Clinical trial NCT02519023
Conditions: Acute Pain
Sponsor: University of Minnesota
Start date: 2016-07-01; Completion date: 2017-06-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.

Detailed description:
This is a double blinded randomized study. All patients will receive one form of local anesthetic pain relief either from TAP or infiltration. Patients will be randomized to one of two study arms in a double-blinded, placebo controlled study. All patients will receive a TAP infiltration and all patients will receive infiltration into the incision.

In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.

In the second arm the bilateral TAP infiltration will consist of 30 mL of normal saline per side. In the same arm the surgeon infiltration will consist of 10 mL of 0.25% bupivacaine per port site. The surgeon infiltration will consist of 5 ml of 0.25% bupivacaine prior to incision and 5 ml of 0.25% bupivacaine prior to closure at each port site.

A TAP infiltration is an injection of local anesthetic under the covering of the transversus abdominis muscle layer which provides effective post operative analgesia.2-5 This layer is found using an ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound the investigators can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is infiltrated into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and facial layers of the abdomen. This is currently standard of care at our institution and will be performed within one hour of surgical incision. The injection will consist of 10 mL of 0.25% bupivacaine with epinephrine followed by 20 mL of liposomal bupivacaine saline mixture or 10 ml of saline followed by 20 ml of saline and then repeated on the contralateral side.

Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.

Investigational Drug Service (IDS) pharmacy will be charged with the blinding of medications vs. saline for these procedures.

Following the procedure, all individuals will receive scheduled acetaminophen (1 gram every 6 hours), scheduled ibuprofen (800 mg every 8 hours), and PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.

Arms: arm 1: TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site. arm 2: Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
Interventions: intervention 1: Liposomal Bupivacaine intervention 2: Bupivacaine intervention 3: Ultrasound intervention 4: Epinephrine intervention 5: acetaminophen intervention 6: ibuprofen intervention 7: Oxycodone
Intervention descriptions: intervention 1: In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. intervention 2: Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions. intervention 3: An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane intervention 4: TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine. intervention 5: all individuals will receive scheduled acetaminophen (1 gram every 6 hours), intervention 6: all individuals will receive scheduled ibuprofen (800 mg every 8 hours) intervention 7: all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.

Protocol documents:
Prot_000.pdf: 
 
HEALTH & BIOLOGICAL/MEDICAL APPLICATION FORM 
Version 6.2 
Updated January 2015, check http://www.irb.umn.edu for the latest version 
 
Route this form to: 
 
See instructions below. 
U Wide Form: 
UM 1571 
 
Jan. 2015
 
 
Submit this application, along with all required appendices and 
supplemental documents to the University of Minnesota IRB  
IRB Use Only  
IRB Study # Click here to enter text. 
Electronic Submission (preferred): 
Submit to: irb@umn.edu 
PI must submit request using 
University of Minnesota e-mail 
Account. Academic advisor and/or Co-
investigators must be cc’ed on the emailed 
submission. 
U.S. Mail Address:                     
Human Research Protection Program 
MMC 820 
420 Delaware St. SE 
Minneapolis, MN 55455-0392 
For more information please visit our website 
http://www.research.umn.edu/irb/index.html  
Contact our office 
Phone: 612-626-5654 
Email: irb@umn.edu  
Fax: 612-626-6061 
Project Title  
If the project is funded, the Sponsored Project Administration (SPA) project title must match the IRB project title. If 
the project is funded by multiple grants, provide all grant titles below: 
Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and 
Robotic assisted Hysterectomy  
Section 1   Principal Investigator 
Name  
Geller, Melissa A 
Highest Earned Degree:  
MD 
Preferred contact information:  gelle005@umn.edu 
Preferred email or phone number at which the PI may be contacted by IRB staff or reviewers to resolve questions or concerns. 
Affiliation and contact information 
University of Minnesota (complete contact info section 1 only) 
Fairview (complete contact info section 2 only) 
Gillette (complete contact info section 2 only) 
Required Contact information 
U of M Internet ID (x.500): 
gelle005 
Section 1 - U of M only 
U of M Employee/student ID 
Number: 
      
 
University Department: 
Department of Obstetrics, Gynecology and Women's 
Health, Division of Gynecologic Oncology 
Required contact information 
Section 2  Non-U of M only 
Address: 
       
 
Phone number: 
      
Mobile 
  Pager  
Office 
Email address: 
      
 


Health & Biological/Medical Application Form  
 
 
       2 
Occupational Position:  
Faculty 
Physician 
Staff  
Student  - Students must complete the faculty academic advisor section below and submit Appendix J 
Other:        
Conflict of Interest: 
Does the PI have a reportable conflict as defined in Section 11 of the application? 
Yes    
 No 
Required CITI Human Subjects Training   
Date (Month/Year) CITI completed (either initial or refresher course): 
        
Note: The IRB requires researchers to complete refreshers courses every three years after 
completion of initial course.   For more information on training requirements see IRB 
Training 
HIPAA TRAINING 
Check box below if HIPAA training is 
required. 
 HIPAA Required – Data contains PHI 
HIPAA Training completed through: 
 UMN  
 Other:       
For information regarding human subjects and HIPAA training requirements please go to http://www.irb.umn.edu/training.html, 
As Principal Investigator of this study, I assure the IRB that the following statements are true: 
• 
The information provided in this form is correct.  
• 
I have evaluated this protocol and determined that I have the resources necessary to protect participants, such as adequate 
funding, appropriately trained staff, and necessary facilities and equipment.   
• 
I will seek and obtain prior written approval from the IRB for any substantive modifications in the proposal, including changes in 
procedures, co-investigators, funding agencies, etc. 
• 
I will promptly report any unexpected or otherwise significant adverse events or unanticipated problems or incidents that may 
occur in the course of this study.  
• 
I will report in writing any significant new findings which develop during the course of this study which may affect the risks and 
benefits to participation.  
• 
I will not begin my research until I have received written notification of final IRB approval.  
• 
I will comply with all IRB requests to report on the status of the study.  
• 
I will maintain records of this research according to IRB guidelines.  
• 
The grant that I have submitted to my funding agency which is submitted with this IRB submission accurately and completely 
reflects what is contained in this application.  
• 
If these conditions are not met, I understand that approval of this research could be suspended or terminated. 
      
MD 
Today’s date. 
Signature/Digital signature/x.500 of PI  
Title of PI 
Date 
 
Faculty Academic Advisor - Student Research 
If the PI of this research is a student, include Appendix J filled out by the advisor with this application form. 
Student research requires the approval of a faculty academic advisor. As academic advisor to the student investigator, the advisor assumes 
responsibility for ensuring that the student complies with University policies and federal regulations regarding the use of human subjects in 
research. 
Faculty Academic Advisor Name (Last name, First name MI): 
      
University Department:  
      


Health & Biological/Medical Application Form  
 
 
       3 
U of M Employee ID: 
      
U of M x.500 ID (ex. smith001):  
      
Conflict of Interest: 
Does this person have a reportable conflict as defined in Section 11 of the application? 
Yes     
No 
Human Subjects Training: 
CITI – Date completed (either initial or refresher course):  
      
 
Note: The IRB requires researchers to complete refreshers courses every three years after 
completion of initial course.   For more information on training requirements see IRB Training 
HIPAA TRAINING 
Check box below if HIPAA training is 
required. 
 HIPAA Required – Data contains PHI 
HIPAA Training completed through: 
 UMN  
 Other:       
      
Today’s date. 
Signature/Digital signature/x.500 of Advisor 
Advisor must be cc’ed on emailed submission to the IRB 
Date 
 
Person preparing this document  
 PI prepared this application – section 1 complete 
 The person named below prepared this application 
Name:       
Preferred contact info:       
Role on study:  
Co-Investigator   
Study Coordinator (Research Staff) 
The person preparing the document must be listed on the application as a co-investigator or in a role that allows 
him/her to receive correspondence related to the application.  See section 13 of the application for more 
information 
Additional study personnel? Complete section 13 of this application.   
 
