placebo-controlled arm? 
*  No  
  
 
View: 2.04 
Section 2 - Research Design and Methods 
2.4 
Will any research subjects be withdrawn from known effective therapy for the purpose of 
participating in this research study? 
 
*  No   
 
2.4.1 Provide a justification for discontinuing subjects from known effective therapy for the 
purpose of study participation. 
 
2.4.2 Describe the risks to subjects associated with discontinuing them from known effective 
therapy for the purpose of study participation. 
 
    
View: 2.05 
 
Section 2 - Research Design and Methods 
2.5 
Will screening procedures (i.e., procedures to determine research subject eligibility) be 
performed specifically for the purpose of this research study? 
 
 
*  Yes  
   
2.5.1 List the screening procedures that will be performed for the purpose of this research 
study.  Do NOT include the inclusion/exclusion criteria in this section as they will be 
addressed in section 3; questions 3.13 and 3.14. 
 
Obtain Informed Consent, assignment of subject unique identifierMedical and surgical history 
review: The PI and/ or co-investigator will perform a medical and surgical history review 
inclusive of past medical and surgical procedures pertaining to the craniofacial trauma, laboratory 
tests, radiological tests, and consults pertaining to trauma event. If medical records do not 
accompany the subject or are not available at the time of screening evaluation for investigator 
review, the investigator in lieu of direct medical record review will accept direct report from the 
referring physician, and/or other referral source and /or subject self-report and will document this 
reported information to research chart. This report will consist of past medical /surgical history 
pertaining to the craniofacial defect and trauma. The Principal Investigator will base 
determination of study eligibility on a combination of evaluation criteria to include physical 
examination, referral physician/other source direct report and /or subject self-report and 
psychological (SCID) assessment all pertaining to past injury and current status of the area of 
interest.Performance of a medical history and physical exam inclusive of participant's height and 
 

weight, Body mass index (BMI) calculation and craniofacial exam will be completed by PI and 
/or a co-investigator. Collection of subject's vital signs (Temperature, heart rate (HR), respiratory 
rate, blood pressure (BP), medication profile to include prescription and vitamins / supplements. 
Collection of demographic information to include date of birth, gender, race and ethnicity, 
smoking history, relationship status, educational level, dominant handedness, and allergies. 2D 
Photographs: Pictures will be taken of the entire face (only) with a professional-grade camera 
creating images with high resolution and excellent detail. The pictures that will be taken may 
include following views: 1. Front view2. AP three-quarter Right 3. AP three-quarter Left 4. 
Lateral Right5. Lateral Left Dependent on investigator evaluation we may opt to obtain the 
following views: 1. Inferior view2. Superior viewThe pictures will be taken at the UPMC 
Aesthetic Plastic Surgery Center in a private room and will take approximately 10 minutes. 2D 
photographs will be taken by the PI, Co-Investigator or a research coordinator.A Structured 
Clinical Interview for DSM-IV (SCID) will be included in the baseline to evaluate the 
presence/absence of psychiatric disorders. This evaluation will be completed using a standard 
psychiatric diagnostic interview that enables determination of DFSM-IV-based diagnoses. As 
part of the clinical interview a demographic history will be completed. Participants who are 
women of child bearing potential will receive a urine pregnancy dip test. All screening 
procedures will be performed at the UPMC Aesthetic Plastic Surgery Center in a private room 
and will take approximately 2-3 hours of the participant's time. Eligibility Determination: Upon 
the completion and evaluation of all screening procedures subject eligibility determination for 
continued study participation will be completed by the Principal Investigator (PI),.Due to 
participant's schedule, travel distance and/or coordination of the screening study visit, procedures 
may be performed on different days as long as the screening procedures do not exceed a length of 
2 weeks for completion. The principal investigators eligibility determination will occur up to 45 
days post the date of completion of the last screening visit procedure date. 
2.5.2 What steps will be taken in the event that a clinically significant, unexpected disease or 
condition is identified during the conduct of the screening procedures? 
Addressed below:  
 
Upon discovery the PI and/ or co-investigator will notify the subject of any event that could be of 
clinical significance needing further evaluation, or of a diagnosis of any unexpected disease or 
condition that occurred during the conduct of the study's research procedures. The study 
investigator will at the time of discovering the event contact the referring physician or primary 
physician for further evaluation of the event. Should the event be of a critical nature needing 
immediate intervention, the study investigator or co-investigator will proceed with immediate 
clinical intervention and screening procedures will be concluded.  
 
    
View: 2.06 
 
Section 2 - Research Design and Methods 
  
   
2.6 
Provide a detailed description of all research activities (e.g., all drugs or devices; 
psychosocial interventions or measures) that will be performed for the purpose of this 
research study. This description of activities should be complete and of sufficient detail to 
permit an assessment of associated risks.  At a minimum the description should include:  
• 
all research activities  
• 
personnel (by role) performing the procedures  
 
 

• 
location of procedures  
• 
duration of procedures  
• 
timeline of study procedures 
Upon the completion of screening procedures and if tests are within normal range (including a 
negative pregnancy test for women), the investigator will invite the subject to participate in the 
study. The research procedures for this clinical trial are as follows:Pre-Graft Study Visit 
(PGSV)Collection of subject's vital signs (Temperature, heart rate (HR), respiratory rate, blood 
pressure (BP), medication profile to include prescription and vitamins / supplements, allergies, 
weight, Body mass index (BMI) calculation and Adverse Event Assessment.3-Dimensional 
imageThe investigator or study staff will take photographs of the entire face (only) with the 
Canfield 3D camera system. The camera takes 2 simultaneous photographs of the face from 
different angles and makes a 3-dimensional image. The 3D camera system is not a medical 
device and is not regulated by the FDA. The pictures will be taken at the UPMC Aesthetic Plastic 
Surgery Center in a private room and will take approximately 10 minutes. Limited medical 
history and physical exam with a craniofacial exam by the investigator. The investigator will rate 
the appearance/volume of the graft site using a craniofacial volume and appearance grading scale. 
2D Photographs the pictures will be taken at the UPMC Aesthetic Plastic Surgery Center in a 
private room and will take approximately 10 minutes. 2D photographs will be taken by the PI, 
Co-Investigator on the study or a research coordinator.Digital Recordings: for subjects who 
consent, digital recordings (photography or video) will be collected at any and all portion's of the 
subject's pre-operative, operative and post-operative study participation. These may include but 
not be limited to, videos of personal interviews, functional assessment testing and study physical 
exams or photos of the subject's follow-up course, biopsies, etc. We will ask the subject's 
permission to allow Dr. J. Peter Rubin and research team to use any and all these digital 
recordings for medical education and training, publication and media reports-and, in any mode of 
transmission, including but not limited to: print, email, television, internet, etc. Serial Computed 
Tomography Imaging A high resolution Computed Tomography (CT) Scan of the face will be 
performed at Presbyterian Hospital and will take approximately 60 minutes. This scan will be 
pre-procedural and will serve as a baseline. All CT scans will be performed on a 64-slice scanner 
(LightSpeed, GE Healthcare), using collimation of 0.625mm and slice interval of 0.3mm, 
resulting in approximately 50% overlap between adjacent slices. kVp, mA, and FOV will be 
optimized to the subject, but will approximately be kVp = 120; mA = 320, FOV = 18cm. Soft 
tissue and bone kernels will be employed. These images will be volumetrically reformatted into 
coronal and sagittal planes for confirmation of findings. Additionally, surface-rendered 
volumetric reformats will be created emphasizing both bony structures and soft tissues. Images 
will be reviewed by a dedicated head and neck radiologist with 9 years of experience in CT of the 
face. Volume measurements of the implanted material will be made on all post-procedural CTs. 
These volumetric measurements are expected to be precise to within 5% of the actual volume of 
material. Trends in volume of tissue will be analyzed over time across the multiple CT scans. 
Both linear and volumetric measurements will be used to quantify implanted 
material.Psychosocial AssessmentAt baseline, patients will be asked to complete a psychosocial 
battery that includes: a) self-report measures of satisfaction with physical appearance, anxiety 
and depressive symptoms, social functioning and social avoidance and distress and; b) 
questionnaires that assess significant predictors of quality of life outcomes from post-trauma 
craniofacial surgery: perceived social support, self-esteem, coping style and pre-surgical 
expectations of/post-surgical outcomes. A research technician experienced in psychosocial 
interviewing with patients (DM) will meet with each patient during the baseline evaluation to 
administer the self-report battery of psychosocial questionnaires. A comprehensive battery of 
tests for evaluation of quality of life has been assembled for this study. It is important to properly 
determine the impact of the surgical changes and the investigators have selected Psychosocial 

assessment instruments to evaluate four domains:a) Satisfaction with appearance/surgical 
outcomes: The Satisfaction with Appearance (SWAP) scale is a 14-item questionnaire with good 
internal consistency and test-retest reliability that measures both subjective and social–behavioral 
aspects of body image and has been used in populations with significant physical disfigurements 
or deformities. b) Satisfaction with Medical/Health Services - Patient Satisfaction with Health 
Services – the Client Satisfaction Questionnaire (CSQ-8) (38) is a widely used brief inventory of 
satisfaction with services (amount of help, kind of help, availability of help) provided by a 
medical service or program. This 8-item self-report questionnaire will be administered at each of 
the post-surgery visits.c) Social Distress, Depression and Avoidance: Social Distress and 
Avoidance - Individuals with facial disfigurement can suffer extreme anxiety and avoidance in 
interpersonal interactions. The Social Anxiety and Distress (SAD) Scale (40) is a widely used 
measure of social avoidance and distress that has shown to be sensitive to pre-/post- surgical 
improvement in recent studies of patients undergoing reconstructive surgery for significant 
physical deformity. Anxiety and Depressive Symptomatology will be monitored using the Patient 
Health Questionnaire (PHQ-Brief) (41) and the PCL-S (Brief) (42), a self-report questionnaire 
that taps PTSD symptoms for use among individuals. Self-esteem will be assessed by the 
Rosenberg Self Esteem Inventory (SES)(43), a brief (10-item), self-report inventory has been 
widely used in research on reconstructive surgery for facial trauma. Coping Style will be assessed 
with the Brief COPE inventory (44) an abbreviated version of the situation-specific coping 
inventory (45) that has been effectively used to characterize psychological coping with physical 
illness and disability. An extensive body of research on clinical and psychosocial outcomes from 
surgical and medical interventions has yielded evidence that psychosocial coping style is an 
important factor that contributes to psychological well-being, physical health and quality of life 
outcomes. Presence of d epression will be captured in a self-report inventory, one of the most 
widely used instruments for measuring the severity of depression. The Beck Depression 
Inventory is composed of 21 items relating to symptoms of depression such as hopelessness and 
irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms 
such as fatigue, weight loss, and lack of interest in sex.Perceived Social Support will be analyzed 
by the Perceived Social Support Questionnaires(PSSQ)-Family and Friends (46). This 6-item 
self-report inventory with satisfactory internal reliability and construct validity regarding the 
perceived availability of social support for needs for support, information and feedback. Social 
support, along with psychosocial coping cognitions and behaviors contributes significantly to 
psychological well-being, physical health and quality of life outcomes. Each of these may be 
important covariates that contribute to variance in quality of life outcomes in this study. d) 
Quality of Life and General Functioning Outcomes - Quality of life and general functional status 
will be evaluated using the SF-36 (47, 48), a self-report inventory widely used in medical 
outcome research with self-rated indices of health, quality of life, energy, role limitations due to 
physical problems or emotional problems, and functionality in everyday physical, emotional, and 
social function domains. A brief (shortened) demographic history form will be completed as part 
of the psychosocial assessments. These baseline clinical and psychosocial evaluation will take an 
estimated 1 hour and will take place at the UPMC Plastic Surgery Center in a private room. A 
research coordinator or research technician certified with psychosocial assessment experience 
will administer these questionnaires.PRE-OP Laboratory blood tests will be obtained via a 
peripheral stick performed by laboratory personnel located on the 5th floor of the UPMC MUH 
building to include CBC with Differential,Platlets Comprehensive Chemistry panel, and PT/ 
PTT/ INR. If the subject is a female of child bearing potential, we will obtain a urine pregnancy 
dip test. If the test result is positive the subject will not continue participation in this research 
study. Electrocardiogram (EKG) Chest X-ray as indicated by past medical history and/or 
physician discretionA coordinator note will be completed summarizing the study visit and placed 
into the subject's chart. The total time duration for subject participation for this visit is estimated 
to be approximately 3-4 hours in length. FAT GRAFT Surgical Procedure: For the purpose of 

this study the fat grafting procedure is a research procedure. It is very important to note that this 
research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical 
procedure that has been widely used by plastic surgeons within reconstructive surgery for many 
years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue 
structure. The fat grafting procedure will occur at UPMC Magee or Montefiore Hospital Surgical 
Suites. On the day of the surgical procedure, prior to entering the operating room, the Investigator 
physician will mark the subject's facial area(s) intended for fat grafting procedure. 2D pictures 
may also be obtained for research purposes at this time. With the fat graft procedure the subject 
will be given general anesthesia, a medicine that will relax and assist to in keeping the subject 
unconscious (in a sleep like state) during the entire procedure. Once unconscious, the plastic 
surgeon, using small narrow tube-like instruments called cannulas, will remove fat from various 
places throughout the body (commonly the abdomen and thighs). The processing of the fat graft 
material is done using a Tefla non-adherent gauze pad in a rolling technique that separates the 
aqueous and oil layers from the injected component. The plastic surgeon will then use the 
Coleman cannulas (specialized smaller cannulas with varied shapes and tip sizes specifically 
made to deliver smaller amounts of fat) to fill the desired area. The facial areas which are known 
to have tight spaces with varying angles and can have scarring bands (scar tissue) makes the 
Coleman cannula appropriate for this type of fat delivery. The Coleman Cannula System is also 
associated with less graft re-absorption than other techniques. The Coleman Cannula System is 
not experimental and is commercially available in the United States and in compliance with 
Federal regulations. During the Fat grafting reconstructive surgery the PI and /or Co-investigator 
will obtain a portion of the fat (lipoaspirate) up to 80ccs specimen will be collected as a research 
sample. If the subject refuses to give consent for this sample, the subjects will not be able to 
participate in the clinical trial. The sample will remain under the oversight of Kacey Marra, PhD, 
Co-Investigator examined for cellular information in the Plastic surgery lab located on the 16th 
floor of the Biomedical Science Tower, University of Pittsburgh. The samples will be de-
identified, labeled with the subject's study ID number. Once the surgical procedure has been 
completed the subject will go to the recovery room where he /she will be monitored until stable 
enough to be released to home. There might be a possibility that the subject would be admitted to 
the hospital overnight for observation as deemed necessary by the plastic surgeon. The following 
lab process will take place in the University of Pittsburgh Adipose Stem Cell Center lab:Up to 
80cc of the lipoaspirate specimen will be used to obtain preadipocytes. The specimen will be 
digested in balanced salt solution containing 1 mg/ml collagenase and 3.5% fatty acid free BSA 
in a 37°C shaking water bath until fragments are no longer visible and digest has a milky 
appearance. Digests are filtered and centrifuged at 1000 rpm for 10 minutes. Floating adipocytes 
are removed and the remaining digests are treated with an erythrocyte lysis buffer. Plating media 
will be changed every two days until confluence (~4 days to reach 90% confluence). 1x106 
adiposed-derived stem cells/patient will be stored at -80°C. Remaining cells will be utilized in the 
experiments below. We have been successfully culturing human preadipocytes in our laboratory 
for the past 7 years.[1-12]Preadipocyte yield: The number of cells isolated per gram of adipose 
tissue will be determined using a hemacytometer. Comparison of isolated cells from gentle 
centrifugation of lipoaspirate at 200 rpm for 3 minutes to adipose-derived stem cells will be 
determined.Preadipocyte Viability: Cell viability will be determined using the Live/Dead assay. 
The live cells will be stained with fluorescein diacetate (FDA, Green) and dead cell nuclei will be 
stained with propidium iodide (PI, Red). Preadipocyte Proliferation: Cellular proliferation of 
preadipocytes will be assessed with the CyQUANT Cell Proliferation Assay Kit (Invitrogen, 
Carlsbad, CA) at 48 and 96 hours. Media will be changed every 48 hours.Preadipocyte 
Differentiation: To assess the potential of the preadipocytes to differentiate into the adipogenic 
cell type within the HA gels, cells will be treated plating media containing 0.2 nM 
dexamethasone, 0.5 uM insulin, 0.2 nM triiodothyronine, antibiotics, and 540 uM IBMX in 
addition to their current media. To confirm adipogenesis, lipid inclusions cells will be confirmed 

