Clinical trial NCT02266875
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: OhioHealth
Start date: 2014-10-01; Completion date: 2017-01-30
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale scores after 4 treatments within 24 hours.

Detailed description:
Hypothesis:

A clinically significant difference exists between albuterol treatments with nebulized 3% saline versus standard saline, for improvements in the patient's modified Borg dyspnea score during an acute exacerbation of COPD.Study

Population:

This study will involve 146 patients admitted to Doctors Hospital in Columbus, Ohio from September 2014 through September 2015 with a clinical diagnosis of an acute exacerbation of COPD, defined as an increase in the patient's dyspnea, cough, or change in sputum consistency/volume/color from the patient's baseline during stable conditions.

Study Design:

Patients will be randomly assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or hypertonic saline.

Once the patient is enrolled, they will be randomly assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or hypertonic saline. They will then receive the 2.5mg albuterol treatment, and saline solution as determined by the randomization plan (Group 1 will receive 0.9% saline and Group 2 will receive 3% saline), every six hours for at least the first 24 hours, with allowance for PRN (pro re nata= as needed) use every four hours by patient request.

The patient's dyspnea will be evaluated prior to starting the treatment and after the intervention period is completed using the Modified Borg Dyspnea Scale.

Arms: arm 1: Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).

Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale. arm 2: Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).

Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.
Interventions: intervention 1: hypertonic saline intervention 2: standard saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 
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Nebulized Hypertonic Saline for Inpatient Use in Chronic Obstructive 
Pulmonary Disease 
 
Kruti Patel, D.O., Jeffrey Kaufman, D.O.  
 
 
Introduction 
Chronic obstructive pulmonary disease (COPD) continues to be a significant contributor to 
morbidity and mortality with significant resources allocated for inpatient COPD 
exacerbations1,2,3,4, defined on clinical symptoms of increased cough from baseline, a change in 
sputum characteristics from baseline (color, consistency, volume), or increase in the patient’s 
dyspnea from baseline5,6,7.  Current guidelines for treating exacerbations of COPD utilize 
steroids for reducing inflammation, supplemental oxygen for hypoxemia, antibiotics if suspicion 
is for a bacterial cause of the exacerbation, and bronchodilators for symptom control and 
improving airflow per the guidelines published by the Global Initiative for Chronic Obstructive 
Lung Disease8.  Additionally, counseling on cessation of cigarette smoking should be given to 
those still smoking.  Supportive therapy with mechanical ventilation (invasive or non-invasive) 
may be necessary as well as fluid balance management, nutrition, and vaccinations as 
appropriate for Pneumococcal pneumonia and seasonal influenza.  Symptomatic treatment may 
include pulmonary hygiene with chest physiotherapy such as by a respiratory 
therapist/percussion vest/Acapella or flutter valve device, and mucolytics such as guaifenesin or 
N-acetylcysteine (NAC) (as mucolytic or antioxidant)8.   
Although mucolytic therapy is mainly symptomatic and long-term studies are not definitive, 
some patients may have benefit9,10,11,12,13.  Additionally, NAC may have benefit in COPD 
exacerbations14,15,16,17.  However, with the recent drug shortages, NAC is not readily available in 
many hospitals.  With difficulty in obtaining a potentially beneficial medication and with 
significant costs, it is beneficial to explore other possibilities that may deliver equal or better 
options.   
Nebulized hypertonic (3%) saline has been used for sputum induction and as a mucolytic, mainly 
in pediatric populations with bronchiolitis, and in cystic fibrosis patients with 
bronchiectasis18,19,20.  Potential benefits of nebulized hypertonic saline include its availability and 
its costs.  Its packaging includes both individual respules for nebulization and bulk solutions.   
 