Section 2   Summary of Activities 
The following questions must be answered in lay language or language understood by a person unfamiliar with 
your area of research.  A research plan or protocol is required with this submission.  In the responses below, area-
specific jargon should be avoided or explicitly explained.   Do not say “see protocol” or “protocol attached”. 
Protocol templates are available on the IRB forms page. 
2.1 What is your research question? 
State hypothesis or primary objective, and provide a brief background on subject population, treatment 
procedures, and the rationale for conducting the study. 
This study aims to test whether there is a difference in the analgesic effect between TAP blocks and surgical 
infiltration during the first 72 hours following laparoscopic and robotic total hysterectomies. 
Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to 
remove the uterus, which has less scarring and fewer complications.  However, this procedure, much like its open-
surgical counterpart, is often associated with significant post-operative pain.  To augment this pain there are many 


Health & Biological/Medical Application Form  
 
 
       4 
different analgesic techniques available to offset pain.  Ultrasound-guided transversus abdominis plane (TAP) block 
is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal 
muscle where the terminal branches of nerves lie.  A similar, yet different analgesic approach is that of direct 
injection of local anesthetic into the incision by the surgeon during or just after surgical procedures.  These two 
approaches have both been proven to decrease post-operative pain in patients for many procedures, but never 
compared to one another.  
Background and Significance 
Even with the advancement of using laparoscopic and robotic technologies in total hysterectomies, patients still 
suffer from pain.  This study hopes to use a randomized controlled double-blinded approach to investigate the 
different analgesic outcomes from surgical infiltration of analgesics to that of ultrasound-guided transversus 
abdominis plane (TAP) blocks in this procedure. 
Other studies have looked at the enhanced analgesic efficacy of both TAP blocks in laparoscopic and robotic 
procedures, as well as that of direct infiltration of anesthetics into the incisions following surgery.1 Up to this point, 
however, these two practices have not been undertaken in a single double-blind study in which to compare the 
analgesic efficacies. 
  
2.2  Who developed the research plan/protocol? 
 Principal Investigator 
 Business and Industry Sponsor 
 Other:        
2.3 Explain how the study design and methods will answer the research question. 
This is a double blinded randomized study.  All patients will receive one form of local anesthetic pain relief either 
from TAP or infiltration.  Patients will be randomized to one of two study arms in a double-blinded, placebo 
controlled study.  All patients will receive a TAP infiltration and all patients will receive infiltration into the incision.  
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 
mL of a 50:50 mixture of liposomal bupivacaine and normal saline.  This will then be repeated on the contralateral 
side.  In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 
ml prior to incision and 5 ml prior to closure at each port site.  
In the second arm the bilateral TAP infiltration will consist of 30 mL of normal saline per side.  In the same arm the 
surgeon infiltration will consist of 10 mL of 0.25% bupivacaine per port site. The surgeon infiltration will consist of 5 
ml of 0.25% bupivacaine prior to incision and 5 ml of 0.25% bupivacaine prior to closure at each port site.  
A TAP infiltration is an injection of local anesthetic under the covering of the transversus abdominis muscle layer 
which provides effective post operative analgesia.2-5  This layer is found using an ultrasound, which is a beam of 
high frequency sound that allows one to visualize images in the body.  Then using this ultrasound we can see our 
needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is 
infiltrated into this plane.  This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and 
facial layers of the abdomen.  This is currently standard of care at our institution and will be performed within one 
hour of surgical incision. The injection will consist of 10 mL of 0.25% bupivacaine with epinephrine followed by 20 
mL of liposomal bupivacaine saline mixture or 10 ml of saline followed by 20 ml of saline and then repeated on the 
contralateral side.  
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior 
to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site 


Health & Biological/Medical Application Form  
 
 
       5 
incisions. 
Investigational Drug Service (IDS) pharmacy will be charged with the blinding of medications vs. saline for these 
procedures.   
      
2.4 What will the subjects be asked to do solely for the purpose of this research?  
Subjects will be asked to be randomly assigned to receive either a TAP with liposomal bupivacaine or infiltration 
with bupivacaine.  They will also be asked to answer questions at various time points related to their pain, answer a 
survery on their quality of recovery.  They will also be asked to allow the research staff to access their medical chart 
to obtain information about their pain medication use, complications, demographics, and time of discharge.   
2.5 Does the study involve treatment? 
 
No.   
 
Yes. List any procedure that would be performed if research was not conducted (i.e. procedures performed 
for diagnostic or treatment purposes). 
 
all procedures would be performed if research was not conducted as both the TAP and infiltration are 
standard of care.  
2.6 Indicate whether your research includes any of the following to determine which supplemental forms must 
be submitted with your application: 
If the research includes 
Appendices and supplemental materials required  
 
Administration of approved or unapproved 
drugs, chemical or biological agents 
Appendix E required with the application 
 
Administration of approved or unapproved 
devices 
Appendix F required with the application 
 
Genetic testing (whether or not results are 
returned to subjects) 
Appendix G required with the application 
 
Use of (collecting or having access to) 
Protected Health Information (PHI)  
Appendix H required with the application 
 
Field Work 
Appendix L required with the application 
 
Use of a deceptive technique 
Appendix N required with the application  
A debriefing script is also required. 
 
Community based participatory research 
Appendix Q required with the application 
 
Collection or storage of biological samples 
Appendix T required with the application 


Health & Biological/Medical Application Form  
 
 
       6 
(including blood draws, marrow biopsy 
sampling, biopsy of other tissues) 
 
Use of Magnetic Resonance devices housed 
at the Center for Magnetic Resonance 
Research (CMRR) 
Documentation of CMRR Safety Committee approval 
required.   
CMRR users must submit the completed CMRR Device and 
Safety Review form to the CMRR prior to submission of 
their IRB application.   A draft copy of the IRB application 
must be included for CMRR Safety Committee review.   
Documentation of approval by the CMRR Safety 
Committee will be provided to the researcher to include 
with the IRB application.  
 
Potential biohazards including recombinant 
and synthetic nucleic acid, human gene 
transfer, biologically-derived toxins or 
infectious agents 
Institutional Biosafety Committee approval required prior 
to final approval.  If an IBC application has been submitted 
for this research, provide the study number.  
      
 
Biologically-derived toxins (including 
truncated or mutated toxins) 
Institutional Biosafety Committee approval required prior 
to final approval.  If an IBC application has been submitted 
for this research, provide the study number. 
      
 
Infectious agents (bacteria, viruses, 
protozoans, fungi) 
Institutional Biosafety Committee approval required prior 
to final approval.  If an IBC application has been submitted 
for this research, provide the study number. 
      
 
Use of radiation (x-ray imaging, 
radiopharmaceuticals, external beam or 
brachytherapy) 
All University Radiation Protection Committee (AURPAC) 
approval required prior to final IRB approval.   
 
Section 3   Risks and Benefits 
 
3.1  Please indicate if the proposed research will include any of the following (check all that apply). The list 
below is not exhaustive but represents common elements or procedures in research with associated risks that 
are frequently overlooked or not clearly articulated. 
 
Administration of physical stimuli 
 
Probing for personal or sensitive information in surveys or interviews 
 
Collection of data with identifiers 


Health & Biological/Medical Application Form  
 
 
       7 
 
Possible invasion of privacy of the subject or the subject’s family 
 
Modification or extension of a surgical process to achieve research related objectives. 
 