by staining with Oil Red-O. Additionally, protein expression of PPAR and FABP4 will be 
determined using western blot analysis, and RNA expression of these adipogenic markers will be 
determined using PCR.Preadipocyte characterization. We will characterize preadipocytes from 
each patient for stem cell surface antigens using flow cytometry. Passage zero preadipocytes 
isolated (as described above) from the abdominal subcutaneous tissue will be divided into 
aliquots of 5x105 cells and stained with selected monoclonal antibodies (mAbs) against 
progenitor cell surface markers. The antibodies include mAbs against CD34, CD45, CD90, 
CD133, CD105 and CD166. Rationale for these surface markers includes the following: 1) these 
markers are routinely examined for bone marrow stem cell markers, and have also been 
examined as adiposed-derived stem cells markers,[13]and 2) we will be able to discern stem cell 
purity by testing for these markers. The cells will be incubated with mAbs for 30 min at 4 ?C, 
and washed in PBS. At least 100,000 viable cells based on 7AAD(-) staining in each sample will 
be acquired and analyzed using a FACSAria fluorescence-activated cell sorter (Becton-
Dickinson).The samples will remain at University of Pittsburgh's Adipose Stem Cell under the 
oversight of Kacey Marra, PhD, Co-Investigator, on the 16th floor of the Biomedical Science 
Tower, University of Pittsburgh  
2.6.1 Will blood samples be obtained as part of this research study? 
*  Yes *If submitting a protocol for expedited review, it should be clear that the planned blood 
draws are within the parameters described here: 
http://www.hhs.gov/ohrp/policy/expedited98.html  (see Expedited Research Category #2) 
If Yes, address the frequency, volume per withdrawal, the total volume per visit, and the 
qualifications of the individual performing the procedure:Laboratory blood tests will be obtained 
via a peripheral stick performed by laboratory personnel located on the 5th floor of the UPMC 
MUH building to include CBC with Differential, Comprehensive Chemistry panel, and PT/ PTT/ 
INR  
  
 
The purpose of the flowchart is to enhance and not replace the detailed description for all 
research activities in question 2.6. 
It is the responsibility of the PI to ensure consistency of the content within the entire IRB 
application which includes all uploaded documents (e.g., sponsor protocol, consent, flow charts). 
   
Study Flow Chart: 
Name 
Modified Date 
BTI++ Study Schema  
7/2/2015 1:17 PM 
 
View: 2.07 - 2.07(b) 
Section 2 - Research Design and Methods 
2.7 Will follow-up procedures be performed specifically for research purposes?  Follow-up 
procedures may include phone calls, interviews, biomedical tests or other monitoring 
procedures.*  Yes  
 
 
Detailed procedures listed in the textbox below:  
 

Post graft study visits:POST op study visit (Day 3-6)This study visit will occur with the study 
investigator or research team and will take place approximately in 3-6 days post surgical procedure 
for the purpose of incision assessment and suture removal. The entire visit will take approximately 
30-45 mins and will be scheduled with the subject prior to hospital discharge post fat graft 
procedure. 1.) Limited medical history and physical exam with craniofacial exam 2.) Collection of 
any Adverse events (Should an adverse medical event occurred prior to the visit and be reported by 
the subject, the research team will do due diligence to collect information pertaining to the event 
through subject report and /or medical record review and /or referring physician report)3.) 
Collection of current medications, allergies and vital signs. Study visits (V1-V3): This study visit 
will occur with the study investigator or research team and will take place 7-21 days (+2 weeks) 
after the fat grafting surgical procedure, the entire visit will take approximately 2-3 hours. This 
visit will be scheduled by the research coordinator and discussed with the subject prior to the fat 
graft procedure. These research procedures will be repeated at both 3 months after the fat grafting 
procedure [Visit 2 (V2)] and at 9 months after the fat grafting procedure [Visit 3 (V3)]. The 
following research procedures will be completed:1.) Subject weight and BMI measurement 
calculation 2.) 3-Dimensional photographs 3.) Limited medical history review and physical exam 
with a craniofacial exam completed by the PI and /or the Co-investigator 4.) 2D Photographs5.) 
Psychosocial questionnaires assessment 6.) Collection of subject's vital signs (Temperature, heart 
rate (HR), respiratory rate, blood pressure (BP), medication profile to include prescription and 
vitamins / supplements, and allergies.7.) The investigator will rate the appearance/volume of the 
graft site using a craniofacial volume and appearance grading scale 8.) A urine pregnancy test will 
be given to women of child bearing age prior to the CT scan. 9.) CT Scan with 3D renderings10.) 
Structured Clinical Interview for DSM-IV (SCID) (Visit 3 V3 only) A Structured Clinical 
Interview for DSM-IV (SCID) will be included to evaluate the presence/absence of psychiatric 
disorders. This evaluation will be completed using a standard psychiatric diagnostic interview that 
enables determination of DFSM-IV-based diagnoses. The information contained in the SCID will 
be collected by a research technician, a member of Dr. Gretchen Haas's clinical team who is 
experienced in psychosocial interviewing with patients. This SCID will take approximately 45-60 
minutes of the subject's time to complete. 11.) Adverse Event Reporting (Should an adverse 
medical event occurred prior to the visit and be reported by the subject, the research team will do 
due diligence to collect information pertaining to the event through subject report and /or medical 
record review and /or referring physician report)Due to the subjects traveling distances who are 
enrolled into this trial, we have included a (+/-) of 14 days (2 weeks) for the completion of Visit 2 
and Visit 3 as a convenience for the coordination of schedules.  
 
    
View: 2.08 
 
Section 2 - Research Design and Methods 
2.8 Does this research study involve the use of any questionnaires, interview or survey 
instruments?*  Yes  
  
Upload a copy of all materials except for the SCID or KSADS which are on file at the 
IRB.  The use of all instruments must be addressed in question 2.6 and/or question 2.7 (except 
for an exempt submission where they should be addressed on the appropriate uploaded 
exempt form). 
Name 
Modified Date 
QOL demographic baseline form  
2/25/2015 10:12 AM 
Beck Depression Inventory  
2/24/2015 3:25 PM 
Rosenburg Self-esteem 
2/24/2015 3:17 PM 
 

Social Avoidance (SAD)  
2/24/2015 3:16 PM 
PCL-S 
2/24/2015 3:21 PM 
CSQ-8 
2/24/2015 3:21 PM 
Perceived Social Support Questionnaire (PSSQ)  
2/24/2015 3:22 PM 
SWAP 
2/24/2015 3:16 PM 
Coping Scale  
2/24/2015 3:18 PM 
SF_36.pdf  
2/24/2015 3:17 PM 
PHQ_Brief.pdf  
2/24/2015 3:22 PM 
Brief Demographic Form 
2/24/2015 3:17 PM 
Previously the name and publisher for commercially available materials were listed in the 
textbox below but effective 9/1/2015, all materials (except for the SCID and KSADS) must be 
uploaded using the Add button above. 
View: 2.09 - 2.10 
 
Section 2 - Research Design and Methods 
2.9 
If subjects are also patients, will any clinical procedures that are being used for their 
conventional medical care also be used for research purposes?*  no  
  
If Yes, describe the clinical procedures (and, if applicable, their frequency) that will be used for 
research purposes:  
 
2.10 The blood sample question was moved to 2.6.1. 
 
View: 2.11 
Section 2 - Research Design and Methods 
2.11 What is the total duration of the subject's participation in this research study across all 
visits, including follow-up surveillance?*  Approximately 12-13 months  
 
View: 2.12 
  
Section 2 - Research Design and Methods 
2.12 
Does this research study involve any type of planned deception? If Yes, you are required to 
request an alteration of the informed consent process (question 4.7) 
 
*  No  
 
2.12.1 Describe the planned deception: 
* 
 
2.12.2 Provide a justification for this planned deception: 
* 
 
2.12.3 Describe when and how subjects will be debriefed: 
* 
 
    
View: 2.13 HB 

  
Section 2 - Research Design and Methods 
2.13 
Does this research study involve the use of UPMC/Pitt protected health information that 
will be de-identified by an IRB approved "honest broker" system? 
  
 
*  No  
   
2.13.1 Identify the name of the honest broker system: 
 
2.13.2 Specify the IRB-assigned honest broker system number (e.g., HB123456): 
 
2.13.3 Specify the names of the individuals who will provide the honest broker services: 
Last 
First 
Organization 
There are no items to display 
Previous inputted information for Question 2.13.3:  
 
2.13.4 Upload the signed honest broker assurance agreement: 
Name 
Modified Date 
There are no items to display 
 
    
View: 2.14 
  
  
Section 2 - Research Design and Methods 
2.14 
Will protected health information from a UPMC/Pitt HIPAA covered entity be accessed 
for research purposes or will research data be placed in the UPMC/Pitt medical 
record?*  Yes  
 
 
If you answer Yes, you are required to submit this study to the Center for Assistance in 
Research using e-Record (CARe).  Per UPMC Policy HS-RS0005, all research projects that 
access or involve UPMC electronic protected health information (e-PHI) must be submitted to 
CARe, with the exception of clinical trials that are contracted through the UPMC Office of 
Sponsored Programs and Research Support (OSPARS).  Complete the online submission form 
at https://care.upmc.com/request.aspx.  After the study is submitted in OSIRIS, a CARe 
representative will conduct a review. You will be notified once your CARe review is complete 
or if anything further is needed. Studies that will access only paper-based medical records (not 
in combination with any electronic records) do not need to be submitted to CARe.For additional 
information, please see https://care.upmc.com. 
Describe the medical record information that will be collected from the UPMC/Pitt 
HIPAA covered entity and/or the research-derived information that will be placed in the 
medical records.The medical record information that may be extracted from the medical chart 
during a review are only those items pertaining to the subject's history of the trauma and all 
surgical procedures, consults, medications, lab values leading up to and after the fat graft 
procedure. Pre-procedure blood tests, including but not limited to blood clotting, red blood cell, 
electrolytes and cultures, history /physical exams of the face and body, MRI and CT scans, 
menstrual status and/or the results of pregnancy tests, and any medical record information that 
could adversely impact the outcome of the fat grafting reconstructive surgery procedure.This 
research study will result in identifiable information that will be placed into the subject's 
medical records held at UPMC. The nature of the identifiable information resulting from the 
 
 

subject's participation in this research study that will be recorded in their medical record will be 
derived from the medical/surgical (fat grafting procedure). Psychiatric interview information 
will be entered into the medical record only if it is important to ensure the subject's 
medical/physical safety.  
2.14.1 Will protected health information from a non-UPMC/Pitt HIPAA covered entity be 
obtained for research purposes or will research data be placed in the non-UPMC/Pitt 
medical record?  *  No  
  
 
If Yes, describe how the HIPAA requirements will be met: 
 
 
I, J. Peter   Rubin , certify that any member of my research team accessing, reviewing 
and/or recording information from medical records have completed HIPAA Researchers 
Privacy Requirements (Formerly RPF Module 6) training.   The HIPAA certificates must 
be available for review if audited but do not need to be uploaded into this OSIRIS 
application. 
* Yes  
  
 
2.14.2 Are you requesting a waiver of the requirement to obtain written HIPAA authorization 
for the collection of the PHI from a UPMC/Pitt covered entity? Note that the University of 
Pittsburgh IRB cannot grant a HIPAA waiver for entities outside of UPMC/Pitt.* No  
 
    
View: 2.15 
Section 2 - Research Design and Methods 
2.15 
Does this research study involve the long-term storage (banking) of biological specimens?  
  
 
*  Yes  
   
2.15.1 Broadly describe the intended future use of the banked biological specimens:To assess 
cellular properties of the grafted material in each patient for future correlation of the clinical 
outcomes.  
 
2.15.2 Indicate the planned length of storage of the banked biological specimens: 
* Indefinite  
 
2.15.3 Will biological specimens be stored without identifiers or linkage codes? 
If you answer Yes, the samples will not be stored with any identifiers or linkage codes and 
it is highly unlikely to be linked back to the individual. 
If you answer No, the samples will be stored with an identifier or linkage code and can be 
linked back to the individual.  
  * No  
 
    
View: 2.15.4 
 
Section 2 - Research Design and Methods 

2.15.4 Will subjects (including family members, if applicable) be informed of their personal 
results from analyses performed on their biological specimens? 
  
*  No  
 
View: 2.15.4.1 
Section 2 - Research Design and Methods 
2.15.4.1 Justify why the personal results will not be disclosed to the research subjects at this 
time. Under what conditions, if any, might personal results be disclosed to research 
subjects in the future? 
   
 
Personal results of analyses performed on the banked samples will not be disclosed to the 
research subjects because the involved research laboratory is not CLIA certified and the 
analysis/ results of future testing can not yet be interpreted or applied in a clinically 
relevant or meaningful manner.  
 
 
   
View: 2.15.4.7 - 2.15.4.9 
Section 2 - Research Design and Methods 
2.15.4.7 Describe the procedures that will be employed to protect the confidentiality of subjects' 
private information associated with use of biological specimens:Unique subject identifiers 
will be used to label all data and research samples. All samples and data will be stored using 
codes assigned by the investigators or their designee, and any information linking these code 
numbers to the corresponding subjects’ identities, medical and research information and all 
subject personal information collected from all study participants will be kept in a separate, 
locked file within the offices of the Department of Plastic Surgery, University of Pittsburgh. 
Stored specimens will be de-identified and may be provided to secondary investigators. Any 
information obtained from or for this research study will be kept as confidential as possible. 
All records pertaining to the subjects’ involvement in this research study, including the 
lipoaspirate specimens, will be indicated by a code number only. The specimens will be kept 
indefinitely and stored in a –80 degree freezer on the 16th floor of the Biomedical Science 
Tower under the supervision of Kacey Marra, PhD. The specimens will be rendered 
anonymous, so no identifiers can be linked back to the subjects. Upon subject withdrawal, 
storage of the specimens will continue and only the PI will have access to the linkage code to 
the subject’s identity. Data will be maintained and monitored in a password protected 
computer system. Printed data will be stored in the research study binders in a locked filing 
cabinet within the Department of Plastic Surgery office. Information linking the code numbers 
to the subjects will be kept in a separate locked filing cabinet that can only be accessed by the 
investigators and their research study staff. Subjects will not be identified by name in any 
publication of the research results unless they sign a separate release form giving permission.  
 
 
2.15.4.8 Will the banked biological specimens or data derived from them be provided 
with subject identifiers to any secondary investigators or external entities?*  No  
 
2.15.4.9 Will  research subjects be remunerated in the event of the future commercial 
development of inventions or products based on the research use of their biological 
specimens?*  No  
 
 
View: 2.16 
Section 2 - Research Design and Methods 
2.16 
Will research participants be asked to provide information about their family members or 
acquaintances? 
 

