LIFEBRIDGE HEALTH, INC.

Institutional Review Board

Policies and Standard Operating Procedures

Revised as of 23 May 2017

TABLE OF CONTENTS

I. INTRODUCTION 1

II. STATEMENT OF AUTHORITY AND PURPOSE 2

A. Governing Principles 2

B. Institutional Authority 2

C. IRB Authority 4

D. Responsibilities of the IRB 5

III. ORGANIZATION OF THE IRB 7

A. Composition of the Board 7

B. Management 9

C. Duties of IRB Members 10

D. Scope of IRB Reviews 14

IV. GENERAL ADMINISTRATION 15

A. Policies and Procedures Maintenance 15

B. Education and Training 17

V. FUNCTIONS AND OPERATIONS 21

A. Research Submission Requirements 21

B. Exemptions from IRB review 25

C. IRB Meeting Administration 27

D. Administrative Review and Distribution of Materials 33

E. Documentation and Document Management 35

VI. REVIEW OF RESEARCH 37

A. Expedited Review 37

B. Facilitated IRB Reviews (Central IRB) 44

C. Full IRB Initial Review – Criteria for IRB Approval 45

D. Full IRB Continuing Review – Criteria for Renewal 49

E. Continuing Review – Ongoing 53

F. Investigator Reporting of Serious Adverse Events in Research Subjects 59

G. Suspensions of Studies 65

H. Study Completion 67

I. Categories of Action by the IRB 68

VII. informed consent 70

A. General Requirements and Documentation 70

B. Economic Considerations in Research Involving Human Subjects 79

C. Exceptions To Informed Consent Requirements 81

D. Procedures by Which Research Subjects May Voice Complaints or Concerns 84

VIII. Vulnerable Subject Populations 85

A. Children 85

B. Employees or Students 89

C. Cognitively Disabled Persons 89

D. Pregnant Women, Fetal Research, and Prisoners 91

IX. CATEGORIES OF RESEARCH 91

A. Investigational Drugs, Biologics and Medical Devices 91

B. Review Of Research Involving Medical Devices 91

C. Humanitarian Use Devices (HUD) 92

D. Emergency Use of Investigational Agents 99

E. Single Patient or Small Group Use “Compassionate Use” of Investigational Agents in non-emergency situations 101

F. Medical Records and Chart Review 103

G. Genetic Research 104

H. Gene Therapy, Tissue and Cell Transplantation Research 105

X. INVESTIGATOR RESPONSIBILITIES 105

A. Required Investigator Actions 105

B. Responsibility 108

C. Applicable Regulations and Guidelines 108

XI. QUALITY ASSURANCE 108

A. Quality Assurance and Quality Control 108

B. Audits by Regulatory Agencies 109

XII. Appendix 111

A. IRB Forms 111

1. Application for New Research 111

2. Disclosure/Use of De-Identified Data/Materials for Research 111

3. Adverse Event Report 111

4. IRB Co-Investigator Signature Page 111

5. IRB Protocol Review 111

6. Financial Interest Disclosure Form 111

7. Certification for Use of PHI in Activities Preparatory to Research 111

8. LBH Investigator Delegation of Responsibility 111

9. LBH Humanitarian Use Devices (HUD) Information and Signature Form 111

10a. Consent to Undergo Treatment with a Humanitarian Device 111

10b. Humanitarian Use Device Informed Consent and Privacy Authorization Form 111

11. Site Visit/Audit Report 111

11a. HRP-430 LBH Audit Form 111

11b. HRP-443 LBH Audit - Consent Process Form 111

12. IRB Member and Alternate Confidentiality Agreement 111

13. IRB Member and Alternate Conflict of Interest Disclosure and Recusal Agreement 111

14. LifeBridge Health Institutional Review Board (IRB) Member Agreement 111

15. LifeBridge Health Institutional Review Board (IRB) Alternate Member Agreement 111

16. Member Responsibilities and Reviewer Duties 111

17. Renewal Research Form 111

18. Human Gene Transfer / Recombinant DNA Research 111

19. Exemption Screening Questions 111

20. Claim of Exemption 112

21. Request for Expedited Review 112

22. Protocol Application Checklist 112

23. Humanitarian Use Device Renewal Form 112

24. Request for Exception to Informed Consent Requirements for Research 112

25. Informed Consent Template 112

26. Request of Expedited Review and Waiver of Disclosure for Use of Protected Health Information (PHI) in a Research Study 112

26a. Waiver of Disclosure for Use of Protected Health Information (PHI) in a Research Study 112

