Conditions: Skin Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: yes

Brief summary:
Postoperative medicinal grade honey in post-operative care may prevent bone anchored hearing aid associated skin breakdown better than standard care of bacitracin ointment alone in adult patients.

Detailed description:
This is a prospective study. Multiple surgeons will perform the bone anchored hearing aids (BAHI) implantation surgery. Patients will be randomized to either postoperative medicinal honey or postoperative standard care of bacitracin ointment alone using a random number generator. There will be a total of two patient groups. The type of BAHI device used, laterally and the surgical technique will be recorded.

Treatment groups:

Group 1-patients undergoing BAHI implantation who will be postoperatively treated with medicinal honey.

Group 2- patients undergoing BAHI implantation who will be postoperatively treated with bacitracin ointment as standard care.

Arms:
arm 1: Standard care: Bone-anchored hearing aid (BAHI) abutment incision is coated in bacitracin. A healing cap is placed over the abutment and left for a week. The healing cap is removed on postoperative day 7. Patient is instructed to apply bacitracin ointment to the area for 2 weeks. arm 2: Medicinal honey: Medicinal honey will be applied to the abutment site immediately after surgery. The healing cap will be placed on the BAHI site. The healing cap is removed on postoperative day 7. Patient is instructed to apply medicinal honey daily to the area for 2 weeks.

Interventions: intervention 1: Medicinal honey intervention 2: Bacitracin
Intervention descriptions: intervention 1: Treat healing surgical site with medicinal honey intervention 2: Treat healing surgical site with bacitracin

Protocol document:
Prot_SAP_000.pdf: 
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated 
Skin Breakdown 
 
NTC03929224 
February 4, 2022 
 
 


The Use of Medical Grade Honey in the Prevention of 
Bone Anchored Hearing Aid Associated Skin Breakdown 
 
Anya Costeloe, MD;  Robert Conway, MD; Seilesh Babu, MD 
Michigan Ear Institute 
 
 
Background 
 
Medical grade honey has recently became much more widely used and research continues to 
prove its strong antimicrobial effects. Medical grade honey is currently used across medicine 
for burns, wound infections, skin ulcers and more. In otolaryngology, it has been used for post-
tonsillectomy pain, radiation induced mucositis, necrotizing fasciitis, and allergic fungal sinusitis 
(1). One study previously looked at the use of Medihoney to treat BAHA associated skin 
infections and saw a decrease in healing time from 5.25 weeks with just antibiotics, to less than 
2 weeks with the addition of Medihoney (2). 
 
Bone anchored hearing aids (BAHAs) implantation is a common otologic operation done today. 
BAHAs are generally reserved for those who fail conventional air conduction hearing aids, 
typically secondary to external or middle ear pathology such as aural atresia or a chronically 
draining ear (3). BAHAs can be done in a single step or two-part operation. A titanium screw is 
placed into the mastoid bone for osteointegration. An abutment is then attached to the screw 
which protrudes through the skin. A sound processor then attaches to this abutment to allow 
bone conduction to the cochlea. Complications due to this procedure are relatively few; due to 
the abutment that comes through the skin, soft tissue infections are the most common, 
followed by failure of integration (4).  
 
The Holger scale is typically used when classifying skin complications post operatively. It 
involves a scale from 0-4, 0 being no involvement, 4 being involvement that necessitates BAHA 
removal. Depending on the severity of the disease, treatment can include anything from topical 
antibiotics, topical steroids and wound care for mild cases, to oral antibiotics and steroid 
injections for moderate cases, to simple skin excision or skin flaps for the more severe 
involvement (5).  
 
A typical post-operative course after BAHA surgery at our institution includes bacitracin 
ointment with a bandage that stays on for seven days. After the seventh postoperative day, the 
bandage is removed and bacitracin is applied two times per day for the next two weeks.  
 


Since medical honey has been shown useful for treatment of skin complications after BAHA, we 
propose using medical honey in the postoperative period, which we believe will decrease the 
number of skin infections and lower the average Holger score. 
 
Objective/Research Question  
Does postoperative use of medicinal grade prevent bone anchored hearing aid (BAHA) 
associated skin breakdown better than standard care alone in adult patients? 
 
Hypothesis 
Postoperative use of medicinal honey will decrease the rate of BAHA associated complications 
caused by skin breakdown and reactions in adult patients. 
 
