A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease
Phase: NA
Conditions: Idiopathic Parkinson Disease
Sponsor: University of Massachusetts, Amherst

Cover Page 
 
Official Title: A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease   
 
NCT: NCT03700684 
 
Document Date: April 10, 2023 
 
 
 
 

Background 
 
Motor impairment is a hallmark feature of Parkinson’s disease (PD). The motor-based symptoms are 
characterized by reduced amplitude and speed of movement and difficulty initiating and coordinating 
movement. An important functional consequence of these motor-based impairments is a marked reduction 
in speaking intensity. This condition, known as hypophonia, is estimated to effect approximately 75% of 
patients in some stage of the disease process. 
 
Our two current, evidence-based treatments for hypophonia, LSVT LOUD® and the SpeechViveTM, use 
high effort speech tasks to increase motor output across the speech mechanism. While LSVT LOUD® 
and the SpeechViveTM share the same therapeutic target (increased speech intensity), they differ 
substantially in the type of cueing used in therapy. LSVT LOUD® targets louder speech using internal, 
self-initiated cues. The SpeechViveTM, in contrast, elicits louder speech using a naturalistic, external 
noise cue. While data show that LSVT LOUD® and the SpeechViveTM both yield significant 
improvements in sound pressure level (SPL)/vocal intensity, the supportive physiologic adjustments used 
by speakers are not well understood. Our long-term goal is to improve voice rehabilitation for persons 
with PD. Our objectives are to determine the influence of treatment on the respiratory and laryngeal 
adjustments used by speakers with PD to support increased speech volume, and to identify the 
perceptions of physical and mental effort associated with each form of therapy. Our central hypothesis is 
that treatment strategy will differentially impact the physiologic systems that support louder speech and 
mediate speaker perceptions of effort. We plan to objectively test our central hypothesis and, thereby, 
attain the objective of this application by pursuing the following two specific aims: 
 
Aim 1: To examine physiologic adjustments in respiratory and laryngeal function in response to treatment 
utilizing internal cueing (LSVT LOUD®) and external cueing (SpeechViveTM) strategies. Based on 
published research and preliminary data, we hypothesize that the external cueing treatment will elicit 
more efficient respiratory and laryngeal patterns during louder speech, in comparison to the internal 
cueing treatment. 
 
Aim 2: To assess participants’ level of perceived physical and mental effort associated with LSVT 
LOUD® and SpeechViveTM therapies. We hypothesize that speakers with PD will assign lower ratings 
of perceived physical and mental effort for SpeechViveTM therapy, in comparison to LSVT LOUD®. 
This hypothesis is predicated on programmatic differences in training intensity level and cognitive load. 
 
Methods 
 
Participants: Thirty-six individuals with a neurological diagnosis of idiopathic PD will be enrolled for 
study in West Lafayette, Indiana (and surrounding areas) and in Amherst, Massachusetts (and 
surrounding areas). Participants will be randomly assigned to one of three groups: LSVT LOUD® (n=12), 
SpeechViveTM (n=12), non-treatment PD control (n=12). Participants assigned to the non-treatment 
control group will be sampled at the same time points as the experimental groups. The sample size has 
been chosen to detect a 5 dB SPL difference with a study power of 0.8 and significance level of 0.05. 
Inclusionary criteria include: (i) problems with speech volume as determined by an ASHA-certified 
speech-language pathologist, (ii) unaided hearing in at least one ear (to accommodate the 
SpeechViveTM), (iii) non-smoking in the past 5 years, (iv) no recent history of respiratory illness; (v) no 
neurological conditions other than PD and no history of neurosurgeries, (vi) free of depressive symptoms 
(Beck Depression Inventory score < 19), (vii) no voice therapy or voice therapy maintenance within the 
last six months, (viii) negative laryngeal pathology as determined by a videolaryngoscopic examination. 
Participants who present with normal vocal fold closure or incomplete vocal fold closure will be included 
for study. Patients with vocal fold lesions, hyperadduction, or other laryngeal pathology will be excluded 
and referred for treatment.  

 
Methods and Analysis: LSVT LOUD® and SpeechViveTM follow a standardized treatment protocol 
which will ensure treatment fidelity across sites. The research personnel responsible for administering 
treatment will be LSVT LOUD®-certified and trained in the SpeechViveTM protocol. Data will be 
collected at three time points for each group: pre-treatment, mid-treatment, and immediately post-
treatment. In accordance with specific aim 1, outcomes measures will include sound pressure level (SPL), 
utterance length, respiratory kinematic patterns, and laryngeal aerodynamic patterns. Pre-to-post 
treatment changes in SPL will serve as a primary indicator on the effectiveness of each intervention 
technique. SPL and utterance length will be captured and analyzed during a two-minute monologue task. 
Respiratory and laryngeal aerodynamic data will be collected and analyzed during connect speech. 
Respiratory kinematic data will be captured using inductance plethysmography to transduce the 
movement of the ribcage and abdomen during a monologue and reading task.  Laryngeal aerodynamic 
data will be captured during a sentence-level task (‘‘Buy pop or pop a papa”) using a circumferentially-
vented pneumotachograph mask. In accordance with specific aim 2, a modified version of the National 
Aeronautics and Space Administration Task Load Index (NASA-TLX) [46] will be used to examine the 
participants’ perceived level of physical and mental effort associated with LSVT LOUD® and 
SpeechViveTM therapies. Following each treatment session, participants will be instructed to complete 
the computerized NASA-TLX scale and assign a visual analogue rating for the Mental Demand (how 
much mental and perceptual activity was required) and Physical Demand (how much physical activity 
was required) domains. Higher scores reflect speakers’ perceptions of increased effort.  
 
For specific aim 1, the statistical approach will involve a repeated measures analysis of variance for each 
outcome variable: SPL, utterance length, respiratory kinematic measures, and laryngeal aerodynamic 
measures. The within-subject factor will be Session (pre, mid, post) and the between-subject factor will be 
Group (LSVT LOUD®, SpeechViveTM, and non-treatment control). Participant will be included as a 
random effect in the model to account for expected inter-subject differences in response to treatment. If 
the measures exhibit strong skewness or outlying values, we will compare the groups using appropriate 
non-parametric methods. Bonferroni-adjusted p-values will be used to reduce Type I error. For specific 
aim 2, each domain score of the NASA-TLX will be statistically analyzed using a separate, repeated 
measures analysis of variance. Treatment session will be included as a factor in each analysis. The model 
will include random effects to account for within-subject correlation. If the measures exhibit strong 
skewness or outlying values, we will compare the groups using non-parametric methods. Bonferroni-
adjusted p-values will be used to reduce Type I error.   
 

