B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
Phase: PHASE3
Conditions: HIV Infection, Hepatitis B
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

ACTG NETWORK COORDINATING CENTER 
Social & Scientific Systems, Inc., a DLH Holdings Company 
8757 Georgia Avenue, 12th Floor 
Silver Spring, MD  20910-3714 
Phone: 301-628-3000 
 
 
VERSION 2.0 LETTER OF AMENDMENT #1 
 
DATE:  
February 18, 2022 
 
TO: 
 
ACTG CTU Principal Investigators, CRS Leaders, and CTU/CRS Coordinators 
 
FROM: 
A5379 Protocol Team 
 
SUBJECT: 
Letter of Amendment #1 for Version 2.0 Protocol A5379 
 
The following information affects the A5379 study and must be forwarded to the 
institutional review board (IRB)/ethics committee (EC) responsible for oversight of the 
study as soon as possible for their information and review. This Letter of Amendment 
(LOA) must be approved by the IRB/EC before implementation. 
 
The following information affects the Sample Informed Consent. Your IRB/EC is responsible 
for determining the process of informing participants of the contents of this LOA. 
 
Upon receiving final IRB/EC and any other applicable regulatory entity approvals for this 
LOA, sites should implement the LOA immediately. Sites are still required to submit an 
LOA registration packet to the DAIDS Protocol Registration Office (PRO) at the 
Regulatory Support Center. Sites will receive a registration notification for the LOA once 
the DAIDS PRO verifies that all required LOA registration documents have been received 
and are complete. A copy of the LOA registration notification, along with this letter and 
any IRB/EC correspondence, should be retained in the site’s regulatory file. 
 
This LOA is being implemented for the following reasons: 
• 
To correct blood volumes listed in the sample informed consent. 
• 
To note that trained study staff may administer the study vaccination. 
• 
To add that changes in ART in the 28 days prior to study entry are allowed unless the 
change is due to ART toxicity.  
• 
To add inactive or resolved cutaneous Kaposi sarcoma as an exception to exclusion criterion 4.4.7. 
• 
To add that receipt of flu vaccine within 14 days prior to study entry is allowed. 
• 
To add a complete history of COVID-19 vaccines to medication history. 
• 
To allow remote data collection of post-entry evaluations due to illness or quarantine. 
• 
To describe that COVID-19 vaccines are not prohibited on study. 
• 
To clarify that pregnancy testing results must be negative within 2 days prior to the 
participant receiving study vaccine. 
• 
To remove pregnancy testing at screening. 
• 
To change “regardless of grade” to “Grade ≥1” for the following:  
a. Any concomitant medication associated with Grade ≥1 local and systemic injection 
reactions within 7 days after any study vaccine injection must be recorded on the eCRF. 
b. All Grade ≥1 local and systemic injection reactions within 7 days of any study vaccine 
injection must be recorded on the eCRF. 
• 
To add a paragraph in Appendix I, Sample Informed Consent (WHAT ABOUT CONFIDENTIALITY?) 
now that the SDAC work in the ACTG is also covered by an approval from the Advarra IRB. 
• 
To update language in Appendix I, Sample Informed Consent (WHAT HAPPENS IF I AM 
INJURED?) 
• 
To add agreed-upon language from the ACTG Leadership Steering Committee in 
ATTACHMENT B, CONSENT FOR USE OF SAMPLES IN OTHER STUDIES. 

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• 
To update the Protocol Team Roster and Study Management sections. 
 

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TABLE OF CONTENTS 
1. 
Protocol Signature Page ................................................................................................. 4 
2. 
Protocol Team Roster ..................................................................................................... 4 
3. 
Study Management ........................................................................................................ 5 
4. 
Inclusion Criterion 4.1.2 .................................................................................................. 6 
5. 
Exclusion Criterion 4.4.7 ................................................................................................. 6 
6. 
Exclusion Criterion 4.4.16 ............................................................................................... 6 
7. 
5.3.1 HEPLISAV-B ......................................................................................................... 6 
8. 
5.3.2 ENGERIX-B ........................................................................................................... 7 
9. 
5.5.2 Prohibited Medications .......................................................................................... 7 
10. 
Table 6.1-1 Group A (Arm 1 only) ................................................................................... 7 
11. 
Table 6.1-2 Group A (Arms 2 and 3 only) ....................................................................... 8 
12. 
Table 6.1-3 Group B Only ............................................................................................... 8 
13. 
Table 6.3.3-1 Medication History .................................................................................... 8 
14. 
6.2.3 Post-Entry Evaluations .......................................................................................... 9 
15. 
6.3.4 Clinical Assessments ............................................................................................. 9 
16. 
6.3.5 Laboratory Evaluations .........................................................................................10 
17. 
7.2  Adverse Event Collection Requirements for This Protocol ......................................10 
18. 
APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT DO I HAVE TO DO IF I AM IN 
THIS STUDY?” ..............................................................................................................10 
19. 
APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT DO I HAVE TO DO IF I AM IN 
THIS STUDY?” ..............................................................................................................11 
20. 
APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT DO I HAVE TO DO IF I AM IN 
THIS STUDY?” ..............................................................................................................11 
21. 
APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT ABOUT CONFIDENTIALITY?”
 ......................................................................................................................................11 
22. 
APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT HAPPENS IF I AM INJURED?”
 ......................................................................................................................................11 
23. 
ATTACHMENT A: STUDY VISITS AND PROCEDURES ..............................................12 
24. 
ATTACHMENT B: CONSENT FOR USE OF SAMPLES IN OTHER STUDIES .............12 
SIGNATURE PAGE ..................................................................................................................14 

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The following are changes (noted in bold or strikethrough) to A5379, Version 2.0, 07/01/20, 
titled, “B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEe-
HIVe): Evaluation of HEPLISAV-B.” These changes will be included in the next version of the 
A5379 protocol if it is amended at a future date. 
 
1. Protocol Signature Page 
 
A Protocol Signature Page (PSP) is appended for submission to the DAIDS Protocol 
Registration System (DPRS) as part of the LOA registration packet. 
 
2. Protocol Team Roster 
 
a. The DAIDS Clinical Representative was replaced: 
 
DAIDS Clinical Representative  
Leonard Sowah, MBChB, MPH, FACP 
CCRB/TRP/DAIDS/NIAID/NIH/DHHS 
Therapeutics Research Program 
5601 Fishers Lane  
Room 9F41 
Rockville, MD 20852 
Phone: 301-761-7231 
Fax: 240-627-3107 
E-mail: leonard.sowah@nih.gov 
Beverly L. Alston-Smith, MD  
DAIDS/NIAID/NIH/CCRB 
Complications and Co-Infectious Research Branch 
5601 Fisher Lane 
Room 9F50 
Rockville, MD 20852 
Phone: 301-435-3773 
E-mail: balston@niaid.nih.gov 
 
b. A second Data Manager has been added to the protocol team: 
 
Data Managers 
Lillian Collins, MPH 
Frontier Science & Technology Research Foundation, Inc. 
4033 Maple Road 
Amherst, NY 14226 
Phone: 716-834-0900, Ext. 7308 
E-mail: collins@frontierscience.org 
 
c. The Industry Representative was replaced: 
 
Industry Representative 
Kelvin McKoy, MD, MBA 
Dynavax 
2100 Powell Street, Suite 900 
Emeryville, CA 94608 

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Phone: 202-271-0098 
E-mail: kmckoy@dynavax.com 
Randall Hyer, MD, PhD, MPH 
Dynavax Technologies Corporation 
2929 Seventh Street 
Berkeley, CA 94710 
Phone: 510-665-0451 
E-mail: rhyer@dynavax.com 
 
d. A second Laboratory Data Manager has been added to the protocol team: 
 
Philip Marzinek, BS 
Laboratory Data Manager 
Frontier Science Foundation 
Phone: 716-834-0900, Ext. 7399 
4033 Maple Road 
Amherst, NY 14226 
E-mail: marzinek@frontierscience.org 
 
e. The Laboratory Specialist was removed, and two new Laboratory Specialists have been 
added to the protocol team: 
 
Rose Lagattuta 
ACTG Laboratory Center at UCLA (ALC-UCLA) 
11075 Santa Monica Boulevard 
Suite 200 
Los Angeles, CA 90025 
Phone: 310-794-9979 
E-mail: rlagattuta@milabcentral.org 
 
Ceora Beijer, BS 
ACTG Laboratory Center at UCLA (ALC-UCLA) 
675 Charles E. Young Drive South 
Los Angeles, CA 90095 
Phone: 310-794-9052 
E-mail: cbeijer@milabcentral.org 
 
Sara Zabih, MS 
ACTG Laboratory Center at UCLA (ALC-UCLA) 
675 Charles E. Young Drive South 
Los Angeles, CA 90095 
Phone: 310-794-9084 
Email: szabih@milabcentral.org 
 
3. Study Management 
 
Lillian Collins was added to the second and third bullet points under subsection Data 
Management: 
 

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• 
For transfers, reference the Study Participant Transfer SOP 119, and contact Stephanie 
Caruso and Lillian Collins directly. 
• 
For other questions, send an e-mail message to actg.teamA5379@fstrf.org 
(ATTENTION: Stephanie Caruso and Lillian Collins). 
 
4. Inclusion Criterion 4.1.2 
 
The criterion was updated as shown below: 
 
4.1.2    On current HIV-1 antiretroviral therapy (ART) for >56 days immediately prior to 
study entry.  
 
NOTE: Changes to ART due to ART toxicity in the 28 days prior to study 
entry is not allowed. For questions related to ART toxicity, sites should 
contact the team per the Study Management section. Individuals must not 
have changed ART within 56 days prior to study entry except for changes in 
integrase inhibitors, which will be allowed. 
 
5. Exclusion Criterion 4.4.7 
 
The criterion was updated as shown below: 
 
4.4.7 Cancer diagnosis within 5 years prior to study entry, other than squamous or 
basal cell carcinoma of the skin and resolved or inactive cutaneous Kaposi 
sarcoma. 
 
6. Exclusion Criterion 4.4.16 
 
The criterion was updated as shown below: 
 
4.4.16 Receipt of any inactivated virus vaccine within 14 days prior to study entry. 
 
 
NOTE: Receipt of flu vaccine within 14 days prior to study entry is allowed. 
 
7. 5.3.1 HEPLISAV-B 
 
Study clinician was replaced with study staff in items 3 and 5 as shown below: 
 
3. The center seals of the vials will be removed, and the vial stoppers wiped with an alcohol 
wipe prior to insertion of a sterile needle attached to a sterile syringe. The study staff 
clinician will determine the needle size depending upon the participant’s deltoid muscle 
size. 
 
5. For the prefilled syringes, attach a sterile needle and administer intramuscularly. The 
study staff clinician will determine the needle size depending upon the participant’s 
deltoid muscle size. HEPLISAV-B should be administered as soon as possible. 
HEPLISAV-B can be kept at room temperature (20°C-25°C) for up to 8 hours but 
exposure time to room temperature should be minimized. 
 

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8. 5.3.2 ENGERIX-B 
 
Study clinician was replaced with study staff in items 3 and 5 as shown below: 
 
3. For the vials, remove the center seals of the vials and wipe the vial stoppers with an 
alcohol wipe prior to insertion of a sterile needle attached to a sterile syringe. The study 
staff clinician will determine the needle size depending upon the participant’s deltoid 
muscle size. 
 
5. For the prefilled syringes, attach a sterile needle and administer intramuscularly. The 
study staff clinician will determine the needle size depending upon the participant’s 
deltoid muscle size. ENGERIX-B should be administered as soon as possible. 
ENGERIX-B can be kept at room temperature (20°C-25°C) for up to 72 hours but 
exposure time to room temperature should be minimized. 
 
9. 5.5.2 Prohibited Medications 
 
Clarification about COVID-19 administration was added as shown below: 
 
HBV vaccine preparations other than study vaccines HEPLISAV-B and ENGERIX-B are 
prohibited. Standard-of-care (SOC) vaccines, including COVID-19 vaccines, will be 
permitted during the conduct of this study. If administration of a COVID-19 vaccine 
occurs after study entry and near the 2nd or 3rd study vaccine dose, adjust the 2nd or 
3rd dose of the study vaccine to avoid immediate overlap reactogenicity; however, it 
is not prohibited to give them together, and this is at the discretion of the site 
investigator. If an SOC vaccine and/or COVID-19 vaccine is administered on the same 
day as the study-provided vaccine, use different arms. Refer to the A5379 PSWP for 
further details about COVID-19 vaccines and this study. 
 
 
10. Table 6.1-1 Group A (Arm 1 only) 
 
Pregnancy testing at screening was removed as shown below: 
 
Evaluations 
Screening 
Entry 
(Day 0) 
Post-Entry Evaluations 
(Weeks) 
Premature 
Study 
Discontinuation 
Evaluations 
(*refer to 
section 6.2.4) 
 
4 
8 
12 
24 
28 
52 
72 
Visit Windows 
Within 45 
days 
≥24 hours 
after 
screening 
-4/+7 
days 
±7 days 
±14 days 
Pregnancy Testing 
X 
X 
X 
 
 
 
 
 
X 
X 
 
 

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11. Table 6.1-2 Group A (Arms 2 and 3 only) 
 
Pregnancy testing at screening was removed as shown below: 
 
Evaluations 
Screening 
Entry 
(Day 0) 
Post-Entry 
Evaluation 
Post-Entry Evaluations 
(Weeks) 
Premature 
Study 
Discontinuation 
Evaluations 
(*refer to 
section 6.2.4) 
4 
8 12 24 28 32 48 72 
Visit Windows 
Within 45 
days 
≥24 hours 
after 
screening 
≥16 to ≤28 
hours post 
1st 
vaccination; 
at US sites 
only and is 
optional 
-4/+7 
days 
±7 days 
±14 
days 
Pregnancy Testing 
X 
X 
 
X 
 
 
X 
 
 
 
X 
X 
 
 
12. Table 6.1-3 Group B Only 
 
Pregnancy testing at screening was removed as shown below: 
 
Evaluations 
Screening 
Entry 
(Day 0) 
Post-Entry Evaluations 
(Weeks) 
Premature 
Study 
Discontinuation 
Evaluations 
(*refer to 
section 6.2.4) 
4 
8 12 24 28 32 48 
72 
Visit Windows 
Within 45 
days 
≥24 
hours 
after 
screening 
-4/+7 
days 
±7 days 
±14 days 
Pregnancy Testing 
X 
X 
X 
 
 
X 
 
 
 
X 
X 
 
 
13. Table 6.3.3-1 Medication History 
 
“COVID-19 vaccines” was added: 
 
Table 6.3.3-1: Medication History 
Medication Category 
Complete History or Timeframe 
Antiretroviral therapy 
Within 60 days prior to entry 
HBV vaccination1 
Complete history 
Immune-based therapy 
Within 1 years prior to entry 
Blinded study treatment 
Within 1 years prior to entry 
HIV-1-related vaccines 
Within 1 years prior to entry 
COVID-19 vaccines 
Complete History 
Prescription drugs for treatment of 
opportunistic infections 
Within 60 days prior to entry 

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Medication Category 
Complete History or Timeframe 
Prescription drugs for prophylaxis of 
opportunistic infections 
Within 60 days prior to entry 
Prescription drugs (other) 
Within 45 days prior to entry 
Herbal/dietary supplements 
Within 45 days prior to entry 
Sex-hormone medications or sex-
hormone analogues or antagonists2 
Within 1 year except as noted below 
 
14. 6.2.3 Post-Entry Evaluations 
 
The following was added under the Missed Vaccination Visits section: 
 
Remote Data Collection 
Study visits may be conducted remotely (e.g., telephone, telehealth) in the following 
situations: 
• 
A participant is unable to attend a visit because of illness, lockdown status, or 
quarantine; the site must inform the CMC (actg.cmca5379@fstrf.org) 
• 
The site is temporarily unable to conduct non-essential visits in the clinic; the site 
must inform the CMC (actg.cmca5379@fstrf.org) 
 
Remote visits should be conducted during the visit window according to the SOE. 
Regardless of the situation, sites should document which visits were conducted 
remotely. For visits that are conducted remotely, the site should attempt to obtain as 
much of the visit-specific required information based on the SOE as possible and 
record it on the relevant eCRF. 
 