*  No  
 
2.16.1 Describe what information about the third party will be obtained from the participant: 
 
2.16.2 If the information about the third party is of a private nature, can the identity of the third 
party be readily ascertained or associated with this information? 
* 
 
 
Describe the private information that will be collected and recorded about the third party:  
 
    
View: 2.17 - 2.18 
Section 2 - Research Design and Methods 
2.17 What are the main outcome variables that will be evaluated in this study? 
   
Analysis of all 2D and 3D Photographs, CT scans, Psychosocial assessments, outcomes of manual 
vs. centrifuged method of separating the aqueous portions of the fat graft material.Basic assays of 
adipose cell behavior to elucidate the functional properties of adipose cells used for grafting, with 
correlation to outcomes.   
 
2.18 Describe the statistical approaches that will be used to analyze the study data. 
 
 
*  Addressed below:  
   
Serial computed tomography imaging will be performed to assess the total soft tissue volume 
before fat grafting and afterwards at three time points: immediately post-grafting, three months 
post-graft and nine month post-graft. Comparisons of the post-graft tissue volume to pre-treatment 
volume will be performed using a paired t-test model. Repeated measures analysis of variance 
will be used to evaluate change over time in all outcome measures. Using standard conventions of 
alpha=0.05 and beta=0.8, an enrollment of ten patients will provide sufficient power to detect a 
clinically meaningful differences in the volume of soft tissue between groups.. Based on 
published effect sizes for clinically significant medical outcomes on the SF-36 (i.e., 0.5 to 0.7), 
e.g., following surgery for dentofacial deformities (d = 0.6) (64), and medium (0.5 – 0.79) to large 
(0.8 to > 3.0) effect sizes on SF-36 social functioning outcomes of neck surgery (65) and 
orthopedic surgery (66), it is expected that a sample of 10 patients will provide sufficient power to 
detect a medium effect size (d = 0.5) on SF-36 measures of social functioning and quality of life, 
applying standard conventions of alpha = 0.05 and beta = 0.8. The cotton rolling fat processing 
technique takes place in the Operative Room during the study surgery directly following the 
collection of the lipoaspirate. Outcome of facial appearance and soft tissue volume in subjects 
who were injected with fat grating material processed by the cotton rolling technique in this 
protocol will be compared to those subjects in protocol PRO09060101 who were injected with fat 
grafting material using the centrifuged technique. Significance level (adjusted for sidedness) 
=.025, standard deviation = 15 (15%), number of patients = 10, power= .0.8, difference in means 
= undefined, location of mean in one group as a percentile of the other group = undefined. The 
variable calculated was the minimum detectable difference. The probability is 80 percent that the 
study will detect a treatment difference at a two-sided 0.05 significance level, if the true 
difference between the treatments is 19.881 units or 19.8%. This is based on the assumption that 
the standard deviation of the response variable is 15 units or a 15% inter-individual coefficient of 
variation.  
 
View: 2.19 - 2.19.6 

Section 2 - Research Design and Methods 
2.19 
Will this research be conducted in (a) a foreign country and/or (b) at a site (e.g., Navajo 
Nation) where the cultural background of the subject population differs substantially 
from that of Pittsburgh and its surrounding communities?*  No  
Note that copies of training records, licenses, certificates should be maintained in the study 
regulatory binder and are subject to audit by the Research Conduct and Compliance Office 
(RCCO). 
In addition, individuals planning to conduct human subject research outside the United States 
must complete an optional module on the CITI training website: International Studies.  Click 
here to access the instruction sheet for accessing optional CITI modules. 
 
 
2.19.1 
Address the following for each of the foreign/culturally different sites where this 
research will be conducted:• Name of site• Name of authorized individual (e.g., IRB Chair) 
from the local IRB or other human subject protections entity that is responsible for the review 
and approval of the project; upload approval letter with an English translation, if applicable 
• Name and qualifications of the site collaborator responsible for the conduct of the research 
(e.g., site PI)• The anticipated number of subjects that will be enrolled at that site  • If 
Federally funded, provide the Federalwide Assurance number (FWA) assigned to the site * 
  Site 
Date Modified 
 There are no items to display 
 
2.19.1.1 Provide a description of the context of cultural norms and local laws and highlight 
differences  between U.S. culture in all areas relevant to your study, including, at a 
minimum: 
• Age of majority of participants to be enrolled• If study includes minors or decisionally 
impaired subjects, summarize laws on guardianship • If your study involves any invasive 
medical procedure (including blood draws), provide assurance that the individuals undertaking 
those procedures for research purposes are appropriately credentialed.  • If your study involves 
the administration of a drug, device or biologic for research purposes, describe the process for 
shipping, labeling, storing and dispensing, and indicate how these are consistent with all 
relevant local (and US) laws, including those requiring import / export permits.• If your study 
involves collection of biological specimens, describe the process for shipping, labeling, 
storing and using such samples.  Identify any special local consent requirements, and any 
special permits that may be required by local law. 
 * 
 
2.19.1.2 Describe any aspects of the local cultural, political or economic climate that might 
increase the risks of harm for either local participants or researchers.  Describe the steps 
you will take to minimize these risks.  UPitt Faculty, Staff, and Students must access the 
Travel Registry page. Go to my.pitt.edu and the link is displayed under My Resources. 
 * 
 
2.19.2 
Will all individuals being recruited to participate in this research study be able to read 
and comprehend English*  
 

If No, describe how consent will be obtained.  Explain provisions for culturally appropriate 
recruitment and consent accommodations such as, translations or involvement of native 
language speakers, especially if literacy is not widespread in this country. 
 
2.19.2.1 If translated documents are used, upload a signed translator certification form and back 
translations (if applicable):(Translator Certification Form is available under the Resources 
tab located to right of this item) 
   
Name 
Modified Date 
There are no items to display 
 
 
 
2.19.3 
Will all of the research procedures described in this IRB application be conducted at the 
foreign/culturally different sites? 
*   
Yes 
No  
 
 
If No, describe the subset of research procedures to be performed at the sites: 
   
2.19.4 
To what extent do the local site requirements to protect subject confidentiality and 
privacy differ from US standards. If applicable, explain how those will be addressed by 
this research team:*  
 
2.19.5 
If the researcher is a student, describe how the student will communicate with the 
advisor during the conduct of the research and how the advisor will oversee the 
research: 
 
 
    
View: 2.21 
 
Section 2 - Research Design and Methods 
2.21 
Will this research study be conducted within a nursing home located in Pennsylvania? 
*  No  
 
 
2.21.1 Does this research involve a medical procedure or an experimental treatment?*  
   
2.21.2 Does the research study involve the exposure of nursing home residents to pain, injury, 
invasion of privacy, or ask the resident to surrender autonomy? 
*  
 
 
If Yes to either question, upload the Pennsylvania Department of Health approval letter. 28 PA 
Code Section 201.29 (o) specifies that prior to the initiation of research, and in addition to IRB 
approval, any study that includes experimental research or treatment conducted in a nursing 
home must be approved by the Pennsylvania Department of Health. A signed consent form from 
nursing home resident-subject is also required.  
Name Modified Date 
  
 

    
View: 3.01 - 3.04(a) 
Section 3 - Human Subjects  
3.1 
What is the age range of the subject population?18 years of age and older.  
 
  
3.2 
What is their gender?*  Both males and females  Provide a justification if single gender 
selected: 
 
3.3 
Will any racial or ethnic subgroups be explicitly excluded from participation?*  No  If Yes, 
identify subgroups and provide a justification:  
  
3.4 
For studies conducted in the U.S., do you expect that all subjects will be able to comprehend 
English?  
*  Yes  
 
If No, identify what languages will be understood by subjects and describe your plan to manage 
communication with non-English speaking subjects during all phases of the study: 
 
3.4.1 If translated documents are used, upload a signed translator certification form and back 
translations (if applicable): 
Name 
Modified Date 
There are no items to display 
 
 
 
    
View: 3.05 - 3.05(a) 
Section 3 - Human Subjects  
3.5 
Participation of Children: Will children less than 18 years of age be studied?*  No  
  
If No, provide a justification for excluding children: Children will be excluded because any 
active growth of the craniofacial complex will obscure our ability to detect changes due the 
surgical procedure over time.  
 
3.5.1 
Specify the age range of the children to be studied.  (Check all that apply below:) 
* 
Choices 
There are no items to display 
 
 
 
3.5.2 
Provide a rationale for the specific age ranges of the children to be studied: 
 
3.5.3 
Describe the expertise of the study team for conducting research with children within this 
age range: 
 
3.5.3.1 Have you obtained the following clearances from all research staff who may have direct 
contact with children under the age of 18?  Direct contact under the law includes face-to-
face, and telephonic or electronic, contact with minors.  Please see the Child Clearances 
guidance document for further explanation? 
  
  
 

Pennsylvania Department of Public Welfare Child Abuse History 
Clearance;Pennsylvania State Police Criminal Record Check; andFBI Criminal 
Background Check 
Note: If No, once all clearances are obtained, a modification must be submitted.If you 
selected N/A, please explain:  
It is important to note that “direct contact” refers not only to face-to-face meetings but also 
extends to communication via phone (including text messaging), social media or 
internet.   Direct contact also includes the care, guidance, supervision or control, or routine 
interaction with, minors.  Conversely, a participating investigator or support staff member who 
does not have direct contact, either electronically or in person, with children does not need to 
obtain clearances (e.g., statistician, non-clinical laboratory personnel, etc.).  If your research 
study provides babysitting services, the babysitters must have the required child clearances. * 
Note: It is the responsibility of the principal investigator to ensure that all research staff 
have these clearances prior to any interaction with children. Contact Human Resources at 412-
624-8150 for assistance with this process.  
 
3.5.4 
Describe the adequacy of the research facilities to accommodate children within this 
age range:* 
 
3.5.5 
Permitted Categories of Research: The Federal Policy and FDA regulations governing 
human subject protections specify that research involving children must fall into one of 
the following permitted categories.   
* 
45 CFR 46.406 
• 
The risk represents only a minor increase over minimal risk.  
• 
The research procedures present experiences to the subjects that are reasonably 
commensurate with those inherent in their actual or expected medical, dental, 
psychological, social, or educational situations.  
• 
The research procedures are likely to yield generalizable knowledge about the subjects’ 
disorder or condition which is of vital importance for understanding or amelioration of 
the subjects’ disorder or condition. 
45 CFR 46.407 
• 
The risk is justified by the anticipated benefit to the subjects; and the relation of the 
anticipated benefit to the risk is at least as favorable to the subjects as that presented by 
available alternative approaches. 
 
 
Provide a justification which must address all considerations related to the 
designated category of research: 
 
    
View: 3.06 
Section 3.0 - Human Subjects 

3.6 
Does this research study involve prisoners, or is it anticipated that the research study may 
involve prisoners?*  No  
  
3.6.1 The Federal Policy and FDA regulations specify that research involving prisoners must fall 
into one of the following permitted categories. 
* 
 
 
*Provide a justification for your designation: 
 
 
General Requirements: The Federal Policy and FDA regulations specify that research 
involving prisoners must also conform to each of the following general requirements.  Describe 
how your study meets each of the following regulations.   
  
 
3.6.2 Any possible advantages accruing to the prisoner through his or her participation in the 
research, when compared to the general living conditions, medical care, quality of food, 
amenities, and opportunity for earnings in the prison are not of such a magnitude that the 
prisoner’s ability to weigh the risks of the research against the value of such advantages in 
the limited choice environment of the prison is impaired. [45 CFR 46.305 (a)(2)]* 
 
3.6.3 The risks involved in the research are commensurate with risks that would be accepted by 
nonprisoner volunteers.[45 CFR 46.305 (a)(3)]  * 
 
3.6.4 The procedures for the selection of subjects within the prison are fair to all prisoners and 
immune from arbitrary intervention by prison authorities or prisoners.[45 CFR 46.305 
(a)(4)] * 
 
 
3.6.5 Information regarding the research is presented to the potential prisoners-subjects in a 
language which is understandable to them.[45 CFR 46.305 (a)(5)]* 
 
3.6.6 Adequate assurance exists that the parole boards will not take into account a prisoner’s 
participation in the research in making decisions regarding parole, and each prisoner is 
clearly informed in advance that participation in the research will have no effect on his or 
her parole. [45 CFR 46.305 (a)(6)]  * 
 
 
3.6.7 Where there may be a need for follow-up examination or care of the prisoners-subjects 
after the end of their participation in the research, adequate provision has been made for 
such examination or care; taking into account the varying lengths of individual prisoners’ 
sentences, and the prisoners have been informed of this fact. [45 CFR 46.305 (a)(7)]. * 
 
 
    
View: 3.07 
Section 3 - Human Subjects  
3.7 
Will pregnant women be knowingly and purposely included in this research study? 
   
*  No  
 
General Requirements: The Federal Policy [45 CFR 46, Subpart B] specify that research 
involving pregnant women and/or fetuses must also confirm to each of the following criteria. 
Describe how your study meets each of the requirements.  
 
 
3.7.1 Where scientifically appropriate, preclinical studies, including studies on pregnant animals, 
and clinical studies, including studies on non-pregnant women, have been conducted and 
 

provide data for assessing potential risks to pregnant women and fetuses. [45 CFR 46.204 
(a)]  [Include references]* 
3.7.2 The risk to the fetus is caused solely by interventions or procedures that hold out the 
prospect of direct benefit for the women or the fetus; or, if there is no such prospect of 
direct benefit, the risk to the fetus is not greater than minimal and the purpose of the 
research is the development of important biomedical knowledge which cannot be obtained 
by any other means.  [45 CFR 46.204 (b)]   
* 
 
 
3.7.3 Any risk is the least possible for achieving the objectives of the research. [45 CFR 46.204 
(c)]* 
 
3.7.4 No inducements, monetary or otherwise, will be offered to terminate the pregnancy. [45 
CFR 46.204 (h)] 
* 
 
3.7.5 Individuals engaged in the research will have no part in any decisions as to the timing, 
method, or procedures used to terminate a pregnancy. [45 CFR 46.204 (i)] 
* 
 
3.7.6 Individuals engaged in the research will have no part in determining the viability of a 
neonate. [45 CFR 46.204 (j)] 
* 
 
    
View: 3.08 
Section 3 - Human Subjects  
3.8 
Does this research study involve neonates of uncertain viability or nonviable neonates? 
   
*  No  
  
General Requirements:  The Federal regulations [45 CFR 46.205] specify that research 
involving neonates of uncertain viability and nonviable neonates must conform to each of the 
general requirements. Describe how each of the following requirements will be met. 
 
 
3.8.1 
Where scientifically appropriate, preclinical and clinical studies have been conducted and 
provide data for assessing potential risks to neonates (include references). [45 CFR 46.205 
(a)(1)] * 
 
3.8.2 
Individuals engaged in the research will have no part in determining the viability of the 
neonate. [45 CFR 46.205 (a)(3)]* 
 
3.8.3 
Does this research study involve neonates of uncertain viability? [45 CFR 46.205(b)]*  
 
3.8.3.1 The Federal regulations specify that, until it is ascertained whether or not a neonate is 
viable, a neonate may not be involved in research unless one of the following conditions is 
met.  * 
 
*Provide a justification for your selection: 
 

3.8.4 
Does this research study involve nonviable neonates? [45 CFR 46.205(c)]*  
General Requirements: The Federal regulations specify that, after delivery, a nonviable neonate 
may not be involved in research unless each of the following additional conditions are met [45 
CFR 46.205(c)]. 
 