 
 


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Methods 
Study Population: 
This study will involve 146 patients admitted to Doctors Hospital in Columbus, Ohio from 
September 2014 through September 2015 with a clinical diagnosis of an acute exacerbation of 
COPD, defined as an increase in the patient’s dyspnea, cough, or change in sputum 
consistency/volume/color from the patient’s baseline during stable conditions. To achieve 80% 
power to detect a clinically significant difference between study groups, a minimum sample size 
of 130 patients (65 in each study group) is necessary.  To account for issues such as patient study 
withdrawal and protocol deviations, a sample size of 146 patients (73 per study group) is ideal. 
 Inclusion Criteria: 
 Patients at least 18 years of age 
 Admitted to Doctors Hospital with a clinical diagnosis of COPD within 24 hours. 
Exclusion Criteria:  
 Patients younger than 18 years of age 
 History of smoking less than twenty pack-years 
 Possibility of other primary cause of the patient’s change in dyspnea or cough (e.g. 
pneumonia, congestive heart failure with pulmonary edema, myocardial infarction) 
 Patient is found  to have a different primary cause after initial enrollment 
 Patients admitted over 24 hours prior to contact by study staff/investigator 
 Non-English speaking subjects  
Hypothesis: 
A clinically significant difference exists between albuterol treatments with nebulized 3% saline 
versus standard saline, for improvements in the patient’s modified Borg dyspnea score during an 
acute exacerbation of COPD. 
Study Design: 
This randomized, single-blind, prospective study will involve 146 patients admitted to Doctors 
Hospital with a clinical diagnosis of an acute exacerbation of COPD. Patients will be randomly 
assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or 
hypertonic saline. The Doctors Hospital biostatistician will create a randomization plan that will 
be kept with the consent forms. The investigator or study staff will maintain the list and 
determine the study treatment by subject number.  


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 Once the patient has been identified by the inclusion/exclusion criteria, they will be approached 
by a study staff member and informed of the opportunity to participate in the study. The study 
staff will then provide a detailed explanation of the study and obtain patient consent. 
Once the patient is enrolled, they will receive the 2.5mg  albuterol treatment, and saline solution 
as determined by the randomization plan (Group 1 will receive 0.9% saline and Group 2 will 
receive 3% saline), every six hours for at least the first 24 hours, with allowance for PRN (pro re 
nata= as needed) use every four hours by patient request. The nebulized saline will be kept in the 
pharmacy and will be ordered in the same way as the standard saline. The patient’s dyspnea will 
be evaluated prior to starting the treatment and after the intervention period is completed using 
the Modified Borg Dyspnea Scale21.  The scale will be administered by either the investigator or 
study staff.   
Participation in the study will be complete once the patient is discharged from the hospital. All 
patients will be recommended to have spirometry or full pulmonary function testing as an 
outpatient once stable, if not already obtained.   
Data Storage and Confidentiality  
 
Only de-identified or non-identifiable data will be reported in the study.  Only the research 
investigators and study staff will have access to patient information.  All resulting data will be 
stored in electronic format; files will be stored on a password-protected computer and stored in a 
secured facility with limited access.  Participants will not be excluded on socioeconomic, racial 
or religious identity.  No form of deception will be used.  The data collection and storage 
processes will follow HIPAA guidelines, in accordance with 21 CFR 46.115 (b); to protect both 
confidentiality and privacy of each participant.  All PHI data will be erased or destroyed per 
institution protocol. 
Study Variables: 
 The data to be collected from this study will include:  
 Demographic (age, sex) 
 Treatment group (normal saline/hypertonic saline) 
 Modified Borg Scale Score (pre and post treatment) 
 prn albuterol use  
 30 day readmission 
 30 day all cause mortality 
 Spirometry data within 30 days 
Statistical Analysis: 
 


