Shear Wave Elastography in Native Kidney Disease: a Pilot Study
Phase: NA
Conditions: Acute Kidney Disease, Chronic Kidney Disease
Sponsor: Albert Einstein Healthcare Network

 
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Date Initially Completed:    3/24/2016                    or Date Updated:   5/9/2016 
IRB # (if known):    4837 
Protocol  
Title:  
Shear wave elastography in native kidney disease: a pilot study 
 
 
 
Protocol 
Version/ Date: 
5/9/2016 
Sponsor: 
AES grant 
Investigator: 
Talal Alnabelsi 
Email:   alnabelt@einstein.edu 
Please carefully review and complete each section of this form.   If your study already has a separate protocol (e.g. 
developed by a sponsor or submitted as part of a grant application), you have the option to reference the section and page 
numbers of that protocol where appropriate in this form.   PLEASE NOTE:  many of the questions below are looking 
specifically for what will be happening locally to protect participants.   This information is generally not found in a protocol 
written for multiple sites.   
 
NOTE:  Depending on the nature of your research, certain sections below may not be applicable.  Indicate “N/A” as 
appropriate.  You must provide a response for each section.  DO NOT DELETE SECTIONS OR LEAVE SECTIONS BLANK. 
 
Keep an electronic copy of this form.  You will need to modify this form when making changes to the protocol. 
 
1)   Protocol Abstract (Briefly (in 250 words or less) describe the study in language understandable to a layperson.  Include a 
brief description of the study purpose, target disease/condition if applicable, key eligibility criteria, and main study 
interventions): Kidney biopsy is the primary technique to assess the degree of kidney damage and disease 
progression. However, this procedure is costly and has complications including bleeding, infection and patient 
discomfort. It is also impractical to perform biopsies on patients who are ill or have bleeding tendencies. The 
ultrasound technique has been used for many years to assess kidney structure and status. However, it is not 
accurate or reliable at quantifying the degree of fibrosis (long term damage) of diseased kidneys. Interestingly, 
a promising new ultrasound technique called shear wave elastography (SWE) has been developed to assess 
tissue stiffness. This technique has been studied previously in transplanted kidneys with promising results. It 
has only been done in few studies on native kidneys and these studies had major limitations. Our study will 
attempt to build upon these prior studies and overcome their shortcomings by comparing results obtained by 
SWE across a broad range of patients with kidney disease as assessed by biopsy results. We are aiming to 
determine whether SWE can serve as a non-invasive marker of kidney fibrosis. This technique can serve as a 
marker to follow up the rate of progression of kidney disease besides laboratory tests. More importantly, SWE 
has the potential to revolutionize practice by helping clinicians make decisions about getting a kidney biopsy.   
 
2)   Project Objectives and Hypotheses:  Objective: To determine whether differences exist in elasticity 
measurements between native kidneys with and without fibrosis.  
Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher (up to x 1.5) measures of tissue 
elasticity and stiffness compared to kidneys with zero fibrosis.  
 
 

 
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3)   Background/Significance of Research (Provide the scientific or scholarly background and rationale for the research 
based on the existing literature (include references).  Describe relevant prior experience and gaps in current knowledge.  
Describe any relevant preliminary data.  Explain the significance of the research in terms of why it’s important and how it will 
add to existing knowledge.):  Chronic kidney disease (CKD) is a major public health problem with over 19 million adults in the US 
diagnosed with early CKD and 640,000 adults with end stage renal disease (ESRD) [1-5]. Currently, CKD is staged based 
formulas derived by creatinine values. Limitations of such measures include confounding factors such as age, race and muscle 
mass.  Acute kidney injury (AKI) on the other hand is an abrupt deterioration in renal function with or without reduced urine output. 
Using lab values to distinguish acute and chronic kidney disease can be impossible even to the trained physician, however their 
pathogenesis and treatment are different highlighting the need for an accurate diagnosis. Fibrosis is the common final pathway of 
CKD, with the degree of fibrosis directly related to severity [6, 7]. Acute processes on the other hand lead to inflammation or 
tubular dysfunction in the absence of fibrosis. Until now, the gold standard for diagnosing intrinsic kidney disease remains to be a 
biopsy. Kidney biopsies are usually indicated when pre renal or post renal causes of AKI have been excluded and a cause of the 
intrinsic renal dysfunction remains elusive. However, kidney biopsies are not without their disadvantages which include cost, risks 
related to its invasive nature and sampling error [8-11]. There are also instances, such as the acutely ill patient or those with 
bleeding tendencies, when a biopsy is contraindicated.Therefore, it seems prudent to develop a non-invasive marker for kidney 
fibrosis that would aid clinicians to decide about the need to obtain a biopsy. This is the premise of our research project, to 
determine whether shear wave elastography can be a reliable marker for kidney fibrosis.  
 
Shear wave elastography (SWE) is an emerging technique which permits the non-invasive measurement of tissue elasticity [12]. This 
technique is now FDA approved for use in liver disease due to its ability to discriminate normal and cirrhotic liver tissue. Similar 
techniques have been investigated with varied success in other tissues including breast, thyroid and prostate.  Studies of SWE 
have been performed on transplanted renal allografts showing an association between tissue stiffness measured by SWE and 
kidney fibrosis [13-15]. Transplanted kidneys are more superficial compared to native kidneys; thus estimates of tissue elasticity of 
transplanted allografts may not apply to native kidneys [16, 17]. Only few studies examined SWE in native kidneys and those had 
inherent limitations [18-20]. The main limitation being, there was no matchup between kidney fibrosis scores and SWE values. We 
propose to replicate the studies performed on transplanted kidneys while building upon and improving on the limitations of the prior 
studies conducted in native kidneys.  
 
Kidney biopsy remains the gold standard for evaluation of kidney fibrosis in patients with abnormal kidney function. However, this 
invasive procedure is associated with: cost, risk of bleeding, infection, patient discomfort and sampling error. In other scenarios 
where patients are acutely ill, on anticoagulation or with very low platelet counts biopsies are in-fact contraindicated. SWE as a 
non-invasive marker of kidney fibrosis has the potential to provide immediate results at little cost with no harm to the patient. It will 
also likely reduce the rates of unnecessary biopsies and eliminate the complications associated with such an invasive procedure.  
 
SWE is a novel FDA approved technique to assess organ fibrosis. Its successful application in the hepatology community has raised 
interest about its utility in other organs. We hope to extend the utility of this technique and use it in native kidney disease. Our 
study’s goal is to determine whether SWE can be used as a non-invasive marker of kidney fibrosis. This study may have great 
clinical ramifications as the field of nephrology is expanding towards the development of non-invasive markers of kidney disease. 
The results of our study would provide clinicians with a tool that rapidly assesses tissue fibrosis while limiting the need for invasive 
and risky procedures. . Given the clinical and scientific need for this type of research, background of the investigators, identified 
population and potential for multiple future avenues of research, this project is important, novel, feasible and an excellent use of 
research resources. 
 
 
4)   Setting of the Human Research: 
 
a.  Indicate all AEHN locations where the human research will be conducted (check all that apply): 

 
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Tabor Rd campus 
 
Elkins Park campus 
 
Belmont Center for Comprehensive Treatment 
 
Center One 
 
Montgomery campus 
 
Other:  please specify -       
 
b.  Indicate if human research will be conducted at external location(s) overseen by the AEHN investigator (e.g. 
private physician office, collaborating hospital/university) 
 
  
 
   Yes (Complete Appendix B: External Site Approvals on Application for Human Research) 
 
 
  
 
   No 
 
 
5)  Resources available to conduct the Human Research: 
 
 
a.  Target population (e.g. Adult subjects with a diagnosis of Type II diabetes for greater than two years”: 
 
      Adults over the age of 18 who underwent native kidney biopsy at the Einstein Medical Center in Philadelphia will be 
eligible for the study 
 
b.  For prospective studies: 
 
i.) Total number of subjects planned to be enrolled in the study at AEHN site(s):   40 
 
ii)  For multi-site projects, please indicate total number of subjects planned to be enrolled in the  
study at all sites:  N/A 
iii)  Describe access to a population that would allow recruitment of the targeted number of subjects (i.e.  
how many potential subjects do you have access to? What percentage of those potential subjects do you need 
to recruit? ) :  A list of patients who recently underwent a native kidney biopsy will be obtained 
from the pathology department on a weekly basis. Our research team will then contact the 
patients and discuss participation in the project. If they agree, during a follow up visit with the 
nephrologist formal informed consent will be obtained and questions answered. On a yearly 
basis, 50-60 native kidney biopsies are performed at AEMC. Therefore, we will need to recruit 
80-90% of those patients. 
Telephone script: Hello. My name is Dr " " and I am a medical doctor at the Albert Eisntein Medical 
Center. I am calling you with regards to a study we are conducting at our center involving a new 
ultrasound technique called shear wave elastography. We are recruting interested subjects who 
have had a kidney biopsy. You are qualified to participate in the study. If you are interested, 
your nephrologist will discuss the details of this study with you in greater detail during your 
follow up visit. Thank you and have a wonderful day.   
 
c.  For retrospective studies: 
 
i.)  Estimated number of charts to be reviewed:  N/A 
 

 
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ii.)  Time period of interest for data being collected (e.g. Subjects who had XX procedure between  
6/1/00 and 6/1/05:        
 
d.  Describe the number and qualifications of the study team members, their experience in 
conducting research, their knowledge of the local study site(s), culture, and society:  The study 
team members include 3 PGY2 residents, 1 PGY4 resident with prior research experience in this 
field, 1 PGY intern with interest in nephrology, 1 radiology resident PGY3, 1 radiology attending 
with experience in ultrasound imaging (director of body ultrasound at AEMC) and 1 nephrology 
attending with vast clinical and research experience.  
 
e.  Describe the time that the investigator and other study team members, if applicable, will 
devote to conducting and completing the study within the anticipated study period (e.g. 10% of 
PI’s time and full-time coordinator):  80% of the PGY1 research half day will be used to conduct the 
study. Additional time may be required afterwards, in which case 10-20% of residents' time will 
be used to complete the study.  
 
f. Describe the plan for ensuring that all investigators/staff assisting in this research are adequately informed of:  
1) the protocol, including revisions to protocol and other study specific changes, 2) investigational product 
information if applicable, and 3) study related duties and functions:  Regular meeting will be held to ensure 
all participants are on the same page. All members will be informed of changes to the protocol or study.  
 
g.  Describe the facilities available to conduct this research:  The patients will undergo shear wave elastography 
imaging at the radiology department using the latest equipment to conduct such testing. This will take place at the AEMC. 
We will also use AECIS to access pathology reports and patients' demographics.  
 
h.  If applicable, describe the availability of medical or psychological resources that subjects might need as a  
result of the anticipated consequences of this research:  Written and informed consent will be obtained from all the 
patients. In order to ensure the subject's understanding, they will be given the opportunity to ask as many 
questions as necessary. Furthermore, the consenting team will use "teach back" to assess the subjects 
understanding of the study's purpose and protocol.  
 
6)  Study Design 
 
a. Recruitment Methods:  
 
i. 
Describe when, where, and how potential subjects will be recruited (Describe the source of subjects.  
Describe the methods that will be used to identify potential subjects.  Describe materials, such as 
advertisements, that will be used to recruit subjects (include these with submission materials. If study is a 
chart review, describe which records will be accessed to collect data and how you will access them :   A list 
of patients who recently underwent a native kidney biopsy will be obtained from the 
pathology department on a weekly basis. Our research team will then contact the patients and 
discuss participation in the project. If they agree, during a follow up visit with the nephrologist 
formal informed consent will be obtained and questions answered  
 
ii. 
Will payments to subjects be provided? 