 
3.8.4.1 Vital functions of the neonate will not be artificially maintained. [45 CFR 46.205 (c)(1)]* 
 
3.8.4.2 The research will not terminate the heartbeat or respiration of the neonate. [45 CFR 
46.205 (c)(2)]* 
 
3.8.4.3 There will be no added risks to the neonate resulting from the research. [45 CFR 46.205 
(c)(3)] * 
 
3.8.4.4 The purpose of the research is the development of important biomedical knowledge that 
cannot be obtained by other means. [45 CFR 46.205 (c)(4)]* 
 
    
View: 3.09 
Section 3 - Human Subjects  
3.9 
Fetal Tissues: Does this research involve the use of fetal tissues or organs?*  No  
 
General Requirements: In accordance with the Pennsylvania Abortion Control Act, fetal tissues 
or organs may only be obtained for use in research subsequent to obtaining the written informed 
consent of the mother.  The Pennsylvania Abortion Control Act specifies that research involving 
the use of fetal tissue or organs must also conform to each of the 
following requirements.  [Indicate how you will conform to each requirement] 
 
 
3.9.1 Informed consent for the research use of fetal tissue derived from an abortion will be 
obtained separate from, and after, the decision and consent to abort has been made. 
* 
 
3.9.2 No consideration of any kind (i.e., monetary or otherwise) will be offered to the mother in 
obtaining her consent for the research use of the fetal tissue or organs. 
* 
 
3.9.3 The mother will not be permitted to designate a recipient of the fetal tissue or organs for 
use in research. 
* 
 
3.9.4 All persons who participate in the procurement or use of the fetal tissue or organs will be 
informed as to the source of the tissue (e.g., abortion, miscarriage, stillbirth, ectopic 
pregnancy). 
* 
 
    
View: 3.10 - 3.12(a) 
---> 

Section 3.0 - Human Subjects 
3.10 What is the total number of subjects to be studied at this site, including subjects to be 
screened for eligibility?Note: The number below is calculated by summing the data entered in 
question 3.11. Any additions or changes to the values entered in 3.11 will be reflected in 
3.10.*  20  
 
 
3.11 Identify each of the disease or condition specific subgroups (include healthy volunteers, if 
applicable) that will be studied.   
Click on the "Add" button and specify for each subgroup:  
1) how many subjects will undergo research related procedures at this site; and 
2) if applicable, how many subjects will be required to undergo screening procedures (e.g., 
blood work, EKG, x-rays, etc.) to establish eligibility.  Do Not include subjects who will 
undergo preliminary telephone screening.*   
  
Subgroup 
Number to undergo research 
procedures 
Number to undergo screening 
procedures 
 
View  Study 
group 
10 
20 
 
 
 
   
 
 
3.12 Provide a statistical justification for the total number of subjects to be enrolled into this 
research study at the multicenter sites or this site.*  Described below:  Serial computed 
tomography imaging will be performed to assess the total soft tissue volume before fat grafting 
and afterwards at three time points: immediately post-grafting, three months post-graft and nine 
month post-graft. Comparisons of the post-graft tissue volume to pre-treatment volume will be 
performed using a paired t-test model. Repeated measures analysis of variance will be used to 
evaluate change over time in all outcome measures. Using standard conventions of alpha=0.05 
and beta=0.8, an enrollment of ten patients will provide sufficient power to detect a clinically 
meaningful differences in the volume of soft tissue between groups.. Based on published effect 
sizes for clinically significant medical outcomes on the SF-36 (i.e., 0.5 to 0.7), e.g., following 
surgery for dentofacial deformities (d = 0.6) (64), and medium (0.5 – 0.79) to large (0.8 to > 3.0) 
effect sizes on SF-36 social functioning outcomes of neck surgery (65) and orthopedic surgery 
(66), it is expected that a sample of 10 patients will provide sufficient power to detect a medium 
effect size (d = 0.5) on SF-36 measures of social functioning and quality of life, applying standard 
conventions of alpha = 0.05 and beta = 0.8. Outcome of facial appearance and soft tissue volume 
in subjects in this protocol will be compared to those subjects in PRO09060101. Significance 
level (adjusted for sidedness) =.025, standard deviation = 15 (15%), number of patients = 10, 
power= .0.8, difference in means = undefined, location of mean in one group as a percentile of the 
other group = undefined. The variable calculated was the minimum detectable difference. The 
probability is 80 percent that the study will detect a treatment difference at a two-sided 0.05 
significance level, if the true difference between the treatments is 19.881 units or 19.8%. This is 
based on the assumption that the standard deviation of the response variable is 15 units or a 15% 
inter-individual coefficient of variation.  
 
 
View: 3.13 - 3.15(a) 
 
Section 3.0 - Human Subjects 

3.13 Inclusion Criteria: List the specific criteria for inclusion of potential subjects.1. Aged 18 
years or older and able to provide informed consent2. Who are post injury and/or post surgery 
(e.g. tx of aneurism, intercranial bleed, and tumor resections that do not involve radiation and 
would be analogous to trauma population requiring craniotomy) resulting in craniofacial volume 
defect which could be treated with a graft volume of between 5 and 150 cc of lipoaspirate3. Be at 
least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is 
resolved4. Volume defects are covered by intact skin and do not communicate with oral cavity or 
sinuses5. The three dimensional geometry of the volume defect(s) would allow for treatment with 
lipoaspirate injection that at least a single distinct treated area can be discerned on gross 
examination.6. Willing and able to comply with follow up examinations, including radiographic 
studies  
 
3.14 Exclusion Criteria: List the specific criteria for exclusion of potential subjects from 
participation.1. Age less than 18 years2. Inability to provide informed consent3. Craniofacial 
defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: 
presence of such a defect in the setting of another defect(s) that meets treatment criteria will not 
exclude the patient from participating).4. Active infection anywhere in the body5. Diagnosed with 
cancer within the last 12 months and /or presently receiving chemotherapy or radiation 
treatment6. Known coagulopathy7. Pregnancy8. Subjects with an Axis I DSM-IV diagnosis (e.g., 
Schizophrenia, Bipolar disorder) who are found to be clinically (i.e. medically) unstable at 
baseline. Individuals who manifest either: 1) evidence of currently active alcohol or psychoactive 
drug abuse or dependence on the SCID interview, or 2) a GAF score of 40 or lower due to any 
acute psychiatric symptomatology (e.g. suicidality, psychosis, severe depression or mania) will be 
reviewed by the Co-I for Psychosocial Assessment with the PI for determination of possible 
medical instability. Final determination of medically unstable status will be made by the PI on the 
basis of overall medical status and appropriateness for medical procedures; the patient may be 
considered ineligible for study participation per the Physician’s discretion.  
 
3.15 Will HIV serostatus be evaluated specifically for the purpose of participation in this 
research study?*  No If Yes, provide a justification: 
  
View: 4.01 - Version 2 
Section 4 - Subject Recruitment and Informed Consent Procedures  
4.1 Select all recruitment methods to be used to identify potential subjects: 
Advertisements 
CTSI Research Participant Registry 
 
 
 
Advertisements   
Upload the advertisements for review:  
Name 
Modified Date 
BTI++ pull of tab advertisement 
4/11/2014 11:29 AM 
UPMC - Facial Reconstruction Study - R1.mp4 7/23/2014 1:43 PM 
BTI++ audio and visual TV advertisement  
8/24/2015 11:03 AM 
BTI++ Recruitment flyer Mod 7.2.15 
7/2/2015 1:23 PM 
BTI ++ TV advertisement_script 7.23.2015  
7/23/2015 4:44 PM 
Facial study script 5 27 14revised (2)pas.doc 
7/23/2014 3:01 PM 
 
 
  
 
   

Honest Broker  
Identify the name of the honest broker system and name of the specific individuals who will 
provide those services: 
 
 
 
Specify the IRB-assigned honest broker system number (e.g., HB123456): 
   
 
Upload the signed honest broker assurance agreement: 
Name 
Modified Date 
There are no items to display 
  
 
  
 
   
Recruitment Letters and Scripts 
Upload recruitment letters/scripts/text: 
Name Modified Date 
 
  
 
   
 
Research Registry 
List the IRB approval number and title for each registry source: 
  
 
  
 
   
4.2 Provide a detailed description of your recruitment methods, including identifying and 
initiating contact with participants:    
Potential subjects will also be recruited using advertisements (see section 4.1) placed throughout 
the local Oakland and Pittsburgh area, through registration of the study with the CTSI Research 
Participant Registry, through TV and digital advertising (inclusive of social networking sites i.e. 
facebook, etc.), clinicaltrials.gov, the Center for Innovation in Restorative Medicine (CIRM) 
website, and via our existing contacts with support groups, and Plastic surgery clinics and 
Physicians throughout the University of Pittsburgh area and nationally. The research coordinator, 
utilizing a telephone script (attached section 4.5) will obtain and document into the research binder, 
the verbal consent of the potential subject for participation for the pre-screening activity. The 
research coordinator will only pre-screen potential subjects for exclusion criteria by phone. The 
research coordinator will also obtain information specific to the registration of the potential subject 
for the screening visit. Upon completion of the telephone interview, qualified and interested 
subjects will be instructed to come to the UPMC Aesthetic Plastic Surgery Center for the scheduled 
screening visit. At the time of the screening visit if the potential subject, after review of the 
informed consent document and upon resolution of any questions, then verbalizes continued 
interest in study participation, the PI and/or Co-investigator who is a physician will obtain 
informed consent. A copy of the informed consent will be given to the subject for his/ her files. 
Original consent will placed to the research chart. This consenting process will minimize the 
possibility of coercion and undue influence. No research related activities would be conducted until 
a fully executed informed consent document is obtained. 
 
    

Note: Questions jump from 4.2 to 4.6 as questions 4.3-4.5 have been removed and the information is now 
captured in 4.1  
View: 4.06 
 
Section 4 - Subject Recruitment and Informed Consent Procedures  
4.6 
Are you requesting a waiver to document informed consent for any or all participants, for 
any or all procedures? (e.g., a verbal or computerized consent script will be used, but the 
subjects will not be required to sign a written informed consent document.  This is not a 
waiver to obtain consent. 
 
*  Yes  
 
4.6.1 
Identify the specific research procedures and/or the specific subject populations for which 
you are requesting a waiver of the requirement to obtain a signed consent form. 
Addressed below:  
 
If not all, identify the specific procedures and/or subject populations for which you are 
requesting a waiver: A telephone screening interview script will be utilized for potential 
craniofacial trauma subject that are calling in to inquire about the advertisements.  
 
4.6.2 
Indicate which of the following regulatory criteria is applicable to your request for a 
waiver of the requirement to obtain a signed consent form. 
  45 CFR 46.117(c)(2)  
45 CFR 46.117(c)(1) That the only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether 
the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or 
45 CFR 46.117(c)(2) That the research presents 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. 
  
 
4.6.2.1 Address why the specific research procedures for which you are requesting a waiver of 
the requirement to obtain a signed consent form present no more than minimal risk of 
harm to the research subjects: 
This telephone screening process within the research study presents 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. We believe the information being obtained during the screening 
phone call is the same type of information that would be collected on patients setting up an 
appointment for a routine well visit. 
 
4.6.2.2 Justify why the research listed in 4.6.1 involves no procedures for which written informed 
consent is normally required outside of the research context: 
We have requested and obtained a waiver of the requirement to obtain signed informed consent 
for the screening process, which will take place over the phone. We believe we meet the 
following criteria: The respective research procedures present no more than minimal risk of 
harm to the involved subjects and involve no procedures for which written consent is normally 
required outside of the research context. We believe the information being obtained during the 
screening phone call is the same type of information that would be collected on patients setting 
up an appointment for a routine well visit.If the subject does not meet inclusion criteria, all the 
information collected during the screening process will be destroyed and the subject will be 
 

informed of this activity at the time of telephone screening. In addition, written informed 
consent will be obtained at the screening visit prior to any research activities. The investigator 
or co-investigator will obtain written informed consent. 
4.6.3 
Address the procedures that will be used and the information that will be provided (i.e., 
script) in obtaining and documenting the subjects' verbal informed consent for study 
participation: 
Potential subjects will call the research coordinator in response to the advertisement. The 
research coordinator will read from the the screening script with the pre screening criteria being 
reviewed. If the potential subject meets this criteria the potential subject's information will be 
reviewed with the PI for further action. The PI will make a final determination on continuing 
the evaluation process and the potential subject will be contacted for further coordination of a 
screening visit. Upon completion of the telephone interview, qualified and interested subjects 
will be instructed to come to the Aesthetic Surgery Center for the scheduled screening visit. At 
the time of the screening visit if the potential subject, after review of the informed consent 
document and upon resolution of any questions, then verbalizes continued interest in study 
participation, the principal investigator or co-investigator who is on the Investigational Review 
Board (IRB) approved research protocol and consent documents, and is a physician will obtain 
subject signature. The physician will then sign the Certification of Informed Consent Statement 
ensuring a Health Insurance Portability and Accountability Act (HIPAA)- compliant informed 
consent document for the study, thereby minimizing the possibility of coercion and undue 
influence. No research related activities would be conducted until a fully executed informed 
consent document is obtained. 
  
 
Upload Scripts: 
Name 
Modified Date 
BTI++ telephone script  7/2/2015 8:22 AM 
 
    
View: 4.07 - Version 2.0 
Section 4 - Subject Recruitment and Informed Consent Procedures  
4.7 
Are you requesting a waiver to obtain informed consent or an alteration of the informed 
consent process for any of the following?  
  
* No  
  
4.7.1 If Yes, select the reason(s) for your request: 
There are no items to display 
 
 
General Requirements: The Federal Policy [45 CFR 46.116 (d)] specifies in order for a waiver of 
consent to be approved, the request must meet four criteria. For each request, you will be asked to 
provide a justification addressing how each of these criterion is met. 
   
  
 
   
Medical record review for the identification of potential subjects: 
 The research involves no more than minimal risk to the subjects; [45 CFR 46.116 (d)(1)] 
The waiver or alteration will not adversely affect the rights and welfare of the subjects;[45 
CFR 46.116 (d)(2)] 
 

The research could not practicably be carried out without the waiver or alteration;[45 CFR 
46.116 (d)(3)] 
Whenever appropriate, the subjects will be provided with additional pertinent information after 
participation; [45 CFR 46.116 (d)(4)] 
  
 
   
Review of identifiable medical records:  [Note: A waiver of HIPAA Authorization must be 
requested (2.14.2)]  Include the approximate number of medical records and/or specimens 
that will be accessed and enter -1 in question 3.11 for the number of subjects to be enrolled. 
The research involves no more than minimal risk to the subjects;[45 CFR 46.116 (d)(1)] 
The waiver or alteration will not adversely affect the rights and welfare of the subjects;[45 
CFR 46.116 (d)(2)] 
The research could not practicably be carried out without the waiver or alteration;[45 CFR 
46.116 (d)(3)] 
Whenever appropriate, the subjects will be provided with additional pertinent information after 
participation.[45 CFR 46.116 (d)(4)] 
 
 
  
 
   
Parental Permission and/or Child Assent 
 
The research involves no more than minimal risk to the subjects;[45 CFR 46.116 (d)(1)] 
 
The waiver or alteration will not adversely affect the rights and welfare of the subjects;[45 
CFR 46.116 (d)(2)] 
The research could not practicably be carried out without the waiver or alteration;[45 CFR 
46.116 (d)(3)] 
Whenever appropriate, the subjects will be provided with additional pertinent information after 
participation.[45 CFR 46.116 (d)(4)] 
 
  
 
   
Alteration of informed consent process 
The research involves no more than minimal risk to the subjects;[45 CFR 46.116 (d)(1)] 
The waiver or alteration will not adversely affect the rights and welfare of the subjects;[45 
CFR 46.116 (d)(2)] 
The research could not practicably be carried out without the waiver or alteration;[45 CFR 
46.116 (d)(3)] 
 
aWhenever appropriate, the subjects will be provided with additional pertinent information 
after participation.[45 CFR 46.116 (d)(4)]. 
 