27. LBH IRB – CIRB Authorization Agreement 112

28. Individual Investigator Agreement 112

29. NCI CIRB Application Checklist 112

30. NCI CIRB FACILITATED APPLICATION FORM FOR NEW RESEARCH 112

31. Study Summary 112

32. Translation Certification Form 112

33. Use or Disclosure of Protected Health Information (sponsor-initiated) 112

34. Use or Disclosure of Protected Health Information (Investigator-initiated) 112

B. IRB Guidelines

1. Case Reports & Chart Reviews………………………………………………………………….112

2. Disclosure / Use of De-Identified Data / Materials for Research 112

3. Adverse Event Reporting 112

4. Adverse Event and Safety Report Continuing Review Reporting 112

5. Policy of Conflict of Interest in Research 112

6. Conflict of Interest Guidelines for Clinical Research 112

7a. NCI CIRB Program Submissions 112

7b. External Institutional Review Board Facilitated Review 112

8. Humanitarian Use Devices 112

9. IRB Review Fees 112

10. Defining Community Outreach Research and Non-Research Projects 112

11. Audit Policy 112

12. Evaluating and Monitoring Risk in Human Subjects Research 113

13. Exemption for Human Subjects Research Training 113

14. Human Gene Transfer/Recombinant DNA Research 113

15. Retrospective Research 113

16a. Emergency and Compassionate Use of an Unapproved Drug, Device, or Biologics 113

16b. Expanded Access for an Unapproved Drug, Biologic, or Device 113

17. Questionnaires by Telephone or Mail 113

18. External Institutional Review Boards - Evaluation and Use 113

19. Evaluating Significant Risk and Non-Significant Risk Device Studies 113

20. Guidelines for Department Residency Research Programs 113

21. Federal-Wide Assurance of Protection for Human Subjects 113

22. Study Closure 113

23. Translation of Foreign Language Documents for IRB Review 113

24. LBH Guidelines Governing Human Research Subject Follow-Up 113

25. Member Responsibilities and Reviewer Duties 113

Please refer to the LifeBridge Health Internet for the latest version of all available forms for your use. Forms are also available at the LifeBridge Health Office.

I.  INTRODUCTION

Federal regulations detailed in the Code of Federal Regulations (CFR) 21 CFR 56, 21 CFR 50, and 45 CFR 46, concerning protection of human subjects indicate the required review process to be followed by Institutional Review Boards ("IRBs") at all facilities conducting Federally funded research or research under the jurisdiction of the Food and Drug Administration. Maryland State House Bill 917 applies the requirements of 45 CFR 46 [and counterpart Food and Drug Administration (FDA) regulations] to all research conducted in Maryland regardless of funding source.

LifeBridge Health applies these regulations to (1) all research conducted at LifeBridge Health facilities by LifeBridge Health faculty or others and to (2) all research conducted by LifeBridge Health attending physicians, housestaff, LifeBridge Health employees, faculty, and students at all LifeBridge Health affiliated sites.

These policies and procedures are issued by LifeBridge Health IRB to explain its institutional charge, outline the process by which it operates in compliance with the regulations, and define the obligations of Principal Investigators and their staff who conduct human subjects research.

Suggestions on the content of the guidelines and the IRB process are encouraged and may be directed to the IRB office.

Institutional Review Board

LifeBridge Health

Sinai Hospital of Baltimore

2401 W. Belvedere Avenue

Schapiro Building, Suite 203

Baltimore, MD 21215

Jeanette Linder, MD, Chairman

Patty Lohinski, CIM, Research Coordinator

(410) 601-9021 Office

(410) 601-8282 Fax

Principal investigators are invited to consult the IRB office prior to submitting a protocol for review. This document was developed to explain the review process and what is required of investigators and research staff who submit applications to the IRB.

II.  STATEMENT OF AUTHORITY AND PURPOSE

  1. Governing Principles

Institutional Review Boards (IRBs) are guided by key ethical principles applied to all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, titled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"). These principles are defined in the Belmont Report as follows:

·  Beneficence -- The sum of the benefits to the subject and the importance of the knowledge to be gained from the research so outweigh the risks to the subjects as to warrant a decision to allow the subject to accept these risks and participate in the research.

·  Autonomy -- Legally effective informed consent is obtained, so that subjects may be fully informed of the potential risks of participation in the research and that participation is voluntary and free of coercion.

·  Justice -- The selection of subjects is equitable and is representative of the population that will benefit from the research.