Major changes in diet, exercise, or sleep 
 
Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological 
stresses 
 
Placebo Use 
 
Treatment will be withheld or subjects will discontinue current treatment (a wash out period is included) 
 
None of the above 
3.2 Describe in detail the nature and degree of the risk associated with participation. The risks must be disclosed 
in the consent form.  Include in the response all potential risks, not just those indicated in the checklist above. 
There is the potential of loss of privacy as the medical chart is accessed by the research staff.  In addition there is a 
placebo used however no patient will be without pain medication.  The TAP will either consist of local anesthetic or 
saline.  When the TAP consists  of saline the infiltration will consist of local anesthetic and when the TAP consists of 
local anesthetic the infiltration will consist of saline.   
With injection of local anesthetic there is risk of the block or infiltration not working.  There is risk of it being 
injected in the wrong area and there is risk of local anesthetic toxicity albeit the dosages used are well below those 
which would place the patient at risk of local anesthetic toxicity.  
3.3 Describe the precautions that will be taken to minimize each of the risks identified in questions 3.1 and 3.2. 
All patient charts will be accessed by a trained research personnel.  They will not record any identifiers.  Patient's 
will be asked if they are willing to answer questions prior to each round of questions regarding pain scores and 
surveys.   
All TAP and infiltration are standard of care.  Either or would be used if we were not doing the research.  The TAP 
infiltration is performed by trained anesthesiologists and are under ultrasound real time guidance.  The infiltration 
is performed by trained surgeons.   
3.4 List any anticipated direct and societal benefits to participation in this research project. If none, state that in 
the space provided below and in the consent form.  The benefit of receiving treatment is not necessarily a benefit 
to participation in the research project.   Compensation paid to subjects is not considered a benefit. 
none 
3.5 Justify the risk in terms of the potential scientific yield and in relation to the anticipated benefits to the 
subjects. 
The benefits of this study would be to find the most effective method of pain control which would not only 
decrease patient's pain but decrease their use of opioids.  As opioids are a significant burden on society in terms of 
misuse, addiction, and even death.  It is important we find ways to minimize postoperative pain and postoperative 


Health & Biological/Medical Application Form  
 
 
       8 
opioid use.   
 
Section 4   Subject Profile 
 
4.1  How many people will need to go through the consent process (but not necessarily enroll) to get the data 
sets necessary? Subjects who go through the consent process are counted toward the total number of subjects 
approved by the IRB even if they have no further participation in the study (i.e. Drop out, are screened out, etc.)   
Note that this is the number of subjects for which IRB approval will be granted. 
Total: 80 
Of the total requested indicate 
Percent Male 0% 
Percent Female 100% 
 
4.1.1 Provide justification if all or more of one gender is targeted for participation 
Hysterectomy 
4.2. How many subjects are needed to enroll to get the data sets required to answer the research question?  For 
multi-center trials provide the number enrolled locally.  
Total: 60 
 
 
 
4.3  if this is a multi-center study, provide the total number of subjects to be enrolled from all centers: 
Total: n/a 
 
 
 
4.4 Which of the following describe the subjects (check all that apply) 
 Inpatients 
 Outpatients 
 Healthy volunteers 
 Condition-matched controls 
4.5 What is the age range of the subjects? 
Exact Age Range: 18 to 99 
See information below for required supplemental materials. 
If age range 
includes 
Required Supplemental Materials 
0-7 years 
Parental consent form and Appendix Y required 
8-17 years 
Child’s assent, parental consent form and Appendix Y required 
4.6 List the criteria for subject INCLUSION in this study: 
• 
ASA physical status I-III 
• 
Females >/=18-years of age 
• 
Scheduled for laparoscopic/robot-assisted hysterectomy. 
 


Health & Biological/Medical Application Form  
 
 
       9 
4.7 List the criteria for subject EXCLUSION from this study: 
• 
Contraindication to surgical infiltration or regional blockade  
• 
History of long term opioid intake (greater than 3 weeks prior to surgery) or chronic pain disorder 
• 
Inability to understand the informed consent and demands of the study 
• 
Surgery scheduled to start after 1700 
 
4.8  Are children included or excluded from this study? 
 
Included – Appendix Y required – go to question 4.8 
 
Excluded.  Provide Justification below  
 
 No direct benefit to participation (exclusion of children permissible) 
 Potential for direct benefit exists for adults only (i.e. disease/condition does not occur in children) 
 Potential for direct benefit exists for children. Provide justification for exclusion of children: 
 
 
      
Note Regarding Exclusion of Children 
NIH guidelines advise that the exclusion be justified, so that potential for benefit is not unduly denied.  Indicate whether there 
is potential for direct benefit to subjects in this study and if so, provide justification for excluding children.   
Note: If inclusion of children is justified, but children are not seen in the PI’s practice, the sponsor must address plans to 
include children in the future or at other institutions. 
4.9 Indicate if the research includes or specifically targets the populations listed below for participation. 
Inclusion of the populations below, either incidentally or by design, requires the investigator to provide additional 
information to the IRB.  In some cases, such as the inclusion of prisoners, certification by the Office of Human 
Research Protection is required by federal regulations.  If, after final approval, the subject population pool 
changes to include any listed below, complete a Change in Protocol Form and complete any relevant appendices. 
Population group/description 
Resources and Required supplemental materials 
 
Children 
Appendix Y required.  Review the University of Minnesota policy 
regarding Safety of Minors 
 
Pregnant women/fetuses/neonates 
Appendix B required. 
See guidance at 45CFR46 subpart B and 
http://www.research.umn.edu/irb/guidance/women.html.  
 
Prisoners 
Appendix C required.  See guidance at 45 CFR 46 subpart C. 


Health & Biological/Medical Application Form  
 
 
       10 
 
Minority groups  
Appendix I “Populations with Special Considerations” required. 
 
Groups with socioeconomic or 
educational disadvantage  
Appendix I “Populations with Special Considerations” required. 
 
Non-English speakers targeted 
Appendix I “Populations with Special Considerations” and consent 
forms in the language spoken by participants and an English 
translation.  
 
Non-English speakers included (i.e., 
non-English speakers will not be 
turned away) 
See guidance regarding the short form consent process.  Consent 
short forms in Arabic, Croatian, French, Hmong, Khmer, Lao, 
Oromo, Russian, Somali, Spanish and Vietnamese are available for 
download. 
 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders and 
behavioral disorders.    
Appendix I “Populations with Special Considerations” required. 
 
Section 5  Study Location(s) 
Indicate in the table below all of the locations where the research will take place. 
 
LOCATION 
Required Supplemental Materials 
 
Hospital/Clinic (specify below) 
 
 
 University of Minnesota Medical Center (UMMC) – 
Fairview, Amplatz 
 Fairview Health Services (Southdale, Ridges, Lakes, 
Northland 
 Gillette Children’s Specialty Healthcare 
 Clinical and Translational Science Institute (CTSI) 
 University of Minnesota Physicians (UMP) Clinics 
(Oncology Clinic, Phalen, Family Medicine, etc.) 
 Fairview Clinics (Maple Grove, Oxboro, Eden Center, 
etc.) 
 TRIA Orthopedic Center 
 Other, Specify:      
 
University Campus (Non-clinical location) 
 
 
 Minneapolis/St Paul   
 Rochester 
 Duluth                           
 Crookston 
 Morris 
 Other, specify:        
 
Veteran’s Administration Medical Center 
Veteran Administration IRB approval 


Health & Biological/Medical Application Form  
 
 
       11 
 
Center for Magnetic Resonance Research (CMRR) 
Submit Documentation of CMRR Safety 
Committee approval.   
CMRR users must submit the completed CMRR 
Device and Safety Review form to the CMRR 
prior to submission of their IRB application.   A 
draft copy of the IRB application must be 
included for CMRR Safety Committee review.   
Documentation of approval by the CMRR Safety 
Committee will be provided to the researcher to 
include with the IRB application. 
 
Elementary school/secondary school 
Submit Appendix M “Research in Schools” and 
appropriate documentation of approval from 
school district 
 
University of Minnesota Child Care Center 
 
 
Prison/Halfway House 
Submit Appendix C “Prisoners as Subjects” 
 
 Federal Prison 
 State Prison 
Halfway house, specify:       
 
International Location 
Submit Appendix K “International Research” 
 
Sovereign Nation within United States borders 
Submit documentation of approval from 
sovereign nation 
 
Military base or facility owned by any component of the 
Department of Defense 
Submit Appendix D “Department of Defense” 
 
Nursing home, specify:       
Documentation of approval from site 
administrators 
 
Community center, specify:        
Documentation of approval from site 
administrators 
 
Research will be conducted online  
 
 
Other, specify:       
 
 
Section 6 
Recruitment & Compensation 
University of Minnesota policy prohibits researchers from accepting gifts for research activities. 
Research staff must decline any incentive (i.e. finders fees, recruitment bonus, etc.) offered by the 
study sponsor connected with subject enrollment or completion of the research study. For more 
information, please see Code of Conduct  
 
http://www1.umn.edu/regents/policies/academic/Code_of_Conduct.pdf  
6.1  Which of the statements below describes the recruitment strategy? If both apply, select both. 
 