Page 1 of 5 
Consent Form for Participation in a Research Study 
Researchers: 
Kelly Richardson, Ph.D., Assistant Professor 
University of Massachusetts Amherst 
Jessica Huber, Ph.D., Professor 
Purdue University 
Study Title: 
A comparison of two behavioral voice interventions for Parkinson’s disease. 
1. WHAT IS THIS FORM?
This form is called a Consent Form. It will give you information about the study so you can make an
informed decision about participation in this research project.
This consent form will give you the information you will need to understand why this study is being done 
and why you are being invited to participate. It will also describe what you will need to do to participate 
and any known risks or discomforts that you may have while participating. We encourage you to take 
some time to think this over and ask questions now and at any other time. If you decide to participate, you 
will be asked to sign this form and you will be given a copy for your records. 
2. WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of this research study is to compare two behavioral voice treatment programs commonly used
to treat the speech and voice problems associated with Parkinson’s disease.
3. WHO IS ELIGIBLE TO PARTICIPATE?
Subjects must present with i) a diagnosis of Parkinson's disease, (ii) have problems with speaking volume
due to Parkinson's disease, (iii) present with a negative history for other neurological involvement (other
than Parkinson's disease), (iv) no history of asthma or respiratory problems (COPD, emphysema), (v) no
history of head, neck or chest surgery (pacemaker surgery is okay), (vi) non-smoker for the last 5 years,
(vii) no currently participating in another treatment study, (viii) access to transportation to and from
campus, (ix) typical cognitive skills, (x) free of symptoms of depression, xi) healthy vocal folds xii) no
voice therapy or voice therapy maintenance within the last 12 months.
4. WHERE WILL THE STUDY TAKE PLACE AND HOW LONG WILL IT LAST?
The research study will be conducted at (the University of Massachusetts Amherst/Purdue University).
You have been assigned to the non-treatment control group. As a participant in the control group, you
will be asked to participate in three data collection sessions over an eight week period at the university
laboratory. Each testing session lastly approximately 90-120 minutes. As a participant in this study, you
will not be contacted directly for future studies.
5. WHAT WILL I BE ASKED TO DO?
You could have been placed into one of three groups: LSVT LOUD® treatment, SpeechViveTM treatment, or 
non-treatment control group. You have been placed in the non-treatment control group. As a part of the 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
07/06/2018
10/03/2018
2017-4212

Page 2 of 5 
 
control group, you are not eligible for voice treatment. Since this is a treatment study, we will ask you to not 
engage in other form of therapy (surgical, pharmacological, or behavioral) for the duration of the study. As a 
research participant, you are ask to attend 3 data collection sessions at the university laboratory with each 
session lasting 90-120 minutes. 
 
In this first visit to the lab, you will be asked to complete additional screening tasks in order to be certain that 
you are appropriate to participate in this study. You will first be asked to i) complete a depression inventory 
to assess your mood, ii) pass a cognitive screening inventory, and iii) participate in a laryngeal examination. 
As part of the cognitive screening, you will be asked a series of questions related to orientation of place and 
time, remember a sequence of words for a short period of time (e.g. a few minutes), name objects, and follow 
a series of short commands. The laryngeal examination will be conducted by a trained member of the research 
team. For this examination, you will be seated and a Velcro strap will hold a microphone comfortably on the 
side of your neck. You will be asked to stick out your tongue, which will be held by the examiner with sterile 
gauze. An endoscope will then be slowly inserted towards the back of your mouth so that a video recording 
of your larynx (voice box) can be made. The endoscope is a straight blunt metal rod (about the diameter of a 
“pinky finger”) with a tiny camera lens at the end. Neither the endoscope nor the Velcro strap will interfere 
with your breathing. You will say an “ee” sound and then the endoscope will be removed. The endoscope will 
be disinfected after each use.  
 
Based on the results of these tests, you may be deemed ineligible to participate. In such instances, you will be 
compensated for the time you participated at a prorated rate of $10 per hour. 
 
If you are deemed eligible to participate, you will be asked to complete a questionnaire that focuses on your 
medical history which includes questions about your Parkinson’s disease, general health, medications, and 
any speech and voice problems you may be experiencing. You may skip any question that you feel 
uncomfortable answering. We will also ask you to release a test score from your neurologist to us which 
indexes the severity of your Parkinson’s disease. You do not need to agree to this release to participate in the 
study. In addition, you will undergo a brief heading screening which requires you to listen for tones and 
raise your hand when you hear the tone. 
 
In addition, you will be asked to wear a microphone and perform a variety of speaking tasks including, but 
not limited to reading sentences, short passages, and/or citing a monologue. You will also be asked to 
perform different breathing exercises while wearing nose clips including breathing in and out as much as 
you can into a cardboard mouthpiece. The nose clips and mouthpiece are disposable and are thrown out after 
use. You will also be fitted with elasticized bands that are worn on the outside your clothing around your rib 
cage and abdomen. The bands do not impede your ability to breathe. We will ask you to breathe quietly, to 
breathe in and out as much air as you can, and to move your abdomen in and out. You will also be asked to 
talk about a topic of interest for several minutes. Lastly, we will place a mask over your mouth and nose. 
The mask will measure the air as it comes out of your mouth. A small tube will be placed between your lips 
and behind your teeth. It will not impede your ability to talk. We will ask you to read a sentence several 
times with the mask in place. The mask and tube will be disinfected after each use. You may take breaks as 
needed or cease participation at any time. You have just completed your pre-treatment lab session. You will 
be asked to perform these tasks again in week 4 (mid-treatment) and week 8 (end of treatment). 
 