B. Institutional Authority

The LifeBridge Health IRB (LBH IRB) is established and empowered under the auspices of the LifeBridge Health executive administration, and, for Federally Funded research, by the Institution’s Federal–Wide Assurance (FWA) with the Office for Human Research Protections (OHRP) of the Department of Health and Human Services (DHHS). The LBH IRB's Federal-Wide Assurance Number is FWA00003667 and is renewable every 3 years. Copies of this document (See “Federal-Wide Assurance of Protection for Human Subjects”) are filed with the DHHS and also available in the LBH IRB office and on the LBH Department of Research website.

Two LBH IRB committees have been established (IRB-A and IRB-B) which adhere to the same underlying principles and are responsible to the same authorities. This Institution requires that all research projects involving humans as subjects or human material be reviewed and approved by the LBH IRB prior to initiation of any research related activities, including recruitment and screening of potential subjects. The LBH IRB was established to review biomedical and behavioral research involving human subjects within LifeBridge Health regardless of the source of funding or sponsorship. All research conducted on or about human subjects, and all other activities that even in part involve such research, unless specifically exempted, are subject to these policies and procedures if one or more of the following apply:

·  The research is sponsored by institutional authorities of LifeBridge Health and/or;

·  The research is conducted by or under the direction of any member of the medical staff, employee, faculty, resident, fellow, student or agent of the LifeBridge Health in connection with his or her institutional responsibilities; and/or

·  The research is conducted by or under the direction of any member of the medical staff, employee, faculty, resident, fellow, student or agent of the LifeBridge Health using any property or facility of the Institution; and/or

·  The research involves the use of the Institution's nonpublic information to identify or contact human research subjects.

These policies and procedures apply to any research performed on the premises of Sinai Hospital of Baltimore, Carroll Hospital Center, Inc, Northwest Hospital Center, and Levindale Hebrew Geriatric Center and Hospital (hereinafter referred to as LifeBridge Health) and to any such activity performed elsewhere by LifeBridge Health medical staff, faculty, house staff, students, or employees under LifeBridge Health auspices. Part-time and volunteer members of the Medical Staff are subject to these rules and regulations with respect to any research conducted under the auspices of LifeBridge Health. Research is considered to be conducted under the auspices of LifeBridge Health when it is supported financially or by in kind services of LifeBridge Health, when the research will take place at LifeBridge Health, when the research will involve participation by LifeBridge Health students or employees, or when the use of a faculty appointment or LifeBridge Health affiliation is made in correspondence with research subjects, agreements with research sponsors, or descriptions of the research in other contexts. The responsibility for appointing members and maintaining the LBH IRB rests with the Senior Vice-President of LifeBridge Health, or his/her designee.

C. LBH IRB Authority

The LBH IRB will have the authority to determine whether or not any activity is covered by these policies and procedures and whether it requires review by the LBH IRB or may be exempted. The LBH IRB has the authority to ensure that research is designed and conducted in such a manner that protects the rights and welfare of participating subjects. Specifically:

·  The LBH IRB may approve, disapprove, or request modification to proposed studies based upon consideration of the potential risks and benefits, scientific merits and human subject protection concerns;

·  The LBH IRB reviews, and has the authority to approve, require modification in, or disapprove, all research activities that fall within its jurisdiction;

·  The LBH IRB has the authority to conduct continuing review as it deems necessary to protect the rights and welfare of research subjects, including requiring progress reports from the Investigators and auditing the conduct of the study (See Section XII B11. - Audit Policy) , observing the informed consent process and/or auditing the progress of any study under its jurisdiction as it deems necessary to protect the rights and welfare of human subjects;

·  The LBH IRB may suspend or terminate approval of a study; and

·  The LBH IRB may place restrictions on a study or investigator, when necessary.

For Federally funded research, if the study is part of an application to a Federal sponsoring agency, the human protocol must be reviewed by the LBH IRB before or when the application is processed and prior to expenditure of any grant funds. The LBH IRB also has a relationship to other institutional research review committees such as the LifeBridge Health Administrative Review Board (LBH ARB). The LBH IRB functions independently of, but in coordination with, those other committees. Research that has been reviewed and approved by the LBH IRB may be subject to review and disapproval by institutional officials or other committees. However, those officials or committees may not approve research if it has been disapproved by the LBH IRB.

D. Responsibilities of the LBH IRB

1.  LBH IRB Review of Research

All research involving human subjects (as defined below), and all other activities, which even in part involve such research, must be reviewed and approved by the LBH IRB. No intervention or interaction with human subjects in research, including recruitment of prospective subjects, may begin until the LBH IRB has reviewed and approved the research protocol. Specific determinations as to the definition of “research” or “human subjects,” and their implications for the jurisdiction of the LBH IRB under LifeBridge Health policy are determined by the LBH IRB (see below).