A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
Phase: NA
Conditions: Open Angle Glaucoma, Ocular Hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, Pigment Dispersion Syndrome, Glaucoma
Sponsor: Temple University

 
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180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as 
Initial Therapy for Glaucoma 
NCT02628223 
Document Date: 11/13/16 
Date Uploaded: 11/3/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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INSTRUCTIONS: 
1) Abstract of the study 
Selective laser trabeculoplasty (SLT) is a well-recognized way to 
lower eye pressure in treatment of glaucoma.  This treatment is 
performed for 180 degrees or 360 degrees, and studies at 
academic centers have shown mixed results when comparing the 
success rates of 180 degrees or 360 degrees. Both protocols are 
now typically done by comprehensive ophthalmologists. However, 
there is no data that compares success rates of 180 degrees and 
360 degrees in the community setting.  This study is designed as a 
prospective evaluation of the two treatment algorithms for SLT by 
measuring intraocular pressure (IOP) after treatment. 
 
2) Protocol Title 
A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser 
Trabeculoplasty as Initial Therapy for Glaucoma 
3) IRB Review History 
Not applicable. 
4) Investigator 
Primary Investigator: Jeffrey D. Henderer, MD. 
Drew Chronister, MD 
Steve Luminais, MD 
Richard Sherry, MD 
Sophia Siu, MD 
Daohai Yu, PhD 
 
5) Objectives 
The purpose of this study is to compare the efficacy of two 
treatment algorithms (180 vs 360 degrees) of SLT as initial therapy 
for glaucoma in two comprehensive ophthalmology practices.   
The hypothesis is that 360 degrees of SLT will produce a greater 
reduction in IOP than 180 degrees of SLT at 3 months follow up. 
6) Background 
Glaucoma is a leading cause of blindness in the United States and in the world. It 
is a chronic, degenerative optic neuropathy characterized by optic-nerve cupping 
and loss of retinal ganglion cell axons. Patients with glaucoma lose peripheral 

 
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vision initially, but because the disease is often not diagnosed until extensive 
visual field loss has already occurred, all vision may be lost if untreated.1 Primary 
open angle glaucoma (POAG) is the most common form of glaucoma. It is often 
associated with an elevated intraocular pressure but may also occur in the 
presence of a normal IOP. Elevated IOP is considered the only modifiable and 
causative risk factor for POAG; other risk factors include older age, black race, 
family history, myopia, and low diastolic perfusion pressure.1 Randomized clinical 
trials suggest that reducing IOP in patients with ocular hypertension or glaucoma 
can slow the onset and progression of disease and can reduce the long term risk 
of visual field loss.2,3  
 
Treatment of glaucoma is aimed at reducing intraocular pressure by 
decreasing aqueous production or increasing aqueous outflow using medical, 
laser, or surgical treatments. Evidence suggests that a greater reduction of IOP 
offers a larger protection against visual field loss.3 Topical therapies with 
prostaglandin analogues, α-adrenergic agonists, β-adrenergic blockers, 
cholinergic agonists and carbonic anhydrase inhibitors are often used for IOP 
reduction. Surgical treatments can also enhance aqueous humor drainage. 
 
Laser trabeculoplasty has been proven to lower IOP. Although results may 
be variable or gradually lose effect, laser therapy may allow decrease of medical 
therapy or postponement of surgery. Argon laser trabeculoplasty (ALT) has been 
shown to be a safe and effective means of lowering IOP in patients with POAG 
possibly by coagulative thermal damage to the trabecular meshwork, allowing 
improved outflow.4 In more recent years, selective laser trabeculoplasty (SLT) 
has been used as an alternative means to lower IOP in patients with open angle 
glaucoma. Unlike ALT, SLT selectively targets pigmented trabecular meshwork 
cells. Because SLT uses much less energy than ALT, it does not cause the same 
thermal burn to the entire trabecular meshwork and does very little mechanical 
damage.5 The exact mechanism by which SLT lowers intraocular pressure is 
unknown, but some theories postulate that thermal energy from the laser 
stimulates macrophage remodeling of the extracellular matrix in the trabecular 
meshwork, improving aqueous outflow. Release of cytokines involved in certain 

 
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metalloprotease expression may further contribute to remodeling of the 
extracellular matrix.5,6 
 
SLT appears to be a safe and effective therapy in lowering IOP in 
glaucoma. Studies suggest that SLT appears to be equivalent to ALT in terms of 
lowering IOP with the added benefit of less pain and anterior chamber 
inflammation compared to ALT.6 The IOP-lowering effects of SLT also appears to 
be comparable to medical therapy, with the added benefit of better compliance. 
Potential adverse effects of SLT treatment include a transient elevation of IOP 
and mild uveitis associated with transient ocular discomfort for the first few days 
after treatment. 
 