 
Statement A.  Potential subjects will self-identify based on response to an advertisement, flyer, presentation or 
respondent driven sampling.  If ONLY statement A selected, go to question 6.2 
 
 
Statement B.  Potential subjects will be recruited based on information contained in private/protected records 
(medical records, student records). This also includes subjects who will be recruited from the PI or Co-I’s 


Health & Biological/Medical Application Form  
 
 
       12 
patient population. 
If statement B is selected, answer the questions 6.1.1. – 6.1.3 below 
 
6.1.1  Explain how the researcher has legitimate access to these records.  
 
The PI is a surgeon at the University of Minnesota 
 
 
6.1.2 Identify who will make initial contact with potential subjects. 
 
THe PI or Co-Investigators 
 
 
6.1.3 Will the records include MEDICAL records? 
 
 
No, go to question 6.2 
 
 
Yes.   Indicate the mechanism the PI will use to confirm that the patient has agreed to release their PHI 
contained in their medical record for research purposes; for example, the patient has documented 
consent to research on their treatment, intake or hospital admitting form. (MN Statue 144.334 Subd. 3; 
Access to Medical Records for Research) 
 
 Academic Health Center Information Exchange (AHC-IE) 
 
 Other.  Describe: EPIC 
 
6.2   Check the box(es) that describe the recruitment strategy.  Any required documents as detailed below should be 
submitted with this application. 
 
Method 
Required Supplemental Materials  
 Flyers  
Submit Flyer with application 
 Newspaper ads  
Submit draft of ad with application 
 Radio or television ads  
Submit script with application 
 Social networking sites 
 
Text, page mock up or description of posting including any 
images or videos 
Indicate site(s):       
 Letters or emails  
Submit letter or email with application 
 Phone call  
Submit phone script with application 
 Group presentations  
Submit outline of presentation and any materials provided to 
participants with application 
 
 
University of Minnesota research recruitment 
tool (e.g. REP, SONA or Carlson School 
Recruitment) 
 


Health & Biological/Medical Application Form  
 
 
       13 
 Non-University of Minnesota research 
recruitment tool (e.g. MTURK, Research 
Match) 
 
 Other method not described above 
Specify: Patients will be identified in clinic.  There they will be 
presented with the consent form and then on day of surgery 
they will sign final consent after speaking with the 
anesthesiologist.  
 
6.3 Provide a brief narrative to describe the recruitment process. Include in the description how potential subjects 
will be informed of the research. 
Patients will be identified in clinic.  There they will be presented with the consent form and then on day of surgery 
they will sign final consent after speaking with the anesthesiologist.They will be able to ask quesitons in surgery clinic 
as well as on the day of surgery.  A phone number will be made available so they can ask questions regarding the 
study prior to day of surgery as well.   
6.4 Will gifts, payments, compensation, reimbursement, services without charge or extra credit be provided to the 
subject for participation in research? 
 
No 
If no, go to Section 7 Confidentiality and Privacy 
 
Yes 
Complete 6.4.1 – 6.4.4 
 
6.4.1 Indicate the type of compensation and the maximum value a subject may receive during the course of 
his/her participation. 
 
      
 
6.4.2 When will compensation be provided?  Include in the response if payment for multiple visits is 
prorated and the compensation schedule 
 
      
 
6.4.3  Who will receive the compensation? 
 
 
Subject 
 
 
Other, specify:       
 
6.4.4  Will Research Experience Points (REP) be awarded? 
 
 
Yes 
 
 
No 
 
Section 7   Confidentiality and Privacy 


Health & Biological/Medical Application Form  
 
 
       14 
Confidentiality refers to how the subject’s identifiable data will be handled, managed, stored, and, if applicable, 
disseminated. 
Privacy refers to having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally 
or intellectually) with others 
 
7.1. Will researchers maintain any identifiers (e.g. names, addresses, telephone numbers, etc.)? 
 
 
No.  Go to question 7.13 
 
Yes. 
7.2 Indicate which of the direct identifiers below will be maintained? 
 
 Full names 
 
Initials 
 
Photographs of participant 
 Telephone 
numbers 
 
Email address 
 
Videos of participant 
 Birth date 
 
Postal Address 
 
Other:       
7.3 Why it is necessary to maintain direct identifiers? 
      
 
7.4 Describe the coding system that will be used to protect against disclosure of these identifiers. 
      
7.5 How long will the link between identifiers and code be maintained? 
      
7.6 Could any disclosure of the participant’s responses place the participant at risk of criminal or civil liability or 
could the disclosure be damaging to the participant’s financial standing, employability, or reputation? 
 
No 
 
 
Yes 
Explain how the researcher will mitigate these risks (e.g. limiting access to identifiers, obtaining a 
Certificate of Confidentiality, etc.)? 
 
 
      
7.7 Will the researcher obtain a Certificate of Confidentiality for this project? 
 
No 
 
 
Yes 
Documentation of Certificate of Confidentiality must be provided to the IRB when obtained. 


Health & Biological/Medical Application Form  
 
 
       15 
7.8 How long will the identifiable data be maintained? 
n/a 
7.9 What format will be used to maintain the data (paper, digital, electronic media, video, audio or photographic)? 
n/a 
7.10 Where will data be stored? 
All data will be stored on a password protected encrypted jump drive in a locked drawer in locked office.  
7.11 What security provisions will be taken to protect the data (password protection, encryption, etc.)?  See the 
University of Minnesota’s Safe Computing recommendations 
password protection and encryption 
7.12 Will a copy of the consent form or other research study information be placed in the subjects’ non-research 
records such as medical, employment or educational records? 
 
No 
 
 
Yes 
This information must be included the confidentiality section of the consent form. 
7.13 Even if direct identifiers are not recorded or maintained, are there potential ethical or legal circumstances 
when it would be necessary to break confidentiality (e.g. requirements for mandated reporting)? 
 
No 
 
 
Yes 
This information must be included in the consent form. Explain below the circumstances when breaking 
confidentiality is required. 
 
      
7.14  Describe the conditions under which interaction with subjects will occur (e.g., consent discussion occurs in a 
private room).  Explain how these conditions adequately protect the PRIVACY interests of subjects. 
consent discussion will occur in a private room as well as signing of the consent.  All staff will undergo research 
training to ensure they protect privacy of the patients.  
 
Section 8 
Expedited Review Eligibility  
Federal criteria for risk assessment make some studies eligible for Expedited Review (see 45 CFR46.110 and 21 CFR 
56.110).  Expedited review categories are below and may also be found at http://www.irb.umn.edu/expedited.html   
Studies eligible for Expedited Review must meet the federal definition of minimal risk which is: 
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves 
than those ordinarily encountered in daily life or during the performance of routine physical or psychological 


Health & Biological/Medical Application Form  
 
 
       16 
examinations or tests. 
8.1 What is the level of risk to subjects in this research study? 
 
Greater than minimal risk (full committee review required) – go to Section 9 Informed Consent Process 
 
Not greater than minimal risk.   
Review the table in question 8.2 below and check the box next to the expedited review category the 
investigator asserts applies to this research.  
Note: Final expedited review eligibility decisions are made by the IRB after initial review of the application.  
Studies involving drugs/biologics or devices are rarely eligible for expedited review. 
8.2 Check the box next to the Expedited Review Categories (2-7) that apply to the proposed project.  Per UMN IRB 
policy,  clinical studies involving drugs or devices are not eligible for expedited review category 1. 
Not 
available 
per UMN 
IRB policy 
1. Clinical studies of drugs and medical devices only when condition (1) or (2) is met. 
1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. 
(Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of 
the risks associated with the use of the product is not eligible for expedited review.) 
2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 
812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device 
is being used in accordance with its cleared/approved labeling. 
 