This is a research study that involves questions related to sensitive topics that may cause distress. As 
researchers, we do not provide mental health services and we will not be following up with you after this 
study. However, we want to provide every participant in this study with contact information for available 
clinical resources, should you decide you need assistance at any time. In a serious emergency, remember 
that you can also call 911 for immediate assistance. The facilities identified below offers services to 
individuals who are not affiliated with UMass Amherst/Purdue University. 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
07/06/2018
10/03/2018
2017-4212

Page 3 of 5 
 
University of Massachusetts Amherst 
Purdue University 
Counseling and Psychological Health 
Counseling and Psychological Services 
127 Hills North 
601 Stadium Mall Drive, Room 224 
Amherst MA 01003 
West Lafayette, IN 47907-2052 
(413) 545-2337 
(765) 494-6995 
 
6. WHAT ARE MY BENEFITS OF BEING IN THIS STUDY? 
Your participation in the study will advance our knowledge of what treatment approaches may help 
alleviate the speech and voice problems commonly reported by individuals with Parkinson's disease. 
 
7. WHAT ARE MY RISKS OF BEING IN THIS STUDY? 
We believe there are minimal physical risks associated with this research study. A possible risk to you 
however, might include fatigue. To lower the risk of fatigue, you will have periods of rest throughout each 
laboratory session. You may also request a break at anytime. There is also a risk of a breach of 
confidentiality. To minimize this risk, you will be assigned a unique identifier which will be assigned to 
your records and collected voice samples. Your consent form, which contains identifying information, 
will be stored in a locked filing cabinet in a secured room, only accessible to key research personnel for a 
period of three years. After three years, all study records will be destroyed. Should a breach of 
confidentiality occur you will be immediately informed of the breach verbally and in writing. There is 
also a minimal risk of infection. To minimize this risk, all instruments used during data collection are 
sterilized with medical grade disinfectant prior to use. The nose clips and mouthpieces will be discarded 
after one use. The mask and tube will be disinfected after each use. During the examination of the larynx, 
some people find that they gag temporarily if the endoscope touches the back of their tongue or throat. 
The sensation is similar to what you may have experienced while brushing your tongue with a tooth 
brush. In addition, there may be a remote chance of damage to teeth and dental work. A trained member 
of the research team will guide the endoscope using techniques designed to minimize this risk. The 
endoscope will be disinfected after each use.  
 
As a participant in this study, you will be asked to provide sensitive information about your physical and 
mental well-being and demographic data (age, gender, height, weight, race/ethnicity). You may refuse to 
answer any question without repercussion. There is a low psychological risk that you may be upset by 
some of the questions centered on health-related issues. We can provide you with a list of mental health 
professionals in your community, if this information would be helpful. 
 
8. HOW WILL MY PERSONAL INFORMATION BE PROTECTED? 
The following procedures will be used to protect the confidentiality of your study records. The researchers 
will keep all study records in a locked file cabinet in a secure room accessible only to project staff. 
Electronic data files will be stored on a password protected computer in a secure room accessible only to 
project staff. Copies of all records will also be maintained on a HIPAA and HITECH compliant data 
sharing platform. All records will be labeled with a unique code. A master key which links participant 
names with their unique codes will be maintained in a separate and secure location accessible to key 
research personnel. The master key and data files will be destroyed 3 years after the close of the study. At 
the conclusion of this study, the researchers may publish their findings. Information will be presented in 
summary format and you will not be identified in any publications or presentations. 
 
9. WILL I RECEIVE ANY PAYMENT FOR TAKING PART IN THE STUDY? 
You will be compensated $10/hour for each laboratory session you participate in. 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
07/06/2018
10/03/2018
2017-4212

Page 4 of 5 
 
10. EXTRA COSTS TO PARTICIPATE 
There are no extra costs for you related to your participation in this study. Parking at (UMass 
Amherst/Purdue University) will be covered. 
 
11. WHAT IF I HAVE QUESTIONS? 
Take as long as you like before you make a decision. We will be happy to answer any question you have 
about this study. If you have further questions about this project or if you have a research-related problem, 
you may contact the researcher, Dr. Kelly Richardson, at (413) 545-2007. If you have any questions 
concerning your rights as a research subject, you may contact the University of Massachusetts Amherst 
Human Research Protection Office (HRPO) at (413) 545-3428 or humansubjects@ora.umass.edu. 
 
12. CAN I STOP BEING IN THE STUDY? 
You do not have to participate in this research project. If you agree to participate, you can withdraw your 
participation at any time without penalty. Please tell the experimenter if you wish to end your 
participation at any point in the study. If you wish to withdraw your records or data after you have 
completed your participation, please contact the primary investigator by phone, email, or writing. 
 
13. WHAT IF I AM INJURED? 
The University of Massachusetts does not have a program for compensating subjects for injury or 
complications related to human subjects’ research. This does not waive any of my legal rights nor release 
any claim I might have based on negligence. 
 
14. CONTACT INFORMATION 
If you have any questions about this research project and/or scheduling, you may contact the principal 
investigator Dr. Kelly Richardson, UMass Amherst, at 413-545-2007 or by email 
krichardson@comdis.umass.edu. Or you may contact the co-investigator, Dr. Jessica Huber, Purdue 
University, at 765-494-3796 or by email at jhuber@purdue.edu. If you have any questions about your 
rights as a participant in a research project, or questions, concerns or complaints about the research and 
wish to speak with someone who is not a member of the research team, you should contact (anonymously, 
if you wish) the Human Research Protection Office at the University of Massachusetts Amherst at (413) 
545-3428 or by mail at Human Research Protection Office, Mass Venture Center, 100 Venture Way, Suite 
116, Hadley, MA 01035. 
 
15. CONFLICT OF INTEREST DISCLOSURE 
The following disclosures are made to give you an opportunity to decide if these relationships will affect 
your willingness to participate in the research study. Dr. Huber, the primary investigator on the study, is the 
inventor of the SpeechViveTM device. She is on the Board of Directors of SpeechViveTM, Inc, the company 
that manufactures and sells the SpeechViveTM device. She also owns stock in the company. Sandy Snyder, a 
staff member in Dr. Huber’s laboratory, also owns stock in SpeechViveTM, Inc. The researchers will not 
make any attempt to initiate the sale of the SpeechViveTM medical device either during the study or after 
study completion. 
 
16. DATA SHARING 
This research study will adhere to the NIH Grants Policy on Sharing of Unique Research Resources 
including the “NIH Data Sharing Policy” issued in April 2007; 
http://grants.nih.gov/grants/policy/data_sharing/. 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
07/06/2018
10/03/2018
2017-4212

Page 5 of 5 
 
Final data will be shared primarily through the vehicle of peer reviewed publications and scientific 
conference proceedings. Raw data will be considered for sharing under the following rules. Raw datasets to 
be released for sharing will not contain identifiers. Data and associated documentation will be made 
available to users only under a signed and properly executed data-sharing agreement that provides for 
specific criteria under which the data will be used, including but not limited to: 1) a commitment to using the 
data only for research purposes; 2) a commitment to securing the data using appropriate computer 
technology; and 3) a commitment to destroying or returning the data after analyses are completed. 
 
17. SUBJECT STATEMENT OF VOLUNTARY CONSENT 
When signing this form I am agreeing to voluntarily enter this study. I have had a chance to read this 
consent form, and it was explained to me in a language which I use and understand. I have had the 
opportunity to ask questions and have received satisfactory answers. I understand that I can withdraw at 
any time. I understand that will receive a copy of this signed Informed Consent Form. 
 
 
 
 
Participant Signature: 
Print Name: 
Date: 
 
By signing below I indicate that the participant has read and, to the best of my knowledge, understands the 
details contained in this document and has been given a copy. 
 
 
 
Signature of Person 
Print Name: 
Date: 
Obtaining Consent 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
07/06/2018
10/03/2018
2017-4212

Page 1 of 5 
Consent Form for Participation in a Research Study 
Researchers:   
Kelly Richardson, Ph.D., Assistant Professor 
University of Massachusetts Amherst  
Jessica Huber, Ph.D., Professor  
Purdue University  
Study Title:  
A comparison of two behavioral voice interventions for Parkinson’s disease.  
1. WHAT IS THIS FORM?
This form is called a Consent Form. It will give you information about the study so you can make an 
informed decision about participation in this research project.  
This consent form will give you the information you will need to understand why this study is being done 
and why you are being invited to participate. It will also describe what you will need to do to participate 
and any known risks or discomforts that you may have while participating. We encourage you to take 
some time to think this over and ask questions now and at any other time. If you decide to participate, you 
will be asked to sign this form and you will be given a copy for your records.  
2. WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of this research study is to compare two behavioral voice treatment programs commonly used 
to treat the speech and voice problems associated with Parkinson’s disease.  
3. WHO IS ELIGIBLE TO PARTICIPATE?
Subjects must present with i) a diagnosis of Parkinson's disease, (ii) have problems with speaking volume 
due to Parkinson's disease, (iii) present with a negative history for other neurological involvement (other 
than Parkinson's disease), (iv) no history of asthma or respiratory problems (COPD, emphysema), (v) no 
history of head, neck or chest surgery (pacemaker surgery is okay), (vi) non-smoker for the last 5 years, 
(vii) no currently participating in another treatment study, (viii) access to transportation to and from
campus, (ix) typical cognitive skills, (x) free of symptoms of depression, (xi) healthy vocal folds, (xii) no
voice therapy or voice therapy maintenance within the last 12 months.
4. WHERE WILL THE STUDY TAKE PLACE AND HOW LONG WILL IT LAST?
The research study will be conducted at (the University of Massachusetts Amherst/Purdue University). 
You have been assigned to the LSVT LOUD® treatment group. As a participant in this treatment group, 
you will be asked to participate in an eight-week home-based voice treatment program. In addition, you 
will be asked to attend 3-4 laboratory sessions at the university campus, with each session lastly 
approximately 90-120 minutes. As a participant in this study, you will not be contacted directly for future 
studies.  
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
07/06/2018
10/03/2018
2017-4212

Page 2 of 5  
  
5. WHAT WILL I BE ASKED TO DO?  
Treatment Overview: You could have been placed into one of three groups: LSVT LOUD® treatment, 
SpeechViveTM treatment, or non-treatment control group. You have been placed in the LSVT LOUD® 
treatment group. As a part of the study, you will be asked to participate in 60 minutes of voice therapy, 4 
days per week, for four weeks. After this time, you will be asked to participate in a home maintenance 
program where you will be asked to record the day and time of your vocal practice. In the home 
maintenance program, you will be asked to practice the vocal exercises 4 days per week for 4 weeks. A 
homework DVD will be provided which provides an overview of the vocal exercises to be completed. The 
LSVT LOUD® treatment will be provided by an LSVT-certified practitioner. Since this is a treatment 
study, we will ask you to not engage in other form of therapy (surgical, pharmacological, or behavioral) 
for the duration of the study.   
 
Number of Days of LSVT LOUD®: 4 days per week  
Number of Weeks for LSVT LOUD®: 4 weeks  
Number of Days of LSVT Maintenance: 5 days per week  
Number of Weeks for LSVT Maintenance: 4 weeks  
  
Data Collection:  In the first visit to the lab, you will be asked to complete several screening tasks in order to 
be certain that you are appropriate to participate in this study. The first part of the screening was completed 
with the questions you answered over the phone. To confirm eligibility, you will first be asked to i) complete 
a depression inventory to assess your mood, ii) pass a cognitive screening inventory, and iii) participate in a 
laryngeal examination. As part of the cognitive screening, you will be asked a series of questions related to 
orientation of place and time, remember a sequence of words for a short period of time (e.g. a few minutes), 
name objects, and follow a series of short commands. The laryngeal examination will be conducted by a 
trained member of the research team. For this examination, you will be seated and a Velcro strap will hold a 
microphone comfortably on the side of your neck. You will be asked to stick out your tongue, which will be 
held by the examiner with sterile gauze. An endoscope will then be slowly inserted towards the back of your 
mouth so that a video recording of your larynx (voice box) can be made. The endoscope is a straight blunt 
metal rod (about the diameter of a “pinky finger”) with a tiny camera lens at the end. Neither the endoscope 
nor the Velcro strap will interfere with your breathing. You will say an “ee” sound and then the endoscope 
will be removed. The endoscope will be disinfected after each use. Based on the results of these tests, you 
may be deemed ineligible to participate. In such instances, you will be compensated for the time you 
participated at a prorated rate of $10 per hour.    
  
If you are deemed eligible to participate, you will be asked to complete a questionnaire that focuses on your 
medical history which includes questions about your Parkinson’s disease, general health, medications, and 
any speech and voice problems you may be experiencing. You may skip any question that you feel 
uncomfortable answering.  We will also ask you to release a test score from your neurologist to us which 
indexes the severity of your Parkinson’s disease. You do not need to agree to this release to participate in the 
study. In addition, you will undergo a brief heading screening which requires you to listen for tones and 
raise your hand when you hear the tone.     
  
In addition, you will be asked to wear a microphone and perform a variety of speaking tasks including, but 
not limited to reading sentences, short passages, and/or citing a monologue. You will also be asked to 
perform different breathing exercises while wearing nose clips including breathing in and out as much as 
you can into a cardboard mouthpiece. The nose clips and mouthpiece are disposable and are thrown out after 
use. You will also be fitted with elasticized bands that are worn on the outside your clothing around your rib 
cage and abdomen. The bands do not impede your ability to breathe. We will ask you to breathe quietly, to 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
07/06/2018
10/03/2018
2017-4212

Page 3 of 5  
  
breathe in and out as much air as you can, and to move your abdomen in and out. You will also be asked to 
talk about a topic of interest for several minutes. Lastly, we will place a mask over your mouth and nose. 
The mask will measure the air as it comes out of your mouth. A small tube will be placed between your lips 
and behind your teeth. It will not impede your ability to talk. We will ask you to read a sentence several 
times with the mask in place. The mask and tube will be disinfected after each use. You may take breaks as 
needed or cease participation at any time. You have just completed your pre-treatment lab session. You will 
be asked to perform these tasks again in week 4 (mid-treatment) and week 8 (end of treatment).  
  
This is a research study that involves questions related to sensitive topics that may cause distress. As 
researchers, we do not provide mental health services and we will not be following up with you after this 
study. However, we want to provide every participant in this study with contact information for available 
clinical resources, should you decide you need assistance at any time. In a serious emergency, remember 
that you can also call 911 for immediate assistance. The facilities identified below offers services to 
individuals who are not affiliated with UMass Amherst/Purdue University.  
  
University of Massachusetts Amherst  
  
  
Purdue University   
Counseling and Psychological Health   
  
  
Counseling and Psychological Services 
127 Hills North   
  
  
601 Stadium Mall Drive, Room 224  
Amherst MA 01003  
  
  
West Lafayette, IN 47907-2052  
(413) 545-2337  
  
  
(765) 494-6995  
  
6. WHAT ARE MY BENEFITS OF BEING IN THIS STUDY?   
If the therapy proves effective for you, you may benefit by improved speech loudness and intelligibility. 
In addition, your participation in the study will advance our knowledge of what treatment approaches may 
help alleviate the speech and voice problems commonly reported by individuals with Parkinson's disease.  
  
7. WHAT ARE MY RISKS OF BEING IN THIS STUDY?   
We believe there are minimal physical risks associated with this research study.  A possible risk to you 
however, might include fatigue. To lower the risk of fatigue, you will have periods of rest throughout each 
laboratory session. You may also request a break at anytime. There is also a risk of a breach of 
confidentiality. To minimize this risk, you will be assigned a unique identifier which will be assigned to 
your records and collected voice samples. Your consent form, which contains identifying information, 
will be stored in a locked filing cabinet in a secured room, only accessible to key research personnel for a 
period of three years. After three years, all study records will be destroyed. Should a breach of 
confidentiality occur you will be immediately informed of the breach verbally and in writing.   
  
During the examination of the larynx, some people find that they gag temporarily if the endoscope touches 
the back of their tongue or throat. The sensation is similar to what you may have experienced while 
brushing your tongue with a tooth brush. In addition, there may be a remote chance of damage to teeth 
and dental work. A trained member of the research team will guide the endoscope using techniques 
designed to minimize this risk. The endoscope will be disinfected after each use. The audiometer 
headphones will be disinfected before and after you use them in order to minimize the slight risk that you 
will come into contact with substances such as bacteria. The nose clips and mouthpieces will be discarded 
after one use. The mask and tube will be disinfected after each use.  
  
As a participant in this study, you will be asked to provide sensitive information about your physical and 
mental well-being and demographic data (age, gender, height, weight, race/ethnicity). You may refuse to 
answer any question without repercussion. There is a low psychological risk that you may be upset by 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
07/06/2018
10/03/2018
2017-4212

Page 4 of 5  
  
some of the questions centered on health-related issues. We can provide you with a list of mental health 
professionals in your community, if this information would be helpful.  
  
8. HOW WILL MY PERSONAL INFORMATION BE PROTECTED?   
The following procedures will be used to protect the confidentiality of your study records. The researchers 
will keep all study records in a locked file cabinet in a secure room accessible only to project staff. 
Electronic data files will be stored on a password protected computer in a secure room accessible only to 
project staff. Copies of all records will also be maintained on a HIPAA and HITECH compliant data 
sharing platform. All records will be labeled with a unique code. A master key which links participant 
names with their unique codes will be maintained in a separate and secure location accessible to key 
research personnel. The master key and data files will be destroyed 3 years after the close of the study. At 
the conclusion of this study, the researchers may publish their findings. Information will be presented in 
summary format and you will not be identified in any publications or presentations.  
  
9. WILL I RECEIVE ANY PAYMENT FOR TAKING PART IN THE STUDY?   
You will receive eight weeks of voice treatment at no cost to you. In addition, you will be compensated 
$10/hour for each laboratory session you participate in.   
  
10. EXTRA COSTS TO PARTICIPATE  
There are no extra costs for you related to your participation in this study. Parking at (UMass 
Amherst/Purdue University) will be covered.  
  
11. WHAT IF I HAVE QUESTIONS?  
Take as long as you like before you make a decision. We will be happy to answer any question you have 
about this study. If you have further questions about this project or if you have a research-related problem, 
you may contact the researcher, Dr. Kelly Richardson, at (413) 545-2007. If you have any questions 
concerning your rights as a research subject, you may contact the University of Massachusetts Amherst 
Human Research Protection Office (HRPO) at (413) 545-3428 or humansubjects@ora.umass.edu.  
  