 
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     Yes, amount and timing:  25$ (cash) at the visit for the shear wave elastography 
measurements 
 
No 
     N/A 
 
b. Inclusion and Exclusion Criteria:  
i. 
Describe how you will screen for eligibility (e.g. review charts, perform specific screening tests, etc.):  
Adults over the age of 18 who underwent native kidney biopsy at the Einstein Medical Center 
in Philadelphia will be eligible for the study 
 
ii. 
Describe the criteria that define who will be included or excluded in your final study sample: 
 Patients will be excluded for the following conditions: 
• BMI > 35 
• Patients with polycystic kidney disease, renal cell carcinoma, hydronephrosis or renal 
stones. 
• Patients who develop severe post biopsy complications (infection, significant bleeding 
requiring transfusion or intervention) 
• Pregnant patients.    
 
c. Study Timelines: 
i. 
Duration of an individual subject’s participation in the study:  2-3 months 
 
ii. 
Time period anticipated to enroll all study subjects or to complete chart review:  9 months 
 
iii. 
Estimated overall study duration (i.e. from initiation to completion of primary analyses):  12 months 
 
d. Study Endpoints:  
i. 
Describe the primary and secondary study endpoints (i.e. the outcome(s) that the study is designed to 
evaluate): The primary outcome measure of this study is to determine whether tissue elasticity 
determined by SWE can assess kidney fibrosis.  
 
 
ii. 
Describe any primary or secondary safety endpoints (e.g.  any disease or symptom that would result in 
the withdrawal of that subject from the study): N/A 
 
e.  Human Research Methods: 
 
i. 
Describe and explain the study design (e.g. randomized, double-blind, placebo-controlled clinical trial 
or retrospective chart review):  Prospective cross-sectional study. 
 
 
ii. 
Describe all research activities involved in this protocol, including a study visit timeline if 
appropriate:  We will collect data on consecutive patients with the aim to have 10 patients 
in each fibrosis group (0-3). After consent, patients will be scheduled to come for a renal 
ultrasound and SWE. SWE examination will be conducted using an ultrasound machine 
equipped with a Philips Epiq ARFI Shear wave ElastPQ C1-5 mHz transducer. Shear wave 

 
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velocity will be obtained and an estimate of tissue elasticity (Young’s modulus) will be 
calculated. All measurements will be performed by one of two qualified radiology 
physicians who will be blinded to the clinical and pathological data. We will allow a period 
of 90 days to obtain the images after the biopsy; otherwise the patient is no longer eligible 
to participate.   
 
 
iii. 
Identify which tests/procedures are being administered solely for research purposes and which are 
being conducted as part of standard of care (i.e. procedures that would be done even if the 
participant were not involved in research):  A renal ultrasound will be done as standard of care 
prior to any kidney biopsy. The shear wave elastography measurement will be done for 
research purposes.  
 
iv. 
Describe steps taken to lessen the probability or magnitude of risks associated with tests/procedures 
being done for research purposes only (e.g. only appropriately trained personnel involved in procedures, 
extra tests being done for safety purposes):  The shear wave elastography testing is harmless and 
painless with no implications on patients. Zero radiation exposure.   
 
 
v. 
Describe alternative treatments that are available to subjects if they choose not to participate in 
research:  N/A 
 
 
vi. 
Describe the source records that will be used to collect data:  AECIS will be used to obtain demographic 
data about the patients as well as laboratory values.  
 
 
vii.Describe what data (variables) will be collected for this research: Baseline demographic 
information (Age, gender, race, height, weight, BMI), past medical history (Hypertension, 
heart failure, Diabetes Mellitus, Cerebrovascular accidents, dyslipidemia, 
hyperparathyroidism, coronary artery disease, peripheral vascular disease) laboratory 
data (serum electrolytes, complete blood count), kidney length and depth measurements 
as well as biopsy results will be obtained from the electronic medical record. Shear wave 
velocity will be obtained using a Philips ultrasound transducer and an estimate of tissue 
elasticity (Young’s modulus) will be calculated. Use of any potential nephrotoxic 
medication will be noted including but not limited to: diuretics, Non-steroidal 
antiinflammatroy drugs, Angiotensin converting enzyme inhibitors / Angiotensin receptor 
blockers.  
 
 
viii. 
Describe any plans to conduct audio or video recording of research participants during the conduct 
of the research.  Specify whether recording is optional or not and how information on how 
recordings will be used and how long they will be retained is being shared with subject:  N/A 
 
f.   Specimen Management:   
 
i. 
Will any type of specimen (e.g. blood or tissue) be collected for this study?   