Methodology 
This will be a prospective study. Multiple surgeons will perform the BAHA implantation surgery 
and their combined patients will be used in this study. Patients presenting in clinic for BAHA 
implantation surgery will be explained the details of the study, asked to participate and if 
agreeable asked to sign an informed consent document. The surgeon who will be performing 
the surgery or the resident working with that surgeon will recruit participants. Patient 
demographic information, including age, sex, and reason for implantation will be collected and 
recorded in a table. 
 
The patients will be randomized to either postoperative medicinal honey and standard care or 
postoperative standard care alone using a random number generator. There will be a total of 
two patient groups. The type of BAHA device used, laterality and the surgical technique will be 
recorded in a table. The different types of implanted hearing devices will include BAHA 
Connect, BAHA Attract and Sophono brand hearing devices.  
 
a. Treatment groups 
i. 
Group 1 - patients undergoing BAHA implantation who will be postoperatively 
treated with medicinal honey. 
ii. 
Group 2 - patients undergoing BAHA implantation who will be postoperatively 
treated with standard care. 
 
b. Postoperative care 
i. 
Standard care: BAHA abutment incision is coated in bacitracin. A healing cap is 
placed over the abutment and left on for a week. The healing cap is removed on 
postoperative day 7. Patient is instructed to apply bacitracin ointment to the 
area for 2 weeks.  


ii. 
MediHoney: BAHA abutment incision is coated with MediHoney.  The healing 
cap will be placed over the BAHA site. The healing cap is removed on 
postoperative day 7. Patient is instructed to apply MediHoney daily to the area 
for 2 weeks.  
 
Patients will be seen in clinic 1-week post-op, 1-month post-op, 3 months post-op and 6 
months post-op. During each visit the BAHA site will examined. Pictures will be taken of the  
site and blindly reviewed by appropriate clinicians. Any skin breakdown will be graded based on 
the Holgers Classification: Grade 0 = no reaction; Grade 1 = reddish discoloration of the skin 
around the implant; Grade 2 = red and moist surface of the skin around the implant; Grade 3 = 
formation of granulation tissue around the implant; and Grade 4 = extensive soft-tissue 
reaction that requires implant removal or leads to implant loss. 
 
The study will be included on clinicaltrials.gov.  
                                                                                              
Inclusion Criteria 
Adults >18 years old undergoing bone-anchored hearing aid implantation surgery. 
 
Exclusion Criteria 
Patients who are undergoing revision BAHA surgery, history of radiation to the implantation 
site. 
                                                                            
 
Data Analysis 
The main study hypothesis will be evaluated using one-way ANOVA to compare the rates of skin 
breakdown in the group treated with medicinal honey  versus the group treated only with 
standard care for both the adult patients. 
 
Additionally, between-group differences in demographics and relevant clinical characteristics 
will be probed using ANOVA and chi-square analyses. If significant group differences in these 
factors are detected, follow-up ANOVA analyses will be conducted to control for covariates that 
may influence group differences in weight gain. 
 
Power analysis 
To achieve statistical significance of power and alpha of 0.05 for a 2 group ANOVA, we will 
calculate the minimum total sample required to detect difference. 
 


Typical postoperative BAHA skin reactions occur at a rate between 5-20%. One study looking at 
medihoney in secondary intention wound healing saw a 12.2% increase in wound healing in the 
medihoney group at 12 weeks. 
 
Using 16% for a incidence rate in the control group and 3.8% as a possible incidence in the 
experimental group; at a 5% significance level and a power of .8 a sample size of 186 would be 
required. 
 
Data Safety Monitoring Plan 
Patients' medical record numbers will be recorded on the data collection sheet for purpose of 
accurate retrieval of records. For the analysis of the data the Excel file will have a log number 
assigned to each patient. This log number will be used to identify subjects in the database to be 
created. Chart reviews will be conducted only by the principal authors and those directly 
involved with the research project. No patient-identifiable protected health system information 
will be removed from the hospital. Conscious effort will always be made to keep all patient-
related information logs and sheets in a secure place free from public display and access. All 
electronic data will be stored on a password-protected computer drive. If data are emailed, 
email encryption will be used.  
 