 
  
 
   
Other Minimal Risk activity 
 
The research involves no more than minimal risk to the subjects;[45 CFR 46.116 (d)(1)] 
 
The waiver or alteration will not adversely affect the rights and welfare of the subjects;[45 
CFR 46.116 (d)(2)] 
 

The research could not practicably be carried out without the waiver or alteration;[45 CFR 
46.116 (d)(3)] 
Whenever appropriate, the subjects will be provided with additional pertinent information after 
participation.[45 CFR 46.116 (d)(4)]. 
  
 
   
4.7.2 Under what circumstances (if any) will you obtain consent from some of these subjects?  
   
    
View: 4.08 
Section 4 - Subject Recruitment and Informed Consent Procedures 
4.8 Are you requesting an exception to the requirement to obtain informed consent for research 
involving the evaluation of an 'emergency' procedure?Note: This exception allows research on 
life-threatening conditions for which available treatments are unproven or unsatisfactory and where 
it is not possible to obtain informed consent.*  No  
 
 
 
View: 4.09 Informed Consent 
   
Section 4 - Subject Recruitment and Informed Consent Procedures  
4.9 
Upload all consent documents for watermarking:Draft Consent Forms for editing: 
Name 
Modified Date 
BTI++ RUBIN Mod 10  12/2/2016 12:07 PM 
Approved Consent Form(s): 
Name 
Modified Date 
BTI++ RUBIN Mod 10  12/2/2016 12:07 PM 
 
 
View: 4.10 
 
Section 4 - Subject Recruitment and Informed Consent Procedures 
4.10 
Will all potential adult subjects be capable of providing direct consent for study 
participation? * Yes  
  
 
Indicate why direct consent is not possible: 
   
4.10.1 Provide a justification for the inclusion of adult subjects who are unable to provide direct 
consent for study participation. 
 
4.10.2 Specify the criteria used to determine that a potential adult subject is not able to provide 
direct consent for participation and identify who will be responsible for that 
determination. 
 
 
4.10.3 Will you obtain the potential adult subject's assent for study participation? 
*  
 
 
If No, provide a justification for not obtaining assent: 
   

4.10.4 Identify who will provide proxy consent for the participation of the decisionally impaired 
adult: 
  
    
View: 4.11 - 4.11(b) 
Section 4 - Subject Recruitment and Informed Consent Procedures 
4.11 
At what point will you obtain the informed consent of potential research subjects or their 
authorized representative?Prior to performing any of the screening procedures   
 
If Other, address below: 
 
4.11.1 Address why you feel that it is acceptable to defer obtaining written informed consent 
until after the screening procedures have been performed. 
 
4.11.2 Taking into account the nature of the study and subject population, indicate how the 
research team will ensure that subjects have sufficient time to decide whether to 
participate in this study.  In addition, describe the steps that will be taken to minimize the 
possibility of coercion or undue influence. 
A screening visit will be scheduled during the telephone pre-screening conversation with the 
study coordinator and the potential subject. This screening visit will take place at UPMC 
Aesthetic Plastic Surgery Center located at 3380 Boulevard of the Allies, Suite 158, Pittsburgh 
Pa. 15213 and will include review of the informed consent. The study investigator or co-
investigator will discuss with the subject the nature of the research study, design schema, the 
risks and benefits, cost and payments and their rights as a research subject. The potential subject 
will review the informed consent document allowing ample time to review all information and 
ask questions. Should the potential subject wish to take the consent and review it outside of the 
office setting or discuss with other family, medical personnel he/she will be able to leave the 
office and return at a later date. The study investigator will provide the potential subject a 
private area to conduct this study document review prior to signing the informed consent. After 
this detailed discussion of the study and conclusion of any and all questions, the study 
investigator, who is a physician, will obtain informed consent. The research coordinator will 
document the consenting process and prior to beginning any research activities provide a copy 
of the fully executed informed consent document to the subject for his or her records. No 
research related procedures, including but not limited to the screening procedures or the review 
of medical records will be performed before the informed consent has been obtained.  
 
    
View: 4.12 - 4.14(a) 
Section 4 - Subject Recruitment and Informed Consent Procedures  
4.12 Describe the process that you will employ to ensure the subjects are fully informed 
about this research study. *  Addressed below: This description must include the following 
elements:  
• 
who from the research team will be involved in the consent process (both the discussion 
and documentation);  
• 
person who will provide consent or permission;   
• 
information communicated; and  
 
 
 

• 
any waiting period between informing the prospective participant about the study and 
obtaining consent 
In addition, address the following if applicable based on your subject population: 
• 
process for child assent and parental permission 
o continued participation if a child subject turns 18 during participation 
• 
process for obtaining proxy consent and assent for decisionally impaired subjects 
o continued participation if subject regains capacity to consent 
The study investigator or co-investigator will discuss with the subject the nature of the research 
study, design schema, the risks and benefits, cost and payments and their rights as a research 
subject. The potential subject will review the informed consent document allowing ample time to 
review all information and ask questions. The study investigator will provide the potential subject 
a private area to conduct this study document review prior to signing the informed consent. After 
this detailed discussion of the study and conclusion of any questions, the study investigator, who 
is a physician, will obtain informed consent. The research coordinator will document the 
consenting process and prior to beginning any research activities provide a copy of the fully 
executed informed consent document to the subject for his or her records. No research related 
procedures, including but not limited to the screening procedures or the review of medical records 
will be performed before the informed consent has been obtained.If a re-consenting process is 
required based on regulatory guidance, the subject will be re-consented at their next scheduled 
visit or at an interim visit determined to be necessary for subject safety. The research member will 
highlight all changes with the subject while providing opportunity for the subject to review these 
changes at their leisure and make an informed decision to continue or discontinue study 
participation based on these changes.  
4.13 Are you requesting an exception to either IRB policy related to the informed consent 
process? 
• 
For studies involving a drug, device or surgical procedures, a listed physician investigator 
is required to obtain the written informed consent unless an exception to this policy has 
been approved by the IRB  
• 
For all other studies, a listed investigator is required to obtain consent (Note: In order to 
request an exception to this policy, the study must be minimal risk) 
*  No  
If Yes, provide a justification and describe the qualifications of the individual who will obtain 
consent:  
 
 
4.14 Will you inform research subjects about the outcome of this research study following its 
completion?*  No  If Yes, describe the process to inform subjects of the results: 
 
View: 5.01.1 - 5.01.2 Version 2 
Section 5 - Potential Risks and Benefits of Study Participation 
5.1 
Describe potential risks (physical, psychological, social, legal, economic or other) associated 
with screening procedures, research interventions/interactions, and follow-up/monitoring 
procedures performed specifically for this study: *   
 
 

View  
Research Activity:  
Chest X-ray   
Common Risks:  
The chest x-ray is one of the lowest radiation exposure medical examinations performed 
today. The effective radiation dose from this procedure is about 0.1 mSv, which is about the 
same as the average person receives from background radiation in 10 days.   
Infrequent Risks:  
No Value Entered  
Other Risks:  
No Value Entered  
View  
Research Activity:  
CT Scan-Risks of Radiation Exposure   
Common Risks:  
Experimental Interventions: This study will involve exposure to radiation. The amount of 
radiation exposure that each patient will receive will be about 1.3 rem per scan (a total of 5.2 
rem) with minimum exposure of other areas of the body. There is no Follow up Procedures: 
This study will involve exposure to radiation. The amount of radiation exposure that each 
patient will receive will be about 1.3 rem per scan (a total of 5.2 rem) with minimum 
exposure of other areas of the body. There is no minimum amount of radiation exposure that 
is recognized as being totally free of the risk of causing genetic mutations or cancer. 
However, the risk associated with the amount of radiation exposure is felt to be low and 
comparable to everyday risks.   
Infrequent Risks:  
No Value Entered  
Other Risks:  
No Value Entered  
View  
Research Activity:  
Medical History Assessment, Medical chart review and Physical Exam  
Common Risks:  
Screening Procedures: Breach of Confidentiality   
Infrequent Risks:  
No Value Entered  
Other Risks:  
No Value Entered  
 
 
View  
Research Activity:  
Photographs   
Common Risks:  
Experimental Interventions: There may be feelings of embarrassment during the 
photographs.   
Infrequent Risks:  
Experimental Interventions: Loss of Confidentiality.   
Other Risks:  
No Value Entered  
 
View  
Research Activity:  
Psychosocial Assessment   
Common Risks:  
Experimental Interventions: Anxiety and depressive symptoms are common among 
individuals who have experienced significant facial trauma and disfigurement and among 
individuals who have been in military combat. Follow up Procedures: Anxiety and depressive 
symptoms are common among individuals who have experienced significant facial trauma 
and disfigurement and among individuals who have been in military combat.   
Infrequent Risks:  
No Value Entered  
Other Risks:  
No Value Entered  
View  
Research Activity:  
Risk of Breach of Confidentiality   
Common Risks:  
All Follow up Procedures: Participation in this research study does involve the potential risks 
of a breach of confidentiality of the medical record information and associated privacy of the 
participants. The study investigators will take steps to reduce these risks by: 1) removing 
direct participant identifiers (i.e., names, social security numbers, medical record numbers) 
from information stored in the study records; 2) securing, in a separate location, and limiting 
access to information linking codes assigned to the study record information with direct 
participant identifiers; and 3) limiting access to information contained within the study 
records to study investigators only.   
Infrequent Risks:  
No Value Entered  
Other Risks:  
Screening Procedures: Participation in this research study does involve the potential risks of a 
breach of confidentiality of the medical record information and associated privacy of the 
participants. The study investigators will take steps to reduce the Experimental Interventions: 
Participation in this research study does involve the potential risks of a breach of 
confidentiality of the medical record information and associated privacy of the participants. 
The study investigators will take steps to reduce these risks by: 1) removing direct participant 
identifiers (i.e., names, social security numbers, medical record numbers) from information 
stored in the study records; 2) securing, in a separate location, and limiting access to 
information linking codes assigned to the study record information with direct participant 

identifiers; and 3) limiting access to information contained within the study records to study 
investigators only.   
View  
Research Activity:  
Risk of the Clinical Interview (SCID)   
Common Risks:  
Screening Procedures: Anxiety and depressive symptoms are common among individuals 
who have experienced significant facial trauma and disfigurement and among individuals 
who have been in military combat.  
Infrequent Risks:  
No Value Entered  
Other Risks:  
Screening Procedures: A feeling of emotional discomfort for the participant while answering 
questions during the interview process.   
View  
Research Activity:  
Risk of Venipuncture (blood draw)   
Common Risks:  
No Value Entered  
Infrequent Risks:  
Experimental Interventions: Infrequent (Occurs in 1% to 10% or 1 to 10 out of 100 people): 
mild pain and discomfort at the injection or needle insertion site as well as possible infection, 
bleeding, bruising and soreness.   
Other Risks:  
Experimental Interventions: Rare (Occurs in less than 1% or less than 1 out of 100 people): 
severe pain; swelling; possibly an infection from the actual injection; fainting.   
View  
Research Activity:  
Risks from reactions to anesthetic medicines   
Common Risks:  
No Value Entered  
Infrequent Risks:  
No Value Entered  
Other Risks:  
Experimental Interventions: Some anesthetic medicines may cause allergic or other abnormal 
reactions in some people, but these are rare. If you suspect you may have such a problem, 
you should tell both your surgeon and anesthesia specialist well before your surgery. Testing 
will then be arranged as necessary. A rare, potentially fatal condition called malignant 
hyperthermia (MH) may be triggered by some anesthetics. The anesthetics most commonly 
associated with malignant hyperthermia include the inhalation anesthetics and the muscle 
relaxant medicines.   
 
View  
Research Activity:  
Risks of Echocardiogram (EKG)   
Common Risks:  
Experimental Interventions: It is common (Occurs in 10-25% of people (10 to 25 out of 100 
people) that you may experience irritation or redness at the sites where small adhesive disks 
are placed on the chest skin to hold the wires that are hooked to the computer that measures 
heart rhythm.   
Infrequent Risks:  
No Value Entered  
Other Risks:  
No Value Entered  
View  
Research Activity:  
Surgical Anesthesia   
Common Risks:  
Experimental Interventions: Although all types of anesthesia involve some risk, major side 
effects and complications from anesthesia are uncommon. Your specific risks depend on your 
health, the type of anesthesia used, and your response to anesthesia. Some people who are 
going to have general anesthesia express concern that they will not be completely 
unconscious but will "wake up" and have some awareness during the surgical procedure. 
Awareness during general anesthesia is very rare because anesthesia specialists devote 
careful attention and use many methods to prevent this.   
Infrequent Risks:  
Experimental Interventions: Infrequent Risks: General anesthesia suppresses the normal 
throat reflexes that prevent aspiration, such as swallowing, coughing, or gagging. To help 
prevent aspiration, an endotracheal (ET) tube may be inserted during general anesthesia. 
When an ET tube is in place, the lungs are protected so stomach contents cannot enter the 
lungs. Aspiration during anesthesia and surgery is very uncommon. To reduce this risk, 
people are usually instructed not to eat or drink anything for a specific number of hours 
before anesthesia so that the stomach is empty. Anesthesia specialists use many safety 
measures to minimize the risk of aspiration. Insertion or removal of airways may cause 
respiratory problems such as coughing; gagging; or muscle spasms in the voice box, or 
larynx (laryngospasm), or in the bronchial tubes in the lungs (bronchospasm). Insertion of 
airways also may cause an increase in blood pressure (hypertension) and heart rate 
(tachycardia). Other complications may include damage to teeth and lips, swelling in the 
larynx, sore throat, and hoarseness caused by injury or irritation of the larynx.   

Other Risks:  
Experimental Interventions: Other serious risks of General anesthesia: These include changes 
in blood pressure or heart rate or rhythm, heart attack, or stroke. Death or serious illness or 
injury due solely to anesthesia is rare and is usually also related to complications from the 
surgery. Death occurs in about 1 in 250,000 people receiving general anesthesia, although 
risks are greater for those people with serious medical conditions. Serious side effects of 
general anesthesia are uncommon in people who are otherwise healthy. But because general 
anesthesia affects the whole body, it is more likely to cause side effects than local or regional 
anesthesia. Most side effects of general anesthesia are minor and can be easily managed.  
View  
Research Activity:  
Surgical Fat Grafting procedure   
Common Risks:  
Experimental Interventions: Change in appearance: Typically the transferred Fat loses some 
of it's volume over time and then becomes stable. It is possible that more treatments maybe 
needed to maintain the desired volume of the transferred fat and resulting appearance. Less 
commonly, if you experience significant weight gain, the transferred fat may increase in 
volume and cause an undesirable appearance. Skin Contour: While most transferred fat 
results in a natural feel, it is possible that some or all of the fat may become firm, hard or 
lumpy. If some of the fat does not survive the transfer it may result in fat necrosis (fat tissue 
death) caussing firmness and discomfort and pain. Cysts may also form at the site of the 
transferred fat. Asymmetry: symmetrical body appearance may not result from a fat graft 
procedure. Factors such as skin tone, fatting deposits, boney prominences, and muscle tone 
may contribute to normal asymmetry in body features. Pain: Chronic pain may occur rarely 
after fat removal or graft.   
Infrequent Risks:  
Experimental Interventions: Bleeding: It is possible, though unusal to experience a bleeding 
episode during or after this procedure. Should bleeding occur, it may require emergency 
treatment to drain accumulated blood (hematoma). Seroma: Although unlikely, a collection 
of fluid may appear at the site where the fat was removed. This is usually treated by draining 
the fluid with a needle. Infection: Infection is unusual after this procedure should infection 
occur additional treatment including antibiotics or surgery may be necessary. Tissue Loss: In 
rare cases, the grafted fat may cause the skin over the transferred area to be injured resulting 
in loss of the skin and surrounding tissue. This may leave scars and disfigurement. Damage 
to deeper structures: Deeper structures such as nerves, blood vessels and muscles may be 
damaged during the course of this procedure. The potential for this to occur varies according 
to where on the body the procedure is being performed. The injury to deeper structures may 
be temporary or permanent. serous complications may include blood clots, partial collapse of 
lungs, pulmonary embolism, fat embolism, stroke, infection, blindness loss of vision, and/or 
death.   
Other Risks:  
Experimental Interventions: Scarring: All invasive procedures produce scars, some more 
visible than others. although good wound healing after a procedure is expected, abnormal 
scars may occur both within the skin and within the deeper tissues. Scars may be unattractive 
and of different color than the surrounding skin. There is the possibility of visible marks from 
sutures used to close the wound. Scars may also limit motion and function. Additional 
treatment including surgery may be needed to treat scarring. Long term effect: subsequent 
changes in the shape or appearance of the area were the fat was removed or placed may occur 
as a result of aging, weight loss or gain, or other circumstances not related to the Fat grafting 
procedure. Unsatisfactory result: There is a possibility of unsatisfactory result from the 
procedure resulting in unacceptable visible deformities, loss of function, wound disruption, 
skin death and loss of sensation. Allergic reaction: In rare cases local allergies to tape, suture 
material, or topical preparations have been reported. Systemic reactions, which are more 
serious, may result from drugs used during the procedure.   
 