Cat. 2 
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 
1. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn 
may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times 
per week; or 
2. from other adults and children, considering the age, weight, and health of the subjects, the collection 
procedure, the amount of blood to be collected, and the frequency with which it will be collected. For 
these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period 
and collection may not occur more frequently than 2 times per week. 
 
Cat. 3 
Prospective collection of biological specimens for research purposes by noninvasive means. 
Examples: 
1. hair and nail clippings in a nondisfiguring manner; 
2. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; 
3. permanent teeth if routine patient care indicates a need for extraction; 
4. excreta and external secretions (including sweat); 
5. uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or 
wax or by applying a dilute citric solution to the tongue; 
6. placenta removed at delivery; 
7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; 
8. supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive 
than routine prophylactic scaling of the teeth and the process is accomplished in accordance with 
accepted prophylactic techniques; 
9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; 
10. sputum collected after saline mist nebulization. 
 
Cat. 4 
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely 
employed in clinical practice, excluding procedures involving x-rays or microwaves. 
Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to 
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, 


Health & Biological/Medical Application Form  
 
 
       17 
including studies of cleared medical devices for new indications.) 
Examples: 
1. physical sensors that are applied either to the surface of the body or at a distance and do not involve 
input of significant amounts of energy into the subject or an invasion of the subject’s privacy; 
2. weighing or testing sensory acuity; 
3. magnetic resonance imaging; 
4. electrocardiography, electroencephalography, thermography, detection of naturally occurring 
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and 
echocardiography; 
5. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where 
appropriate given the age, weight, and health of the individual. 
 
 
Cat. 5 
Research involving materials (data, documents, records, or specimens) that have been collected, or will be 
collected solely for nonresearch purposes (such as medical treatment or diagnosis). 
(NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human 
subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) 
 
 
Cat. 6 
Collection of data from voice, video, digital, or image recordings made for research purposes. 
 
Cat. 7 
Research on individual or group characteristics or behavior (including, but not limited to, research on 
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social 
behavior) or research employing survey, interview, oral history, focus group, program evaluation, human 
factors evaluation, or quality assurance methodologies.  
(NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human 
subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) 
 
 
Section 9 
Informed Consent Process 
Document the Elements of the Informed Consent Process 
It is the responsibility of the investigator to assess comprehension of the risks and benefits of participation in the 
research and only enroll subjects who can demonstrate understanding of the research study (45 CFR 46.116). The 
federal regulations require that consent be in language understandable to the subject. If subjects do not comprehend 
English, translated consent forms are required, or the use of short forms with an oral explanation can be accepted. 
 
Consent forms must be submitted for IRB review. It is highly recommended that researchers use the sample consent 
for template available on the IRB Forms page. Do not submit sponsor prepared forms without editing the form to 
include University of Minnesota IRB standard language and all essential elements of informed consent. 
 
Resources for preparing consent forms are available at: 
Informed Consent Online Tutorial – http://www.research.umn.edu/consent/ 
 
If the researcher is requesting a waiver of consent, complete questions 9.9 and 9.10 only. Be advised that 
waiver of consent is rarely granted. 
 
9.1   Document the informed consent process timeline. Detail when consent will be discussed and documented in 
relation to research data collection, if there will be any waiting period or if process will occur over multiple contacts 
or clinical visits. 
The consent will be discussed in the ciinic visit with the surgeon.  They will be given a copy of the consent and a 
phone number to call if they have questions.  Then on the day of surgery after they have had adequate time to 


Health & Biological/Medical Application Form  
 
 
       18 
review the consent they will sign consent after discussion with the anesthesiologist (co-PI).   
 
9.2  Will anyone not listed on this application obtain consent? Except in rare circumstances, all individuals who will 
obtain consent must be listed as research personnel on the IRB application so that basic human subjects’ research 
training is documented.  If in-person consent will not be obtained, select the option below and provide rationale. 
 
No 
If no, go to question 9.3 
 
Yes 
Explain who, other than those listed as personnel on this application, will obtain consent 
      
 
 
 
N/A 
In-person consent will not be obtained.  Explain below: 
      
9.3  Provide a brief description of the plan to train those individuals who will be obtaining consent from subjects to 
participate in this project.   
all staff will complete CITI training.  
 
Note:  Everyone obtaining consent must complete CITI training.   
9.4  Will all subjects consent for themselves? 
 
Yes 
If yes, adults lacking capacity to consent must be listed in the exclusion criteria (question 4.7).   
 
No 
If no, indicate below who, when appropriate, will provide consent 
 Parent/guardian 
 Legally authorized representative – Appendix I required 
 
9.5  What questions will be asked to assess the subjects’ understanding? Questions should be open-ended and go 
beyond requiring a yes/no response. 
What are the benefits and risks of the tap or infiltration? 
What are the benefits and risks of either local anesthetic medication? 
How will your pain be managed post-operatively in both options of the study? 
What are the alternative treatment options to control your pain post-operatively? 
What will be done if you have an allergic reaction or reaction to the pain medication in this study? 
 
 
9.6   Participation in research must be voluntary.  Describe the steps taken to minimize the possibility of undue 
influence on potential subjects. 
As the intervention we are providing two options which is the current standard of care, it is considered safe and 
efficacious.  We will discuss the options, as well as the risks and benefits with the patient.  No additional benefit is 
gained by the anesthesiologist if this technique is used and this will be discussed with the patient.   
Care of Subjects in Case of Accident 
If this research involves a potential for injury, injury compensation language must be included in the consent form (see 
21 CFR 50.25).  If a contract to pay for research-related injuries exists, the language in the consent form should not 
contradict the language in the contract. 
 
9.7   Is there a potential for research related injury? 
 


Health & Biological/Medical Application Form  
 
 
       19 
 
No 
If no, go to question 9.8 
 
Yes 
If yes, indicate which of the following statements is included in the consent form 
 
 
 
Non-Sponsor Funded Compensation 
 
In the event that this research activity results in an injury, treatment will be available, including 
first aid, emergency treatment and follow-up care as needed.  Care for such injuries will be billed 
in the ordinary manner, to you or your insurance company.  If you think that you have suffered a 
research related injury let the study physicians know right away.   
 
 
 
 
Sponsor Funded Compensation 
 
In the event that this research activity results in an injury, treatment will be available, including 
first aid, emergency treatment and follow-up care as needed.  Care for such injuries will be billed 
in the ordinary manner, to you or your insurance company.  The sponsor of the study has some 
funds available to pay for care for injuries resulting directly from being in this study.  If you think 
that you have suffered a research related injury and that you may be eligible for reimbursement 
of some medical care costs, let the study physicians know right away. 
 
 
 
 
If the preferred injury compensation language is unacceptable to the study sponsor, the 
following alternative language may be used: 
 
Under some circumstances the sponsor of the study will pay for care for injuries resulting directly 
from being in the study.  If you want information about those circumstances or if you think you 
have suffered a research related injury let the study physicians know right away. 
 
 
Waiving Documentation of Consent 
Waiving written documentation assumes that there will be an informed consent process but signatures will not be 
collected on the consent form. The IRB may waive the requirement for written documentation under specific 
conditions.   
 
9.8 Does the researcher wish to waive documentation of consent? 
 
 
No 
If no, go to question 9.9 
 
Yes 
If yes, check the statement below that applies to justify waiving documentation of consent.  If neither 
statement applies, researcher may not request waiver of documentation 
 
 
 
The only record linking the subject and the research would be the consent form and the principal 
risk of the research would be the potential harm from a breach of confidentiality (the IRB may 
allow an option to sign or decline) 
 
 
 
The research presents no more than minimal risk and includes no procedures for which written 
consent is normally required outside the research context. 
NOTE: Researchers requesting a waiver of documentation must submit a consent form without signature lines with 
the IRB application. 
 
Waiving Consent 
The IRB may, in some rare and specific circumstances, waive the requirement for consent in accordance with 45 CFR 
46.116(d).  Answer the questions below to determine if waiver of consent may be considered. 