 
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 Yes  
  No , skip to section on Data Management  
 
ii. 
What information will be associated with the specimens collected for this study?           
 
iii. 
If specimens will be banked for future use, describe where and how the specimens will be stored:  
      
 
iv.        Specify how long specimens will be stored locally:       
 
v.       Specify who will have access to the specimens locally:        
 
  vi.       Will specimens be sent out or received:    
 No     
 Yes 
 
a. Who is responsible for receipt or transmission of the specimens?        
 
b. How will specimens be transported?        
c.    Describe the procedures to release specimens, including: the process to request a 
release, approvals required for release, who can obtain specimens, and the data to be 
provided with specimens:        
g.  Data Management 
 
i. 
Describe steps that will be taken to secure the data (e.g. training, authorization of access, password 
protection, encryption, physical controls, certificates of confidentiality and separation of identifiers 
and data) during storage, use and transmission:  A master list of MRNs of patients meeting the 
criteria will be composed. Each patient will then be assigned a study ID number. All 
information will be tabulated and kept as a data collection file which will not contain 
identifiers. All eligible patient data will be numbered and analyzed. The information will be 
stored on a secure HIPPA compliant folder on an Einstein computer as a password protected 
file. Upon completion of all necessary information on file, the master list with identifiers will 
be deleted.  
 
ii.       Describe the data analysis plan, including any statistical procedures and method for determining the 
sample size for the study: Descriptive statistics will be used to summarize the patient 
characteristics.  Data for continuous variables will be presented as mean + SD and categorical 
variables as numbers and percentages. Linear regression analysis will be performed to 
describe the relation of the extent of fibrosis and parenchymal stiffness. Stiffness values of 
patients with different fibrosis grades will be compared using the Mann-Whitney U-test. 
Statistical analyses will be performed using JMP version 9.0 (Cary, North Carolina, USA). 
 
iii. 
Describe where and how data will be stored locally:  Data will be stored on a shared drive as a 
password protected file with access only to members of the research team.  
 
iv. 
Specify how long data will be stored locally: 6 years.  
 
v. 
Specify who will have access to the data locally:  Participants in this research project only 

 
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vi. 
Describe process that will be followed to ensure accuracy of collected data:  Renal ultrasound and 
shear wave elastography measurements will be performed by an experienced radiologist with over 10 years of 
ultrasound imaging experience.  
 
vii. 
Will data be sent out or received:    
 No     
 Yes 
 
a. Who is responsible for receipt or transmission of the data?  N/A 
 
b. How will the data be transported?  N/A 
 
h.   Provisions to monitor the data for the safety of subjects (Required only when Human Research 
involves more than minimal risk):   
 
i. 
Describe plans to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe.  Include what data will be reviewed, who will review the 
data and when the data will be reviewed:  Baseline demographic data, laboratory results, SWE 
measurements and biopsy results will be aggregated into an encrypted study database; all data will be 
checked twice upon entering it into the database to ensure accurancy. The data will be checked and 
updated by the primary and co-investigators on a weekly basis.      
 
i.  Withdrawal of Subjects:   
 
i. 
Describe the anticipated circumstances under which subjects will be withdrawn from the research 
without their consent:  Patients are fully entitled to decline in participating in the study. They 
will only have undergo a renal ultrasound and shear wave elastography measurement on 
one occasion and will not be required to follow up with us afterwards.   
 
ii.      Describe the procedures that will be followed when subjects withdraw from the research (or 
request that their data be withdrawn), including partial withdrawal from procedures with 
continued data collection:  Patients who chose not to participate will have their data deleted / removed 
from the data base.  
 
 
 
 
 
7)  Risks to Subjects:   
 
 
a) List the reasonably foreseeable risks, discomforts, hazards or inconveniences to the subjects.  For each 
indicate the probability, magnitude, and duration when possible (consider physical, psychological, social, 
legal and economic risks as well as risks related to confidentiality):  Risk of violation of confidentiality. To 
minimize the risk: password protected list of patients accessible only to members of the research team. 
In terms of the ultrasound measurements, the Gel used to improve visualization is cold and causes very 
mild discomfort but no pain.    
 