 
  
5.1.1 Describe the steps that will be taken to prevent or to minimize the severity of the potential 
risks: Screening Procedures:Subject will be in a private room. All Study materials will be 
assigned a study ID code. No personal information will be on said study materials. All paper files 
will be in a locked file cabinet within the Department of Plastic and Reconstructive Surgery 
offices. All computer based files will be password protected. Experimental Interventions:The 
plastic surgeons performing the fat graft procedures are highly trained and skilled with years for 
surgical procedures inclusive of grafting. The anesthesiologists are highly trained and skilled 
with many years of clinical surgical procedures with the use of various methods of sedation. All 
research staff are trained in research conduct and compliance having completed all required 
research modules and have education in Good Clinical Practice in research. All research staff are 
 
 
 

trained in the use of the 3D and 2D cameras. The pictures will be taken in a timely manner so as 
not to prolong any possible discomfort for the subject. Also, the photographs will labeled with 
subject ID only and will not be stored with any additional identifiable information. The 
photographs will be located within a secure database within a locked office. Only the Study 
Investigators and associated research staff will have access to these photographs.In addition to 
our screening and subsequent pregnancy tests, the CT technicians are well-versed in the risks and 
thoroughly question the subject prior to each exam, including excess exposure to radiation. All 
exams will be terminated as soon as the subject expresses any discomfort. The psychosocial 
evaluations will be conducted by the research technician. A clinically significant symptom 
elevation or increase on these measures will direct the technician to contact the clinical 
psychologist on the team (GLH) who will visit with the patient on-site to ascertain need for 
further evaluation and possible referral for mental health support services. Follow up 
Procedures:All research staff are trained in the use of the 3D and 2D cameras. The pictures will 
be taken in a timely manner so as not to prolong any possible discomfort for the subject. Also, the 
photographs will be de-identified and labeled with subject ID only. The photographs will be 
located within a secure database within a locked office.In addition to our screening and 
subsequent pregnancy tests, the CT technicians are well-versed in the risks and thoroughly 
question the subject prior to each exam, including excess exposure to radiation. All exams will be 
terminated as soon as the subject expresses any discomfort. The psychosocial evaluations will be 
conducted by the research technician. A clinically significant symptom elevation or increase on 
these measures will direct the technician to contact the clinical psychologist on the team (GLH) 
who will visit with the patient on-site to ascertain need for further evaluation and possible referral 
for mental health support services.  
5.2 
What steps will be taken in the event that a clinically significant, unexpected disease or 
condition is identified during the conduct of the study?*  Addressed below:  
Upon discovery the PI and/ or co-investigator will notify the subject of any event that could be of 
clinical significance needing further evaluation, or of a diagnosis of any unexpected disease or 
condition that occurred during the conduct of the study's research procedures. The study 
investigator will at the time of discovering the event contact the referring physician or primary 
physician for further evaluation of the event. Should the event be of a critical nature needing 
immediate intervention, the study investigator or co-investigator will proceed with immediate 
clinical intervention and screening procedures will be concluded.  
  
 
5.3 
All the risk questions (screening, intervention/interaction, follow-up) have been merged into 
one question (5.1). 
 
View: 5.04 
Section 5 - Potential Risks and Benefits of Study Participation 
5.4 
Do any of the research procedures pose a physical or clinically significant psychological risk 
to women who are or may be pregnant or to a fetus?* Yes  
 
5.4.1 List the research procedures that pose a risk to pregnant women or fetuses: 
Ct scan and anesthesia for the fat graft surgery 
 
5.4.2 Describe the steps that will be taken to rule out pregnancy prior to exposing women of 
child-bearing potential to the research procedures that pose a risk to pregnant women or 
fetuses: 
 

All participants who are women of child bearing potential will receive a urine pregnancy dip test 
at screening and prior to any CT scan and surgical procedure. Educate the subject that during 
participation in this clinical trial they are not to become pregnant and that pregnancy will result in 
their removal from the clinical trial.  
5.4.3 Describe the measures to prevent pregnancy, and their required duration of use, that will 
be discussed with women of child-bearing potential during and following exposure to 
research procedures: 
All participants who are women of child bearing potential will receive a urine pregnancy dip test 
at screening and prior to any CT scan and surgical procedure. Educate the subject that during 
participation in this clinical trial they are not to become pregnant and that pregnancy will result in 
their removal from the clinical trial.  
 
    
View: 5.05 
Section 5 - Potential Risks and Benefits of Study Participation 
5.5 
Do any of the research procedures pose a potential risk of causing genetic mutations that 
could lead to birth defects?*  Possibly or Definitely  
 
5.5.1 List the research procedures that pose a potential risk of genetic mutations/birth defects: 
CT Scans and Anesthesia used for Fat grafting procedure  
 
5.5.2 Describe the measures to prevent pregnancy, and their required duration of 
use, in female subjects and female partners of male subjects during and following exposure 
to research procedures:  
All participants who are women of child bearing potential will receive a urine pregnancy dip test 
at screening and prior to any CT scan and surgical procedure. Educate the subject that during 
participation in this clinical trial they are not to become pregnant and that pregnancy will result in 
their removal from the clinical trial.  
 
 
    
View: 5.06 - 5.06(a) 
Section 5 - Potential Risks and Benefits of Study Participation 
5.6 Are there any alternative procedures or courses of treatment which may be of benefit to the 
subject if they choose not to participate in this study?*  Yes - Describe below:  
If Yes, describe in detail:- Receive fat grafting procedure as standard of care- Receive another 
plastic surgery procedure to address their injury and/or appearance.  
 
 
View: 5.07 - 5.07(a) 
Section 5 - Potential Risks and Benefits of Study Participation  
5.7 Describe the specific endpoints (e.g., adverse reactions/events, failure to demonstrate 
effectiveness, disease progression) or other circumstances (e.g., subject's failure to follow 
study procedures) that will result in discontinuing a subject’s participation?*  Describe below:  
 

Noncompliance of study visits (including but not limited to completion of screening and study visit 
procedures). Development of complications that obscures evaluation of the fat graft results, i.e. 
severe infection at the graft site resulting in a need for further surgery.  
View: 5.08 -5.08(a) 
Section 5 - Potential Risks and Benefits of Study Participation 
5.8 
Will any individuals other than the investigators/research staff involved in the conduct of 
this research study and authorized representatives of the University Research Conduct and 
Compliance Office (RCCO) be permitted access to research data/documents (including 
medical record information) associated with the conduct of this research study?*  Yes  
 
 
 
5.8.1 Identify the 'external' persons or entity who may have access to research data/documents 
and the purpose of this access: 
Department of Defense and their contracted entities will review and/or obtain identifiable 
information; which may include the subject’s identifiable medical information related to 
participation in this research study for the purpose of monitoring the accuracy and completeness 
of the research data and for preparing required scientific analyses of the research data. 
Authorized representatives of the UPMC hospitals or other affiliated health care providers may 
have access to identifiable information (which may include the subject's identifiable medical 
information) related to their participation in this research study for the purpose of (1) fulfilling 
orders, made by investigators, for hospital and health care services (e.g. laboratory tests) 
associated with this research study participation, (2) addressing correct payment for tests and 
procedures ordered by the investigators, and/or (3) for internal hospital operations (i.e. quality 
assurance).This research study will result in identifiable information that will be placed into the 
subject's medical records held at UPMC. The nature of the identifiable information resulting from 
the subject's participation in this research study that will be recorded in their medical record will 
be derived from the medical/surgical (fat grafting procedure). Psychiatric interview information 
will be entered into the medical record only if it is important to ensure the subject's 
medical/physical safety. In unusual cases, the investigators may be required to release identifiable 
information (which may include your identifiable medical information) related to your 
participation in this research study in response to an order from a court of law. If the investigators 
learn that you or someone with whom you are involved is in serious danger or potential harm, 
they will need to inform, as required by Pennsylvania law, the appropriate agencies. 
  
 
5.8.2 Will these 'external' persons or entity have access to identifiable research data/documents? 
*Yes - Describe below:  
 
 
If Yes, describe how they will protect the confidentiality of the research data:While the study 
funding source, Department of Defense (DOD), understands the importance of maintaining the 
confidentiality of the identifiable research and medical information, the UPMC and the 
University of Pittsburgh cannot guarantee the confidentiality of this information after it has been 
obtained by the Department of Defense. 
  
 
5.9 
Has or will a Federal Certificate of Confidentiality be obtained for this research study? 
*  No  
 
 
5.10 Question has been moved to 5.17 
   
5.11 Question has been moved to 5.16 
  

    
View: 5.12 - 5.13 
Section 5 - Potential Risks and Benefits of Study Participation 
5.12 Does participation in this research study offer the potential for direct benefit to the research 
subjects?Yes - Describe the direct benefit that subjects may receive as a result of study 
participation. Indicate if all, or only certain, of the subjects may derive this potential 
benefit.  Describe the benefit:Historically fat grafting procedures performed for clinical purposes 
have supported positive cosmetic and surgical results in patients. Although we cannot guarantee a 
positive outcome from this research fat grafting procedure, there may be a direct benefit to the 
research subject from his/her participation in this research study. In addition, this research may 
provide a greater understanding of the effects of fat grafting over time. 
 
 
5.13 Describe the data and safety monitoring plan associated with this study. If the research 
study involves multiple sites, the plan must address both a local and central review 
process.Data Safety Monitoring PlanThe Data Safety and Monitoring Plan for this trial will 
consist of two parts. A Local Data and Safety Monitoring Plan will be implemented by the 
Principal Investigator to ensure that there are no changes in the risk/benefit ratio during the course 
of the study and that confidentiality of research data is maintained. This DSMB will consist of the 
PI, Co-Investigators and study personnel who will meet and discuss monthly the study (e.g., study 
goals and modifications of those goals; subject recruitment and retention; progress in data coding 
and analysis; documentation, identification of adverse events or research subject complaints; 
violations of confidentiality) and address any issues or concerns at that time. Minutes will be kept 
for these meetings and will be maintained in the study DSMB binder. Any instances of adverse 
events will be reported immediately to the University of Pittsburgh IRB in accordance with the 
guidance on the IRB website. The annual IRB renewal for this study will include a summary 
report of the Data and Safety Monitoring Plan findings from the study for the prior year. We will 
include the following information at the time of the IRB renewal regarding the frequency of the 
monitoring, the dates that the monthly meetings took place, a summary of the cumulative adverse 
events, external factors or relevant information that might have an impact on the safety or ethics 
of the study, and final conclusions regarding changes to the anticipated risk/benefit ratio to study 
participation and final recommendations related to the continuation, changing, or termination of 
the study. The protocol will be not be initiated until written notification of approval of the 
research project is issued by the HRPO. A copy of the approved continuing review report and the 
local IRB approval notification will be submitted to the USAMRMC ORP HRPO as soon as these 
documents become available. A copy of the approved final study report and local IRB approval 
notification will be submitted to the USAMRMC ORP HRPO as soon as these documents become 
available. Substantive modifications to the research protocol and any modifications that could 
potentially increase risk to subjects must be submitted to the HRPO for approval prior to 
implementation. The USAMRMC ORP HRPO defines a substantive modification as a change in 
Principal Investigator, change or addition of an institution, elimination or alteration of the consent 
process, change to the study population that has regulatory implications (e.g. adding children, 
adding active duty population, etc.), significant change in study design (i.e. would prompt 
additional scientific review), or a change that could potentially increase risks to subjects. All other 
amendments must be submitted with the continuing review report.All unanticipated problems 
involving risk to subjects or others must be promptly reported by phone (301-619-2165), by email 
(HRPO@amedd.army.mil), or by facsimile (301-619-7803) to the HRPO. A complete written 
report will follow the initial notification. In addition to the methods above, the complete report 
can be sent to the US Army Medical Research and Materiel Command, ATTN: MCMR-RP, 504 
Scott Street Fort Detrick, Maryland 21702-5012 Suspensions, clinical holds (voluntary or 
involuntary), or terminations of this research by the IRB, the institution, the sponsor, or regulatory 
 
 
 

agencies will be promptly reported to the USAMRMC ORP HRPO.A copy of the continuing 
review report and the re-approval notification by the UP IRB must be submitted to the HRPO as 
soon as possible after receipt of approval. Please note that the HRPO also conducts random audits 
at the time of continuing review and additional information and documentation may be requested 
at that time.The final study report submitted to the UP IRB, including a copy of any 
acknowledgement documentation and any supporting documents must be submitted to the HRPO 
as soon as all documents become available.The knowledge of any pending compliance 
inspection/visit by the Food and Drug Administration (FDA), Office for Human Research 
Protections, or other government agency concerning this research; the issuance of inspection 
reports, FDA Form 483, warning letters, or actions taken by any regulatory agencies including 
legal or medical actions; and any instances of serious or continuing noncompliance with the 
regulations or requirements must be reported immediately to the HRPO.Accurate and complete 
study records will be maintained and made available to representatives of the USAMRMC as a 
part of their responsibility to protect human subjects in research. All research records are stored in 
a confidential manner so as to protect the confidentiality of subject information.Per DoD 
Directive 3216.02, all greater than minimal risk studies require a Medical Monitor. The 
USAMRMC ORP HRPO also reserves the authority to require assignment of a Medical Monitor 
for those protocols assessed as presenting no greater than minimal risk to the subjects 
participating in the study. The second part of the DSMP will be the inclusion of an Independent 
Data Safety Monitoring Board (IDSMB). This IDSMB will convene once a year or as needed for 
review of all unanticipated events, adverse events, and serious adverse events affecting the risk to 
the human subject or others. The members of the IDSMB include Drs. Ernest Manders and James 
Russavage who are all present faculty members within the Department of Plastic Surgery at the 
University of Pittsburgh, without any involvement in this research protocol, they are not under the 
supervision of the PI or have a conflict of interest. Dr Manders, a member of the Independent 
Data Safety and Monitoring Board (IDSMB) will act as the Research Monitor for this study; he is 
available on site to respond to any urgent or emergency situations that may arise during the study 
and to serve as the subject advocate. The Research Monitor is required to review all unanticipated 
problems involving risk to subjects or others, serious adverse events and all subject deaths 
associated with the protocol and provide an unbiased written report of the event. At a minimum, 
the Research Monitor must comment on the outcomes of the event or problem and in case of a 
serious adverse event or death, comment on the relationship to participation in the study. The 
Research Monitor must also indicate whether he/she concurs with the details of the report 
provided by the principal investigator. The Medical Monitor has the authority to stop the research 
at any time; he /she can remove individuals from the study, and take any steps necessary to 
protect the safety and well being of participants until the IRB has time to assess the study. This 
IDSMB will evaluate any adverse events and research staff adherence to subject confidentiality 
and de-identification processes. The IDSMB members will discuss, if necessary, any changes to 
the risk/benefit ratio of this study for the PI’s report to the local IRB of all reporting adverse 
events, external factors or relevant information that might have an impact on the safety or ethics 
of the study, and final conclusions regarding changes to the anticipated risk/benefit ratio to study 
participation and final recommendations related to the continuation, changing, or termination of 
the study as outlined by the University of Pittsburgh IRB. 
View: 5.14 - 5.17 
Section 5 - Potential Risks and Benefits of Study Participation 
5.14 What precautions will be used to ensure subject privacy is respected? (e.g. the research 
intervention will be conducted in a private room; the collection of sensitive information about 
subjects is limited to the amount necessary to achieve the aims of the research, so that no 
 
