1-irb form 1_initial application revised

8/7/2019 1-IRB Form 1_Initial Application Revised

http://slidepdf.com/reader/full/1-irb-form-1initial-application-revised 1/17

PI:

Initial Review Application – IRB Form 1

Instructions: Please submit this completed form for all research involving human subjects to

[email protected] 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 atthis facility and/or have contact with VA subjects at this facility and/or have access to VAinformation 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-relatedhealthcare decisions.

VA Annual Research Education: All study personnel involved in the conduct of the study mustcomplete 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

mailto:[email protected]

mailto:[email protected]



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:




VA Annual Research Education completed on:


6. Co-Investigators:

Name, Degrees

(Use the enter key in

this column to insert

additional names and information)

Telephone

Perform

research

activities at

ENRM VA?

Interact

with VA

research

subjects?

Access toidentifiable

subject

information/

data?

VA Annual

Research

Education

Date Completed

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

Service/Department:




Annual VA Research Education completed on:


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

(Use the enter key in

this column to insert

additional names and information)

Telephone Role in

Study

Perform

research

activities

at ENRM

VA?

Interact

with VA

research

subjects?

Access to

identifiable

subject

information/

data?

VA Annual

Research

Education

Date

Completed



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 tothe Food and Drug Administration (FDA) regulations. Documentation of FDA approval for theexperimental use of these agents must be provided for review. Additionally, all products must bedispensed and tracked through the ENRM VA Research Pharmacy.

An M.D. must be listed as a Principal Investigator and/or Responsible Investigator for all studiesthat 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-approvedmanner, 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 becompleted 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 drugfor a particular indication or indications in patients with the disease or condition under study and todetermine the common short-term side effects and risks.PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidencesuggesting effectiveness of the drug has been obtained, and are intended to gather additionalinformation 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 thedrug'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):

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=89

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=89



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):

http://www.va.gov/resdev

http://www.va.gov/resdev



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?


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

for referring or enrolling subjects?


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 complicationsPregnancy 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 arenot greater, considering probability and magnitude, than those ordinarily encountered in daily lifeor 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 wherewill 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.)?


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?


57. Will researchers obtain identifiable private information about anyone other than the

target subject (e.g., family members, friends, colleagues, classmates)?


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 $10,000or 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 therights 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 VAregulations at 38 CFR Part 16, FDA regulations at 21 CFR Part 50 & Part 56 and DHHSregulations at 45 CFR Part 46, and (ii) ENRM VA IRB policies and the ENRM VA FederalwideAssurance (FWA), such that:

•

The protocol will be performed by qualified personnel according to the ENRM VAIRB approved protocol,

• All changes in the protocol and consent form will be approved by the ENRM VAIRB 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 finalreport, 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 untilapproval 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 withhuman subjects and has sufficient training and experience to conduct this particular study in accordwith 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 adverseeffects 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 analternate ENRM VA staff member to assume responsibility during my absence and I willadvise the ENRM VA IRB by letter of such arrangements, and

• I ensure that the investigator will complete the required educational program onethical principles and regulatory requirements in a timely manner.

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

Signature of Responsible Investigator Date

The Responsible Investigator must be a member of the ENRM VA staff. The staff member isconsidered 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 andapproval 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 researchregulations and ENRM VA policies relative to the protection of the rights and welfare of thesubjects 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

Name:

Date

1-irb form 1_initial application revised

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