Health & Biological/Medical Application Form  
 
 
       20 
 
9.9 Does the researcher wish to waive consent? 
 
 
No 
If no, go to section 10 - Funding 
 
Yes 
Indicate if the following statements apply 
 
 
The research involves no more than minimal risk to subjects. 
 
 
 
Yes 
 
 
 
No – waiver may not be requested 
 
 
Granting a waiver will not adversely affect the rights and welfare of the subjects. 
 
 
 
Yes 
 
 
 
No – waiver may not be requested 
 
 
The research could not practically be carried out without a waiver or alteration. 
 
 
 
Yes 
 
 
 
No – waiver may not be requested 
 
 
If consent is waived, whenever appropriate the subjects will be provided with additional pertinent 
information after participation.  Describe below the process for providing subjects with this 
information. 
 
 
      
 
Section 10 Funding 
10.1  Has funding for this project been applied for, requested or received or do you intend to request/apply for 
funding? 
 
 
No  
Explain how the research will be conducted without funding: 
 
 
      
 
YES 
Indicate in the table below who will provide/manage funds.   
 
 
 
Funds provided/managed by 
Required Supplemental Materials  
 
Internal University of Minnesota (departmental 
funds, internal grant program, etc.)  
Describe: Anesthesiology funds 
none 
 
University of Minnesota Sponsored Project Funding  
Appendix A required 
 
Non-University of Minnesota source or management 
Appendix A required 
 
Section 11   Conflict of Interest 
Federal Guidelines emphasize the importance of assuring there are no conflicts of interest in research projects that could affect 
the welfare of human subjects. Reporting of financial interests is required from all individuals responsible for the design, conduct 
or reporting of the research. If this study involves or presents a potential conflict of interest, additional information will need to 
be provided to the IRB. 
 
Examples of conflicts of interest may include, but are not limited to: 
 
• 
A researcher participating in research on a technology, process or product owned by a business in which the researcher 
or family member holds a significant financial interest or a business interest. 


Health & Biological/Medical Application Form  
 
 
       21 
• 
A researcher participating in research on a technology, process or product developed by that researcher or family 
member. 
• 
A researcher or family member assuming an executive position in a business engaged in commercial or research 
activities related to the researcher’s University responsibilities. 
• 
A researcher or family member serving on the Board of Directors of a business from which that member receives 
University supervised Sponsored Research Support. 
• 
A researcher receiving consulting income from a business that funds his or her research. 
• 
A researcher receiving consulting income from a business that could benefit from the results of research sponsored by a 
federal agency (i.e. NIH). 
 
11.1  Do any of the Investigators or personnel listed on this research project have a business interest or a financial 
interest of $10,000 or more ($5,000 or more if research is funded by a Public Health Service (PHS) agency or 
researcher is involved in clinical health care) associated with this study when aggregated for themselves and their 
family members? 
 
No   
 
Yes  List the investigator(s) with conflicts: 
Jacob Hutchins is on speakers bureau, consultant and has received research funds 
11.2. Do any of the investigators or personnel (when aggregated for themselves and their family members) listed 
on this research have: 
 
11.2.1 Ownership interests more than $10,000 ($5,000 if research is funded by PHS or researcher is involved 
in clinical health care) when the value of interest could be affected by the outcome of the research? 
 No 
 Yes  List the investigator(s) with conflicts: 
 
 
      
 
11.2.2 Ownership interests exceeding 5% interest in any one single entity (or any equity interest in a 
non-publicly traded entity if research is funded by PHS or researcher is involved in clinical health care)? 
 No 
 Yes  List the investigator(s) with conflicts: 
 
 
      
 
11.2.3 Compensation greater than $10,000 ($5,000 if research is funded by PHS or researcher is involved in 
clinical health care) when the value of the compensation could be affected by the outcome of the research? 
 No 
 Yes  List the investigator(s) with conflicts: 


Health & Biological/Medical Application Form  
 
 
       22 
 
      
11.3  Have all business or financial interests indicated above been reported? 
 
No  
 
Yes 
 
N/A  There are no conflicts of interest on this study  
• 
University of Minnesota researchers need to report business or financial interest online via the Report of External 
Professional Activities (REPA)  
• 
Fairview Health System researchers need to complete the Fairview Health Services Conflict of Interest Disclosure 
forms and submit the completed forms to the Fairview Office of Research. 
• 
Gillette Children’s Specialty Healthcare researchers must contact the Director of Research Administration, at 
651-229-1745. 
The IRB will verify that a management plan is in place with the Conflict of Interest (COI) Program. If the COI Program does not 
have an approved management plan in place for this research, they will contact the individual(s) for additional information. 
Final IRB approval cannot be granted until the IRB has reviewed the management plan and all potential conflict matters are 
settled. The IRB receives a recommendation from the Conflict of Interest Review Committee regarding disclosure to subjects 
and management of any identified conflict. The convened IRB determines what disclosure language should be in the consent 
form. 
 
Section 12 Research Services, Assessment and Oversight 
Section 12.1    RESEARCH COLLABORATIONS  
12. 1  Does this research project involve collaborations with any sites or personnel outside of the University of 
Minnesota, its coordinate campuses, the Fairview Health Systems or Gillette Children’s Specialty Healthcare? 
 
No 
Go to question section 12.2 
 
Yes 
Briefly describe the collaboration (with whom and for what purpose): 
      
Additional requirements for ensuring appropriate IRB oversight may apply.  These requirements are often 
dependent on whether or not the site/personnel is considered “engaged” in human subjects research according to 
federal definitions.  Contact the UMN IRB office (irb@umn.edu) to determine how IRB oversight of the research 
activity with the external site/personnel should be address.   
Section 12.2  AFFILIATED ENTITIES WITH OVERSIGHT RESPONSIBILITIES 
12.2.1   Will this research use services, resources, or funding from the Clinical and Translational Science 
Institute?  Examples include pilot funding, career development awards, biostatistics support, facilities, staffing, 
project management, regulatory assistance, or informatics consultation and support 
 No 
Go to question 12.2.2 


Health & Biological/Medical Application Form  
 
 
       23 
 Yes 
Provide CTR Portal ID#:       
12.2.2 Does this research require Masonic Cancer Center Protocol Review Committee (CPRC) review?   
The CPRC is required to evaluate, approve or reject, monitor, and re-review on an annual basis all University of Minnesota 
clinical cancer research protocols including those with non-therapeutic intent.   
 No 
Go to question 12.2.3 
 Yes 
Documentation of approval must be provided to receive final IRB approval. 
12.2.3  Will this research utilize Gillette Children’s Specialty Healthcare resources or medical records? 
  No 
Go to section 12.3 
 Yes 
If using Gillette resources, please contact: 
Joyce Trost, PT 
Research Administration Manager 
Gillette Children's Specialty Healthcare 
651-325-2339/651-312-3182/jtrost@gillettechildrens.com 
12.2.4  Will this research use Magnetic Resonance (MR) Devices housed at the Center for Magnetic Resonance 
Research (CMRR) facilities? 
  No 
Go to section 12.3 
  Yes 
Review and approval by the CMRR Safety Committee is required prior to IRB submission.   
CMRR users must submit the completed CMRR Device and Safety Review form to the CMRR prior to 
submission of their IRB application.   A draft copy of the IRB application must be included along with 
the CMRR Device and Safety Review form for CMRR Safety Committee review.   Documentation of 
approval by the CMRR Safety Committee will be provided to the researcher to include with the IRB 
application submission. 
Section 12.3  PAYMENT FOR RESEARCH RELATED SERVICES 
 
12.3. 1 Does the protocol require the use of tests, procedures, clinic space, clinic visits, professional fees, lab 
services, pharmacy services, or hospital services in order to answer the research question? 
 No 
Go to section 12.4 
 Yes 
 
12.3.2 Will subjects or a third party be charged for research related procedures? 
 No 
 
 Yes 
Explain: These are standard of care and as such are charged to  the patient as per routine 
Provide written documentation from the FDA to charge for investigational products. 