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We will test the hypothesis that a clinically significant difference in dyspnea scores exists 
between patients who receive hypertonic saline and those who do not.  Descriptive statistics will 
be produced, using means, medians, ranges and standard deviations for continuous variables, and 
percentages for categorical variables.  Independent variables will include modified Borg scores, 
30-day mortality and length of hospital stay.  Inferential statistics will determine statistically 
significant differences between comparison variables, using paired sample t-tests or the 
Wilcoxon signed rank test.  Statistical significance will be evaluated at the 5% (α=0.05) level.  
References 
1) World Health Statistics 2014.  World Health Organization. Available from URL: 
http://www.who.int/gho/publications/world_health_statistics/2014/en/statistics.htm. 
2) Lopez AD, Shibuya K, Rao C, et al. Chronic obstructive pulmonary disease: current 
burden and future projections.  Eur Respir J 2006;27:397-412. 
3) Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 
to 2030.  PLoS Med 2006;3:e442. 
4) National Heart, Lung, Blood Institute.  2012 Morbidity and mortality chartbook.  
Nastional Institutes of Health.  Accessed at: http://www.nhlbi.nih.gov/resources/docs/cht-
book.htm; 2012. 
5) Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest 
2000;117:398S-401S. 
6) Burge S, Wedzicha JA. COPD exacerbations: definitios and classifications.  Eur Respir J 
Suppl 2003;4:46S-53S. 
7) Celli BR, Barnes PJ.  Exacerbations of chronic obstructive pulmonary disease.  Eur 
Respir J 2007;29:1224-1238 
8) Global Initiative for Chronic Obstructive Lung Disease.  Global strategy for the 
diagnosis, management, and prevention of chronic obstructive pulmonary disease, 
updated 2013. Accessed at: http://www.goldcopd.org/guidelines-resources.html. 
9) Allegra L, Cordaro Cl, Grassi C. Prevention of acute exacerbations of chronic obstructive 
bronchitis with carbocysteine lyseine salt monohydrate: a multicenter, double-blind, 
placebo-controlled trial. Respiration 1996;63:174-180. 
10) Guyatt GH, Townsend M, Kazim F, Newhouse MT. A controlled trial of ambroxol in 
chronic bronchitis.  Chest 1987;92:618-620. 
11) Petty TL. The National Mucolytic Study.  Results of a randomized, double-blind, 
placebo-controlled study of iodinated glycerol in chronic obstructive bronchitis.  Chest 
1990;97:75-83. 
12) National Institute for Clinical Excellence (NICE).  Chronic obstructive pulmonary 
disease.  Management of chronic obstructive pulmonary disease in adults in primary and 
secondary care.  http://guidanceniceorguk/CG101/Guidance/pdf/English 2010. 
13) Celli BR, MacNee W. Standards for the diagnosis and treatment of patients with COPD: 
a summary of the ATS/ERS position paper.  Eur Respir J 2004;23:932-946. 
14) Hansen NC, Skriver A, Brorsen-Riis L, et al.  Orally administered N-acetylecysteine may 
improve general well-being in patients with mild chronic bronchitis.  Respir Med 
1994;88:531-535. 


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Page 5 of 5 
15) British Thoracic Society Research Committee.  Oral N-acetylcysteine and exacerbation 
rates in patients with chronic bronchitis and severe airways obstruction.  Thorax 
1985;40:832-835. 
16) Boman G, Backer U, Larsson S, Melander B, Wahlander L. Oral acetylcysteine reduces 
exacerbation rates in chronic bronchitis: report of a trial organized by the Swedish 
Society for Pulmonary Diseases. Eur J Respir Dis 1983;64:405-415. 
17) Rasmussen JB, Glennow C. Reduction in days of illness after long-term treatment with 
N-acetylcysteine controlled-release tablets in patients with chronic bronchitis.  Eur Respir 
J 1988;1:351-355. 
18) Chen YJ, Lee WL, Wang CM, Chou HH. Nebulized hypertonic saline treatment reduces 
both rate and duration of hospitalization for acute bronchiolitis in infants: an updated 
meta-analysis. Pediatr Neonatol. 2014 Jan 21. pii: S1875-9572(13)00229-5. doi: 
10.1016/j.pedneo.2013.09.013. [Epub ahead of print] 
19) Wu S, Baker C, Lang ME, et al. Nebulized hypertonic saline for bronchiolitis: a 
randomized clinical trial. JAMA Pediatr. 2014;168(7):657-663. 
20) Pezzulo AP, Stoltz DA, Hornic DB, Durairaj L. Inhaled hypertonic saline in adults 
hopsitalised for exacerbation of cystic fibrosis lung disease: a retrospective study. BMJ 
Open. 2012;2(2):e000407. 
21) Bausewein C, Farquhar M, Booth S, et al.  Measurment of breathlessness in advanced 
disease: a systemic review. Resp Med 2007;101:399-410. 

ICF_001.pdf: 
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Patient Initials______ 
 
OHIOHEALTH 
 
CONSENT FORM 
 
TITLE OF STUDY:  NEBULIZED HYPERTONIC SALINE FOR INPATIENT USE IN 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 
PRINCIPAL INVESTIGATOR: KRUTI PATEL, D.O. 
 