References 
 
1. Costeloe, A., Vandjelovic, N. D., Evans, M. A., & Saraiya, S. S. (2018). The use of honey in 
cochlear implant associated wounds in pediatric patients. International Journal of 
Pediatric Otorhinolaryngology, 111, 80–83. https://doi.org/10.1016/j.ijporl.2018.05.026 
2. Faucett, E. A., Reghunathan, S., & Jacob, A. (2015). Medicinal honey as treatment for 
skin reactions associated with bone-anchored hearing implant surgery: Medicinal Honey 
for BAHI Skin Reactions. The Laryngoscope, 125(7), 1720–1723. 
https://doi.org/10.1002/lary.25069 
3. Bento, R., Kiesewetter, A., Ikari, L., & Brito, R. (2013). Bone-anchored hearing aid 
(BAHA): indications, functional results, and comparison with reconstructive surgery of 
the ear. International Archives of Otorhinolaryngology, 16(3), 400–405. 
https://doi.org/10.7162/S1809-97772012000300017 
4. Colquitt, J., Jones, J., Harris, P., Loveman, E., Bird, A., Clegg, A., … Welch, K. (2011). Bone-
anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review 
and economic evaluation. Health Technology Assessment, 15(26). 
https://doi.org/10.3310/hta15260 


5. Fontaine, N., Hemar, P., Schultz, P., Charpiot, A., & Debry, C. (2014). BAHA implant: 
Implantation technique and complications. European Annals of Otorhinolaryngology, 
Head and Neck Diseases, 131(1), 69–74. https://doi.org/10.1016/j.anorl.2012.10.006 
6. Robson, V., Dodd, S., & Thomas, S. (2009). Standardized antibacterial honey 
(MedihoneyTM) with standard therapy in wound care: randomized clinical trial. Journal of 
Advanced Nursing, 65(3), 565–575. https://doi.org/10.1111/j.1365-2648.2008.04923.x 
 
 
 
Data Collection Tables 
I. 
Patient Demographics: age, gender, race, comorbidities, type of hearing loss (HL), 
hearing loss etiologies 
II. 
Type of Hearing Aid, Laterality and Surgical Technique 
III. 
Post-Operative Complications 
 
 
Table I. Patient Demographics 
 
Age 
Gender 
Race 
Type of HL 
HL Etiology 
Level of HL 
Patient ID 
 
 
 
 
 
 
Table II. Type of Hearing Aid, Laterality and Surgical Technique 
 
 
Hearing Aid 
Laterality 
Surgical Technique 
Patient ID 
 
 
 
 
 
Table III. Post-Operative Complications 
 
 
1 week 
1 month 
3 months 
6 months 
Patient ID 
 
 
 
 
 

ICF_001.pdf: 
 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 1 of 9 
 
 
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated 
Skin Breakdown 
 
NTC03929224 
February 4, 2022 


 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 2 of 9 
 
 
The Use of Medical Grade Honey in the Prevention of  
Bone Anchored Hearing Aid Associated Skin Breakdown 
 
Ascension Providence Hospital, Novi Campus 
47601 Grand River Avenue, Novi, MI  48374  
 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
and 
AUTHORIZATION TO USE OR DISCLOSE PROTECTED HEALTH INFORMATION FOR RESEARCH 
(HIPAA) 
 
 
Principal Investigator:  Seilesh Babu, MD 
 
Office Phone: (248) 865-4444 
 
Please read the following material to ensure that you are informed of the nature of this clinical 
research study and how you will participate in it.  Signing this form will indicate that you have 
been informed and that you give your consent to participate in a free manner.  Federal 
regulations require written informed consent prior to participation in this clinical research 
study. 
 
Introduction 
This is an important form. Please read it carefully. It tells you what you need to know about this 
research study.  If you agree to take part in this study, you need to sign this form. Your 
signature means that you have been told about the study and what the risks are. Your signature 
on this form also means that you want to take part in this study.  Your study doctor will explain 
the research study to you. Research studies include only people who choose to take part. 
Please take your time to make your decision about taking part.  You may discuss your decision 
with your friends and family.  You can also discuss it with your health care team.  If you have 
any questions, you can ask your study doctor for more explanation. 
 
You are being asked to take part in this research study because you are getting bone anchored 
hearing aid implant surgery at Ascension Providence Hospital, Novi Campus. 
 
 


 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 3 of 9 
 
 
Why is this research being done? 
Medical grade honey has recently became widely used and research continues to prove its 
strong antimicrobial effects. Medical grade honey is currently used across medicine for burns, 
wound infections, skin ulcers and more. One study previously looked at the use of honey to 
treat bone anchored hearing aid associated skin infections and saw a decrease in healing time 
from 5.25 weeks with just antibiotics, to 2 weeks with the addition of Medihoney. 
 
Bone anchored hearing aids (BAHAs) implantation is a common otologic operation done today. 
Skin problems are the most common type of complication after this surgery; these can occur 
due to skin breakdown from the abutment or soft tissue infection.  
 