12. CAN I STOP BEING IN THE STUDY?  
You do not have to participate in this research project. If you agree to participate, you can withdraw your 
participation at any time without penalty. Please tell the experimenter if you wish to end your 
participation at any point in the study. If you wish to withdraw your records or data after you have 
completed your participation, please contact the primary investigator by phone, email, or writing.        
  
13. WHAT IF I AM INJURED?  
The University of Massachusetts does not have a program for compensating subjects for injury or 
complications related to human subjects’ research. This does not waive any of my legal rights nor release 
any claim I might have based on negligence.  
  
14. CONTACT INFORMATION  
If you have any questions about this research project and/or scheduling, you may contact the principal 
investigator Dr. Kelly Richardson, UMass Amherst, at 413-545-2007 or by email  
krichardson@comdis.umass.edu. Or you may contact the co-investigator, Dr. Jessica Huber, Purdue 
University, at 765-494-3796 or by email at jhuber@purdue.edu.  If you have any questions about your 
rights as a participant in a research project, or questions, concerns or complaints about the research and 
wish to speak with someone who is not a member of the research team, you should contact (anonymously, 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
07/06/2018
10/03/2018
2017-4212

Page 5 of 5  
  
if you wish) the Human Research Protection Office at the University of Massachusetts Amherst at (413) 
545-3428 or by mail at Human Research Protection Office, Mass Venture Center, 100 Venture Way, Suite 
116, Hadley, MA 01035.  
  
15. CONFLICT OF INTEREST DISCLOSURE  
The following disclosures are made to give you an opportunity to decide if these relationships will affect 
your willingness to participate in the research study. Dr. Huber, the primary investigator on the study, is the 
inventor of the SpeechViveTM device. She is on the Board of Directors of SpeechViveTM, Inc, the company 
that manufactures and sells the SpeechViveTM device. She also owns stock in the company. Sandy Snyder, a 
staff member in Dr. Huber’s laboratory, also owns stock in SpeechViveTM, Inc. The researchers will not 
make any attempt to initiate the sale of the SpeechViveTM medical device either during the study or after 
study completion.  
  
16. DATA SHARING  
This research study will adhere to the NIH Grants Policy on Sharing of Unique Research Resources 
including the “NIH Data Sharing Policy” issued in April 2007; 
http://grants.nih.gov/grants/policy/data_sharing/.   
  
Final data will be shared primarily through the vehicle of peer reviewed publications and scientific 
conference proceedings. Raw data will be considered for sharing under the following rules. Raw datasets to 
be released for sharing will not contain identifiers. Data and associated documentation will be made 
available to users only under a signed and properly executed data-sharing agreement that provides for 
specific criteria under which the data will be used, including but not limited to: 1) a commitment to using the 
data only for research purposes; 2) a commitment to securing the data using appropriate computer 
technology; and 3) a commitment to destroying or returning the data after analyses are completed.  
  
17. SUBJECT STATEMENT OF VOLUNTARY CONSENT  
When signing this form I am agreeing to voluntarily enter this study. I have had a chance to read this 
consent form, and it was explained to me in a language which I use and understand. I have had the 
opportunity to ask questions and have received satisfactory answers. I understand that I can withdraw at 
any time. I understand that will receive a copy of this signed Informed Consent Form.  
  
  
   
________________________  ____________________  __________ Participant Signature:   Print 
Name:    Date:  
  
By signing below I indicate that the participant has read and, to the best of my knowledge, understands the 
details contained in this document and has been given a copy.  
  
  
_________________________     
____________________  
  
__________  
Signature of Person  
  
  
Print Name:  
  
  
  
Date:  
Obtaining Consent  
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
07/06/2018
10/03/2018
2017-4212

Page 1 of 5 
Consent Form for Participation in a Research Study 
Researchers: 
Kelly Richardson, Ph.D., Assistant Professor 
University of Massachusetts Amherst 
Jessica Huber, Ph.D., Professor 
Purdue University 
Study Title: 
A comparison of two behavioral voice interventions for Parkinson’s disease. 
1. WHAT IS THIS FORM?
This form is called a Consent Form. It will give you information about the study so you can make an 
informed decision about participation in this research project. 
This consent form will give you the information you will need to understand why this study is being done 
and why you are being invited to participate. It will also describe what you will need to do to participate 
and any known risks or discomforts that you may have while participating. We encourage you to take 
some time to think this over and ask questions now and at any other time. If you decide to participate, you 
will be asked to sign this form and you will be given a copy for your records. 
2. WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of this research study is to compare two behavioral voice treatment programs commonly 
used to treat the speech and voice problems associated with Parkinson’s disease. 
3. WHO IS ELIGIBLE TO PARTICIPATE?
Subjects must present with i) a diagnosis of Parkinson's disease, (ii) have problems with speaking volume 
due to Parkinson's disease, (iii) present with a negative history for other neurological involvement (other 
than Parkinson's disease), (iv) no history of asthma or respiratory problems (COPD, emphysema), (v) no 
history of head, neck or chest surgery (pacemaker surgery is okay), (vi) non-smoker for the last 5 years, 
(vii) no currently participating in another treatment study, (viii) access to transportation to and from
campus, (ix) typical cognitive skills, (x) free of symptoms of depression, (xi) healthy vocal folds, (xii)
unaided hearing in at least one ear (to accommodate SpeechVive device), (xiii) no voice therapy or voice
therapy maintenance within the last 12 months.
4. WHERE WILL THE STUDY TAKE PLACE AND HOW LONG WILL IT LAST?
The research study will be conducted at (the University of Massachusetts Amherst/Purdue University). 
You have been assigned to the SpeechViveTM treatment group. As a participant in this treatment group, 
you will be asked to participate in an eight-week home-based voice treatment program. In addition, you 
will be asked to attend 3-4 laboratory session at the university campus, with each session lastly 
approximately 90-120 minutes. As a participant in this study, you will not be contacted directly for future 
studies.  
5. WHAT WILL I BE ASKED TO DO?
You could have been placed into one of three groups: LSVT LOUD® treatment, SpeechViveTM treatment, 
or non-treatment control group. You have been placed in the SpeechViveTM treatment group. As a part of 
the study, we will provide you with a device which we will ask you to wear 2-4 hours per day, 5 days per 
week, for eight weeks. The device will play noise in one of your ears when you speak. When you stop 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
10/04/2017
10/03/2018
2017-4212

Page 2 of 5 
 
speaking the noise will turn off so it does not interfere with your ability to listen during a conversation. 
Since this is a treatment study, we will ask you to not engage in other form of therapy (surgical, 
pharmacological, or behavioral) for the duration of the study.  
 