The amount of laser to use in a treatment session has traditionally been 
either 180 degrees or 360 degrees.  For SLT, previous work has shown that 
about 80% of eyes that receive a 360 degree SLT can achieve a reduction of 
20% and about 60% achieve a 30% reduction.  There was no statistical 
difference between success rates between 180 and 360 degree treatment.8  A 
different study found 90 degrees to be as effective as 180 degrees,9 while yet a 
third showed that 180 degree treatment often failed to lower IOP.10 A 360 
treatment is associated with less IOP fluctuation compared with a 180 degree 
treatment.11 
 
Because the previous SLT outcomes data was collected from academic 
center and since SLT is a treatment commonly performed in a private practice 
setting, we wish to see if SLT might have a similar effect as the previously 
published data.  We have previously shown that repeat SLT has limited effect in 
a community setting and now wish to investigate the initial response to SLT in the 
same setting and see which treatment algorithm will be better. 
References: 
1. Kwon YH, Fingert JH, Kuehn MH, Alward WL. Primary open-angle glaucoma. 
N Engl J Med. 2009 Mar 12;360(11):1113-24. 
2. Maier PC; Funk J; Schwarzer G; Antes G; Falck-Ytter YT. Treatment of ocular 
hypertension and open angle glaucoma: meta-analysis of randomised controlled 
trials.  

 
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BMJ 2005 Jul 16;331(7509):134. 
3. Heijl A; Leske MC; Bengtsson B; Hyman L; Bengtsson B; Hussein M. 
Reduction of intraocular pressure and glaucoma progression: results from the 
Early Manifest Glaucoma Trial. Arch Ophthalmol 2002 Oct;120(10):1268-79. 
4. Zhao JC, Grosskreutz CL, Pasquale LR. Argon versus selective laser 
trabeculoplasty in the treatment of open angle glaucoma. Int Ophthalmol Clin. 
2005 Fall;45(4):97-106. 
5. Stein JD, Challa P. Mechanisms of action and efficacy of argon laser 
trabeculoplasty and selective laser trabeculoplasty. Curr Opin Ophthalmol. 2007 
Mar;18(2):140-5. 
6. Murthy S, Latina MA. Pathophysiology of selective laser trabeculoplasty. Int 
Ophthalmol Clin. 2009 Winter;49(1):89-98. 
7. Hong BK, Winer JC, Martone JF, Wand M, Altman B, Shields B. Repeat 
selective laser trabeculoplasty. J Glaucoma. 2009 Mar;18(3):180-3. 
8. Nagar M, Ogunyomade A, O'Brart DP, Howes F, Marshall J. A randomised, 
prospective study comparing selective laser trabeculoplasty with latanoprost 
for the control of intraocular pressure in ocular hypertension and open angle 
glaucoma. Br J Ophthalmol. 2005;89:1413-7. 
9. Chen E, Golchin S, Blomdahl S. A comparison between 90 degrees and 180 
degrees selective laser trabeculoplasty. J Glaucoma. 2004;13:62-5. 
10. 
 Song J, Lee PP, Epstein DL, Stinnett SS, Herndon LW Jr, Asrani SG, 
Allingham RR, Challa P. High failure rate associated with 180 degrees 
selective laser trabeculoplasty. J Glaucoma. 2005;14:400-8. 
11. 
 Prasad N, Murthy S, Dagianis JJ, Latina MA. A comparison of the 
intervisit intraocular pressure fluctuation after 180 and 360 degrees of selective 
laser trabeculoplasty (SLT) as a primary therapy in primary open angle 
glaucoma and ocular hypertension. J Glaucoma. 2009;18:157-60. 
 
7) Setting of the Human Research 
This research will be conducted at two comprehensive 
ophthalmology practices. 