This research is being done to determine if skin complications from bone-anchored hearing aids 
can be decreased with medical grade honey. The researchers will compare two different 
groups.  You will be randomized (put into one group by chance).  Your chances of being in one 
group are 1 in 2, like flipping a coin. 
 
How many people will take part in this study? 
Approximately 25-50 patients will be in this study. 
 
How long will I be in this study? 
You will participate in this study for 6 months. You will be seen in clinic 1-week post-op, 1-
month post-op, 3 months post-op and 6 months post-op.  Your part in the study is completed 
once you come to your 6-month postoperative visit. 
 
What will happen if I take part in this research study? 
This research will involve the application of medical grade honey to the bone anchored hearing 
aid abutment site for 2 weeks after surgery. 
 
Immediately after surgery, MediHoney will be applied to the abutment site. The healing cap will 
be placed over the BAHA abutment site. The healing cap will be removed on postoperative day 
7. You will be instructed to MediHoney daily to the area for 2 weeks. You will be seen in clinic 1-
week post-op, 1-month post-op, 3 months post-op and 6 months post-op. During each visit the 
BAHA site will be examined for any skin breakdown. Photo documentation will be made of all 
cases and the photos will be reviewed by a blinded third party.  
 


 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 4 of 9 
 
 
What are the risks of the study? 
Infection is a possible risk to this study. If you develop an infection, it will be treated promptly 
with proper antibiotics. There is also a risk of adverse skin reaction to the medical grade honey. 
This is rare. If you have a history of adverse reactions to honey you will be excluded from the 
study. Every effort will be made to minimize any discomfort and these risks. If you do develop a 
reaction to the honey, we will immediately stop using it.  You should tell the person obtaining 
your consent if you are currently participating in any other medical research studies.  
 
What are the benefits of the study? 
There may be no direct benefit to you in participating in the study.  It is possible that you may 
heal quicker from the surgery and have less of a risk of infection or skin breakdown. In the 
future, other patients may benefit from the results of this study, when they become known. 
 
What other options are there? 
One option is to not participate.  You do not have to participate in this research study in order 
to have a bone anchored hearing aid implant. 
 
Do I have to participate in this study? 
Your participation in this study is voluntary.  Your refusal to participate will cause no penalty or 
loss of benefits which you would otherwise receive.  If you decide to participate, you may 
change your mind about being in the study, and may quit at any time without penalty of loss of 
benefits regarding your future care.  If new information becomes available during the study 
that may affect your willingness to continue in the study, your doctor and/or his/her associate 
will discuss this information with you.  Also, your doctor may stop your participation at any time 
if he/she feels it is in your best interest.  If this happens, you may be asked to return for a 
follow-up visit. 
 
Will it cost anything to participate? 
We do not expect there to be any additional costs to you if you participate in this study.  Items 
related to the routine medical care that you would receive even if you did not participate in this 
study will be billed to you or your insurance company.  You have the right to ask what it will 
cost you to take part in this study. 
 
Will I be paid to participate? 
There will be no compensation to you for your participation in this study. 


 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 5 of 9 
 
 
 
Confidentiality of Records 
The principal investigators will have access to your medical records and your test results.  While 
absolute confidentiality cannot be guaranteed, all research material which could identify you 
will be kept as confidential as possible within the state and federal laws.  You should be aware 
that your medical records could be examined by the sponsor, the Institutional Review Board (a 
group of people who review the research to protect your rights), or government agencies in 
order to verify the data collected during this research study.  If the results of this study are 
presented in any public forum, you will not be personally identified. 
 
What if I am injured? 
There is no compensation or pay offered for your medical care if you are injured as a result of 
participating in this study.  You and/or your medical insurance may have to pay for your 
medical care if you are injured as a result of participating in this study.   You are not giving up 
any of your legal rights by signing this consent form. 
 
Who do I call with questions about the study or to report an injury? 
 
If you have any questions regarding a research-related injury, you can contact: 
Dr. Seilesh Babu at the Michigan Ear Institute at 248-865-4444. 
 
If you have any questions about your rights as a participant in this clinical research study, you 
may contact the IRB representative at 248-849-8889 at Ascension Providence Hospital 
Southfield Campus, Novi Campus. 
 
Participant HIPAA Authorization to Use and Disclose Protected Health Information (PHI) 
Your participation in this study will require the use and disclosure of certain medical and other 
information about you.   The information that may be used or disclosed includes:  any and all 
health care records such as:  laboratory, pathology and/or radiology results; scans; x-rays; and 
Protected Health Information (PHI) previously collected for research purposes. 
 