Number of Days to Wear Device: 5 days per week 
Number of hours to Wear Daily: 2-4 hours/day 
Number of Weeks to Wear Device: 8 consecutive weeks 
 
In this first visit to the lab, you will be asked to complete several screening tasks in order to be certain that 
you are appropriate to participate in this study. The first part of the screening was completed with the 
questions you answered over the phone. To confirm eligibility, you will first be asked to i) complete a 
depression inventory to assess your mood, ii) pass a cognitive screening inventory, and iii) participate in a 
laryngeal examination. As part of the cognitive screening, you will be asked a series of questions related to 
orientation of place and time, remember a sequence of words for a short period of time (e.g. a few minutes), 
name objects, and follow a series of short commands. The laryngeal examination will be conducted by a 
trained member of the research team. For this examination, you will be seated and a Velcro strap will hold a 
microphone comfortably on the side of your neck. You will be asked to stick out your tongue, which will be 
held by the examiner with sterile gauze. An endoscope will then be slowly inserted towards the back of 
your mouth so that a video recording of your larynx (voice box) can be made. The endoscope is a straight 
blunt metal rod (about the diameter of a “pinky finger”) with a tiny camera lens at the end. Neither the 
endoscope nor the Velcro strap will interfere with your breathing. You will say an “ee” sound and then the 
endoscope will be removed. The endoscope will be disinfected after each use. Based on the results of these 
tests, you may be deemed ineligible to participate. In such instances, you will be compensated for the time 
you participated at a prorated rate of $10 per hour.   
 
If you are deemed eligible to participate, you will be asked to complete a questionnaire that focuses on your 
medical history which includes questions about your Parkinson’s disease, general health, medications, and 
any speech and voice problems you may be experiencing. You may skip any question that you feel 
uncomfortable answering.  We will also ask you to release a test score from your neurologist to us which 
indexes the severity of your Parkinson’s disease. You do not need to agree to this release to participate in 
the study. In addition, you will undergo a brief heading screening which requires you to listen for tones and 
raise your hand when you hear the tone.    
 
In addition, you will be asked to wear a microphone and perform a variety of speaking tasks including, but 
not limited to reading sentences, short passages, and/or citing a monologue. You will also be asked to 
perform different breathing exercises while wearing nose clips including breathing in and out as much as 
you can into a cardboard mouthpiece. The nose clips and mouthpiece are disposable and are thrown out 
after use. You will also be fitted with elasticized bands that are worn on the outside your clothing around 
your rib cage and abdomen. The bands do not impede your ability to breathe. We will ask you to breathe 
quietly, to breathe in and out as much air as you can, and to move your abdomen in and out. You will also 
be asked to talk about a topic of interest for several minutes. Lastly, we will place a mask over your mouth 
and nose. The mask will measure the air as it comes out of your mouth. A small tube will be placed between 
your lips and behind your teeth. It will not impede your ability to talk. We will ask you to read a sentence 
several times with the mask in place. The mask and tube will be disinfected after each use. You may take 
breaks as needed or cease participation at any time. You have just completed your pre-treatment lab session. 
You will be asked to perform these tasks again in week 4 (mid-treatment) and week 8 (end of treatment). 
 
This is a research study that involves questions related to sensitive topics that may cause distress. As 
researchers, we do not provide mental health services and we will not be following up with you after this 
study. However, we want to provide every participant in this study with contact information for available 
clinical resources, should you decide you need assistance at any time. In a serious emergency, remember 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
10/04/2017
10/03/2018
2017-4212

Page 3 of 5 
 
that you can also call 911 for immediate assistance. The facilities identified below offers services to 
individuals who are not affiliated with UMass Amherst/Purdue University.  
 
University of Massachusetts Amherst 
 
 
Purdue University  
Counseling and Psychological Health  
 
 
Counseling and Psychological Services 
127 Hills North  
 
 
601 Stadium Mall Drive, Room 224 
Amherst MA 01003 
 
 
West Lafayette, IN 47907-2052 
(413) 545-2337 
 
 
(765) 494-6995 
 
6. WHAT ARE MY BENEFITS OF BEING IN THIS STUDY?  
If the therapy proves effective for you, you may benefit by improved speech loudness and intelligibility. 
In addition, your participation in the study will advance our knowledge of what treatment approaches may 
help alleviate the speech and voice problems commonly reported by individuals with Parkinson's disease. 
 
7.  WHAT ARE MY RISKS OF BEING IN THIS STUDY?  
We believe there are minimal physical risks associated with this research study.  A possible risk to you 
however, might include fatigue. To lower the risk of fatigue, you will have periods of rest throughout 
each laboratory session. You may also request a break at anytime. There is also a risk of a breach of 
confidentiality. To minimize this risk, you will be assigned a unique identifier which will be assigned to 
your records and collected voice samples. Your consent form, which contains identifying information, 
will be stored in a locked filing cabinet in a secured room, only accessible to key research personnel for a 
period of three years. After three years, all study records will be destroyed. Should a breach of 
confidentiality occur you will be immediately informed of the breach verbally and in writing.  
 
The SpeechViveTM device poses no risks to you. Its amplitude will only be adjusted by a member of the 
research team. The amplitude of the device cannot be turned up to a level which would cause hearing loss. 
The loudest level used on the device will be about as loud as a dog barking or a baby crying loudly. 
During the examination of the larynx, some people find that they gag temporarily if the endoscope 
touches the back of their tongue or throat. The sensation is similar to what you may have experienced 
while brushing your tongue with a tooth brush. In addition, there may be a remote chance of damage to 
teeth and dental work. A trained member of the research team will guide the endoscope using techniques 
designed to minimize this risk. The endoscope will be disinfected after each use. The audiometer 
headphones will be disinfected before and after you use them in order to minimize the slight risk that you 
will come into contact with substances such as bacteria. The nose clips and mouthpieces will be discarded 
after one use. The mask and tube will be disinfected after each use. 
 
As a participant in this study, you will be asked to provide sensitive information about your physical and 
mental well-being and demographic data (age, gender, height, weight, race/ethnicity). You may refuse to 
answer any question without repercussion. There is a low psychological risk that you may be upset by 
some of the questions centered on health-related issues. We can provide you with a list of mental health 
professionals in your community, if this information would be helpful. 
 
8. HOW WILL MY PERSONAL INFORMATION BE PROTECTED?  
The following procedures will be used to protect the confidentiality of your study records. The researchers 
will keep all study records in a locked file cabinet in a secure room accessible only to project staff. Electronic 
data files will be stored on a password protected computer in a secure room accessible only to project staff. 
Copies of all records will also be maintained on a HIPAA and HITECH compliant data sharing platform. All 
records will be labeled with a unique code. A master key which links participant names with their unique 
codes will be maintained in a separate and secure location accessible to key research personnel. The master 
key and data files will be destroyed 3 years after the close of the study. At the conclusion of this study, the 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
10/04/2017
10/03/2018
2017-4212

Page 4 of 5 
 
researchers may publish their findings. Information will be presented in summary format and you will not be 
identified in any publications or presentations. 
 
9. WILL I RECEIVE ANY PAYMENT FOR TAKING PART IN THE STUDY?  
You will receive eight weeks of voice treatment at no cost to you. In addition, you will be compensated 
$10/hour for each laboratory session you participate in.  
 
10. EXTRA COSTS TO PARTICIPATE 
There are no extra costs for you related to your participation in this study. Parking at (UMass 
Amherst/Purdue University) will be covered. 
 
 
11. WHAT IF I HAVE QUESTIONS? 
Take as long as you like before you make a decision. We will be happy to answer any question you have 
about this study. If you have further questions about this project or if you have a research-related problem, 
you may contact the researcher, Dr. Kelly Richardson, at (413) 545-2007. If you have any questions 
concerning your rights as a research subject, you may contact the University of Massachusetts Amherst 
Human Research Protection Office (HRPO) at (413) 545-3428 or humansubjects@ora.umass.edu. 
 
12. CAN I STOP BEING IN THE STUDY? 
You do not have to participate in this research project. If you agree to participate, you can withdraw your 
participation at any time without penalty. Please tell the experimenter if you wish to end your participation at 
any point in the study. If you wish to withdraw your records or data after you have completed your 
participation, please contact the primary investigator by phone, email, or writing.       
 
13. WHAT IF I AM INJURED? 
The University of Massachusetts does not have a program for compensating subjects for injury or 
complications related to human subjects’ research. This does not waive any of my legal rights nor release 
any claim I might have based on negligence. 
 
14. CONTACT INFORMATION 
If you have any questions about this research project and/or scheduling, you may contact the principal 
investigator Dr. Kelly Richardson, UMass Amherst, at 413-545-2007 or by email 
krichardson@comdis.umass.edu. Or you may contact the co-investigator, Dr. Jessica Huber, Purdue 
University, at 765-494-3796 or by email at jhuber@purdue.edu.  If you have any questions about your 
rights as a participant in a research project, or questions, concerns or complaints about the research and 
wish to speak with someone who is not a member of the research team, you should contact (anonymously, 
if you wish) the Human Research Protection Office at the University of Massachusetts Amherst at (413) 
545-3428 or by mail at Human Research Protection Office, Mass Venture Center, 100 Venture Way, Suite 
116, Hadley, MA 01035. 
 
15. CONFLICT OF INTEREST DISCLOSURE 
The following disclosures are made to give you an opportunity to decide if these relationships will affect 
your willingness to participate in the research study. Dr. Huber, the primary investigator on the study, is the 
inventor of the SpeechViveTM device. She is on the Board of Directors of SpeechViveTM, Inc, the company 
that manufactures and sells the SpeechViveTM device. She also owns stock in the company. Sandy Snyder, 
a staff member in Dr. Huber’s laboratory, also owns stock in SpeechViveTM, Inc. The researchers will not 
make any attempt to initiate the sale of the SpeechViveTM medical device either during the study or after 
study completion. 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
10/04/2017
10/03/2018
2017-4212

Page 5 of 5 
 
16. DATA SHARING 
This research study will adhere to the NIH Grants Policy on Sharing of Unique Research Resources 
including the “NIH Data Sharing Policy” issued in April 2007; 
http://grants.nih.gov/grants/policy/data_sharing/.  
 
Final data will be shared primarily through the vehicle of peer reviewed publications and scientific 
conference proceedings. Raw data will be considered for sharing under the following rules. Raw datasets to 
be released for sharing will not contain identifiers. Data and associated documentation will be made 
available to users only under a signed and properly executed data-sharing agreement that provides for 
specific criteria under which the data will be used, including but not limited to: 1) a commitment to using 
the data only for research purposes; 2) a commitment to securing the data using appropriate computer 
technology; and 3) a commitment to destroying or returning the data after analyses are completed. 
 
17. SUBJECT STATEMENT OF VOLUNTARY CONSENT 
When signing this form I am agreeing to voluntarily enter this study. I have had a chance to read this 
consent form, and it was explained to me in a language which I use and understand. I have had the 
opportunity to ask questions and have received satisfactory answers. I understand that I can withdraw at 
any time. I understand that will receive a copy of this signed Informed Consent Form. 
 
 
________________________ 
 
____________________ 
 
__________ 
Participant Signature: 
 
 
Print Name: 
 
 
 
Date: 
 
By signing below I indicate that the participant has read and, to the best of my knowledge, understands 
the details contained in this document and has been given a copy. 
 
 
_________________________    
____________________ 
 
__________ 
Signature of Person 
 
 
Print Name: 
 
 
 
Date: 
Obtaining Consent 
 
 
University of Massachusetts Amherst-IRB 
(413) 545-3428 
Approval Date:                         Protocol #:   
Valid Through:             
IRB Signature: 
 
 
10/04/2017
10/03/2018
2017-4212