We are conducting a clinical trial (a type of research study).  Clinical trials include only 
patients who choose to take part in the study.  This consent form serves two purposes.  
First, it provides information on the procedures and risks involved in the clinical trial, so 
that you can decide if you want to take part in the study. 
 
Second, this form will ask for your permission to use and release the medical information 
that we will get from you during this study. Please take your time to make your decision 
about taking part. You may discuss your decision with your friends and family. If you 
have any questions, you can ask your study doctor for more explanation. 
 
This study is being sponsored by Doctors Hospital Research and Education Office. 
 
You are being asked to take part in this study because you were admitted to Doctors 
Hospital with chronic obstructive pulmonary disease (COPD). 
 
WHY IS THIS STUDY BEING DONE? 
The purpose of this study is to see if there is a difference between two different types of 
saline (salt water), mixed with albuterol, a COPD treatment, in regards to improvements 
in a breathing test (Modified Borg Dyspnea Scale).   
 
 
 
WHAT IS INVESTIGATIONAL ABOUT THIS STUDY? 
We would like to see if there is any difference between patients who receive standard 
saline and hypertonic saline in regards to improvements in their COPD symptoms.  
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 
About 146 people will take part in this study locally through Doctors Hospital. 
 
 
 
 


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Patient Initials______ 
 
WHAT WILL HAPPEN IN THE STUDY? 
You will be “randomized” into one of the study groups described below. Randomization 
means that you are put into a group by chance. It is like flipping a coin. A computer will 
decide which group you are in.  Neither you nor the study doctor will choose what group 
you will be in.  You will have an equal chance of being placed in either group. 
 
Once you have agreed to participate in the study, you will be placed in one of the 
following groups.  
 
Group 1 will receive 2.5 mg albuterol with standard 0.9% saline 
 
Group 2 will receive 2.5 mg albuterol with nebulized 3% saline 
 
Prior to receiving your treatment, you will be given the Modified Borg Dyspnea Scale to 
assess the severity of your symptoms prior to your treatment. You will then receive 
albuterol treatments every six hours for 24 hours. After the 24 hour period, we will assess 
your symptoms once again. 
 
HOW LONG WILL I BE IN THE STUDY? 
 
You will be in the study until you are discharged from the hospital.  
 
You can stop being a part of this study at any time. However, if you decide to stop being 
in the study, please talk to the study doctor first.   
 
WHAT ARE THE RISKS OF THE STUDY? 
While on the study, you are at risk for the following side effects. You should discuss 
these with the study doctor. We will be looking at your medical records up to 30 days 
after you leave the hospital to see if you need to return.  
 
Risks and side effects related to nebulized saline include:  
 
Common: 
 Cough, wheeze, shortness of breath due to muscle tightening in the lungs 
(bronchospasm) 
 Sore throat 
 
Uncommon, but serious:  
 Fluid in the lungs (pulmonary edema) 
 Chest pain 
 
 


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Patient Initials______ 
 
Risks and side effects related to albuterol include:  
 
Common: 
 
Fast heart rate (tachyarrhythmia) 
 
Low potassium levels 
 
Sore throat/irritation 
 
Shaking (tremors) 
 
Uncommon, but serious:  
 
Upper respiratory tract infection 
 
Sinus infection (rhinitis) 
 
Abnormal heart rhythm (atrial fibrillation) 
 
Heart attack 
 
Water in the lungs (pulmonary edema) 
 
Rare:  
 
Rapid heart rhythm (supraventricular tachycardia) 
 
Itching 
 
Swelling of the mouth, face, lips, and throat (angioedema) 
 
Rash 
 
Muscle tightening in the lungs (bronchospasm) 
 
Dizziness 
 
Nervousness 
 
Headache 
 
Sleeplessness 
 
Nausea, stomach upset 
 
Nasal congestion 
 
Throat irritation (pharyngitis) 
 
High blood pressure 
 
Cough 
 
There also may be other side effects that we cannot predict. Many of these side effects 
are often manageable and reversible.  You will be observed for side effects and all 
medically appropriate efforts will be made to prevent and/or control them.  If there are 
side effects that cannot be controlled or reversed, they may result in serious injury or 
death. 
 