Your PHI will be used in the following ways:  To conduct the research and to ensure that the 
research meets legal, institutional or accreditation requirements. 
 
Your authorization to use and disclose the above information has no expiration date. 


 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 6 of 9 
 
 
 
Your PHI may be seen, used or disclosed to the following: 
 
 
 
The researchers and members of the research team. 
 
The sponsor, (insert Sponsor’s name) and/or a clinical research organization or 
other agent of the sponsor. 
 
A laboratory outside of Ascension Providence Hospital. 
 
 
Other health care providers or employees of Ascension Providence Hospital who  
 
 
provide services to you for this study. 
 
Representatives of the Institutional Review Board (IRB), the FDA (Food and Drug 
Administration), or other governmental agencies involved in research 
monitoring. 
 
 
Members of a safety monitoring board. 
 
 
Other agencies as required by law. 
 
 
 
You have the right to review your PHI.  However, if you agree to participate in the research 
study and sign below, you will not be able to look at your research information until the 
research study is completed.  
 
You do not have to sign this authorization.   If you decide not to sign the authorization it will not 
affect your treatment or eligibility for health benefits.  However, if you do not sign this 
authorization you may not participate in this study.   
 
You may withdraw your authorization at any time by notifying the principal investigator in 
writing, but the withdrawal will not affect any information already disclosed.  However, you 
need to be aware that your written withdrawal of this Authorization may result in the 
termination of the research-related treatment being provided to you. 
 
Seilesh Babu, MD 
Michigan Ear Institute 
30055 Northwestern Highway, #101 
Farmington Hills, MI  48334 
 
 
 


 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 7 of 9 
 
 
 
 
When you sign this authorization, your health information may be re-disclosed by the 
researcher if permitted or required by applicable federal or state law. 
 
 
CONSENT 
 
You have had the opportunity to fully discuss the purpose of this clinical research study and 
how it will be carried out.  Your questions have been answered.  Your participation in this study 
is fully voluntary and you may withdraw at any time. 
 
Your signature below acknowledges that you voluntarily agree to participate in this clinical 
research study, and you will receive a signed copy of this form. 
 
 
_____________________________________________ 
Printed Name of Research Participant  
 
_____________________________________________ 
_________________________ 
Signature of Research Participant  
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 8 of 9 
 
 
 
Legally Authorized Representative (if applicable): 
 
____________________________________________ 
Printed Name of Legally Authorized Representative 
 
____________________________________________ 
__________________________ 
Signature of Legally Authorized Representative 
 
 
 
Date 
 
Check Relationship to Participant:* 
 
  Legal Guardian or Legally Authorized Representative for Medical Care (LARM)    
  
Spouse 
  Adult Son or Daughter 
  Mother or Father 
  Adult Brother or Sister 
  Other, 
explain: 
 
Reason participant is unable to sign for self: 
 
 
*If a Legal Guardian or Legally Authorized Representative for Medical Care (LARM) has not 
been appointed, then consent should be obtained from the closest next of kin (in the order 
listed above).  When that individual is unavailable or refuses to act the next in order should be 
contacted. 
* If there is a disagreement among next of kin regarding the appropriateness of the 
treatment plan, Clinical Safety Risk Management may be contacted.  Outside of business 
hours, Clinical Safety Risk Management can be contacted through any Ascension Providence 
Hospital operator. 
 
 
______________________________________________ 
Printed Name of Person Obtaining Consent 
 
______________________________________________ 
__________________________ 
Signature of Person Obtaining Consent 
 
 
 
 
Date 
 


 
Ascension Providence Hospital 
Southfield Campus, Novi Campus 
 
 
The Use of Medical Grade Honey                                                                                         
  in the Prevention of Bone Anchored                                                                                   Ascension Providence Hospital 
  Hearing Aid Associated Skin Breakdown                                                                         IRB Approved: 10/25/18-10/2/19 
Page 9 of 9 
 
 
 
 
Use the following only if applicable. 
If this consent form is read to the participant because the participant is unable to read the 
form, an impartial witness, not affiliated with the research study or investigator, must be 
present for the consent and sign the following statement: 
 
I confirm that the information in the consent form and any other written information was 
accurately explained to, and apparently understood by the participant.  The participant freely 
consented to be in the research study. 
 
 
_______________________________________________ 
Printed Name of Impartial Witness 
 
_______________________________________________ ___________________________ 
Signature of Impartial Witness 
 
 
 
 
 
Date 
 
Note:  This signature block cannot be used for translations into another language.  An IRB-
approved translated consent form is necessary for enrolling participants who do not speak 
English.