 
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Steve Luminais, MD - Levin and Luminais, PC in Thorndale, 
 
PA 
 
Rich Sherry, MD - Brandywine Eye Center in Wilmington, DE 
 
8) Resources Available to Conduct the Human Research 
Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed recruitment period.  For example, how 
many potential subjects do you have access to? What percentage 
of those potential subjects do you need to recruit? 
We anticipate enrolling 3 subjects per month in the study. 
Describe the time that you will devote to conducting and completing 
the trial within the agreed trial period.  
How many potential subjects do you have access to? What 
percentage of those potential subjects do you need to recruit? 
Describe the number and qualifications of your staff, their 
experience in conducting research, their knowledge of the local 
study sites, culture, and society.  
The ophthalmologists who will be performing the SLT have years of 
experience performing SLT, and will continue to follow their patients 
after the procedure. 
Describe your facilities.  
Two comprehensive ophthalmology offices. 
Describe the availability of medical or psychological resources that 
subjects might need as a result of anticipated consequences of the 
Human Research.  
The patients will be monitored on a regular basis for adverse 
effects. The patients will receive appropriate follow up care and 
support. 
Describe your process to ensure that all persons assisting with the 
trial are adequately informed about the protocol, the investigational 
product(s), and their trial-related duties and function. 
All staff will be instructed on the study protocol, products, informed 
consent and protection of patient information. 
9) Prior Approvals 
None 
10) 
Study Design 
a) Recruitment Methods 

 
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Potential subjects at the ophthalmology clinic will be approached by 
the investigator. The study will be explained and consent will be 
requested.  
Describe the amount and timing of any payments to subjects.  
Not applicable. 
b) Inclusion and Exclusion Criteria 
 
Inclusion criteria are patients who have been diagnosed with open-angle 
glaucoma, including ocular hypertension, pseudoexfoliation, and pigment 
dispersion syndrome. Patients must be greater than 18 years of age, with 
an initial IOP ≥ 21mmHg,  
Exclusion criteria include prior medical or laser therapy to lower IOP.  
Other exclusion criteria include previous incisional glaucoma surgery 
before the study period. 
 
c) Local Number of Subjects 
Indicate the total number of subjects to be accrued locally.  
If applicable, distinguish between the number of subjects who are 
expected to be enrolled and screened, and the number of subjects 
needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) 
Each of the three comprehensive ophthalmologists is anticipated to 
recruit 37 patients, for a total of 111 patients. This also accounts for 
the possibility that approximately 5% of patients enrolled will be lost 
to follow up.  
d) Study-Wide Number of Subjects 
If this is a multicenter study, indicate the total number of subjects to 
be accrued across all sites. 
We plant to enroll a total of 111 patients. 
e) Study Timelines 
Describe: 
• The duration of a subject’s participation in the study. 
One year 
• The duration anticipated to enroll all study subjects.  
• Three years 
• The estimated date for the investigators to complete this study 
(complete primary analyses) 
• December 2017 

 
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f) Study Endpoints 
 
Describe the primary and secondary study endpoints. This is also called the 
primary outcome parameter. It is defined as the specific parameter or 
observation used to measure the effect of the intervention of interest.  For 
example, a study may be conducted until the reoccurrence of disease, or 
change in blood pressure, or differences in proportions. Note that primary or 
secondary endpoints are not limited to clinical trials. 
 
The primary endpoint is IOP at three months of follow up. 
The secondary endpoint is 1 year of follow up or the point at which 
additional glaucoma therapy is required. 
 
Describe any primary or secondary safety endpoints. Examples may include 
evidence of liver toxicity, an inability to tolerate further chemotherapy, or other 
side effects. 
 
. Anticipated AE include spike in IOP and iritis, which will be treated 
accordingly. 
 
g) Procedures Involved in the Human Research 
Describe and explain the study design.  
We will be conducting a prospective evaluation of two treatment 
algorithms for SLT.  The first algorithm will be a 180 degree treatment and 
the second algorithm a 360 degree treatment.  Treatments will be done by 
Drs. Steve Luminais, Drew Chronister, and Richard Sherry.  
 
Patients will be pre-randomized to the 180 degree treatment or the 
360 degree treatment by physician and by initial IOP (eg ≥ 21mmHg up to 
30mmHg and  ≥ 30mmHg. 
 
 
 
 
Data that will be recorded for each patient include age, gender, 
race, glaucoma medications started during the study, the SLT protocol 
(number of spots, laser power setting and degrees of treatment). Baseline 
IOP before treatment will be recorded, in addition to measurement of IOP 
during a standardized follow up interval. Follow-up IOP measurements will 
also be recorded at one month, three months, six months and one year 
after laser.  The physician will be masked as to the IOP result when 
measuring the IOP at each follow up visit Patients who require additional 

 
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glaucoma therapy will be censured from the study at that point. In addition, 
side effects and patient complaints will be noted. 
For prospective studies: 
Provide a description of all procedures being performed and when 
they are performed, including procedures being performed to 
monitor subjects for safety or minimize risks. Include procedures 
being performed already for diagnostic or treatment purposes and 
differentiate between these and the procedures performed solely 
for the research.  
We will be performing SLT on the trabecular meshwork of eyes. 
Describe procedures taken to lessen the probability or magnitude of 
risks.  
Patients will be monitored after the procedure for symptoms or a 
spike in IOP 
Identify which procedures are being done as part of the Human 
Research and which are being conducted anyway for other reasons 
(standard of care).  
Describe all drugs and devices used in the research and the 
purpose of their use, and their regulatory approval status.  
Describe the source records that will be used to collect data about 
subjects. Attach all surveys, scripts, and data collection forms.  
If you are unable to conduct your research using de-identified 
information, request a waiver of HIPAA authorization in section #13 
(“privacy and confidentiality”) by providing the following information 
as required by the HIPAA regulations: 
1. The use or disclosure of protected health information involves no 
more than a minimal risk to the privacy of individuals, based on, at 
least, the presence of the following elements:   
a. an adequate plan to protect the identifiers from improper use 
and disclosure;  You should describe the plan to protect 
identifiers.  For example: Data will be kept on a password-
protected computer; data is only recorded electronically; 
Data will be saved on a secure server; 
and 
b. an adequate plan to destroy the identifiers at the earliest 
opportunity consistent with conduct of the research, unless 
there is a health or research justification for retaining the 
identifiers or such retention is otherwise required by law. For 

 
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example: once the data is recorded and verified for accuracy 
and completeness the link to the patient identifier will be 
destroyed; 
and   
c. adequate written assurances that the protected health 
information will not be reused or disclosed to any other 
person or entity, except as required by law, for authorized 
oversight of the research project, or for other research for 
which the use or disclosure of protected health information 
would be permitted by this subpart; 
and 
2. The research could not practicably be conducted without the waiver 
or alteration.  (The investigator should not claim a need for a waiver 
to allow recording of the patient’s name or medical record number 
based on making it easier to go back to a medical record to verify 
information or obtain new information.  A coding system should be 
developed and described in this protocol.);  
and       
3. The research could not practicably be conducted without access to 
and use of the protected health information.  
The criteria for a waiver of HIPAA authorization can also be 
found in the CHECKLIST: HIPAA Waiver of Authorization. 
Describe the data that will be collected, including long-term follow-up.  
h) Data and Specimen Banking 
Not applicable. 
If data or specimens will be banked for future use, describe where 
the specimens will be stored, how long they will be stored, how the 
specimens will be accessed, and who will have access to the 
specimens.  
List the data to be stored or associated with each specimen.  
Describe the procedures to release data or specimens, including: 
the process to request a release, approvals required for release, 
who can obtain data or specimens, and the data to be provided with 
specimens. 
i) Data Management  

 
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Describe the data analysis plan, including any statistical 
procedures. 
Multiple IOP values will be analyzed over the one year follow-up 
period. In addition to degrees of SLT, other covariates will be used 
to adjust the observed effects.  These covariates will include age, 
sex, and baseline IOP. A multiple variable linear model (analysis of 
covariance for repeated measures) will be used to evaluate the 
effectiveness of SLT over time.  In addition, change in IOP from 
baseline values to last follow-up will be calculated and compared. 
Provide a power analysis. 
A review of previous retrospective studies, and prospective studies 
performed at glaucoma specialists’ offices found: on average 360 
degrees of SLT lowers IOP by 6.33 +/-5mmHg and 180 degrees of 
SLT lowers IOP by 3.86 +/-5mmHg. Based on these results and a 
5% loss-of-follow-up rate, our power analysis shows that we will 
need 55 patients in each arm of the study. 
Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, Certificates of Confidentiality, and separation of 
identifiers and data) during storage, use, and transmission.  
Patients will be assigned a number and that number will be entered 
in the database.  No other patient identifying information will 
entered in the database 
Describe how data and specimens will be handled study-wide: 
• What information will be included in that data or associated with 
the specimens?  
• Where and how data or specimens will be stored?  
The data will be stored on a Temple University password 
 
protected computer 
• How long the data or specimens will be stored? 
• For the duration of the study 
•  
• Who will have access to the data or specimens?  
Dr. Henderer and study investigators. 
•  
• Who is responsible for receipt or transmission of the data or 
specimens?  