 
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b) If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable: 
N/A 
 
c) If applicable, indicate which procedures may have risks to an embryo or fetus should the subject or the 
subject’s partner be or become pregnant:  N/A 
 
d)   Describe, if applicable, the process that will be followed if a subject or the subjects’ partner becomes pregnant 
while participating in the study:  N/A 
 
e) If applicable, describe risks to others who are not subjects:  N/A 
 
 
8)  Potential Benefits to Subjects 
 
a) Describe the benefits that individual subjects may experience (include when possible the probability, 
magnitude and duration of the potential benefits) or indicate if there is no direct benefit: The subjects will 
not benefit. However, determining whether shear wave elastography measurments can predict the 
degree of fibrosis in diseased kidneys can be of great clinical significance. This may reduce the rates of 
unnecessary biopsies and eliminate the complications associated with such an invasive procedure.    
 
 
9)  Medical care and compensation for injury (Required for Greater than Minimal Risk Studies Only): 
 
a) Describe any provisions for medical care and available compensation in the event of a research related injury: 
N/A 
 
b) Provide the contract language, if any, relevant to compensation for research-related injury:  
N/A 
 
10)  Cost to participants:   
 
a) Describe any actual or potential cost that subjects may incur through participation:  N/A 
 
11)  Provisions to Protect the Privacy Interests of Subjects:   
 
a) Describe the steps that will be taken to protect the subjects’ privacy interests and make them feel at ease.  In 
this case, “privacy interest” refers to a person’s desire to control access of others to themselves (e.g. has  
consideration been made to having same gender interviewers, the disclosing of cameras, conducting physical exams in 
private rooms, discussing study health concerns of subjects in private rooms instead of public waiting areas, etc.):  
Discussion of the study details in private/ physician consultation rooms. The ultrasound diagnostic 
studies will be undertaken in a private radiology room.   
 
 
 
12)  Subject Authorization 

 
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Are you planning to obtain written HIPAA authorization from study subjects? 
   Yes 
   No (if checked, written approval for waiver from Privacy Officer is required) 
 
13)  Consent process: 
 
a) Indicate the type of informed consent you propose to utilize in this research project: 
 
  Requesting Waiver of Consent Process  
 
 
Provide justification for why it would not be practicable (feasible) to conduct this research 
without a waiver:    
 
 
Explain whether or not subjects will be provided with additional pertinent information after their 
participation and if yes, describe what information will be provided and how it will be 
communicated (e.g. a summary of study results will be provided to subjects in a newsletter):  N/A 
 
SKIP TO SECTION 14 
 
  Requesting an Alteration to the Consent Process (i.e. no documentation in writing) 
 
 
 
Provide details on alteration requested (e.g. only verbal consent will be obtained, required information 
will not be disclosed or the research involves deception) and why it is necessary:        
 
  Consent process with Documentation in Writing 
 
b)  Describe when and where the consent discussion will take place:  Our research team will contact the 
eligible patients and discuss participation in the project. If they agree, during a follow up visit with the 
nephrologist formal informed consent will be obtained and questions answered.  
 
c) Describe the role of the individual(s) involved in obtaining consent from study subjects (e.g. investigator, 
study coordinator, recruiter, etc.):  The primary nephrologists will sit down with the patients and explain 
the study details to the individuals. They will be allowed time to ask questions.   
 
d) Specify the time that will be devoted to the consent discussion:  10 minutes. Patients are also allowed to 
contact the investigators for further information / clarification.  
 
e) Will subjects be given the opportunity to think about the information provided as part of the consent 
discussion, ask questions, and discuss the research with family or friends if desired?  
   Yes 
   No  
 
f) Describe the steps that will be taken to minimize the possibility of coercion or undue influence:   
Patients will receive a phone call about the study participation. If they are interested they will have 
sufficient time to think about the study participation until they meet the nephrologist for their follow up 

 
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meeting. During the consultation and if the patient decides to participate, the study will be explained 
including risks/benefits that will allow to the patient to reach an informed decision.   
 
g) From whom will consent or permission for research participation be sought (i.e. subject, parent, legally 
authorized representative):  subjects/patients themselves.  
 
h) Describe process to ensure subject/parent/LAR’s understanding:  Written information will be provided to 
the patient as well as a verbal explanation of the project.  
 
i) Do you plan to consent subjects or their legally authorized representatives when the subject does not speak 
English? 
   Yes  
   No  
If yes, select one of the two options below that best describes your study:  
   The research targets a specific population that is non-English speaking OR a significant 
proportion of subjects are anticipated to be non-English speaking (if this is true, translations of 
the standard (i.e. IRB-approved, full-description) informed consent documents must be reviewed 
and approved by the IRB prior to enrollment of any non-English speaking subjects).  
   The research does not target a non-English speaking population, AND only a small proportion of 
subjects are anticipated to be non-English speaking (if this is true and a translated study consent 
form is not available, the short form consent process must be used.  For more information, see 
the Investigator Manual.) 
 