 

unneeded sensitive information is being collected, drapes or other barriers will be used for 
subjects who are required to disrobe) 
 All aspects of the study will be performed in a private room, including the consenting process, 
exams, photographs, CT scan, laboratory blood draw and the fat grafting procedure. The 
collection of sensitive information about subjects is limited to the amount necessary to achieve the 
aims of the research, so that no unneeded sensitive information is being collected, drapes or other 
barriers will be used for subjects who are required to disrobe. 
5.15 What precautions will be used to maintain the confidentiality of identifiable information? 
(e.g., paper-based records will be kept in a secure location and only be accessible to personnel 
involved in the study, computer-based files will only be made available to personnel involved in 
the study through the use of access privileges and passwords, prior to access to any study-related 
information, personnel will be required to sign statements agreeing to protect the security and 
confidentiality of identifiable information, whenever feasible, identifiers will be removed from 
study-related information, precautions are in place to ensure the data is secure by using passwords 
and encryption, because the research involves web-based surveys, audio and/or video recordings 
of subjects will be transcribed and then destroyed to eliminate audible identification of subjects) 
 Participation in this research study does involve the potential risks of a breach of confidentiality 
of the medical record information and associated privacy of the participants. The study 
investigators will take steps to reduce these risks by: 1) removing direct participant identifiers 
(i.e., names, social security numbers, medical record numbers) from information stored in the 
study records; 2) securing, in a separate location, and limiting access to information linking codes 
assigned to the study record information with direct participant identifiers; and 3) limiting access 
to information contained within the study records to study investigators only. Paper-based records 
will be kept in a secure location and only be accessible to personnel involved in the study, 
computer-based files will only be made available to personnel involved in the study through the 
use of access privileges and passwords, prior to access to any study-related information, personnel 
will be required to sign statements agreeing to protect the security and confidentiality of 
identifiable information, whenever feasible, identifiers will be removed from study-related 
information, precautions are in place to ensure the data is secure by using password restrictions 
and folder level access by permission only on UPMC servers.Reference to sample: All research 
samples will be stored to include assigned code numbers, and any information linking these code 
numbers to the corresponding subjects’ identities will be kept in a separate, secure location 
located in the security manned Biomedical Science Tower. Should the subject decide to withdraw 
or be withdrawn from study participation, the already collected samples will be kept and not 
destroyed. It is the Principal Investigator’s intention to make stored samples and subject de-
identified information available to secondary investigators (investigators not listed on the front 
page of this consent document) after all research study testing has been completed. These stored 
samples and associated subject information will not include subject identifiers.The photographs 
will be housed as electronic files within the Canfield camera system. The system is password 
protected and is located within the locked offices of the Aesthetic Plastic Surgery Center located 
at 3380 Boulevard of the Allies, suite 180 Pittsburgh pa 15213. While the photographs will be 
labeled with an ID code, there is a risk of loss of confidentiality. The digital recordings are being 
collected for the purpose of medical education and training, publication, and media reports – and, 
in any mode of transmission, including and not limited to: print, email, television, internet, etc. 
All digital records (i.e. photography or video) obtained during any or all of the subject's pre-
operative, operative, and post-operative period, may include, but not be limited to videos of 
personal interviews, functional assessment testing and clinical exams or photos of follow up, 
biopsies, etc. will be given a specific code and stored without any additional identifiable 
 
 

information. These recordings will be stored indefinitely in a secure, password protected location 
on the UPMC server.  
5.16 If the subject withdraws from the study, describe what, if anything, will happen to the 
subject’s research data or biological specimens. 
Any identifiable research or medical information recorded for, or resulting from, your 
participation in this research study prior to the date that you formally withdrew your consent will 
continue to be used and disclosed by the investigators for the purposes described above. All 
research samples will be stored to include assigned code numbers, and any information linking 
these code numbers to the corresponding subjects’ identities will be kept in a separate, secure 
location located in the Department of Plastic and Reconstructive Surgery at the University of 
Pittsburgh. Should the subject decide to withdraw or be withdrawn from study participation, the 
already collected samples and all digital recordings will be kept and not destroyed. We are not 
collecting or storing any samples for any use in future research studies with this clinical trial; 
samples will not be retained for testing in future studies. All samples and digital recordings 
collected during your participation in this clinical trial, upon your early withdraw from the study, 
will be kept and not destroyed, but processed specifically as outlined as stated in the research 
design for this trial. It is the Principal Investigator’s intention to make stored samples and subject 
information de-identified available to secondary investigators (investigators not listed on the front 
page of this consent document) after all research study testing has been completed. These stored 
samples and associated subject information will not include subject identifiers. Subjects will be 
instructed that they may choose to withdraw from this study at any time, but it is important that 
they continue to be monitored by a physician after they receive the research Fat grafting 
procedure in order to ensure their safety. It is also important for the subject to contact study 
personnel if they later experience any side effects that they might feel are related to the research 
study.   
 
5.17 Following the required data retention period, describe the procedures utilized to 
protect subject confidentiality. (e.g., destruction of research records; removal of identifiers; 
destruction of linkage code information; secured long-term retention)  
Any information about the subject obtained from or for this research study will be kept as 
confidential (private) as possible. All records related to the subject's involvement in this research 
study will be kept in a locked file cabinet or in a password protected computer database accessible 
only to study personnel as described above. The identity on these records will be indicated by a 
unique study number, rather than by name, and the information linking this study number with the 
subject's identity will be kept separate from the research records. The digital recordings are being 
collected for the purpose of medical education and training, publication, and media reports – and, 
in any mode of transmission, including and not limited to: print, email, television, internet, etc. 
All digital records (i.e. photography or video) obtained during any or all of the subject's pre-
operative, operative, and post-operative period, may include, but not be limited to videos of 
personal interviews, functional assessment testing and clinical exams or photos of follow up, 
biopsies, etc. and will be will be given a specific code and stored without any additional 
identifiable information. The digital recordings will be stored indefinitely in a secure password 
protected, location on the UPMC server. The subject will not be identified in any publication of 
the research study.A description of this clinical trial will be available on www.clinicaltrials.gov, 
as required by US Law. This website will not include information that can identify the subject. At 
most, the website will include a summary of the results. The subject can search this website at any 
time. 
 
    

View: 6.1 
  
  
Section 6 - Costs and Payments 
6.1 
Will research subjects or their insurance providers be charged for any of the procedures 
(e.g., screening procedures, research procedures, follow-up procedures) performed for the 
purpose of this research study?*  No  
 
6.1.1 Specify what research procedures will be billed to the subject or insurance provider: 
   
6.1.2 Provide a justification for billing subjects or insurance providers for procedures that are 
performed solely for the purpose of the research study. 
 
6.1.3 Will subjects or insurance providers be billed for the investigational drug or device being 
evaluated or used in this research study? 
* 
 
Provide assurance that the FDA has given approval for the sponsor of this research study to 
charge investigators for the investigational drug or device.   
 
If this is an investigational device, indicate if the Health Care Financing Administration has 
designated it as a Class B medical device. 
*  
 
6.1.4 Address the contingencies that are in place to ensure that potential subjects, who may 
desire to participate in this research study but are not able to bear this personal financial 
risk, will be afforded access to study participation. 
 
    
View: 6.2 
  
Section 6 - Costs and Payments 
6.2 
Will subjects be compensated in any way for their participation in this research 
study?*  Yes  
 
6.2.1 Describe the amount of payment or other remuneration offered for complete participation 
in this research study.Study subjects will be remunerated for their participation in the research 
study a per diem total rate of $104.00/day. The subjects will receive the remuneration upon 
completion of each study visit. The subject’s reasonable travel expenses are reimbursed at 50.0 
cents per mile round trip. Travel may include air fare coverage round trip booked through the 
University of Pittsburgh travel agency "People's Travel". Proper supporting documentation for 
mileage reimbursement is demonstrated by trip tickets or a Mapquest inquiry from the subject’s 
place of residence to the study site displaying round trip mileage. Subjects will be reimbursed 
using the UPMC “WE PAY” system at the time of each visit. 
 
6.2.2 Describe the amount and term of payment or other remuneration that will be provided for 
partial completion of this research study.Study subjects will be remunerated for their 
participation in the research study a per diem total rate of $104.00/day. The subjects will receive 
the remuneration upon completion of each study visit.  
 
 
 

    
View: 7.1 
Section 7 - Qualifications of Investigators and Sources of Research Study 
7.1 Summarize the qualifications and expertise of the principal investigator and listed co-
investigators to perform the procedures outlined in this research study.               J. Peter 
Rubin, MD is Chair, Department of Plastic Surgery and a Professor of Surgery. He is Board 
certified in plastic surgery and an expert in the areas of upper and lower extremity surgery, body 
contouring surgery as well as adipose research. He is the Co-Director of the Aesthetic Plastic 
Surgery Center, the Director and founder of the Life After Weight Loss Center. He is also the co-
director of the Plastic Surgery research lab. He will actively perform the research procedures and 
provide medical oversight for all study subjects. He is responsible for review and meeting of 
subject research study eligibility criteria, consenting process, research study procedures, overall 
protection of human subject risks and benefits, performance of clinical trial conduct and 
compliance maintaining GCP. Sydney Coleman, MD is a renowned plastic surgeon having over 20 
years of expertise in the Fat grafting procedure. Dr. Coleman is the inventor of the Coleman 
Cannula System which is the instrumentation being used with this research surgical procedure. He 
will serve as a technical consultant where his expertise will be use to enhance this project.T. Oguz 
Acarturk, MD finished his Plastic Surgery Residency (Integrated) at the University of Pittsburgh in 
2004. He then served a year in the Turkish Military at the Gülhane Military Medical Academy in 
Ankara, Turkey. He later joined the Çukurova University Department of Plastic Surgery in Adana, 
Turkey in 2005 and has been there since, as an Associate Professor. T. Oguz Acarturk, MD joined 
the UPMC Department of Plastic Surgery in November 2011, where is main appointment will be in 
the area of head and neck reconstruction. His clinical interests include microsurgery, general 
reconstruction and aesthetic surgery. In addition, he has experience in burn reconstruction, 
pediatric plastic surgery, orthognatic surgery and craniofacial trauma. His research interest includes 
prefabricated flaps, flap physiology and perforator flaps. As a Co-Investigator, he will provide 
clinical oversight for study subjects, will be responsible for collection of information assessing the 
research study eligibility criteria, consenting process, research study procedures, overall protection 
of human subject risks and benefits, performance of clinical trial conduct and compliance 
maintaining GCP.Jeffrey Gusenoff, MD is Co-Director of the Life After Weight Loss Program and 
Visiting Associate Professor of Surgery in the Department of Plastic Surgery at UPMC. He 
completed his undergraduate and medical school training at The Johns Hopkins University in 1998 
and 2002. His residency in General and Plastic Surgery was at the University of Rochester School 
of Medicine in Rochester, NY, and he graduated in 2007. This was followed by a fellowship in 
Post-Bariatric Body Contouring with J. Peter Rubin, MD at the University of Pittsburgh Medical 
Center. From 2008 until 2012, Dr. Gusenoff was an Assistant Professor of Surgery and Director of 
the Life After Weight Loss Program at the University of Rochester Medical Center. His research 
experience includes extensive clinical outcomes research. As a principle/co-investigator, he will 
provide clinical oversight for study subjects, will be responsible for collection of information 
assessing the research study eligibility criteria, consenting process, research study procedures, 
overall protection of human subject risks and benefits, performance of clinical trial conduct and 
compliance maintaining GCP.Albert Donnenberg, PhD, Since 1998, Dr. Donnenberg has also been 
the director of University of Pittsburgh Cancer Institute's (UPCI) Flow Cytometry Facility. 
Additionally, he is currently the Deputy Director of the Stem Cell Transplantation (SCT) Program 
and Director of UPCI Bone Marrow Processing Laboratory. Dr. Donnenberg graduated with a B.A. 
in Philosophy from the University of Colorado in 1973. Following the completion of his Ph.D. in 
Infectious Disease Epidemiology from Johns Hopkins University School Public Health in 1980, 
Dr. Donnenberg served as a Research Fellow in Oncology at Johns Hopkins University School of 
Medicine until 1982. Dr. Donnenberg is the recipient of multiple awards for his research efforts at 
 
 
 

the university. Among his honors are induction into the Delta Omega Honorary Public Health 
Society and his receipt of a 1988 - 1993 Carter-Wallace Fellowship for AIDS Research. Most 
recently, he was honored as a visiting fellow at the Institute Pasteur in Paris in 1994. As the 
director of University of Pittsburgh Cancer Institute's (UPCI) Flow Cytometry Facility and Deputy 
Director of the Stem Cell Transplantation (SCT) Program and Director of UPCI Bone Marrow 
Processing Laboratory, he will have oversight of the cell processing of the adipose tissue, and 
oversee the flow cytomety studies within the GMP hematopoietic stem cell laboratory, analyze the 
data, and assist in manuscript preparation.Vera Svobodova Donnenberg, PhD, Assistant Professor 
of Surgery, University of Pittsburgh, is a co-investigator who will oversee the flow cytometry 
analysis of the cell product and will directly supervise all technical aspects of the flow cytometry 
studies and ensure quality control. Dr. Donnenberg research focuses on flow cytometry, broncho-
alveolar lavage fluid, and the analysis of dendritic cell subsets. Dr. Donnenberg has written over 75 
publications, abstracts and other scientific presentations. Dr. Donnenberg is a member of several 
professional and scientific societies including the American College of Clinical Pharmacology, 
American Association for Cancer Research, and the International Society for Analytical 
Cytology.Kacey Marra, PhD is an expert in the area of adipose research experience. The Co-
director of the Plastic Surgery research lab, Dr. Marra has almost 10 years of adipose research. She 
will be responsible for the oversight of all lab processing, maintenance and storage of all research 
biological samples collected for this study. Barton Branstetter, MD is an experienced radiology 
clinician of 10 years. He will be responsible for the physician review and reporting of the 
radiological CT scans tests conducted in this study. Gretchen Haas, PhD is a psychologist who has 
extensive experience working with veterans, and specializes in measures of social function. She is 
responsible for the initial and ongoing evaluation of potential participant's clinical interview and 
quality of life assessments conducted in this study. Patsy Simon, RN, BS, CCRC, CCRA Director, 
Regulatory and Clinical Affairs University of Pittsburgh, Department of Plastic Surgery at the 
UPMC Center for Innovation in Restorative Medicine. Ms. Simon has over 30 years of clinical 
nursing expertise with 17 years of research trial conduct and compliance expertise inclusive of 
Federal, Industry and Investigator Sponsored IND and IDE clinical trials experience. Ms. Simon’s 
role on this project will consist of the regulatory and clinical oversight and management of this 
department of defense trial. This role includes guidance on the development, execution and 
adherence of good clinical practice and clinical procedure development to ensure compliance with 
trial execution.Diana Mermon, MS has a Master's degree in Counseling with a Certification in 
Education – master’s level. Diana has over 10 years of research experience and will conduct the 
subject's clinical interview and the quality of life assessments. Elizabeth Radomsky, PhD, is a 
clinical psychologist with extensive experience and specific training and expertise in the use of 
neuropsychological assessments and diagnostic and psychopathology rating instruments. She has 
over 25 years of research experience. She will be responsible for conducting the subject's clinical 
interview and the quality of life assessments at baseline and follow-up assessments. Paul Afrooz, 
MD is a plastic surgery resident and is responsible for review and meeting of subject research study 
eligibility criteria, consenting process, research study procedures, overall protection of human 
subject risks and benefits, performance of clinical trial conduct and compliance maintaining GCP. 
Jacqueline Bliley, MS, has over a year of clinical experience and over seven years laboratory 
experience. She will be responsible for providing clinical oversight for study subjects, and 
obtaining research specimens for storage. She will also provide insight into research study 
procedures and the overall protection of human subject risks and benefits. Isaac James, MS has a 
year of laboratory experience within the BST Adipose Stem Cell Laboratory. As co-investigator on 
this study he will be responsible for obtaining lipoaspirate from the operative area and transporting 
specimens to the laboratory (BST and HSC) for processing and analysis. Jordan Fishman, MD is 
employed by UPMC and a member of the Department of Plastic Surgery. As a co-investigator, he 
is responsible for collection of information assessing the research study eligibility criteria and 
consenting process, research study procedures, overall protection of human subject risks and 

benefits, performance of clinical trial conduct and compliance maintaining GCP.Debra Smith, MD 
is employed by UPMC and a member of the Department of Plastic Surgery. As a co-investigator, 
she is responsible for collection of information assessing the research study eligibility criteria and 
consenting process, research study procedures, overall protection of human subject risks and 
benefits, performance of clinical trial conduct and compliance maintaining GCP.Amy Steele, RN, 
MSN, CCRC has over 15 years of regulatory and clinical research experience. Her study role will 
be to actively perform research related activities, access medical records and databases, as well as 
submission of regulatory documents to the University of Pittsburgh IRB associated with the 
conduct and compliance of a clinical trial.Karen Foley, RN, BSN, CCRC has several years of 
regulatory and clinical research experience. Her study role will be to actively perform research 
related activities, access medical records and databases, as well as submission of regulatory 
documents to the University of Pittsburgh IRB associated with the conduct and compliance of a 
clinical trial.John Pang, MD is employed by UPMC and a member of the Department of Plastic 
Surgery. As a co-investigator, he is responsible for collection of information assessing the research 
study eligibility criteria and consenting process, research study procedures, overall protection of 
human subject risks and benefits, performance of clinical trial conduct and compliance maintaining 
GCP.Mark Asher Schusterman, MD is employed by UPMC and a member of the Department of 
Plastic Surgery. As a co-investigator, he is responsible for collection of information assessing the 
research study eligibility criteria and consenting process, research study procedures, overall 
protection of human subject risks and benefits, performance of clinical trial conduct and 
compliance maintaining GCP.Michael Bykowski, MD, MS is employed by UPMC and a member 
of the Department of Plastic Surgery. As a co-investigator, he is responsible for collection of 
information assessing the research study eligibility criteria and consenting process, research study 
procedures, overall protection of human subject risks and benefits, performance of clinical trial 
conduct and compliance maintaining GCP.Dalit Amar, MD is employed by UPMC and a member 
of the Department of Plastic Surgery. As a co-investigator, she is responsible for collection of 
information assessing the research study eligibility criteria and consenting process, research study 
procedures, overall protection of human subject risks and benefits, performance of clinical trial 
conduct and compliance maintaining GCP.Jessica Lee, MD is employed by UPMC and a member 
of the Department of Plastic Surgery. As a co-investigator, she is responsible for collection of 
information assessing the research study eligibility criteria and consenting process, research study 
procedures, overall protection of human subject risks and benefits, performance of clinical trial 
conduct and compliance maintaining GCP.Damien Grybowski, MD is a Research Fellow in the 
Adipose Stem Cell Center. As co-investigator on this study he will be responsible for obtaining 
lipoaspirate from the operative area and transporting specimens to the laboratory (BST and HSC) 
for processing and analysis. Gabriella DiBernardo, BS is a Research Fellow in the Adipose Stem 
Cell Center. As co-investigator on this study she will be responsible for obtaining lipoaspirate from 
the operative area and transporting specimens to the laboratory (BST and HSC) for processing and 
analysis. Danielle Minteer, PhD is employed by University of Pittsburgh, Department of Plastic 
Surgery as a Research Data Manager. As a co-investigator, she will be responsible for data 
collection and building and managing research databases. Edward Ruane, MD is employed by 
UPMC and a member of the Department of Plastic Surgery. As a co-investigator, she is responsible 
for collection of information assessing the research study eligibility criteria and consenting process, 
research study procedures, overall protection of human subject risks and benefits, performance of 
clinical trial conduct and compliance maintaining GCP.Sharona Czerniak, MD is employed by 
UPMC and a member of the Department of Plastic Surgery. As a co-investigator, she is responsible 
for collection of information assessing the research study eligibility criteria and consenting process, 
research study procedures, overall protection of human subject risks and benefits, performance of 
clinical trial conduct and compliance maintaining GCP.Irene Ma, MD is employed by UPMC and a 
member of the Department of Plastic Surgery. As a co-investigator, she is responsible for 
collection of information assessing the research study eligibility criteria and consenting process, 

research study procedures, overall protection of human subject risks and benefits, performance of 
clinical trial conduct and compliance maintaining GCP. 
View: 7.2 
 
Section 7 - Qualifications of Investigators and Sources of Study Support 
7.2 Indicate all sources of support for this research study.*  
Selections 
Federal: Upload a copy of the entire grant application (including the cover sheet) if our site is the 
awardee institution; for federal contracts, upload a copy of the research plan 
 If Federal support, provide the sponsor information: 
  
Federal 
sponsor 
Grant Title 
Grant 
number 
Awardee 
institution 
Federal grant application 
View  DOD 
structural fat grafting 
for craniofacial 
trauma 
W911QY-
09-C-0209 
University of 
Pittsburgh 
COA 09 25 13 without budget 
information.pdf(0.01)  
 
 
 
 
For projects not supported by a federal grant, upload the research plan that was submitted for 
funding: 
Name Modified Date 
If Industry support, provide the sponsor information and level of support: 
  
 
If Foundation support, provide the sponsor information: 
 
If Other support, provide the support information and level of support: 
 
View: 7.3 
Section 7 - Qualifications of Investigators and Sources of Research Study 
Please contact the Conflict of Interest Office if you have any questions 
related to this section. 
   
 
7.3 
Is this study funded in part or whole by a PHS Agency?  
 *  No  
 
 
 
Does any investigator* involved in this study (select all that apply): 
  
Name 
 
 
A. Have a financial interest (aggregated value of equity and remuneration** during the past 
or next twelve months) in a publicly-traded entity that either sponsors*** this research or 
owns the technology being evaluated or developed that exceeds $5,000 but not $10,000? 
 
 
B. Have a financial interest (aggregated value of equity and remuneration during the past or 
next twelve months) in a publicly-traded entity that either sponsors this research or owns 
the technology being evaluated or developed that exceeds $10,000? 
 

 
 
C. Receive remuneration (during the past or next twelve months) from a non-publicly 
traded entity that either sponsors this research or owns the technology being evaluated or 
developed that exceeds $5,000 but not $10,000?  
 
 
D. Receive remuneration (during the past or next twelve months) from a non-publicly 
traded entity that either sponsors this research or owns the technology being evaluated or 
developed that exceeds $10,000?  
 E. Have equity in a non-publicly traded entity that either sponsors this research or owns 
the technology being evaluated or developed? 
 
 
F. Receive reimbursement or sponsorship of travel expenses (for one trip or a series of trips 
during the past or next twelve months) by an outside entity that either sponsors this 
research or owns the technology being evaluated or developed that exceeds $5,000? 
 
 
G. Have rights as either the author or inventor of intellectual property being evaluated or 
developed in this research that is the subject of an issued patent or has been optioned or 
licensed to an entity? 
 
 
H. Have an officer or management position**** with a Licensed Start-up Company 
overseen by the COI Committee that either sponsors this research or owns the technology 
being evaluated or developed? 
 
 
I. Receive compensation of any amount when the value of the compensation would be 
affected by the outcome of this research, such as compensation that is explicitly greater for 
a favorable outcome than for an unfavorable outcome or compensation in the form of an 
equity interest in the entity that either sponsors this research or owns the technology being 
evaluated or developed? 
 None of the above options apply and there are no other financial conflicts of interest in the 
conduct of this research. 
 
 
*Investigator means the PI, co-investigators, and any other member of the study team, regardless 
of title, who participates in the design, conduct, or reporting of this research, as well as his/her 
spouse, registered domestic partner, dependents, or other members of his/her household. The PI 
is responsible for ensuring that s/he and all other relevant members of the study team 
review the above questions describing Significant Financial Interests.   
**such as salary, consulting fees, honoraria, or paid authorship 
***through the provision of funds, drugs, devices, or other support for this research  
****Such as serving on the Board of Directors or Board of Managers or a position that carries a 
fiduciary responsibility to the company (e.g., CEO, CFO, CTO, or CMO).  
Does any investigator* involved in this study (select all that apply): 
  
Name 
 
 
A. Have equity in a publicly-traded entity that either sponsors** this research or owns the 
technology being evaluated or developed that exceeds a 5% ownership interest or a 
current value of $10,000? 
 B. Have equity in a non-publicly-traded entity that either sponsors this research or owns 
the technology being evaluated or developed? 
 

 
 
C. Receive salary, consulting fees, honoraria, royalties or other remuneration from an entity 
that either sponsors this research or owns the technology being evaluated or developed that 
is expected to exceed $10,000 during the past or next 12 months? 
 
 
D. Have rights as either the author or inventor of intellectual property being evaluated or 
developed in this research that is the subject of an issued patent or has been optioned or 
licensed to an entity? 
 
 
E. Have an officer or management position**** with a Licensed Start-up Company 
overseen by the COI Committee that either sponsors this research or owns the technology 
being evaluated or developed? 
 
 
F. Receive compensation of any amount when the value of the compensation would be 
affected by the outcome of this research, such as compensation that is explicitly greater for 
a favorable outcome than for an unfavorable outcome or compensation in the form of an 
equity interest in the entity that either sponsors this research or owns the technology being 
evaluated or developed? 
 None of the above options apply and there are no other financial conflicts of interest in the 
conduct of this research. 
 
 
*Investigator means the PI, co-investigators, and any other member of the study team, regardless 
of title, who participates in the design, conduct, or reporting of this research, as well as his/her 
spouse, registered domestic partner, dependents, or other members of his/her household. The PI 
is responsible for ensuring that s/he and all other relevant members of the study team 
review the above questions describing Significant Financial Interests.   
**through the provision of funds, drugs, devices, or other support for this research 
****Such as serving on the Board of Directors or Board of Managers or a position that carries a 
fiduciary responsibility to the company (e.g., CEO, CFO, CTO, or CMO).  
7.3.1 Provide the name of the investigator(s) and describe the nature of the Significant Financial 
Interest(s):Dr. Sydney Coleman conflict of interest involves the receipt of royalties and 
consulting fees for the Coleman cannules.  
 
7.3.2 If you selected A, B, C, or E, please complete a Standard Conflict of Interest Management 
Plan and submit it with your protocol. Please provide all of the requested information, including 
the correct protocol number and title. Incomplete, inaccurate, or unsigned forms will have to 
be edited and replaced. 
For all other financial interests (D or F), the COI Office will work with you to develop an 
appropriate COI Management Plan.  
 
7.3.2 If you selected B, D, E, or H, please complete a Standard Conflict of Interest Management 
Plan and submit it with your protocol. Please provide all of the requested information, including 
the correct protocol number and title. Incomplete, inaccurate, or unsigned forms will have to 
be edited and replaced. 
For all other financial interests (A, C, F, or G), the COI Office will work with you to develop an 
appropriate COI Management Plan.  
 
 
* 
  
 

Name 
Modified Date 
BTI++ COI management plan 
5/8/2014 2:12 PM 
    
View: Other Attachments 
  
Supporting Documentation Section 
References and Other Attachments 
  
Additional documents: 
Name 
Modified Date 
Version 
References  4/25/2014 9:36 AM 0.01 
  
 
 
View: Clinical Trials Registration 
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical 
studies of human participants conducted around the world. 
"Applicable clinical trials" are required by federal law to be registered in ClinicalTrials.gov.  
Applicable Clinical Trials (ACTs) are studies that meet the following criteria: 
• 
The study is an interventional study AND   
• 
The study intervention is a drug, biologic, medical device, radiation or genetic AND  
• 
The Study is not Phase 0 or 1 AND  
• 
The study has at least one site in the United States or is conducted under an investigational new 
drug application or investigational device exemption 
NIH Policy 
Effective January 18, 2017, revised NIH Policy requires that all clinical trials funded in whole or in part 
by the NIH be registered and results information posted on ClinicalTrials.gov.   
As defined by the NIH, a clinical trial is: 
A research study in which one or more human subjects are prospectively assigned to one or more 
interventions (which may include placebo or other control) to evaluate the effects of those interventions 
on health related biomedical or behavioral outcomes. 
The NIH Policy extends beyond the Food and Drug Administration Amendment Act (FDAAA 801) 
requirements in that it requires registration and results reporting of: 
• 
clinical trials of behavioral, surgical and other types of health and medical interventions  
• 
phase 1 studies of drugs and biological products  

• 
small feasibility studies of device products  
Failure to submit all required registration and results information requested on ClinicalTrials.gov can 
jeopardize University grant funding, the future funding of the grantee and subject the University of 
Pittsburgh to future monetary penalties. 
In addition, to promote transparency of the clinical trials process, the International Committee of 
Medical Journal Editors (ICMJE) has established a policy requiring the entry of clinical trials in a public 
registry, such as ClinicalTrials.gov, prior to subject enrollment as a condition of consideration for 
publication of the trial results. 
* Based on the above information, will this study be registered in ClinicalTrials.gov?Yes   
Who will serve as the Responsible Party? UPMC/Pitt Investigator or IND/IDE Pitt Sponsor Why are 
you registering your study? (Check all that apply) 
It is required for publication by the International Committee of Medical Journal Editors ( 
Registration is required in a publically available, searchable database system prior to informed consent 
being obtained from the first study participant) 
If you are not yet registered and need to establish an account for the PI or other research staff that may 
need to access the record, please send an email to the  University of Pittsburgh PRS administrator at 
ctgov@pitt.edu with the following information for each individual: 
• 
Full name  
• 
Telephone number  
• 
Pitt or UPMC email address 
If you have any questions or concerns, please email us at ctgov@pitt.edu.   
To find out additional information about how to register your study go to: 
https://www.clinicaltrials.gov/ct2/manage-recs/how-register   
 
    
View: Conclusion for Application 
Completion of Application and Submission 
  
Congratulations, you have completed the IRB on-line application!  Click on 'Finish' to 
return to the main page of the application.  Your study has not been submitted for review 
at this point.  
Remember: Only the Prinicipal Investigator is permitted to submit a study for review or 
submit a response to comments. 
  If you are the PI and wish to submit the study for review:  
• 
Go the main study page by clicking on 'Finish'  
 

• 
Click on the 'Submit Application' button located on the left side of the main page under 'My Activities'