In addition to the remote visit, the participant should be scheduled for an in-person 
visit for all evaluations that were not conducted at the remote visit. If the in-person 
visit evaluations are outside of the visits window, have the participant in as soon as 
possible for safety-related evaluations as an unscheduled visit, but if within a week of 
the next scheduled visit window, then wait for the next scheduled visit and add any 
safety lab evaluations not already being performed. If the participant is unable or 
prefers not to come to the site for a visit, priority safety labs are permitted to be done 
at a local lab or as part of the standard of care. Record these on an eCRF. The priority 
safety labs include: chemistry, hematology, and liver function tests. 
 
We ask the sites to prioritize sample collection for HBsAb testing at Week 12 for Arm 1 
in Group A, and Week 28 for Arms 2 and 3 in Group A and for Group B. If there is a 
need to limit in-person interactions at the site, the in-person component can be 
restricted to the blood draw, and the remaining visit evaluations can be completed 
remotely. 
 
15. 6.3.4 Clinical Assessments 
 
a. A bullet point was added after “Inactivated or live virus vaccine” under the Concomitant 
Medications section as shown below: 
 
• 
Vaccines (experimental or standard of care, including COVID-19 vaccines and 
COVID-19 booster vaccines) 

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b. The last bullet point under the Concomitant Medications section was updated as shown 
below: 
 
• 
Any concomitant medication associated with Grade ≥1 local and systemic injection 
reactions regardless of grade, within 7 days after any study vaccine injection. 
 
16. 6.3.5 Laboratory Evaluations 
 
Changes were made in the second and third sentences under Pregnancy Testing as shown 
below: 
 
Pregnancy testing must occur on the day of vaccination and the results must be negative 
within 2 days prior to the participant receiving HEPLISAV-B or ENGERIX-B. Post-entry, 
nNote that a subsequent pregnancy test is not required for pregnant participants who 
consented to continue with the study. 
 
17. 7.2  Adverse Event Collection Requirements for This Protocol 
 
The fourth bullet point in the first paragraph of this section was updated as shown below: 
 
• 
All Grade ≥1 local and systemic injection reactions within 7 days of any study vaccine 
injection regardless of grade. 
 
18. APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT DO I HAVE TO DO IF I AM IN 
THIS STUDY?” 
 
The blood collection amounts under Screening, Entry, and Other Study Visits have been 
updated as follows: 
 
Screening: The fifth bullet point has been revised to read: 
• 
You may have approximately 34 42 mL (about 2 3 tablespoons) of blood collected  
 
Entry: The third bullet point has been revised to read: 
• 
You may have approximately 161 135 mL (about 11 9 tablespoons) of blood collected  
 
Other Study Visits: The second bullet point has been revised to read:  
• 
You will have as little as 3 5 mL (about 1 teaspoon) to as much as 27 132 mL (2 9 
tablespoons) of blood collected at any one visit  
 

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19. APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT DO I HAVE TO DO IF I AM IN 
THIS STUDY?” 
 
The third bullet point under Other Study Visits has been updated as follows: 
 
• 
If you are able to become pregnant, you will have a pregnancy test and the result must 
be negative within 2 days prior to receiving a study vaccine dose. You will also 
have a pregnancy test during the visits when you receive the vaccine and at your last 
study visit. Options about staying on the study if you become pregnant, are explained 
elsewhere in the consent. 
 
20. APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT DO I HAVE TO DO IF I AM IN 
THIS STUDY?”  
 
a. The following bullet point was removed under Screening as shown below: 
 
o If you are able to get pregnant, some of your blood or urine will be collected to test 
for pregnancy. If the pregnancy test is positive, you will not be able to join the study. 
 
b. The following was added under Other Study Visits as shown below: 
 
Remote Data Collection 
Sometimes the study staff may need to conduct a scheduled visit with you remotely 
(for example, by telephone, or via telehealth). This could happen for any of the 
reasons listed below: 
• 
You are not able to attend a visit in person (for example, because you are not 
feeling well or you are in lockdown or quarantine). 
• 
The site is temporarily unable to conduct non-essential visits in the clinic (for 
example, because of a problem at the facility or because of a public health 
emergency). 
 
Regardless of the reason, the study staff will attempt to contact you and obtain as 
much of the required information from you as is possible. Further, the in-person visit 
will be rescheduled.  
 
21. APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT ABOUT CONFIDENTIALITY?” 
 
The following paragraph was added as the fourth paragraph under For Sites outside the US: 
 
All information collected about you as part of the study will be sent securely to the 
ACTG statistical and data management center in the United States for combining with 
information from other study participants and statistical analysis of study results. 
Your name and other personal identifiers will not be sent. Your research site is 
responsible for sending your information in accordance with the laws, regulations, 
and policies of your country and research site. 
 
22. APPENDIX I: SAMPLE INFORMED CONSENT, “WHAT HAPPENS IF I AM INJURED?” 
 
 

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The content was updated as shown below: 
 
[Sites: Please modify (if necessary) and insert one of these two statements, as appropriate 
to your site. If your site is required to carry Clinical Trials Insurance (CTI), this must be 
indicated in the informed consent.] Please note, that for all sites (not as part of an 
either/or statement with CTI) the NIH does not have a mechanism to provide direct 
compensation for research related injury.  
• 
This site has clinical trials insurance. This insurance will allow the site to provide you 
with monetary compensation if you suffer harm as a result of participating in this 
research study. 
OR  
• 
The cost for this treatment will be charged to you or your insurance company. There 
is no program for compensation either through this institution or the NIH, regardless 
of whether CTI is available.  
 
23. ATTACHMENT A: STUDY VISITS AND PROCEDURES 
 
a. Pregnancy testing was removed at screening in Table 1: Expected Study Visit Schedule 
for Participants Receiving Three shots of a Vaccine as shown below: 
 
Procedure 
Screening 
Entry 
On-study (visit weeks) 
End 
Study 
Early 
1st visit after 
1st vaccine 
shot* 
4 
8 
12 
24 
28 
32 
48 
72 
Pregnancy test 
✓ 
✓ 
 
At a few visits 
✓ 
 
b. Pregnancy testing was removed at screening in Table 2: Expected Study Visit Schedule 
for Participants Receiving Two shots of a Vaccine as shown below: 
 
 
 
24. ATTACHMENT B: CONSENT FOR USE OF SAMPLES IN OTHER STUDIES 
 
The following section was updated as follows: 
 
Research with Human Genetic Testing 
Your extra samples will not be used for human genetic testing. 
 
The ACTG has two different studies that collect samples for genetic testing. 
 
If you live in the US, this study is called ACTG A5128, Plan for Obtaining Informed Consent 
to Use Stored Human Biological Materials (HBM) for Currently Unspecified Analyses. 
 
Procedure 
Screening 
Entry 
On-study (visit weeks) 
End 
Study 
Early 
4 
8 
12 
24 
28 
52 
72 
Pregnancy test 
✓ 
✓ 
At a few visits 
✓ 

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If you live outside of the US, this study is called ACTG A5243, Plan for Obtaining Human 
Biological Samples at Non-US Clinical Research Sites for Currently Unspecified Genetic 
Analyses. 
 
Your site might ask you if you would like to participate in one of these studies if it is being 
done where you live. If you would like to participate, you will sign a separate consent form. 
 
Your extra samples will not be used for human genetic testing unless you sign and 
date a consent form for A5128 or A5243. 
 
 

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B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEe-HIVe): 
Evaluation of HEPLISAV-B 
 
SIGNATURE PAGE 
 
 
I will conduct the study in accordance with the provisions of this protocol and all applicable 
protocol-related documents. I agree to conduct this study in compliance with United States 
(US) Health and Human Service regulations (45 CFR 46); applicable US Food and Drug 
Administration regulations; standards of the International Conference on Harmonization 
Guideline for Good Clinical Practice (E6); Institutional Review Board/Ethics Committee 
determinations; all applicable in-country, state, and local laws and regulations; and other 
applicable requirements (e.g., US National Institutes of Health, Division of AIDS) and 
institutional policies. 
 
 
 
 
Principal Investigator: _____________________________________________________ 
 
      Print/Type 
 
 
 
 
Signed: ______________________________________________ Date: _____________ 
 
    Name/Title