 
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Dr. Henderer 
j) Provisions to Monitor the Data to Ensure the Safety of 
subjects 
This section is required when Human Research involves more than 
minimal risk to subjects. 
Describe the plans to periodically evaluate the data collected 
regarding harms and benefits to determine whether subjects remain 
safe.  
The patients will be followed closely to monitor for harms and 
benefits 
Describe who will review the data.  
Data will be reviewed by study investigators 
Describe the data that are reviewed, including safety data, 
untoward events, and efficacy data.  
Primary and secondary endpoints, complications and 
demographics will be reviewed, including a comparison of 180 
versus 360 degrees of SLT 
Describe when data are reviewed. 
Data will be reviewed after all patients have been followed for 1 
year, or have reached another secondary endpoint 
k) Withdrawal of Subjects 
Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent.  
This is not anticipated 
Describe any procedures for orderly termination.  
Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures with 
continued data collection. 
11) 
Risks to Subjects 
List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to the subjects’ participation 
in the research. Include the probability, magnitude, duration, and 
reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks. 
Risks to the subjects include risks of SLT such as a spike in IOP, or 
mild anterior uveitis 

 
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If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable.  
If applicable, indicate which procedures may have risks to an 
embryo or fetus if the subject is or becomes pregnant. 
If applicable, describe risks to others who are not subjects. 
12) 
Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include the probability, 
magnitude, and duration of the potential benefits.  
Benefits include lowering IOP and avoiding glaucomatous nerve 
tissue damage relating to elevated IOP.  
13) 
Privacy and Confidentiality 
Describe whether the study will use or disclose subjects’ Protected 
Health Information (PHI).  
If the study uses or discloses PHI, the PI must do one of the 
following:  
a) 
Submit a HIPAA Authorization Form; 
or  
b) 
Justify a waiver of HIPAA authorization in this protocol. The 
criteria for a waiver of HIPAA authorization can be found in the 
CHECKLIST: HIPAA Waiver of Authorization. 
Do not merely submit the checklist or state “I request a waiver” or 
“the criteria in the checklist are met.” Instead, the PI must justify the 
waiver in this section of the protocol by referring to the checklist 
and explaining how each element of the waiver is met. 
Additional information regarding PHI and HIPAA can be found in 
the “references” section of the Temple IRB website. 
Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, Certificates of Confidentiality, and separation of 
identifiers and data).  
The data will be transported and stored on password protected 
computers and encrypted USB drives.  
Describe whether results (study results or individual subject results, 
such as results of genetic tests or incidental findings) will be shared 
with subjects or others (e.g., the subject’s professor, teacher, 
advisor, counselor, or primary care physician) and if so, describe 
how it will be shared. 

 
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Every effort will be made to maintain the patient’s privacy.  The 
results of the research may be presented at meetings or in 
publications, however the patient’s identity will not be disclosed in 
these presentations.    
Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact with or whom they provide personal 
information to.  
Describe the steps that you will take to make the subjects feel at 
ease with the research situation in terms of the questions being 
asked and the procedures being performed. “At ease” does not 
refer to physical discomfort, but the sense of intrusiveness a 
subject might experience in response to questions, examinations, 
and procedures. 
Study will be explained to the patients. Interview will take place in a 
private clinic room to ensure protection of the individuals’ privacy 
and ease of the patient. 
 
 
 
14) 
Compensation for Research-Related Injury 
If the research involves more than minimal risk to subjects, 
describe the available compensation in the event of research-
related injury. 
Not applicable. 
Provide a copy of contract language, if any, (e.g., clinical trial 
agreement) relevant to compensation for research-related injury. 
15) 
Economic Burden to Subjects 
Describe any costs that subjects may be responsible for because of 
participation in the research. 
Not applicable. 
16) 
Consent Process 
Indicate whether you will you be obtaining consent, and if so 
describe: 
• Where will the consent process take place  
In the private clinic room of the office 