Health & Biological/Medical Application Form  
 
 
       24 
12.3.3  Will Services be provided by Fairview Health Service or U of M Physicians? 
 No 
 
 Yes 
Provide TASCS Number:       
Provide a copy of the TASCS billing grid noting whether the study does or does not meet Medicare 
criteria for a Qualifying Clinical Trial. 
Applications will not be assigned for review until the TASCS information is submitted. 
CLINICALTRIALS.GOV REGISTRATION 
Important Information about clinicaltrials.gov registration 
Resources available, penalties for failure to register and publication requirements  
Potential risks associated with failure to register with clinicaltrials.gov: 
• 
Loss of funding (National Institute of Health) 
• 
Financial penalty levied against the PI 
• 
Denial of publication (ICMJE) 
• 
Denial of payment to healthcare providers. 
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) establishes penalties for 
Responsible Parties who fail to comply with registration or results submission requirements. Penalties include civil 
monetary penalties and, for federally funded studies, the withholding of grant funds. 
The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as any research project that 
prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the 
cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include 
drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.   
Research projects that meet the ICMJE definition may not be accepted for publication if they are not registered in a 
registry that is electronically searchable and accessible to the public at no charge.  For more information on this 
requirement see http://www.icmje.org  Note that retrospective registration of projects is not allowed. 
Additionally, healthcare providers are required to include the clinicaltrials.gov number on all claims during the time 
period the patient participates in the study. 
The Clinical and Translational Science Institute (CTSI) will assist University of Minnesota investigators to comply 
with the registration requirement.  Complete the section below to document status or determine if registration 
is required.  Applications submitted without a Clinicaltrials.gov registration number (either received or pending) 
will be forwarded to the CTSI for review.    
Section 12.4  CLINICALTRIALS.GOV REGISTRATION DETERMINATION 
 
12.4.1 Is this project registered with clinicaltrials.gov? 
 
 No 
Go to 12.4.2 


Health & Biological/Medical Application Form  
 
 
       25 
 Yes 
Clinicaltrials.gov registration number:pending 
If registration is pending enter “pending” in the space provided.   
 
Section complete.  Go to Section 12.5 
Does this project meet the Food and Drug Administration Amendments Act (FDAAA) definition of “applicable 
clinical trial”?  Applicable clinical trials generally include controlled, clinical investigations of drugs and biologics; 
and controlled trials of devices that include health outcomes, including pediatric postmarket surveillance. 
 
12.4.2 Is registration with clinicaltrials.gov required?    
 
 No 
 
The PI understands the registration requirements and the consequences, as described above, of 
failure to register if applicable. CTSI will review this application for concurrence with the PIs 
decision.  CTSI will contact the PI and the IRB to confirm registration requirement.  If registration is 
required, the PI may request assistance with this process from CTSI. Go to Section 12.5 
 Unsure 
CTSI will contact the PI and the IRB with a determination regarding the registration requirement. If 
registration is required, the PI may request assistance with this process from CTSI.  Go to Section 
12.5 
 Yes 
Answer the questions below to determine who (either the PI or other entity) is responsible for 
registration with clinicaltrials.gov   
 
Is this study initiated by a University of Minnesota 
investigator? 
 No 
 Yes – registration by PI required. 
Is this study federally sponsored and the University of 
Minnesota is the only study site OR the study’s coordinating 
center? 
 No 
 Yes – registration by PI required. 
Is a University of Minnesota investigator the holder of an 
Investigational New Drug (IND) application for the test 
article OR it has been determined the proposed use of the 
test article is IND exempt? 
 No 
 Yes – registration by PI required. 
Is a University of Minnesota investigator the holder of an 
Investigational Device Exemption (IDE) for the device being 
studied OR a non-significant risk (NSR) determination has 
been made for the device being studied? 
 No 
 Yes – registration by PI required. 
If registration is required, the registration number must be provided before final IRB approval is 
granted. Email ctsi@umn.edu for additional information and registration assistance.  CTSI will 
evaluate all applications not registered with clinicaltrials.gov. 
 
 
Section 12.5   SCIENTIFIC ASSESSMENT 
 
Research involving human subjects must be reviewed for sound scientific design prior to review by the IRB 
committee.  Documentation of scientific assessment including the content of the review must be provided before the 
project will be reviewed by the IRB.  Scientific assessment is not required for new studies that meet the federal 
criteria for expedited review. If a study is submitted for expedited review but is determined by the IRB to NOT meet 
the criteria for expedited review, then scientific peer review will be required before IRB review. 
 
12.5.1  Has the IRB scientific assessment requirement been met?  
 
N/A 
 
Project qualifies for expedited review.  Sections 12.5, 12.6 and 12.7 are not required if expedited 
review eligible.  GO TO Section 13 Additional Staff. 


Health & Biological/Medical Application Form  
 
 
       26 
 
Yes 
Indicate below how the requirement has been 
met 
Required supplemental materials 
 Option1 
Reviewed by a federal funding 
agency (National Institutes of 
Health, National Science 
Foundation, etc.) employing peer 
review mechanisms for awarding 
of funding. 
 
 Option 2 
Reviewed by a nationally based 
non-federal funding agency 
(March of Dimes, American 
Academy of Pediatrics, etc.) 
employing peer review 
mechanisms for awarding of 
funding 
 
 
Note: industry-sponsored clinical trials designed 
by the sponsor with or without external 
consultants do not satisfy this criterion for 
independent peer-review. 
 
 Option 3 
Reviewed by locally constituted 
mechanisms using peer review 
for awarding of funding, or for 
permission to use resources: 
Cancer Protocol Review 
Committee (CPRC); CTSI funded 
pilot awards; Vikings; 
departmental peer review etc. 
Attach the review and the signed form 
documenting that departmental or collegiate 
peer review of the research protocol has been 
performed.  
 
 
 
 
 
 Option 4 
Reviewed by HRPP facilitated 
Scientific Assessment committee 
Submit approval notification with application. 
Section 12.6  DATA AND SAFETY MONITORING PLAN 
A data and safety monitoring plan (DSMP) is meant to assure that each clinical investigation has a system for 
oversight and monitoring of the conduct of the clinical investigation.  This oversight is intended to ensure the safety 
of the participants and the validity and integrity of the data.  A DSMP should be commensurate with the risks.   
A DSMP can be as simple as the investigator reporting adverse event information to the IRB. A DSMP can be as 
complex as having a Data and Safety Monitoring Board. 
A DSMP can include clinical trial monitoring.  Clinical trial monitoring refers to the methods used to oversee the 
conduct of, and reporting of data from, clinical investigations including appropriate clinical investigator supervision of 
study site staff. Monitoring activities include communication with the investigator and the study site staff; review of 
the study site’s processes, procedures, and records; and verification of the accuracy of the data.   
12.6.1 In addition to the Principal Investigator, are there other DATA monitoring entities responsible for this 
function? Select all that apply. 
 
No, the PI is the only entity monitoring DATA. 
 
Yes 
  A review entity will provide ongoing DATA monitoring 
 
 Clinical and Translational Science Institute (CTSI) 
 Data coordinating center or project principal investigator (multi-center studies) 
 Commercial sponsor, contract research organization (CRO) 


Health & Biological/Medical Application Form  
 
 
       27 
 Other:       
 
12.6.2 In addition to the Principal Investigator, are there other SAFETY monitoring entities responsible for this 
function? Select all that apply. 
 
No, the PI is the only entity monitoring SAFETY. 
 
Yes 
Select all below that apply 
 
 A Data Safety Monitoring Board (DSMB) will be appointed. 
 
When established, the list of the DSMB members including their affiliation and credentials and the 
DSMB charter must be submitted to the IRB.  A description of the DSMB must be provided with the 
application.   
 
A Data and Safety Monitoring Board (DSMB) is an independent group of experts that advises the study 
investigators. Primary responsibilities of a DSMB are to 1) periodically review and evaluate the 
accumulated study data for participant safety, study conduct and progress, and, when appropriate, 
efficacy, and 2) make recommendations concerning the continuation, modification, or termination of 
the trial. The DSMB considers study-specific data as well as relevant background knowledge about the 
disease, test agent, or patient population under study. 
 