 
YOU SHOULD REPORT ANY OF THESE PROBLEMS TO THE STUDY DOCTOR 
IMMEDIATELY SO THAT APPROPRIATE CARE CAN BE GIVEN.  SIDE 
EFFECTS OTHER THAN THOSE LISTED HERE MAY ALSO OCCUR. TALK TO 
THE STUDY DOCTOR ABOUT ANY SIDE EFFECT THAT SEEMS UNUSUAL OR 
THAT IS ESPECIALLY BOTHERSOME TO YOU. 
 
 


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Patient Initials______ 
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
If you agree to take part in this study, there may or may not be direct medical benefit to 
you.  While doctors hope that treatment with hypertonic saline will be more beneficial, as 
compared to standard saline, there is no proof of this.  We do know that the information 
from this study will help doctors learn more about the use of hypertonic saline as a 
treatment for COPD symptoms. This information could help future patients with your 
condition. 
 
WHAT OTHER OPTIONS ARE THERE? 
Since you will be receiving albuterol treatments for your COPD, you will most likely 
receive the standard 0.9% saline.  
Please talk to your doctor about these and other options. 
 
WHAT ARE THE COSTS? 
Taking part in this study will not lead to added costs to you or your insurance company. 
The nebulized saline will be provided free of charge.  Non-routine costs required by the 
study will be paid by the sponsor. 
 
While you are in this study, you may receive tests, procedures, and exams that are 
standard medical care.  This standard medical care may or may not be covered by your 
medical insurance.   
 
If your medical insurance does not pay for this standard medical care, you will be 
responsible for the cost of medical care related to your condition, including but not 
limited to tests, deductibles, co-payments, study doctor and clinic fees, hospitalization 
and procedures. 
 
WHAT IF AN INJURY OCCURS BECAUSE OF THE STUDY 
TREATMENT? 
In the case of injury or illness resulting from this study, emergency medical treatment is 
available but will be provided at the usual charge. No funds have been set aside to 
compensate you in the event of injury or illness.  You or your insurance company will be 
charged for continuing medical care and/or hospitalization. 
 
COMPENSATION? 
You will receive no payment for taking part in this study. 
 
 
 


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Patient Initials______ 
 
WHAT INFORMATION WILL BE COLLECTED FROM ME FOR USE 
IN THE STUDY? 
The medical information that will be collected from you if you take part in this study 
includes: 
 
 
Information obtained from procedures used to determine your eligibility to 
take part in the research study, including a routine medical history, physical 
exam, and spirometry data (breathing test).  
 
Information that is created or collected from you during your participation in 
the study, including your over-all medical condition, albuterol use, results of 
the Modified Borg Dyspnea Scale, and follow-up information up to 30 days.  
 Information contained in your underlying medical records related to your 
medical history and treatment prior to this study 
 
The above information may identify you by name, address, telephone number, social 
security number, health plan number, study number, date of birth, dates relating to 
various medical procedures, or other identifying information.  
 
 
WHAT ABOUT CONFIDENTIALITY? 
If you sign this form and take part in this study, the study staff will be authorized to use 
the information described above to carry out the purposes of the research study.  The 
study staff will also be authorized to disclose the information described above to all of 
the following parties involved in the research study: 
 
Organizations that may inspect and/or copy your research records for quality assurance 
and data analysis include groups such as: 
 
 OhioHealth Institutional Review Board # 2  
 Doctors Hospital Research and Education Office 
 The U.S. Food and Drug Administration (FDA) and other government 
agencies. 
 The Department of Health and Human Services Office of Human Subject 
Research Protections 
 The Centers for Medicare and Medicaid Services (CMS) 
 The financial agent for CMS 
 OhioHealth Research and Innovation Institute Office of Regulatory 
Compliance 
 
 
Efforts will be made to keep your personal information confidential. We cannot 
guarantee absolute confidentiality. Your personal information may be disclosed if 
required by law.   Once your information is disclosed to the study sponsors, the IRB or 
the government agencies described above, there is a potential that your medical 


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Patient Initials______ 
 
information will be re-disclosed and will no longer be protected by federal privacy 
regulations.   
 
Your study number and initials will be used rather than your name as an identifier on 
your study records. 
 
If we publish the information we learn from this study in a medical journal, you will not 
be identified by name or in any other way. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify you.  
At most, the Web site will include a summary of the results.  You can search this Web 
site at any time. 
 
DO I HAVE THE RIGHT TO DECLINE AUTHORIZATION? 
You have the right to decline to sign this authorization to use/disclose your medical 
information.  If you decline, you will not be able to take part in this research study.  
Except as described herein, if you decline to sign this authorization, your rights 
concerning treatment, payment for services, enrollment in a health plan or eligibility for 
benefits will not be affected. 
 
HOW LONG WILL MY AUTHORIZATION REMAIN IN EFFECT? 
The authorization for use and disclosure of your information will remain in effect until 
the study is complete.  
 
CAN I WITHDRAW MY AUTHORIZATION? 
You may withdraw your authorization at any time by sending a written request to the 
Principal Investigator at: 
 
 
 
Kruti Patel, D.O. 
Doctors Hospital Research and Education Office 
5100 W. Broad St. 
Columbus, Ohio 43228 
              
If you withdraw your authorization:  
 
 Your participation in the study will end 
 The study staff will stop collecting your medical information 
 
Your medical information that has already been used and disclosed prior to withdrawing 
your authorization remains a part of the research study data. 
 
 
 


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Patient Initials______ 
 
While the research study is in progress, your access to your study records will be 
temporarily suspended. Afterwards, you have the right to see and copy the medical 
information collected from you in the course of the study, for as long as that information 
is maintained by the study staff and other entities subject to federal privacy regulations.   
 
WHAT ARE MY RIGHTS AS A PARTICIPANT? 
Your doctor has answered your questions.  You can ask your doctor questions at any 
time. 
  
Taking part in this study is voluntary. You may choose not to take part or you may leave 
the study at any time. Leaving the study will not result in any penalty or loss of benefits 
to which you are entitled. 
 
We will tell you about important new information that may affect your health, welfare 
and willingness to stay in this study. 
 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
For questions about the study or a research-related injury, contact the study doctor, Kruti 
Patel, DO, at 614-857-7735.  
 
For questions about your rights as a research participant, contact Dr. Randall Franz, 
Chairman of the OhioHealth Institutional Review Board # 2, which is a group of people 
who review the research to protect your rights at (614) 566-4431 for Dr. Franz or 
Customer Service at (614) 566-5708.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Patient Initials______ 
 
STATEMENT OF CONSENT AND AUTHORIZATION 
I hereby freely and voluntarily consent to take part in the research study described above.  
This consent is given based on the verbal and written information provided and the 
understanding that I am medically and physically qualified to take part in this study. I am 
free to ask questions at any time. 
 
I have the option to decline to take part or to withdraw from the study at any time without 
incurring any penalty or loss of benefits otherwise available, including medical care at 
this institution. 
 
My signature below indicates that I voluntarily agree to take part in this study and that I 
authorize the use and disclosure of my information in connection with the study.  I will 
receive a signed copy of this consent and authorization form. 
 
________________________________ 
___________________     ________ 
Patient Signature* 
Date 
 
 Time 
 
________________________________ 
___________________ _______ 
Research Coordinator/ 
Date 
 
 
Time 
  Person Obtaining Consent 
 
________________________________ 
 
___________________ 
Investigator Signature  
 
 
 
Date 
 
*If this consent is signed by a legal representative of the patient, check applicable box below explaining 
your authority to sign for the patient.  For legal representatives acting in the capacity as a parent/guardian to 
the patient, attach a copy of documentation giving you the authority to sign this consent form on behalf of 
the patient. 
 
Next of Kin 
 
Parent (patient is a minor) 
 
Guardian 
 
Health Care Power of Attorney 
 
Health Care Proxy or Surrogate 
 
 
_______________________________________ 
_______________________      _________ 
Signature of Patient’s Legally 
Date 
Time  
Authorized Representative 
 
 
 
 
 


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Patient Initials______ 
 
IF THE PATIENT IS PARTICIPATING BUT UNABLE TO GIVE CONSENT, 
INDICATE WHY. 
__________________________________________________________________ 
 
__________________________________________________________________ 
 
 
 
 
_________________________ 
___________________ 
_______ 
Witness to consent process 
 
Date 
 
 
 
Time 
(if applicable)