 
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• Any waiting period available between informing the prospective 
subject and obtaining the consent. 
No 
• Any process to ensure ongoing consent. 
• Subjects can opt out at any point 
• The role of the individuals listed in the application as being 
involved in the consent process.  
• The investigators will consent the patients 
• The time that will be devoted to the consent discussion. 
• Adequate time will be taken to discuss the study and address all 
concerns 
•  
• Steps that will be taken to minimize the possibility of coercion or 
undue influence.  
• Steps that will be taken to ensure the subjects’ understanding. 
o The investigators will ask the following questions to ensure 
the subjects’ understanding:                
o  What are your concerns regarding the procedure and its risk 
and benefits? 
o What are your concerns about the study?  
o Do you understand why are you are participating in the 
study? 
o  Do you understand what the study entails? 
•  
Non-English Speaking Subjects 
• Indicate the language(s), other than English, that are 
understood by prospective subjects or representatives.  
• If subjects who do not speak English will be enrolled, describe 
the process to ensure that the oral and written information 
provided to those subjects will be in that language. 
• A certified translator will be used.  
•  
Waiver or Alteration of the Consent Process (consent will not 
be obtained, required information will not be disclosed, or the 
research involves deception) 
• Review the CHECKLIST: Criteria for Waiver or Alteration of the 
Consent Process to ensure you have provided sufficient 
information for the IRB to make these determinations. Do not 
merely submit the checklist or state “I request a waiver” or “the 
criteria in the checklist are met.” Instead, the PI must justify the 

 
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waiver in this section of the protocol by referring to the checklist 
and explaining how each element of the waiver is met. 
• If the Human Research involves a waiver of the consent 
process for planned emergency research, please review the 
CHECKLIST: Criteria for Waiver of the Consent Process for 
Planned Emergency Research to ensure you have provided 
sufficient information for the IRB to make this determination. Do 
not merely submit the checklist or state “I request a waiver” or 
“the criteria in the checklist are met.” Instead, the PI must justify 
the waiver in this section of the protocol by referring to the 
checklist and explaining how each element of the waiver is met. 
• If the Human Research involves a waiver of the consent 
process that includes use or disclosure of protected health 
information (PHI), please review the CHECKLIST: HIPAA 
Waiver of Authorization to ensure that you have provided 
sufficient information for the IRB to make these determinations. 
Do not merely submit the checklist or state “I request a waiver” 
or “the criteria in the checklist are met.” Instead, the PI must 
justify the waiver in this section of the protocol by referring to 
the checklist and explaining how each element of the waiver is 
met. 
Subjects who are not yet adults (infants, children, teenagers) 
Not applicable. 
Adults Unable to Consent 
Not applicable. 
17) 
Special considerations when obtaining consent for 
genetic studies  
Not applicable. 
 
18) 
Process to Document Consent in Writing 
If the consent of the subject will not be documented in writing 
(consent will be obtained, but the subject or representative will not 
sign a consent document) review CHECKLIST: Criteria for Waiver 
of Written Documentation of Consent to ensure that you have 
provided sufficient information for the IRB. Do not submit the 
checklist or state “I request a waiver” or “the criteria in the checklist 
are met.” Instead, justify the waiver in this section of the protocol by 
referring to the checklist and explaining how each element of the 
waiver is met. 
19) 
Vulnerable Populations 

 
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If the Human Research involves individuals who are vulnerable to 
coercion or undue influence, describe additional safeguards to 
protect their rights and welfare. 
Indicate whether you will include any of the following populations: 
• Adults unable to consent 
• Individuals who are not yet adults (infants, children, teenagers) 
• Pregnant women 
• Prisoners 
The consent will be discussed with the subject, their guardians 
and their families.  
If the Human Research involves cognitively impaired adults, review 
the CHECKLIST: Criteria for Research Involving Cognitively 
Impaired Adults to ensure you have provided sufficient information 
for the IRB. 
If the Human Research involves persons who have not attained the 
legal age for consent to treatments or procedures involved in the 
research (“children”), review the CHECKLIST: Criteria for Research 
Involving Children to ensure you have provided sufficient 
information for the IRB. 
If the Human Research involves pregnant women, review the 
CHECKLIST: Criteria for Research Involving Pregnant Women to 
ensure you have provided sufficient information for the IRB. 
If the Human Research involves prisoners, review the 
“CHECKLIST: Criteria for Research Involving Prisoners” to 
ensure you have provided sufficient information for the IRB. 
20) 
Drugs or Devices 
Not applicable. 
 
21) 
Multi-Site Human Research 
If this is a multi-site study where you are the lead investigator, 
describe the management of information (e.g., results, new 
information, unanticipated problems involving risk to subjects or 
others, or protocol modifications) among sites to protect subjects. 
Efforts will be taken to manage information and ensure 
standardization across sites. 
22) 
Sharing of Results with Subjects 
Describe whether results (study results or individual subject results, 
such as results of investigational diagnostic tests, genetic tests, or 

 
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incidental findings) will be shared with subjects or others (e.g., the 
subject’s primary care physicians) and if so, describe how it will be 
shared. 
Individual results with remain part of the subject’s health record. 
Subjects will be aware of their IOP.