The DSMB reports should be provided to the IRB as they are received.   
 
 Medical Monitor 
 Cancer Center Data Safety Monitoring Council 
 Other, describe:       
 
Section 12. 7  DATA AND SAFETY MONITORING RESPONSIBILITIES 
Data to be monitored 
PI 
Review 
entity 
DSMB/other Unassigned 
Study Safety (e.g., collection, reporting, and 
management of AEs, SAEs, and other study 
risks). 
 
 
 
 
Data Accuracy & Quality Assurance (e.g., data 
collection, entry, transmission and analysis). 
 
 
 
 
Trial Management (e.g., site coordination, 
enrollment and population distribution). 
 
 
 
 
Regulatory Issues (e.g., SAE reporting, IRB 
Actions, disclosures of conflict of interest). 
 
 
 
 
Interim Analysis. 
 
 
 
 
It is the investigator’s opinion that this protocol does not require a data safety monitoring plan.  Provide 
justification:       
 
Section 13 Additional Research Staff 
Co-Investigators 
Co-Investigators, responsible for knowing and following the protocol, should be listed below. Include any individual who will 
have responsibility for the consent process, direct data collection from subjects, or follow-up. 
Note: If emailing this application to the IRB, all co-investigators must be cc’ed on the submission email.   


Health & Biological/Medical Application Form  
 
 
       28 
Co-Investigator Name (Last name, First name MI): 
Argenta, Peter,  
Highest Earned Degree: 
MD 
Affiliation and contact information 
 University of Minnesota (complete contact info section 1 
only) 
 Fairview (complete contact info section 2 only) 
 
 Gillette (complete contact info section 2 only) 
 
Other (complete contact info section 2 only) 
Required Contact information 
U of M Internet ID (x.500): 
argenta 
Section 1 - U of M only 
U of M Employee/student 
ID Number: 
      
 
University Department: 
Department of Obstetrics, Gynecology and Women's 
Health, Division of Gynecologic Oncology 
Required contact information 
Section 2  Non-U of M only 
Address: 
       
 
Phone number: 
      
Mobile 
  Pager  
Office 
Email address: 
      
Occupational Position:  
 Faculty   
 Physician   
 Staff  
 Student   
 Other:       
Project responsibilities: 
 Obtain consent from subjects  
 Provide access to patient population 
 Other:       
Conflict of Interest: 
Does this person have a reportable conflict as defined in Section 11 of the application? 
 Yes     
 No 
Required CITI Human Subjects Training   
Date CITI completed (either initial or refresher course): 
       
Note: The IRB requires researchers to complete refreshers courses every three years after 
completion of initial course.   For more information on training requirements see IRB Training 
HIPAA TRAINING 
Check box below if HIPAA training is 
required. 
 HIPAA Required – Data contains PHI 
HIPAA Training completed through: 
 UMN  
 Other:       
      
      
Signature/Digital signature/x.500 of Co-PI  
Title of Co-PI 
 
 
 
Co-Investigator Name (Last name, First name MI): 
Hutchins, Jacob 
Highest Earned Degree: 
MD 
Affiliation and contact information 
 University of Minnesota (complete contact info section 1 
only) 
 Fairview (complete contact info section 2 only) 
 
 Gillette (complete contact info section 2 only) 
 
Other (complete contact info section 2 only) 


Health & Biological/Medical Application Form  
 
 
       29 
Required Contact information 
U of M Internet ID (x.500): 
hutc0079 
Section 1 - U of M only 
U of M Employee/student 
ID Number: 
2182198 
 
University Department: 
Anesthesiology 
Required contact information 
Section 2  Non-U of M only 
Address: 
       
 
Phone number: 
      
Mobile 
  Pager  
Office 
Email address: 
      
Occupational Position:  
 Faculty   
 Physician   
 Staff  
 Student   
 Other:       
Project responsibilities: 
 Obtain consent from subjects  
 Provide access to patient population 
 Other:       
Conflict of Interest: 
Does this person have a reportable conflict as defined in Section 11 of the application? 
 Yes     
 No 
Required CITI Human Subjects Training   
Date (Month/Year)  CITI completed (either initial or refresher course): 
 4/14 
Note: The IRB requires researchers to complete refreshers courses every three years after 
completion of initial course.   For more information on training requirements see IRB 
Training 
HIPAA TRAINING 
Check box below if HIPAA training is 
required. 
 HIPAA Required – Data contains PHI 
HIPAA Training completed through: 
 UMN  
 Other:       
hutc0079 
MD 
Signature/Digital signature/x.500 of Co-PI  
Title of Co-PI 
 
Research Staff 
Research staff, including study coordinators,  responsible for knowing and following the protocol, should be listed below. 
Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up. 
Study Staff Name (Last name, First name MI): 
Cohen, Melissa 
Highest Earned Degree: 
      
Affiliation and contact information 
 University of Minnesota (complete contact info section 1 
only) 
 Fairview (complete contact info section 2 only) 
 
 Gillette (complete contact info section 2 only) 
 
 Other (complete contact info section 2 only) 
Required Contact information 
U of M Internet ID (x.500): 
cohen045 


Health & Biological/Medical Application Form  
 
 
       30 
Section 1 - U of M only 
U of M Employee/student 
ID Number: 
      
 
University Department: 
Anesthesiology 
Required contact information 
Section 2  Non-U of M only 
Address: 
       
 
Phone number: 
      
Mobile 
  Pager  
Office 
Email address: 
      
Occupational Position:  
 Faculty   
 Physician 
  Research Coordinator 
 Staff  
 Student   
 Other:       
Project responsibilities: 
 Obtain consent from subjects  
 Other:       
Conflict of Interest:  Does this person have a reportable conflict as defined in Section 11 of the application? 
 Yes    
 No 
Should This Person Be Copied on All Correspondence? 
 Yes    
 No 
Required CITI Human Subjects Training   
Date (Month/Year) CITI completed (either initial or refresher course): 
       
Note: The IRB requires researchers to complete refreshers courses every three years after 
completion of initial course.   For more information on training requirements see IRB Training 
HIPAA TRAINING 
Check box below if HIPAA training is 
required. 
 HIPAA Required – Data contains PHI 
HIPAA Training completed through: 
 UMN  
 Other:       
 
 
Study Staff Name (Last name, First name MI): 
Bryant-Huppert, Joe 
Highest Earned Degree: 
MS 
Affiliation and contact information 
 University of Minnesota (complete contact info section 1 
only) 
 Fairview (complete contact info section 2 only) 
 
 Gillette (complete contact info section 2 only) 
 
 Other (complete contact info section 2 only) 
Required Contact information 
U of M Internet ID (x.500): 
hupp0037 
Section 1 - U of M only 
U of M Employee/student 
ID Number: 
2973892 
 
University Department: 
Anesthesiology, Medical student at Medical school 
Required contact information 
Section 2  Non-U of M only 
Address: 
       
 
Phone number: 
      
Mobile 
  Pager  
Office 
Email address: 
      


Health & Biological/Medical Application Form  
 
 
       31 
Occupational Position:  
 Faculty   
 Physician  
 Research Coordinator 
 Staff   
 Student   
 Other:       
Project responsibilities: 
 Obtain consent from subjects  
 Other: asssist with data collection 
Conflict of Interest:  Does this person have a reportable conflict as defined in Section 11 of the application? 
 Yes    
 No 
Should This Person Be Copied on All Correspondence?  
 Yes    
 No 
Required CITI Human Subjects Training   
Date (Month/Year) CITI completed (either initial or refresher course): 
 07/15 
Note: The IRB requires researchers to complete refreshers courses every three years after 
completion of initial course.   For more information on training requirements see IRB Training 
HIPAA TRAINING 
Check box below if HIPAA training is 
required. 
 HIPAA Required – Data contains PHI 
HIPAA Training completed through: 
 UMN  
 Other: