PI:

Initial Review Application – IRB Form 1

Instructions: Please submit this completed form for all research involving human subjects to
ann.walsh@med.va.gov or a hardcopy to Ann Walsh at the Edith Nourse Rogers Memorial VA
Hospital (ENRM VA) Research Office (151).
Please contact the IRB office if you have any questions at 781. 687.2839. Human subject research
means research involving interaction or intervention with living human beings or access to identifiable
private information of living human beings.

The information requested in this application is designed to provide the IRB with all necessary information.
Incomplete answers may result in the IRB requesting additional information or clarification.

Section 1 – General Information

1. Date:      

2. Title of Project:      

3. Sponsor or other Support (list industry sponsor, government support, etc.):

     

Section 2 – Investigators and Study Personnel

VA Appointments: All investigators and study personnel listed on this application who work at
this facility and/or have contact with VA subjects at this facility and/or have access to VA
information systems must have a VA appointment.

Principal Investigators (PI): All PIs must have a VA appointment.

Responsible Investigators (RI): All RIs must have a paid VA appointment. An RI is required if
the PI is a student, resident or fellow; or is not credentialed to perform/supervise the study
procedures. An RI is also required if the PI is not qualified to be responsible for all study-related
healthcare decisions.

VA Annual Research Education: All study personnel involved in the conduct of the study must
complete the annual VA Research Education Requirements.

4. Principal Investigator (PI) (name, degrees):      

Curriculum Vitae attached if not currently on file with the IRB
Service/Department:      
Telephone Number:       E-mail:      
Business Address/Routing Symbol or Location Code:      
1 of 17
 Human Subject Protection/Good Clinical Practices Education:
VA Annual Research Education completed on:      
Other (specify course and date completed):      

5. Responsible Investigator (name, degrees):      

Curriculum Vitae attached if not currently on file with the IRB
Service/Department:      
Telephone Number:       E-mail:      
Business Address/Routing Symbol or Location Code:      
Human Subject Protection/Good Clinical Practices Education:
VA Annual Research Education completed on:      
Other (specify course and date completed):      

6. Co-Investigators:
Name, Degrees Access to
Perform Interact VA Annual
identifiable
(Use the enter key in Telephone research with VA Research
subject
this column to insert activities at research Education
information/
additional names and ENRM VA? subjects? Date Completed
data?
information)
                                   

7. Research Coordinator/Research Contact (name, degrees):      

Service/Department:      
Telephone Number:       E-mail:      
Business Address/Routing Symbol or Location Code:      
Human Subject Protection/Good Clinical Practices Education:
Annual VA Research Education completed on:      
Other (specify course and date completed):      

8. Additional Study Personnel: (List other study personnel involved in the conduct of the study,
including additional personnel who will obtain subjects’ informed consent, interact with
subjects in person and/or on the telephone, have access to and/or collect and analyze protected
health information (PHI), have access to individually identifiable data, e.g., lab data or
samples).
Name, Degrees Perform Access to VA Annual
Interact
research identifiable Research
(Use the enter key in Telephone Role in with VA
activities subject Education
this column to insert Study research
at ENRM information/ Date
additional names and subjects?
VA? data? Completed
information)
                                         
 Section 3 – Research Sites

9. Research Sites (check all that apply):

ENRM VA Hospital     
Multi-center clinical trial
Other collaboration and performance sites (list and attach certification or letter of
IRB approval for each):      

Section 4 – FDA-Regulated Products

NOTE: If this research involves the use of any drugs, biologics, or devices, the study is subject to
the Food and Drug Administration (FDA) regulations. Documentation of FDA approval for the
experimental use of these agents must be provided for review. Additionally, all products must be
dispensed and tracked through the ENRM VA Research Pharmacy.
An M.D. must be listed as a Principal Investigator and/or Responsible Investigator for all studies
that involve the use of a drug, biologic, or device.
The ENRM VA Pharmacy and Therapeutics Committee must approve: (1) Studies of
investigational drugs (2) research involving an FDA-approved drug used in a non-approved
manner, and (3) an FDA-approved drug, used as approved, when such use is part of a research
protocol.
VA Form 10-9012 Investigational Drug Information Record – VA Form 10-9012 must be
completed for each drug being evaluated in a research study, regardless of IND status. In addition,
the VA Form 10-9012 provides a listing of all authorized prescribers for the study drug(s).
If no FDA-regulated products are involved, please complete Question 10 and proceed to
Section 5.
10. Type of Product(s) (check all that apply):
Drug(s) (list the generic name, trade name and manufacturer):      
Device(s) (list):      
Biologics or Other (list):      
Not Applicable (No FDA-regulated products involved – Skip to Section 5)

11. Type of Trial (check as applicable):

Phase I Phase II Phase III Phase IV NA

PHASE I TRIALS: Initial studies to determine the metabolism and pharmacologic actions of
drugs in humans, the side effects associated with increasing doses, and to gain early evidence of
effectiveness; may include healthy participants and/or patients.
PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug
for a particular indication or indications in patients with the disease or condition under study and to
determine the common short-term side effects and risks.
PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence
suggesting effectiveness of the drug has been obtained, and are intended to gather additional
information to evaluate the overall benefit-risk relationship of the drug and provide and adequate
basis for physician labeling.
PHASE IV TRIALS: Post-marketing studies to delineate additional information including the
drug's risks, benefits, and optimal use.

12. FDA Status of Product(s) (check as applicable):

Not Approved (list IND/IDE number):      
Pending FDA approval (provide explanation):      
Approved (check as applicable):
Product use is consistent with product labeling
New indication, labeling/advertising change (list IND/IDE Number):      
Change in administration, dosage, recipient (list IND/IDE Number):      
Study involves planned emergency research (list IND/IDE Number):      
Study does not require an IND/IDE (provide documentation):      

13. Drug Information (check as applicable):

Approved Drugs (attach applicable documents and check below):
VA Form 10-9012 Investigational Drug Information Record required
Not Approved (attach applicable documents and check below):
VA Form 10-9012 Investigational Drug Information Record required
Investigator’s Brochure

14. Device Information (check as applicable):

Not Applicable (No FDA-regulated devices involved)
Non-Significant Risk
Significant Risk (i.e., presents serious risk to subject’s health, safety, or welfare by: use
as in implant; supporting or sustaining human life; diagnosing, curing, mitigating or
treating disease; preventing health impairment; or other means)
Device information is attached (i.e., brochure, device label)

15. Please describe how FDA-regulated products will be dispensed and tracked:
     

Section 5 – Research Design and Procedures

16. Please provide a brief summary of the background for this research and its hypotheses or
objectives:
     

17. The research involves the following (check all that apply):
Chart review – retrospective Blood draws
 Chart review – prospective Urine collection
Survey administration Stool collection
Questionnaire (please attach) Biopsy
Drug administration Specimen removal during surgery
Device implantation Use of pre-existing tissues
Surgical procedure Genetic analysis
Ionizing Radiation Exposure Gene therapy
Pregnancy Screening Tissue banking
Audiotaping/Videotaping (complete and attach VA Form 10-3203)
Other (describe):      

18. Does the study include the administration of a study agent that does not require FDA
approval and does not require an IND (e.g. vitamins, food supplements, isotope tracers,
alternative medicines, etc.)?
No Yes**
**If yes, provide a detailed description of the procedures used to assure patient safety:
     

19. Please describe the research design and procedures, and specifically identify any that are
experimental, unusual, or result in less than the usual standard of care:
     

20. Procedures and data / specimen collection will be conducted by (check all that apply):
Principal Investigator House staff / fellows
Responsible Investigator Research Coordinators
Co-Investigators Research Assistants
Other (describe):      

21. Will the research involve the following?

Placebo Group No Yes (describe):      
Other Control Group No Yes (describe):      
Randomization No Yes (describe):      

22. Clinical or Research Laboratory Considerations (check all that apply):

No laboratory will be used
A central lab will be used (name):      
A local lab will be used (name):      
A core lab (e.g. ECG, echocardiogram, angiogram) will be used (name):      
23. Will radioactive material be administered to subjects?
No
Yes – (Radiation Safety Committee approval is required.

24. Will subjects be exposed to ionizing radiation from ionizing radiation generators, e.g.,
radiographic equipment, fluoroscopic equipment, and CT scanners, for one or more
imaging procedures?
No
Yes – (Radiation Safety Committee approval is required.

25. Does the research involve storage or banking of human specimens or identifiable private
information for use in future studies (e.g., submission to a repository)? (check all that
apply)
No (proceed to question 26)
Yes** – involves storing or banking identifiable private information for use in future
studies
Yes** – involves storing or banking human specimens for use in future studies
** If yes, please provide the following information:
a. What identifying information will be required?
     
b. What are the foreseeable uses of the tissue (e.g., research, pharmaceutical
products, production of cellular lines for various uses, etc.)?
     
c. Where and for how long will the tissue and/or information be stored? (NOTE: New
projects must utilize VA-sponsored tissue banks; see VHA Directive 2000-043 “Banking
of Human Research Subject’s Specimens” at
http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=89 for additional
information)
     
d. Is the storage facility an on-site or off-site location?
     
e. Will subjects be able to request that their tissue and/or information be withdrawn
from the bank or repository? (explain)
     

26. Does the research involve genetic testing or DNA/RNA extraction?

No      
Yes** – Test results will be given directly to subjects (check as applicable):
Genetic counseling will not be made available
Genetic counseling will be made available (indicate who will conduct counseling
and applicable charges):      
 Yes** – Test results will be given to treating physicians
Yes** – Test results will not be given outside the research
** If yes, please describe (i) the testing or extraction process; (ii) arrangements for
storage of DNA/RNA samples; and (iii) duration of storage; and note page where
discussed in informed consent document:
     

27. In your judgment, could the objectives of the research be met in a way that presents less
risk to subjects?
No Yes (please explain):      

28. Does the research involve the use and/or disclosure of individually identifiable health
information that is transmitted or maintained electronically or in any other form or
medium, including on paper or orally protected health information (i.e., Protected Health
Information)?
No Yes If yes, complete the required ENRM VA HIPAA forms.

29. Briefly describe the qualifications of the research team:

     

Section 6 – Subject Selection and Recruitment

30. Anticipated duration of study:      

31. Number of subjects to be enrolled (or charts/records to be reviewed) at or by the ENRM

VA:
     

32. Total number of subjects to be enrolled (or charts/records to be reviewed) at all sites:
     

33. Duration of individual subject participation (insert not-applicable for chart/record

reviews):
     

34. Age range of subjects:      

Adults only – 18 years or greater
Children – must have waiver from VACO** (check as applicable):
Waiver attached (provide approval date):      
Waiver pending
** See VA Directive 2001-028 at www.va.gov/resdev for additional information and
instructions.

35. This study will involve (check all that apply):

 Veteran Inpatients Men
Veteran Outpatients Women
Veteran Families
Non-Veterans
Normal volunteers

Medical students or house staff

Employees of the VAMC

Pregnant Women, Human Fetuses, or Neonates

Human Placental or Fetal Material, Embryos, or Stem Cells
Women that are Breastfeeding

Prisoners or Juvenile Offenders

Persons Over Age 65

Persons with Acute/Severe Mental/Physical Disabilities (describe):      
Persons in a Sedated/Traumatized/Crisis State (describe):      
Persons with Cognitive, Social, Economic, or Educational Disadvantages (describe):
     
Non-English Speaking Persons (list languages):      

36. Procedures for Recruiting Subjects (check all that apply and attach all recruitment
materials):
Investigator’s patients Other patients
Letters to Physicians Media/Internet Ads, Press Releases
Bulletin Boards, etc. (describe below): Not Applicable
Other (describe):      

37. Please describe the inclusion/exclusion criteria for the study:

     

38. Are any subjects excluded on the basis of race, ethnic group, understanding of English,
socioeconomic status, education, gender, or pregnancy?
No Yes (provide justification):      

39. Will subjects be compensated or paid an incentive for participating?

No Yes, fixed (describe type and schedule):      
Yes, prorated (describe type and schedule):      
40. If subjects will be compensated or paid an incentive for participating how will they be
paid:

Not applicable (subjects will not be compensated or paid an incentive for participating)

Cash Check Other (please explain):      

41. Will subjects be responsible for any of the costs related to the research?
No Yes (please explain):      

42. Will treating physicians, clinicians, or researchers be compensated or paid an incentive

for referring or enrolling subjects?
No Yes (please explain):      

43. Conditions that may result in removal of subjects from the research (check all that apply):
Medical condition unchanged Medical condition worsened
Serious adverse event Intolerable complications
Pregnancy Investigator’s clinical judgment
Subject withdrawal Subject uncooperative or noncompliant
Study closure by sponsor or FDA Refusal to suspend breast-feeding
Not Applicable Other (describe):      

44. Please describe any steps to ensure that subject selection is fair and equitable:
     

Section 7 – Risks and Benefits

Minimal Risk: Minimal risk means that the risks of harm anticipated in the proposed research are
not greater, considering probability and magnitude, than those ordinarily encountered in daily life
or during the performance of routine physical or psychological examinations or tests.

45. Please describe the reasonably foreseeable physical, psychological, social, and economic
risks, side effects, or discomforts associated with the research:
     

46. Please give your overall estimate of the level of these risks:
Physical Minimal Greater than Minimal Not Applicable
Psychological Minimal Greater than Minimal Not Applicable
Social Minimal Greater than Minimal Not Applicable
Economic Minimal Greater than Minimal Not Applicable

47. Will subjects receive any direct benefit from the research?
 No Yes (please describe):      
48. Will the research yield generalizable knowledge that will benefit future patients with the
subject’s disorder or condition?
No Yes (please describe):      
49. Please explain briefly why you consider the risks associated with the study to be
reasonable in relation to its benefits?
     

Section 8 – Informed Consent

50. Type of Consent (check all that apply):

Written Informed Consent
Waiver of Informed Consent (Submit Consent Waiver) and proceed to question 56)

51. Please describe the process for obtaining informed consent, or if children are involved, for
obtaining permission of the parents and assent of the child-subject (i.e., how and where
will informed consent be obtained):
     

52. List the study personnel who will be obtaining informed consent from subjects or their
legally authorized representatives:
     

53. Will anyone other than the subject be authorized to provide consent or permission for the
subject’s involvement in the research (e.g., parents, court ordered guardian, spouse, etc.)?
No Yes (please explain):      

54. Please describe how informed consent will be obtained from subjects who do not read or
understand English; identify any languages likely to be encountered; and attach a copy of
a translated and authenticated informed consent document:
     

55. Will all adult subjects have the capacity to give informed consent?
No** Yes
** If no, describe the likely range of impairment and explain how, and by whom, their
capacity to consent will be determined. (NOTE: In research involving more than minimal
risk, capacity to consent should be determined by a psychiatrist, clinical psychologist, or
other qualified professional not otherwise involved in the research. Individuals who lack
the capacity to consent may participate in research only if a legally authorized
representative gives consent on their behalf.)
     

Section 9 – Privacy and Confidentiality

 56. Will researchers have access to identifiable private information about subjects or
potential subjects before consent is obtained?
No Yes (please explain):      

57. Will researchers obtain identifiable private information about anyone other than the
target subject (e.g., family members, friends, colleagues, classmates)?
No Yes (please explain):      

58. Please describe how/where informed consent documents and study data will be stored,
and identify the persons that will have access to them:
     

59. Please describe procedures to ensure the privacy of subjects and maintain the
confidentiality of data/information (e.g., how/where data will be stored (location with
room number), who will have access to the data/codes, what will happen to the data when
the research is complete, will data be archived, if so, for how long and in what medium):
     

60. If data with identifiers will be released, specify the person(s) or agency to whom this
information will be released:
     

Section 10 – Safety Monitoring

61. Radiation Safety Committee Approval (check as applicable):

Not applicable
Approval attached (provide approval date):      
Approval pending (forward Radiation Safety Committee approval letter to the IRB office)

62. Pharmacy & Therapeutics (P&T) Committee Approval (check as applicable):

Not applicable
Approval attached (provide approval date):      
Approval pending (forward Pharmacy & Therapeutics Committee approval letter to the
IRB office)

63. Is there a central data safety monitoring plan for adverse events and/or statistical
analysis?
No Yes (please attach the plan)
If no plan is available, provide details including the name of the committee, whether it is
independent from the study sponsor, how often it meets, whether written reports are
available, etc. :      
 If no, and the study involves greater than minimal risk, describe the plan for data safety
monitoring:      

64. Is there a plan for on-site data monitoring of this study by the sponsor, contract research
organization (CRO), or other independent body?

Please note that the Research Office must be notified of all on-site monitoring visits.
No Yes (please describe the monitoring plan and attach a copy):     

Section 11 – Safeguards for Vulnerable Subjects

65. Please describe any safeguards that will be taken to protect the rights and welfare of
potentially vulnerable subjects. If described previously, please simply list them here:
     

66. Please list any other information specific to this study that you believe the IRB should
consider:
     

Section 12 – Budget / Funding Information

67. Funding Sources (check all that apply):

No funding required
VA Central Office
VISN
Bedford Research Corporation, Inc. (BRCI)
NIH / Agency
Other Foundation (name):      
Commercial (name):      
Other (describe):      

68. Grantee (name):      

69. Grant / Contract No. (if applicable):      

70. Administered by:

VA Research Office
BRCI
Boston University
Other (specify):      
No funding required
 Section 13 – Conflict of Interest Disclosure