Describe your plan for conducting study visits and long-term follow-up with these subjects:  Patients will be 
consented using the help of a translator line / person. benefits and risks will be explained in detail. 
Reliable contact information will be obtain (cell phone number) in order to reach the patient in the 
future.  
 
j) Does the study allow for and do you plan to enroll adult participants with diminished decision making 
capacity? 
   Yes  
   No  
If yes, select one of the two statements in each group below that is most appropriate for your study (if neither 
statement applies in one or both groups, your study does not meet the regulatory criteria for enrollment of 
these subjects): 
  
Criterion 1(must select one box below if you plan to enroll adults who are unable to consent for themselves): 
   The aims of the research cannot be accomplished if the subjects were limited to adults capable 
 of consent. 
   The research is intended to be beneficial to the subjects in a manner that is not available outside 
the research context. 
 
Criterion 2 (must select one box below if you plan to enroll adults who are unable to consent for themselves): 
   The research involves no more than minimal risk to subjects.  Minimal risk means that 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 of normal persons or during the 

 
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performance of routine physical or psychological examinations or tests in normal persons [45 
CFR 46.102(i)]. 
   The research involves more than minimal risk to subjects, but the research holds out the prospect 
of direct benefit to the individual subjects. 
 The research involves more than minimal risk to subjects, there is no anticipated direct benefit to 
the individual subjects, but: (1) the subjects have a disease or condition for which the procedures 
involved in the research are intended, (2) foreseeable risks to the subjects are low AND (3) the 
negative impact on the subject’s well-being is minimized and low. 
 
 
Describe your plan for assessing a potential subject’s ability to provide informed consent (e.g. clinical 
interview, standardized psychological or neuropsychological test, specially developed capacity assessment instrument, 
etc.):        
 
 
14)  Vulnerable populations:   
 
a) Indicate if any individuals who are potentially vulnerable to coercion or undue influence will be included in 
the study: 
  Children (if checked, must complete Appendix C. Children on Application for Human Research) 
  Pregnant Women 
  Neonates of Uncertain Viability or Non-viable Neonates 
  Prisoners 
  Adults with Diminished Decision Making Capacity 
  Students/ Employees 
 
 
  
                    *You may not include members of the above populations as subjects in your research unless it is 
indicated in the inclusion criteria of the protocol and approved by the IRB. 
 
 
b)  If vulnerable populations will be participating in the study, describe the rationale for including this population 
and the additional safeguards to protect their rights and welfare:  N/A 
 
 
c)  If research involves children, describe the following: 
 
 
i.  Will parental permission be obtained from either both parents or just one parent:  N/A 
 
ii.  Will assent be obtained from all, some, or none of the children?  If assent will be obtained from some 
children, indicate which children will be required to assent:  N/A 
 
 
  iii.  When assent of children is obtained, describe whether and how it will be documented:  N/A 
 
 
15)  Is this Community-Based Participatory Research (i.e. research conducted in communities in which community 
members, persons affected by condition or issue under study and other key stakeholders in the community's health have the opportunity 
to be full participants in each phase of the work including conception, design, conduct, analysis, interpretation, conclusions, and 
communication of results): 
 
   Yes  
   No, go to section 16)  
 
 
Describe involvement of the community in the design and conduct of the research:        

 
AEHN Protocol/Summary  
NUMBER 
DATE 
PAGE 
HRP-204 
12/27/2012 
13 of 13 
 
13 
 
 
16)   Sharing of results with participants: 
a) Describe any plans for sharing results with participants:  All patients will receive a written layman 
summary about the results of the study if they are interested.   
 
 
If separate protocol is not included, please attach list of references for background section etc. to this form.