Definition: Significant Financial Interests are defined as interests valued at greater than $10,000
or an equity ownership of more than 5% held by all study team personnel and their spouse and/or
dependent children.
Financial Interests (Conflict of Interest Statements are required to be completed by all study
team personnel listed on this application.
Section 14 – Principal Investigator’s Statement of Assurance
I certify that the information provided in this application is complete and correct.
I understand that as Principal Investigator, I have ultimate responsibility for the protection of the
rights and welfare of human subjects, conduct of the study and the ethical performance of the
project. I agree to accept responsibility for the conduct and supervision of this research and the
protection of human subjects as required by (i) state and federal law and regulation, including VA
regulations at 38 CFR Part 16, FDA regulations at 21 CFR Part 50 & Part 56 and DHHS
regulations at 45 CFR Part 46, and (ii) ENRM VA IRB policies and the ENRM VA Federalwide
Assurance (FWA), such that:
• The protocol will be performed by qualified personnel according to the ENRM VA
IRB approved protocol,
• All changes in the protocol and consent form will be approved by the ENRM VA
IRB before they are initiated,
• Legally effective informed consent will be obtained from human subjects if
applicable, and
• Adverse events will be reported to the ENRM VA IRB in a timely manner.
• If I leave the VA, I will assure that all appropriate documents, constituting a final
report, are submitted to the IRB for review.
• I will complete the required educational program on ethical principles and regulatory
requirements in a timely manner.

I further certify that the proposed research is not currently underway and will not begin until
approval has been obtained.

     
Signature of Principal Investigator Date

Section 15 – Responsible Investigator’s Statement of Assurance

By my signature as responsible investigator on this research application, I certify that the student or
guest investigator is knowledgeable about the regulations and policies governing research with
human subjects and has sufficient training and experience to conduct this particular study in accord
with the approved protocol.
In addition,
• I agree to meet with the investigator on a regular basis to monitor study progress,
 • Should problems arise during the course of the study, I agree to be available,
personally, to supervise the investigator in solving them,
• I insure that the investigator will promptly report significant or untoward adverse
effects to the ENRM VA IRB in a timely manner,
• If I will be unavailable, as when on sabbatical leave or vacation, I will arrange for an
alternate ENRM VA staff member to assume responsibility during my absence and I will
advise the ENRM VA IRB by letter of such arrangements, and
• I ensure that the investigator will complete the required educational program on
ethical principles and regulatory requirements in a timely manner.
I further certify that the proposed research is not currently underway and will not begin until
approval has been obtained.

     
Signature of Responsible Investigator Date
The Responsible Investigator must be a member of the ENRM VA staff. The staff member is
considered the responsible party for clinical, legal, and ethical performance of the project.

Section 16 – Signature of Service Chief

As Service Chief, I acknowledge that this research is in keeping with the standards set by our
service and I insure that the Principal Investigator has met all service requirements for review and
approval of this research.

     
Signature of Service Chief Date
Printed Name:      

Section 17 – Co-Investigator and Study Personnel Agreement

I acknowledge my role in this research study and I agree to adhere to applicable federal research
regulations and ENRM VA policies relative to the protection of the rights and welfare of the
subjects enrolled in this study. .
Name (printed) Date Role in Study Signature

           

     

     

     

     
     

     

     

     

     
 Section 18 – Attachments
Please attach the following items as applicable and check those attached:
Protocol Summary
Complete research protocol or research plan (e.g., voluntary agency or commercial
sponsor protocols)
Clinical investigator’s brochure, package insert, PDR monograph, labeling information,
where applicable
VA Form 10-9012 Investigational Drug Record, where applicable
Informed consent document(s), where applicable
Parental permission document(s), where applicable
Child assent document(s), where applicable
Translated & authenticated versions of the above consent, permission, and/or assent
document(s) for likely non-English speakers, where applicable
All advertisements, announcements, letters, or other recruiting materials
All scales, survey instruments, questionnaires, interview scripts, etc.
VA Form 10-3203 Consent for Use of Picture and/or Voice; where applicable
Conflict of Interest Statements for study personnel listed on this application if not already
submitted to the Research Office
Federal cooperative research sample protocol and consent form, where applicable
Complete federal or non-federal grant application (e.g., VA merit review, NIH or
voluntary agency grant applications) except attachments, where applicable
Relevant safety committee approvals, where applicable
Attachment for Informed Consent Waiver, where applicable
Attachment for ENRM VA HIPAA Authorization Form, where applicable
Attachment for ENRM VA HIPAA Waiver of Authorization where applicable
Title of Project:

FOR IRB USE ONLY

     
Approved by Expedited Review      
Approved by Convened (Full) IRB (as proposed)
Approval includes Consent Waiver
Approval includes HIPAA Authorization Waiver
Disapproved

Comments:      

Signature of IRB Chair or Designee Date

Name: