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VA Long Beach Healthcare System

Research and Development

______________________________________

Research and Development

Committee

Standard Operating Procedures

___________________________________Replaces version dated: 09/30/2015Review: Every 3 years by the R&D committee

__________________________________ __________________Timothy Morgan, MD, R&D Chair Date

R&D SOP VA Long Beach Healthcare System/Research and Development

TABLE OF CONTENTS

RESEARCH AND DEVELOPMENT COMMITTEE

PARAGRAPH PAGE

1. Purpose ...................................................................................................................................... 32. Background ................................................................................................................................ 33. Definitions .................................................................................................................................. 34. Scope ......................................................................................................................................... 45. Responsibilities of the Medical Center Director ......................................................................... 56. Responsibilities of the Chief of Staff (ACOS) and Administrative Officer (AO) for R&D ............ 57. Responsibilities of the ACOS for R&D........................................................................................ 68. Responsibilities of the Investigator ............................................................................................ 79. Responsibilities of the R&D Committee ..................................................................................... 710. R&D Committee Responsibilities for the Review of Research ................................................ 1011. R&D Committee Operations .................................................................................................... 1112. R&D Committee Records ........................................................................................................ 1213. R&D Committee Membership .................................................................................................. 1314. Subcommittees of the R&D Committee ................................................................................... 1515. Conflict of Interest .................................................................................................................... 2016. Review Procedures.................................................................................................................... 2117. Project Reviews ….................................................................................................................... 2418. Non-Compliance ….................................................................................................................. 3419. Investigations …....................................................................................................................... 34 20. Additional Reporting …............................................................................................................. 41 21. References .............................................................................................................................. 42 Appendix 1 ............................................................................................................................... 43 Appendix 2 ............................................................................................................................... 44

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RESEARCH AND DEVELOPMENT COMMITTEE

1. PURPOSE

A. This Standard Operating Procedure (SOP) is a local implementation of VHA handbook 1200.01 and establishes the responsibilities and operations of the Research and Development (R&D) Committee at VALBHS.

B. The major change in this revision allows the Research and Development (R&D) Committee to focus on oversight of the local research program rather than individual protocols. This is accomplished by permitting the R&D Committee to assign scientific review and some administrative responsibilities, including compliance issues, to more appropriate subcommittees and individuals. These changes enable the R&D Committee to prioritize their deliberations around broad areas of program development, risk management, and quality and performance activities.

2. BACKGROUND

The research mission of the VALBHS is to ensure that research is conducted according to the highest ethical standards with accountability to all involved stakeholders. Responsibility for oversight and maintaining high standards is assigned to the R&D Committee.

3. DEFINITIONS

A. VA Data or VA Information. VA data or VA information owned or in the possession of VA or any entity acting for, or on behalf of VA.

B. VA Research. VA research is research conducted by VA investigators (serving on compensated, work without compensation (WOC), or Intergovernmental Personnel Agreement (IPA) appointments) while on VA time, utilizing VA resources (e.g. equipment), or on VA property including space leased to, or used by VA. The research may be funded by VA, by other sponsors, or be unfunded.

C. VA Sensitive Information. VA sensitive information is all VA data on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information (VA Handbook 6500). The term includes information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, records about individuals requiring protection under various confidentiality provisions such as the Privacy Act and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, and information that can be withheld under the Freedom of Information Act (FOIA). Examples of VA sensitive information include:

1. Individually-identifiable medical, benefits, and personnel information; 2. Financial, budgetary, research, quality assurance, confidential commercial, critical

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Infrastructure, investigatory, and law enforcement information;

3. Information that is confidential and privileged in litigation, such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney- client privilege; and

4. Other information which, if released, could result in violation of law or harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of Federal programs.

5. Systemic Deficiency. A systemic deficiency is a fundamental, underlying problem that jeopardizes the effectiveness of the facility’s research protection system(s).

4. SCOPE

A. The Medical Center Director has established and authorized the R&D Committee to oversee research that is conducted under the authority of the VALBHS.

B. The R&D Committee is responsible, through the Chief of Staff (COS) to the Medical Center Director for:

1. Advising and assisting the Medical Center Director in providing oversight, planning, and execution of the local research Program; and

2. Assisting the Medical Center Director in maintaining high standards throughout the R&D Program. Those standards include ensuring the:

a. Scientific and ethical quality of VA research projects;b. Protection of human subjects in research;

c. Safety of personnel engaged in research;d. Welfare of laboratory animals;e. Security of VA data; and f. Security of VHA research laboratories.

C. The R&D Committee is assisted by the Associate Chief of Staff (ACOS) for R&D and the Administrative Officer (AO) for R&D in carrying out its duties.

D. Research in which the facility is to be engaged may not be undertaken without review and written approval of all appropriate subcommittees of the R&D Committee. The investigator must not initiate a research project until after being notified in writing by the ACOS for R&D that the project has been approved by all relevant committees, subcommittees, or other entities. The Institutional Review Board (IRB), Subcommittee on Research Safety (SRS), the Subcommittee on Animal Studies (SAS) at the VALBHS and other such entities must notify the R&D Committee of project approvals via a written communication signed by a voting committee member for the committee. The R&D Committee must notify the Associate Chief of Staff (ACOS) for R&D of project approvals via a written communication signed by a voting R&D Committee

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member for the committee. Notifications need not be in the form of minutes, nor is a separate document needed for each approved project. A single memorandum that lists by title, project number, or similar unique identifier all of the protocols receiving final approval at a given meeting is sufficient. Once R&D Committee approval has been given, the research becomes VA approved research.

5. RESPONSIBILITIES OF THE MEDICAL CENTER DIRECTOR

The Medical Center Director, acting in the capacity of the Institutional Official, is responsible for:

A. The facility’s research program, and is assisted by an R&D Committee. The Medical Center Director serves as the Institutional Official responsible for all aspects of the research program including but not limited to: human subjects’ protection, animal welfare care and use, privacy and security of VA data, and biosafety. NOTE: The term Medical Center Director includes Chief Executive Officer or equivalent titles.

B. Ensuring that research in which the facility is engaged is approved by the appropriate R&D Committee subcommittees.

C. Ensuring there are adequate resources and administrative support, including personnel, space, equipment, and training, for the R&D Committee and its subcommittees to fulfill their responsibilities.

D. Ensuring appropriate education and training for members of the R&D Committee, the research administration staff, and other staff involved in research.

E. Ensuring that investigators meet the requirements of Section 8 below.

F. Appointing the members of the R&D Committee following the specifications in Section 13 below.

6. RESPONSIBILITIES OF THE CHIEF OF STAFF AND ADMINISTRATIVE OFFICER FOR R&D

The research responsibilities of the ACOS and AO for R&D are defined in the following documents:

The Human Research Protection Plan Policy The Research Safety Plan The Research Security Plan The SOP for Reporting of Research Events to Institutional Officials and External Oversight

Offices.

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7. RESPONSIBILITIES OF THE ACOS FOR R&D

The ACOS for R&D is responsible for:

A. Notifying the investigator when a research project can be initiated. This notification occurs only after the research project has been approved by all applicable R&D Committee subcommittees, and after the R&D subcommittees’ notifications of approvals have been approved by the R&D Committee. The ACOS for R&D is responsible for notifying the investigator of approval after continuing review by the R&D Committee and subcommittees.

B. Functioning as Executive Secretary of the R&D Committee.

C. Conducting an annual quality assurance review of publications assessing the acknowledgement of VA support and affiliation.

D. Ensuring that information pertaining to all requests for WOC appointments for research have been appropriately justified and the appointments are in compliance with all applicable research, Human Resource Management, and other VA policies.

E. Providing an annual quality assurance review of research employees involved in human subject research to ensure the employees are working within their scopes of practice and their privileges allowed by the facility’s by-laws and granted to them by the facility.

F. Providing an annual quality assurance review of Cooperative Research and Development Agreements (CRADAs) and other agreements in support of the research program or specific research projects and an assessment of the impact of these agreements on the research program, when applicable.

G. Ensuring that all minutes of the R&D Committee and its subcommittees, including those from subcommittees at VA facilities or at the affiliate, are sent to the Medical Center Director and COS for review and appropriate action.

H. Ensuring that all projects have a Data Management and Access Plan (DMAP) prior to final approval by the R&D Committee. The ACOS delegates this responsibility to the R&D Coordinator. The R&D Coordinator will determine if the project’s DMAP involves the disclosure of individually identifiable information. If this is the case, then the R&D Coordinator will alert the Privacy Officer, and the Information Security Officer who must review the DMAP before it is accepted by the R&D Coordinator.

8. RESPONSIBILITIES OF THE INVESTIGATOR

The investigator is responsible for:

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A. Confirming with the applicable service chief that they have been awarded the appropriate credentials and privileges to conduct research at VA prior to initiating any research.

B. Complying with all applicable personnel and other VA requirements whether the investigator is compensated, WOC, or IPA.

C. Obtaining the complete approval of all appropriate non-research entities and R&D Committee subcommittees, and written notification from the ACOS for R&D prior to initiating a research project.

D. Developing a research plan that is scientifically valid; minimizes risk to human subjects, animals used in research, and personnel; and contains a sufficient description of the research including all procedures and the plan for statistical analysis, to allow the R&D Committee subcommittees to fully review the research project.

E. Developing and implementing plans for data use, storage, and security that are consistent with VA Directive 6500, Information Security Program, and its implementing Handbooks and other legal requirements.

F. Preparing and submitting information, at least annually or as required, on their research program(s) and on each project to the appropriate R&D Committee subcommittee for continuing review as required by the respective R&D Committee subcommittees.

G. Ensuring that all research proposals submitted for funding, from any source, support the mission of VHA and enhance the quality of health care delivery to Veterans.

H. Ensuring that all research records are retained by the VA.

I. Uploading notifications about upcoming publications, presentations, media interviews and other professional activities to PubTracker. The website URL is https://vaww.ord.portal.va.gov/sites/comm/PubTracker/Pages/default.aspx.

9. RESPONSIBILITIES OF THE R&D COMMITTEE

A. The R&D Committee assists the Medical Center Director in fulfilling responsibilities for the facility’s research program. The R&D Committee is responsible for ensuring the effective operation of the research program through oversight of the R&D Committee’s subcommittees and making appropriate recommendations, including space and resource needs, to the Medical Center Director based on the Committee’s oversight and evaluation of the research program.

B. The R&D Committee must accomplish its responsibilities through the following activities or procedures:

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1. Planning and developing broad objectives for the research program so that it supports VA’s mission; Research goals will be formulated that are:

based upon the needs of the VALBHS Veteran population the mission of the VA to serve the Veteran population. In establishing goals, the

R&D Committee will give special consideration to: the type of research that is being performed. the benefits of the research to the patient population. the resources that are available to perform the research.

2. Determining the extent to which the research program has met its objectives; The R&D Committee will select metrics to measure the degree to which goals are met. These metrics will be reviewed and revised annually as needed. If the goals are not satisfactorily being addressed then the R&D committee will devise remedial actions and will develop a timeline for review of the remediation process. Progress will be tracked in the R&D Committee meeting minutes.

3. Overseeing all research activities for each VA facility for which it serves as the R&D Committee of record; and

4. Reviewing all written agreements that establish the R&D Committee or one of its subcommittees, as a committee or subcommittee of another VA facility.

5. Reviewing and evaluating all R&D subcommittees both within the VA facility and at external entities that function in lieu of R&D subcommittees, such as affiliate Institutional Review Boards (IRBs), Subcommittee on Animal Studies (SAS), or biosafety committees. . Chairs of each standing subcommittee will submit a written summary of the subcommittee annual review to the R&D committee by July 1 of each year. Written summaries will cover the period since the previous review and will address:

An Executive Brief and description of the committee charge or function. A Review of the status of the Committee SOP. A review of meeting frequency relative to the SOP requirements. A summary of Substantive Actions. A review of Committee Membership. A review of the Adequacy of Resources. A summary of findings from reviews of ORO Checklists (if appropriate). A review of Non-compliance.

6. Reviewing and acting on all requests for expenditures from Research General Post Funds.

7. Ensuring that staff are working within their Scopes of Practice through an annual review.

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8. Principle Investigators with research protocols that involve educational objectives for students, interns, residents or fellows will submit a summary of the accomplishments of educational activities to the R&D Committee annually by July 1 of each year.

9. The Chair of the R&D Committee will submit a written summary report annually to the Medical Center Director that will include:

A review of R&D goals (items 1 and 2 above). A review of Written Agreements. A review of the Reports from Standing Subcommittees (item 5 above). A review of the HRPP Annual Report A review of the Annual Budget. A review of the status of Training & Credentialing. A review of Publications. A copy of the completed Annual Director Certification.

The summary report will be submitted to the Medical Center Director at the time of the submission of the Annual Director Certification to ORO.

C. Review of the utilization of resources.

The R&D Committee does not review resource utilization for individual projects. Principal Investigators submit requests for resource utilization on the Impact Estimation Worksheets. The worksheets are reviewed and approved by the services that will be impacted by the proposed work. The Impact Estimation worksheets are also reviewed by the Executive Director of SCIRE in consultation with the Diagnostic and Molecular Medicine Administrative Officer. The review includes a determination of financial impacts on clinical services. The Executive Director of SCIRE will convene an ad hoc subcommittee if there are concerns that involve a distinction between experimental procedures and standard of care.

The R&D Committee will be notified of approvals through the signed Impact Estimation Worksheet. The R&D Coordinator will track approvals for the R&D Committee.

D. In fulfilling its responsibilities of ensuring the effective oversight of the research program and making appropriate recommendations to the Medical Center Director, including the suspension of a research study or remedial or restrictive action regarding a principal investigator, the R&D Committee needs to rely on a variety of information sources including:

1. Quality assurance activities, reports to the committee by the ACOS for R&D, AO for R&D, or other research staff members, subcommittee reports, facility reports or activities, and other appropriate sources.

2. Review of subcommittee activities including:

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Annual reviews of the Research Safety and Security Program (including planned training, compliance, security issues, etc.) Research Safety and Security reviews are performed by the Research Security Subcommittee (see section 14(5) below);

The Animal Care and Use Program (including inspection reports, SAS composition, SAS arrangements, budgets, space, support staff, training, quality improvement activities, compliance issues, and goals for the next year); and

The Human Research Protection Program (including IRB composition or IRB arrangements, credentialing and training status report, budget, space, support staff, quality improvement activities, compliance issues, and goals for the next year).

E. The R&D Committee is responsible for fulfilling such other functions as may be specified by the Medical Center Director and VHA procedures. These functions may include review and approval of individual research projects. NOTE: The R&D Committee may not approve human subjects' research if it has not been approved by an IRB (see Title 38 Code of Federal Regulations section 16.112).

10. R&D COMMITTEE RESPONSIBILITIES FOR THE REVIEW OF RESEARCH

A. The R&D Committee is responsible for establishing policy to ensure that all research in which the facility is to be engaged has been reviewed and approved for the ethical use of human subjects, animals, and biohazards. This review must promote:

1. Maintenance of high standards of protocol review, and relevance to the mission of VA;

2. Protection of human subjects (including privacy and confidentiality), and the implementation of adequate safety measures for research subjects and personnel;

3. Welfare and appropriate use of animals in research;

4. Safety of personnel engaged in research;

5. Security of research laboratories where hazardous agents are stored or utilized and of all Biosafety Level 3 (BSL-3) research laboratories; and

6. Security of VA data and VA sensitive information.

B. If a research protocol requires review by a facility’s non-research entities, such as the Radiation Safety Committee, this review may be conducted at any time, but the research may not be initiated until: the non-research entity has approved the project, and the project has been approved by all applicable R&D Committee subcommittees, and the investigator has been notified in writing by the research office.

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C. For protocols not meeting criteria for assignment to any subcommittee, the R&D Committee is the review and approving committee of record. R&D Committee Review procedures are described in section 17(d) below.

Concurrence of the R&D Committee or subcommittee under a just in time review process does not represent approval to conduct the research. The investigator must submit the protocol to all applicable R&D Committee subcommittees and any other relevant committees or entities, and have written approval before initiating the research.

Research Conducted by Employees of VA Program Offices. No employees of VA Program Offices currently conduct research at VALBHS. Should such an employee submit a project for approval then the R&D committee will assure that the project fulfills the requirements of VHA Handbook 1058.06 and that it has been approved by a Program Office Supervisor.

11. R&D COMMITTEE OPERATIONS

A. The R&D Committee must meet at least monthly, except for one month during the year, if it appears that a quorum (i.e. a majority of voting members) cannot be obtained. VHA recommends, but does not require, that R&D Committee members be physically present at the meeting. If physical presence is not possible, a member may be considered present if participating through teleconferencing or videoconferencing. In that case, the member must have received all pertinent material prior to the meeting and must be able to participate actively and equally in all discussions.

B. The R&D Committee can hold unscheduled meetings in response to emergent issues under the following rules.

1. There must be a quorum present in person or by teleconference or video conference for any unscheduled meetings.

2. A quorum must be present to conduct business and must be present for each vote.

C. Minutes for each meeting must be recorded. The minutes need to include the following information:

1. A list of all voting members and non-voting members, including ex officio members, indicating the category of their membership and whether they are present or absent. If an alternate is present in place of a voting member, the minutes need to indicate this fact and name who the alternate member is replacing.

2. The presence of a quorum.

3. Actions taken by the Committee, to include: The type of action.

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The vote on the action, including the number voting for, against, and abstaining. In addition, any recused member from the vote must be named, and whether the person was present during the discussion. NOTE: If the member is recused, the member must not be present for the vote, and may not be counted toward the quorum.

All minutes of the R&D Committee and its subcommittees, including those from “in lieu of” subcommittees at VA facilities or at the affiliate, must be sent to the Medical Center Director through the ACOS for R&D and COS for review and appropriate action.

Standard operating procedures or other written procedures must be maintained for all recurring processes. These processes include, but are not limited to, communication with the Medical Center Director, the COS, investigators, and committees or subcommittees.

Review of R&D Committee subcommittee operations must be conducted as an ongoing function of the R&D Committee. The review must be conducted at least annually and must be accomplished in part by: reviewing the minutes of each subcommittee that reviews VA research protocols (whether those of the VA or non-VA institutions when allowed); by close communication with the subcommittees; and through Quality Assurance and Quality Improvement activities.

12. R&D COMMITTEE RECORDS

A. The adequate documentation of all of the activities of the R&D Committee must be maintained, including, but not limited to, the following:

1. Minutes of the R&D Committee and R&D Committee subcommittees.

2. Copies of all written correspondence.

3. Membership lists for the R&D Committee and all R&D Committee subcommittees.

Written records documenting actions taken to carry out the committees’ responsibilities for review of research as listed in section 10, and for oversight of the research program as listed in paragraph 9, if not recorded adequately in the R&D Committee minutes. NOTE: Records are the property of VA and the policy for record retention is outlined in VHA Records Control Schedule (RCS) 10-1. Record retention may be longer depending upon other policies and regulations such as Food and Drug Administration (FDA) regulations or medical record retention policies.

13. R&D COMMMITTEE MEMBERSHIP

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A. Appointment of Members. The members of the R&D Committee are appointed by the Medical Center Director and must reflect the types and amount of research being conducted at the facility. Nominations for membership may be from current R&D Committee members, subcommittee members, and the facility’s staff.

B. Number of Members. The R&D Committee must consist of at least five voting members.

1. Whenever possible for the review of Basic Science studies, one member of the Committee needs to have expertise in biostatistics and research design.

2. If the facility has any Centers, such as Centers of Excellence, (e.g., Health Services Research and Development (HSR&D), Rehabilitation Research and Development (RR&D), or Cooperative Studies Program (CSP) Centers), it is recommended, but not required, that at least one voting member of the R&D Committee be chosen from the Center.

3. The members need to have diverse backgrounds with consideration as to race, gender, ethnicity, and expertise.

C. Voting Members

1. Voting members of the R&D Committee must include:

At least two members from the VA facility’s staff who have major patient care or management responsibilities.

At least two members who are VA investigators actively engaged in major R&D programs or who can provide R&D expertise.

In facilities affiliated with academic institutions, at least one member who holds an academic appointment, and is either a full-time Federal employee or a part-time permanent Federal employee.

2. All voting members must be compensated full-time or permanent part-time Federal employees. The Budget Analyst will maintain a list of the current R&D Committee membership and will notify the R&D Coordinator if any of the members are no longer VA employees.

3. A voting member may fill more than one criterion for required membership, for example, the member may have both major patient care or management responsibilities and be actively engaged in major R&D programs.

4. Alternate members must be appointed by the facility Director. The roster must identify the primary member(s) for whom each alternate member may substitute. The alternate

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member’s qualifications must be comparable to those of the primary member to be replaced. The alternate member can only vote in the absence of the primary member.

5. All members of the R&D Committee must fulfill the educational requirements specified by VHA’s ORD and other applicable requirements found on ORD’s Website at: http://www.research.va.gov/programs/PRIDE/.

6. The R&D Committee may require attendance by R&D subcommittee members, but subcommittee members who are not also members of the R&D committee must recuse themselves (i.e., leave the room or hang up from a conference call) before an R&D Committee vote is taken.

D. Ex officio Members

1. Ex officio (voting) members include the Research Pharmacist and representatives of each of the standing subcommittees (see section 14 below). The subcommittee representatives will be the chairs of the respective subcommittees unless an alternative representative has been approved by the R&D Committee.

2. Ex officio (non-voting) members include the Medical Center Director, the COS, the ACOS for R&D, the AO for R&D, the Information Security Officer, the Privacy Officer, and the Executive Director of the Southern California Institute for Research and Education (SCIRE). The ACOS for R&D functions as Executive Secretary of the R&D Committee.

E. Terms of Members

1. Voting members are appointed by the Medical Center Director in writing and serve terms of 3 years with a possibility for extension. Members may be reappointed without any lapse in time if it is deemed in the Committee’s best interest.

2. The terms of members must be staggered to provide partial change in membership annually.

F. Election of Chairperson. Committee members, exclusive of ex officio members, must elect a Chairperson for a period not to exceed 2 years.

1. The Chairperson must be approved and officially appointed, in writing, by the Medical Center Director for a period not to exceed 2 years.

2. The Chairperson may be reappointed without any lapse in time.

3. The Chairperson must not simultaneously chair a subcommittee of the R&D Committee.

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G. Appointment Letters. Appointment letters must specify: The term of the appointment. Whether the basis is regular, ex officio, or alternate. The voting status of the appointment.

H. Consultants

1. Due to his knowledge of VA regulations, and experience gained through the audit process, the Research Compliance Officer, is a permanent guest and consultant to the R&D Committee.

2. Others may be invited to assist the R&D Committee because of their competence in special areas in the review of issues requiring expertise beyond, or in addition to, that available on the Committee. These individuals may not contribute to a quorum or deliberate or vote with the Committee.

14. SUBCOMMITTEES OF THE R&D COMMITTEE

A. The R&D Committee may establish any subcommittee(s) deemed necessary for the efficient and effective management and oversight of the R&D Program.

1 At a minimum, subcommittees must be appointed to oversee R&D activities related to human studies, animal studies, and biosafety including biosecurity.

2. Findings and recommendations of the subcommittees are recorded and reported to the R&D Committee.

3. The R&D Committee must approve final subcommittee minutes.

4. Continuing review requires approval by relevant non-research committees and R&D Committee subcommittees, and ACOS for R&D notification of the investigator that the approvals have been obtained.

5. The R&D Committee does not perform a continuing review (except exempted studies and for those studies not reviewed by the IRB or the SAS).

B. At VALBHS, the R&D Committee has established the following standing subcommittees:

1. Institutional Review Board (IRB) The IRB is also called the Subcommittee on Human Studies. The IRB has oversight over the conduct of research that involves the use of human

subjects. The R&D Committee will review, evaluate and provide feedback to the individuals

serving the HRPP (including the IRB Chair, Alternate Chair, IRB Members and

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HRPP staff) through the HRPP report and through the HRPP self-evaluation form annually.

The IRB also functions as the Privacy Board and in this role has oversight over projects that involve the use of personal identifiers from deceased persons.

The authorities, responsibilities, and procedures of the IRB are described in the IRB SOPP.

As part of its oversight responsibilities, the R&D Committee must have access to all IRB records and must review all minutes of the IRB(s) reviewing protocols at VALBHS.

Institutional Animal Care and Use Committee (IACUC). The IACUC is also called the Subcommittee on Animal Studies (SAS). The SAS has oversight over the conduct of research that involves the use of animals. The authorities, responsibilities, and procedures of the SAS are described in the SAS

SOP.

The R&D Committee is responsible for:

Ensuring adequate caretaker staffing and proper support of animal research projects at the facility. Once the annual proposed Veterinary Medical Unit (VMU) budget is prepared by research administrators with input from the VMO, the proposed budget should be submitted to the SAS for comments, and then submitted to the R&D Committee for review and final approval.

Initiating and/or reviewing requests for equipment used in the animal research facility and plans for animal research facility construction and renovation.

As part of its oversight responsibilities, the R&D Committee must have access to all SAS records and must review all minutes of SAS reviews of protocols at VALBHS.

2. Subcommittee on Research Safety (SRS)The SRS is charged by the R&D Committee with the responsibility to maintain a Research Safety Program that is consistent with VA policies, Federal laws and regulations from Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), the Nuclear Regulatory Commission (NRC), etc., and any applicable State and local requirements. All applicable National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) guidelines must be followed.

• The authorities, responsibilities, and procedures of the SRS are described in the SRS SOP.


• Establishment and continuing review of a safety program that describes standards

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and procedures for the conduct of research at VALBHS. The safety program is described in the Safety Plan.• Acting upon SRS recommendations for approval or non-approval of reviewed proposals submitted to ORD for funding consideration.• Reviewing and acting upon SRS minutes.• Appointing a Research Safety Coordinator who is responsible for supervising and

operating the Research Safety Program. Specific responsibilities for this position are described in the Safety Plan.

• Ensuring the development and implementation of the laboratory Chemical Hygiene Plan. The Chemical Hygiene Plan is a part of the Safety Plan.

• Appointing a Chemical Hygiene Officer to provide technical guidance on the implementation of the Plan. The Chemical Hygiene Officer is a standing member of the SRS. The roles and responsibilities of the Chemical Hygiene Officer are described in the Safety Plan.

• Ensuring that the Research Office provides support to the SRS to assist in their functions.• Ensuring that the minutes of SRS meetings are documented correctly, and maintained by the Research Office.• Providing the ACOS for R&D, facility, or Veterans Integrated Service Network (VISN) safety officials with adequate information to evaluate the performance of the R&D safety program.• Ensuring coordination with other regulatory programs or committees such as the Radiation Safety Officer or Radiation Safety Committee.• Reviewing accident and injury trends reported by SRS. Recommending and ensuring the implementation of corrective action.• Reviewing all citations issued by regulatory agencies and ensuring that appropriate committee members and PIs take prompt corrective actions, and coordinating the necessary responses to regulatory agencies.

3. The Institutional Biosafety Committee (IBC) The IBC has oversight over research that involves the use of recombinant DNA.

• The authorities, responsibilities, and procedures of the IBC are described in the IBC SOP.


• Ensuring that the research is conducted in full conformity with the provisions of the NIH Guidelines. In order to fulfill this responsibility, the R&D Committer shall:

• Ensure that the IBC is registered with the NIH.• Establish and implement policies that provide for the safe conduct of recombinant

DNA research and that ensure compliance with the NIH Guidelines. R&D Policies for the safe conduct of recombinant DNA research are described in the IBC SOP.

• As part of its general responsibilities for implementing the NIH Guidelines, the institution may establish additional procedures, as deemed necessary, to govern

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the institution and its components in the discharge of its responsibilities under the NIH Guidelines. Such procedures may include:

(i) statements formulated by the institution for the general implementation of the NIH Guidelines, and(ii) any additional precautionary steps the institution deems appropriate.

• Appointing a Biological Safety Officer, if research is conducted at the facility involving:

• The use of recombinant DNA at BSL 3 or 4, or• Large scale (greater than 10 liters of culture) research or production activities

involving viable organisms containing recombinant DNA molecules. • The roles and responsibilities of the Biological Safety Officer are described in

the Safety Plan.

• Appointing at least one individual with expertise in animal containment principles (who is a member of the Institutional Biosafety Committee.) The composition of the IBC is described in the IBC SOP.

• Ensuring that when the institution participates in or sponsors recombinant DNA research involving human subjects: (i) the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants as deemed necessary).

• Ensuring appropriate training for the Institutional Biosafety Committee Chair and members, Biological Safety Officer and other containment experts (when applicable), Principal Investigators, and laboratory staff regarding laboratory safety and implementation of the NIH Guidelines.

4. The Research Security Subcommittee (RSSC)

• The RSSC is charged by the R&D Committee with the responsibility to maintain the security of the research program in a manner that is consistent with VA policies, Federal statutes and regulations from Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), the Nuclear Regulatory Commission (NRC), etc., and any applicable State and local Requirements. In particular the RSSC will Control access to VA research laboratory areas housing select agents, toxins, other hazardous agents and to BSL-3 research laboratories.

• The authorities, responsibilities, and procedures of the RSSC are described in the RSSC SOP.


• Assisting the Medical Center Director in carrying out the responsibilities of the Responsible Official (RO).

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• Establishing and the continuing review of a security program that describes standards and procedures for maintaining the security of research at VALBHS.

• The security program is described in the Security Plan.

• The R&D Committee must oversee the functions of the RSSC through review of minutes, reports, and/or other appropriate mechanisms.

• The R&D Committee may add to the RSSC requirements to obtain approval or may disapprove an action approved by the RSSC. It may not approve an action that the RSSC has disapproved.

• Either the R&D Committee or the RSSC may, at its discretion, invite individuals with competence in special areas to assist it in fulfilling its responsibilities related to a Hazardous Agents Control Program as defined in this Security Plan.

• Actions taken, based on the responsibilities of the R&D Committee and RSSC (e.g., reviews, approvals, disapprovals) must be formally documented in minutes or by other means.

5. Space Subcommittee on Research Space (SSRS).

• The SSR develops policies for the equitable distribution of space for research purposes.

• The SSR conducts an annual review of research space utilization.

• The authorities, responsibilities, and procedures of the SSR are described in the SSR SOP.

C. Each subcommittee must maintain adequate records, and retain such records according to VHA Directive 6300. These records must include the following:

1. Copies of all research proposals and their amendments reviewed by the R&D Committee subcommittees and any accompanying materials;

2. All continuing or final reports; 3. Minutes of its meetings; 4. Copies of all written correspondence; 5. A membership list of all voting, non-voting, and ex-officio members including their

appointed roles;6. Written records documenting actions taken to carry out the subcommittee’s

responsibilities; 7. Standard Operating Procedures (SOPs); and

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8. All communications to and from investigators, other committees, subcommittees, and other entities or individuals. At VALBHS these communications are maintained by the Research Office in the project files.

D. Each subcommittee must make available to the R&D Committee a complete, unredacted, final set of minutes.

NOTE: Research records may be electronic or paper. When original signatures are required on documents, either a paper copy of the signature sheet must be maintained or an electronic signature may be used. If an electronic signature is used, it must meet all of the requirements of VA, the Department of Health and Human Services (HHS), Office of Human Research Protection, the Food and Drug Administration (FDA), and any other relevant requirements.

15. CONFLICT OF INTEREST

The mission of ORD is to discover knowledge, develop VA researchers and health care leaders, and create innovations that advance health care for the Nation and its Veterans. In order to fulfill this mission, VHA must preserve public trust in the integrity and quality of research carried out by its investigators and in its facilities. One way to maintain public trust and safeguard the integrity and quality of VA research is to ensure that VA investigators and members of R&D Committees avoid actual or perceived financial conflicts of interest in the research they conduct or review.

A. VA investigators and R&D Committee members must comply with the Standards of Ethical Conduct for Executive Branch Employees and the Federal criminal code. The obligation to follow applicable ethics laws and regulations also applies to WOC employees and IPAs conducting VA research or participating on a R&D Committee. R&D Committee members and VA investigators must comply with VA requirements on financial conflicts of interest in research. Failure to follow these ethics laws and regulations can have serious consequences. If criminal ethics statutes are violated, civil fines and imprisonment can result. Severe administrative disciplinary action can result from violating ethics regulations, including suspension from employment, termination of employment, and other administrative punishment.

B. R&D Committee members with outside consulting, employment, or royalty payment opportunities must ensure that these activities do not present any actual or perceived financial conflict of interest, and must recuse themselves from the review of proposals for which any conflict of interest may exist. Such members may not be present during the deliberations or the vote on such research proposals.

C. At VALBHS, the R&D Committee has established policies and procedures for the review and management of Conflicts of Interest. These are described in the SOP for Managing Conflicts of Interest. Principal Investigators submit a Disclosure of Relationships and Financial Interests Form. The R&D Coordinator will review the form and determine if there

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is a possible conflict of interest. If there is a possible conflict of interest then the R&D Coordinator will submit the disclosure for to the R&D Committee. The R&D Committee will review the conflict of interest as described in the SOP for Managing Conflicts of Interest.

NOTE: To obtain assistance in any matter concerning government ethics, individual researchers and R&D Committee members should contact the local Regional Counsel.

16. REVIEW PROCEDURES.

A. Eligibility to Conduct Research. Performing research at VALBHS is a privilege and is not a right of employment. The R&D committee will only approve persons to supervise research who:

1. Are qualified by virtue of their education and training and,

2. Have adequately discharged their non-research duties and,

3. Have demonstrated a willingness to comply with standards and regulations whether by affirmation (new investigators) or by record (experienced investigators).

B. Determining Eligibility. The R&D Committee will determine if applicants are eligible to supervise the conduct of research at VALBHS. Persons who are deemed eligible may become Principal Investigators (PI’s).1. Who must be reviewed. Eligibility will be evaluated for all potential PI’s who:

Have never had a previously approved research project at VALBHS, OR Have had a previously approved research project at VALBHS but who currently do

not have an approved project. This category includes investigators who have failed to submit closure documents within 90 days of a lapse of approval.

2. Criteria For Determination. In determining eligibility the R&D committee will consider:

If the applicant has adequate training and credentials to perform research. The R&D Committee will review evidence that will include primary source verification of degrees, certifications, licenses, academic appointments or other experience. At a minimum, PI’s must have an M.D., D.O., Ph.D., (or equivalent) or an R.N. license, or Pharm.D. degree. PI’s must generally also have postgraduate training or experience in the area that is to be the focus of the research. The R&D Committee may waive the degree requirement if:

Applicant has demonstrated unusual competence and Applicant has adequate experience to function as a Principal Investigator. Applicants should generally have a paid position at VALBHS. Students, Fellows,

Interns and other trainees are not eligible to be PI’s. Persons who are without compensation at VALBHS (WOC’s) must have their eligibility approved by the R&D Committee using the following criteria:

o The proposed research must involve significant benefits to the patients that would not otherwise be available, and

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o The proposed research will not compete with research that is being performed by paid investigators at the VALBHS.

3. Students and other Trainee Research: Trainees (e.g., students, residents, or fellows of any profession) may serve as participants, but not PIs within a VA facility, use VA human subjects data, or use human biological specimens that have been collected within VA for clinical, administrative, or research purposes only when:

o The study has been approved by the local VA medical facility and IRB, if appropriate; and either they are: (a) enrolled in an institution with an educational affiliation agreement with that VA facility; or (b) directly appointed to a VA training program that has no external institutional sponsorship (e.g. VA Advanced Fellowship). NOTE: A waiver may be obtained from the CRADO under special circumstances.

A VA investigator sufficiently experienced in the area of the trainee’s research interest must serve as PI and is responsible for oversight of the research and the trainee/student. The PI is responsible for ensuring the trainee/student complies with all applicable local, VA and other federal requirements including those related to research, information security, and privacy.

If the trainee does not complete all aspects of the research prior to leaving VA, the VA investigator must ensure the protocol is completed or terminated in an orderly fashion, and in accordance with all applicable local, VA, and other federal requirements.

When the trainee leaves VA, the VA investigator is responsible for ensuring that all research records are retained by VA.

C. Applicants must have a physical presence at VALBHS that is adequate to supervise research personnel, the conduct of research, and the retention of research records unless the medical program is not available at the VA Long Beach Healthcare System and the proposed research activity would not negatively impact VALBHS research activities.

D. Applicants must adequately demonstrate that they are able to discharge non-research duties in an adequate manner. Persons who have failed to adequately discharge primary duties are not eligible to conduct the extra duties associated with research. The R&D Committee will consult with the Chief of the applicant’s home healthcare group in making this determination.

E. Applicants must affirm that they will be compliant with all procedures and regulations. If the applicant has a previous research history, then the R&D committee will consider any previous history of non-compliance. This may include, but is not limited to:

• Previous suspensions or terminations of approved research.

• Failure to maintain adequate records.

• Failure to perform adequate supervision and/or training of staff.

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• Failure to submit documentation in a timely manner.

Aggressive or hostile actions against staff, or others. These may include oral or physical threats, derogatory remarks, the taking of unauthorized photographs, following persons, surveillance (including the gathering of information about persons). Also included are the filing of excessive numbers of complaints and /or accusations where:

• The outcome of such complaints and/or accusations is a failure to confirm, and

• A reasonable person may consider the number to be excessive, and

• A reasonable person might infer that the applicant might be trying to exert a pressure on the target of the complaint / accusation in order to influence an outcome, or

• The target of the complaint / accusation has VA duties that involve either a recent or pending evaluation of the applicant’s performance.

(3) Determination and Notification. Determinations of eligibility to supervise research may only be made by a convened meeting of the R&D Committee. The Committee will consider the preponderance of evidence and will vote to determine if the applicant is eligible. If the applicant is deemed ineligible, then the Chair of the R&D Committee and the ACOS R&D will notify the applicant in writing within 30 days. The notification will include the general reason(s) for the disapproval. The reasons should be adequately described so as to convey the basis for the decision. However, it should be noted that the decision is made on the basis of the overall evidence and not necessarily on the basis of specific criterion. The letter should also advise the applicant of his right to appeal the decision.

(4) Appeal. The applicant may submit a rebuttal and request for reconsideration to the R&D Committee. Such requests must be submitted in writing to the Chair of the R&D Committee within one month of the date of the disapproval letter. The R&D Committee will review the request within 2 months of receipt by the R&D Chair. It should be noted that disapproval is not a disciplinary action and that the applicant is not entitled to legal representation but may petition to address the R&D committee personally. The R&D committee has the sole authority to grant the privilege of supervising research. “Appeal” is used here in the common rather than the legal meaning of the word. There are no appeals to a higher authority and the R&D decision is final. The applicant may resubmit an application to restore PI status an unlimited number of times. However, the R&D Committee will only consider one application per year.

17. PROJECT REVIEWS.Project reviews are performed by the subcommittees of the R&D Committee. The R&D Committee does not conduct reviews of individual projects that involve animals or human subjects. For the purposes of this SOP, projects that do not involve the use of animals or human subjects are referred to as “Basic Research”.

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Central IRB.

The R&D Committee will ensure that projects approved by the Central IRB are reviewed by the SRS and that all stipulations have been completed. The R&D Coordinator will inform the HRPP Administrator when CSP projects that involve drugs are approved by the R&D Committee so that these can be entered into the drug project list.

Basic Research.

At VALBHS the R&D committee also serves as the subcommittee that reviews projects that only involve Basic Research. In this role the R&D Committee conducts initial and continuing reviews of Basic Research projects. Review procedures differ depending upon whether or not they involve participation by human subjects.

The R&D Committee and its subcommittees will not review initial research applications from any Principal Investigator who has a lapsed project.

• Lapsed Projects.

Any Principal Investigator with lapsed approval is not permitted to submit documents (including modifications and new projects) to the Research Office until the outstanding lapse in approval has been resolved (proper project closure or continuing review documentation submitted and approved). Closure documents must be submitted for any project with approval lapse beyond three months and the project must be re-submitted as a new project if the investigator wishes to conduct the study. If the Principal Investigator does not have any approved studies as a result of a project closure, the R&D Committee will reassess the PI’s qualifications as a new PI as described in section 16(a) above.

• Basic and Animal Research. The following describes the sequence of events for review of basic and animal research proposals.

• Principal Investigators (PI’s) prepare an application package.

• PI’s submit the application package to the R&D Coordinator. The R&D Committee Coordinator is also the SAS Coordinator.

• The R&D Committee Coordinator checks the application package for completeness. The Coordinator also verifies:

• That the R&D Committee has determined that the PI is qualified to perform research.

• That all of the required training requirements have been met.

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• That the VMO review has been completed if the project involves the use of animals.

• That the documents bear all of the required signatures and dates.

• The R&D Committee Coordinator communicates with the PI until all of the required criteria are complete.

• The R&D Committee Coordinator determines if the project requires review by the SAS or R&D Committee. SAS review is required if the project involves the use of animals. R&D Committee review is required for projects that involve Basic Research.

• The R&D Committee Coordinator acts with the committee chairs to select pre-reviewers. Completed application packages are provided to the pre-reviewers for the SRS and either the SAS or R&D Committee (as noted above).

• The R&D committee Coordinator also provides copies of the application package to the committee members.

• The appropriate committees (SRS and either SAS or the R&D Committee) perform project reviews as described in the relevant subcommittee SOP’s. R&D review procedures are described in section 17 (d) below.

• The SRS determines if the project involves the use of non-exempt recombinant DNA. If the project involves the use of such material then the review is passed to the Institutional Biosafety Committee (IBC). IBC review procedures are described in the IBC SOP.

• When committee approval has been granted then the R&D Committee Coordinator prepares a list of approved studies and forwards this list to the R&D Committee as notification. The R&D Chair can approve the list on behalf of the R&D Committee. If accepted in this way, the list will be put on the consent agenda for full committee information.

• When all of the required subcommittee approvals have been collected then the R&D Coordinator will notify the ACOS R&D.

• The ACOS R&D will notify the PI that the project has been approved.

• Scope of Practice. The R&D Committee will not give final initial or continuing approval to any project unless there is a Scope of Practice on file for the Principal Investigator and all study staff.

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• Human Research. The following describes the sequence of events for review of research proposals involving human subjects.

• PI’s prepare an application package.

• PI’s submit the application package to the IRB Assistant.

• The IRB Assistant performs the following functions:• Forwards the names of study staff to the AO R&D. The AO R&D determines if

the training and credentials of the PI and study staff are up to date and that the R&D Committee has determined that the PI is qualified to perform research.

• forwards copies of the application package to:• The Information Security Officer (ISO). ISO review procedures are

described in section 17(e) below.

• The Privacy Officer (PO) PO review procedures are described in section 17(e) below.

• The R&D Committee Coordinator. The R&D Coordinator checks the application package for completeness and forwards the package to the SRS for review. SRS review procedures are described in the SRS SOP.

• The AO R&D, the Pre-reviewer, the ISO, and the PO submit stipulations or approvals to the IRB Assistant.

• IRB Assistant communicates with the PI until all stipulations have been met.

• When all stipulations have been met then the IRB Assistant provides the application package to the HRPP Administrator (HRPPA).

• The HRPPA provides the application package to the IRB.

• The IRB performs a review using the procedures described in the IRB SOP.

• When the IRB has given approval, then the IRB Assistant prepares a list of approved studies and submits the list to the R&D Committee Coordinator for notification of the R&D Committee. The R&D Chair can approve the list on behalf of the R&D Committee. If accepted in this way, the list will be put on the consent agenda for full committee information.

• The R&D Committee Coordinator verifies that all required approvals have been given including approvals by the SRS and IBC if appropriate.

• When all approvals have been met then the R&D Coordinator notifies the ACOS Research.

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• The ACOS Research notifies the PI that the project has been approved.

• The R&D Committee Coordinator notifies the HRPPA that approved Consent forms may be released (if appropriate).

• Basic Research.

(1) The R&D Committee is responsible for reviewing basic research for scientific quality and appropriateness in which the facility is to be engaged.

(2) The R&D Committee review will promote the:

• Maintenance of high scientific standards by critically evaluating the quality, design, desirability, and feasibility of each new and continuing research and development proposal. The R&D Committee may disapprove any study if suitable space/resources are not available to adequately support the proposal.

(3) At least annually, the R&D Committee will evaluate the following for all Basic Research Projects:• Availability of adequate resources (financial and other) to conduct and complete the

research. This includes recommending policies on the recruitment and development of personnel supported by research and development funds.

• Relevance of research to, and in support of, VHA’s mission. • The potential for conflicts of interest.

(4) Each basic research project, including those within all facility research programs and research centers, must be reviewed and approved initially and at least annually thereafter. The period for continuing review must be determined as part of the initial review.

• An initial review of basic research projects requires a review by a convened meeting at which there is a quorum consisting of a majority of voting members of the R&D Committee.

• In conducting an initial review, the R&D Committee must evaluate scientific quality, the relevance to both VA’s mission and the facility’s research program, and the ability of the investigator to perform and complete the research. In addition, the review must include information on the use, storage, and security of VA data and VA sensitive information including VAPI; the budget; the requirements for space, personnel, equipment, and supplies; the role of the investigator at the facility; the investigator’s qualifications; and other information deemed relevant by the R&D Committee.

• The initial approval of research requires a majority vote of the convened quorum.

• The initial approval of research must include a specific approval period, not to exceed 1 year.

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• The R&D Committee will conduct an annual continuing review of all Basic Research projects.

• A continuing review must assess the research activities that have occurred, the progress of the research, and any issues that may impact on the progress of the research including compliance issues.

• A continuing approval of research requires a majority vote of the members of the committee conducting the continuing review. Quorum (a majority of voting members) must be present during the vote.

• Continuing approval of research must include a specific approval period, not to exceed one year.

• Continuing approvals must be must be included in R&D Committee meeting minutes.

• Modifications for changes in non-essential staff may be reviewed and administratively approved by the ACOS/Research and do not require R&D Committee approval.

• Modifications to change the PI or staff determined to be essential to the study will be reviewed by the R&D Committee.

• All other modifications will be reviewed by the full R&D Committee using the criteria as set forth for continuing review described above.

• The R&D Committee will review all modifications to determine if the modification will change the project’s relevance to the VA mission or the availability of resources that are required or available.

• The R&D Committee may approve or disapprove a research project, program, or center. The final approval of the R&D Committee may only occur after all applicable subcommittees have granted final approval. If the R&D Committee finds that it has received insufficient information to review the research, it may defer the review until all required information has been obtained.

• If a subcommittee of the R&D Committee disapproves the research project, program, or center, the R&D Committee may not approve it.

• If a research protocol requires review by a facility’s non-research committee(s) or subcommittee(s), such as the Radiation Safety Committee, this review may be conducted at any time, but the research may not be initiated until the non-research committee has approved it, the R&D Committee has completed its review at a convened meeting, and the investigator is notified of the approval.

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e. Privacy and Information Security. The facility Privacy Officer (PO) and Information Security Officer (ISO) are ex officio members of the R&D Committee. The PO and ISO participate in programmatic reviews of Data and Data Repositories as described in section 17(f) below. The PO and ISO also perform reviews of each project at the time of initial submission and provide approvals to the R&D Committee. Training for the ISO and PO is comprised of the CITI course entitled, “VA Human Subjects Protection and Good Clinical Practices” along with direct education provided by the RCO.

(1) Project Reviews. Principal Investigators provide information to the IRB Assistant using the “Research Data Use and Security Form”. If the project involves human subjects, then the Informed Consent Document (ICD) and HIPAA form or appropriate waivers for these forms, are also included. The IRB Assistant reviews the submitted material for completeness and forwards copies to the PO and ISO. The PO and ISO review the submitted material using the “Research Privacy Review Checklist” and the “Data Security Review Assessment and Checklist”, respectively. The review results are returned to the IRB Assistant. The IRB Assistant then communicates any needed actions to the Principal investigator. The process is repeated until the ISO has given approval and the PO has given approval. The PO and ISO then submit their checklists to the R&D Committee. The R&D Committee collects the approvals and grants project approval when all necessary approvals and checklists have been completed. The ISO and PO must submit their reviews within a timeframe that does not prolong the study approval process. For exempt studies, the ISO and PO must submit summary reports to the ACOS, R&D, and ensure that the study is in compliance before the study is initiated.

(2) Primary Responsibilities. Although there is some degree of overlap between the criteria that are reviewed by the PO and ISO, the following are the areas of primary responsibility:

(a) ISO Review Responsibilities:• The type and location of data storage.

• The Procedures used to code or encrypt data.

• The plan for the retention and destruction of data.

• The media and location used to store data.

• The distribution of data outside of the VALB.

• The methods used to disseminate data.

(b) PO Review Responsibilities:• The HIPAA Authorization Form or waiver of Authorization.

• The appropriate use of disclosure statements on the HIPAA documents.

• Review of the IRB and R&D approval letters.

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f. Data & Data Repositories. The R&D Committee of record for a VA facility that houses the research data repository is responsible for oversight of the research data repository.

(1) The R&D Committee is responsible for: (a) Complying with all requirements in VHA Handbook 1200.1. (b) Reviewing and approving creation and operation of the research data repository, including the research repository SOPs.

NOTE: If the data repository contains identifiable data, IRB approval must first be obtained.

(c) Conducting reviews of the research repository’s activities at least once a year. As part of the review, the R&D Committee must receive the information cited in subparagraph 13k. NOTE: Unanticipated problems may need to be reported promptly depending on the nature of the risk, the type of incident, and current applicable reporting requirements (e.g., requirements of OI&T, OHRP, and ORO).

(2) The R&D Committee is not responsible for approving individual research protocols that propose to use data from the research data repository unless: (a) One or more of the investigators is from the same VA facility that houses the research data repository, or (b) Written procedures of the research data repository require such approval.

(3). VHA facility(ies) from which data originated. Once data (identifiable or de-identified) have been transferred from a local VHA facility, that facility’s R&D Committee is no longer responsible for reviewing and approving research protocols accessing those data if no part of the research will be conducted at the facility or with that facility’s resources (e.g., staff, equipment).

NOTE: The transfer of the data must be in compliance with all VA privacy and security requirements.

(4) VA facility(ies) of the investigator(s) for individual research protocols that will use data from a data repository (research or non-research). The R&D Committee(s) of record for the facility of each principal investigator and for each co-investigator (if they are not at the PI’s facility) must review and approve the individual research protocol before the data can be accessed. It also must comply with all the requirements of VHA Handbook 1200.1, including provisions for initial and continuing review of the research protocol. In reviewing the proposed research, the R&D Committee:

(a) Must receive sufficient information from the investigator to adequately assess the request including:

• The source of the data and the purpose for which the data were originally collected, including whether they were collected for research purposes.

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• If the data were collected for other research projects, whether the reuse is consistent with the research informed consent under which they were collected.

• If the data were collected for administrative or clinical reasons, whether the guidelines under which they were collected allow for storage in a specific data repository and reuse for research purposes.

• If the data is to be obtained from an administrative or clinical data repository, whether the administrative policies and procedures for the data repository allow for use of the data for research purposes, and if so, whether they allow for it as identified, de-identified, or coded.

NOTE: Although some data obtained from an administrative or clinical data repository may be used for a research protocol, the administrative policies for the administrative or clinical repository may not allow the data to be placed in a research data repository for reuse, and use in any other research projects requires requesting the data from the original source repository.

• A description of the data including if they are identified, de-identified, or coded. If the data are identified or coded, a justification for use of this type of data is required.

• A justification for the use of real SSNs, if they are requested.

• Information on data storage and security including:

• All locations where the data is to be stored, accessed, or used including servers, desktop personal computers (PCs), laptops, non-VA locations, or portable media.

• Information on the need and mechanism for copying data from a secure VA server and transmitting or transporting data to other locations.

• Plans for the destruction of data if they will not be placed in a research data repository after the protocol is completed and the retention period has expired.

NOTE: The subject’s contact information including name, address, SSN, and phone number should be maintained in a separate file at the VA and be linked with the remainder of the subject’s data only when it is necessary to conduct the research.

• Information on any plans to contact, re-contact, or recruit the patients or individuals for further information or to recruit them for any research project.

• How the privacy of subjects associated with the data and data confidentiality will be maintained.

• Information on any plans to use the current data and the data obtained from the proposed project for future research. If data will be retained for future research, the protocol must

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describe the repository in which they are to be maintained, its location, and its security measures.

NOTE: If the data are retained for future research, the research data repository must be established and maintained in accordance with the VA 1200 Handbook.

• If any data is to be released outside VA, a discussion regarding why this release is consistent with the VHA policy, the Privacy Act, and HIPAA must occur.

• Information on the PI’s ability to finish the protocol.

• Documentation that all research team members are to be working within their scope of practice, privileges, or functional statements.

(b) Must ensure that, if the data were collected during the conduct of a previous research protocol, the reuse in the new protocol is consistent with the original informed consent. If it is not, or the original informed consent did not address the reuse of the data, the R&D Committee must receive documentation that the IRB specifically-approved the proposed reuse.

NOTE: If the informed consent states specifically the data will not be reused for other purposes, it cannot be reused.

Reuse may be approved where: • The subjects must again provide consent and a new HIPAA authorization must be

obtained;

• The subject's name, SSN, scrambled SSN, or date of birth are not used, plus all criteria are met to waive informed consent and waive HIPAA authorization;

(c) The research is exempt from IRB review (38 CFR 16.101), and the criteria for waiver of HIPAA authorization have been met; or

(d) The data are de-identified prior to use.

(e) Must perform a continuing review of the protocol.

(f) Must ensure the data accessed from the data repository are required by the approved protocol and used only for the purposes defined in the approved protocol. Reuse of the data may not occur without approval of a new protocol unless the use is preparatory to research as defined in the IRB SOPP.

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18. NON-COMPLIANCE

a. Authority. The R&D Committee will initiate a review if there is any allegation or other evidence that there has been a violation of safety policies or procedures. The R&D Committee has the authority to examine all records that involve research. The R&D Committee may also choose to review the working environment at any time and without notice. The R&D will generally delegate investigative responsibility to an R&D subcommittee unless the project only involves Basic Research. Procedures for the conduct of investigations are described in Section 19 below. If an investigation has been conducted by a subcommittee, then the R&D Committee will review the findings and actions of the subcommittee.

The R&D Committee will consider the evidence and will determine by vote if the non-compliance is confirmed.

b. Actions. If non-compliance is confirmed then the noncompliance will be reported as described below.

(1) Basic Research.If the non-compliance is confirmed the R&D Committee will determine by vote if the non-compliance is Serious or Continuing.

The R&D Committee will consider the non-compliance to be Serious if it involves an immediate threat to the safety or health of animals, research participants, or staff.

The R&D Committee will consider the non-compliance to be Continuing if the PI has failed to take corrective remedial action after a previous finding of non-compliance for the same violation, or if there have been more than 3 findings of non-compliance (all projects for a PI) within 3 years.

If the R&D Committee determines that a violation is Serious or Continuing, then the R&D Committee will consider whether or not to Suspend or Terminate the Project. Reports of Serious or Continuing Non-compliance to external agencies will be made by the R&D committee as described section 20 below.

19. INVESTIGATIONS

Investigations are initiated as a result of allegations or other evidence of possible non-compliance (for cause). Investigations that are restricted to reviews of records are For Cause Audits. R&D investigations are performed to determine whether facts are supported or not supported and are not intended to determine guilt or innocence. Investigations may be performed by the R&D committee or its subcommittees. The procedures described in this section apply to all investigations by the R&D committee or its subcommittees. Investigations will generally follow the procedures outlined for Administrative Investigations in VHA Handbook 0700. Research Investigations will not in themselves result in punitive personnel actions but may result in restrictions on, or withholding of approval of, research. The evidence gathered may also be used by other reviews that may result in personnel actions.

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• Convening Authority. The committee or subcommittee that initiates the investigation is the Convening Authority. The Convening Authority will:

• determine if there is a need to perform an investigation. In making this determination, the Convening Authority may consult with VA officials and General/Regional Counsel.

• select members of an Investigation Board (Board) who are impartial and objective with respect to the subject matter of the investigation and who have the ability to conduct the investigation effectively. Membership will be selected by the Convening Authority at a properly convened meeting as described in the SOP of the Convening Authority. All potential members must be reviewed for possible conflicts of interest as described in section b(1) below. If a member may not serve for any reason then the Chair of the Convening Authority may select a replacement but must inform the full committee of this action at the next scheduled meeting. If a replacement is selected then the Convening Authority must assess the potential for conflicts of interest at the next scheduled meeting as described in section b(1) below.

• coordinate, as necessary, for participation of support staff.• provide clear guidance to the Board regarding the scope of the investigation,

• in defining the scope, the Convening Authority will determine if the investigation will focus on a particular project or projects, aspect or aspects, or will include all projects of a particular investigator,

• the Convening Authority will determine if the investigation will be limited to an audit of records, or will also include interviews or the gathering of sworn testimony.

• The Convening Authority will provide the Board with a written Charge. The Charge may be documented in the minutes of the Convening Authority or may be a separate document. The Charge will:

• identify the Chair and members of the Board and any staff that are assigned,

• define the scope of the investigation as described above,• delegate any necessary authority to administer oaths if necessary,• specify a timeline for completion of the investigative report.

• The Convening Authority may amend the Charge at any time but such amendments must be documented in writing.

(5) record an accurate and comprehensive account of all actions in meeting minutes that includes selection of the Investigative Board and a review of conflicts of interest.

(6) ensure that investigative activities are properly coordinated with those of other VA organizations and non-VA entities. The Convening Authority will determine if the investigation involves possible criminal activity, scientific misconduct, the quality of medical care, or protected quality assurance documents or information as described in VA Handbook 0700.

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(7) take reasonable steps to preserve the integrity of documents and computer files, and photographing of physical evidence, until an investigative decision can be made.

i. The Convening Authority will generally require that relevant records be surrendered to the Research Office immediately.

ii. The Research Office will direct the Principal Investigator (PI) to deliver the requested material to the Research Office. Notification may be oral, or in writing. If oral, then it must be documented in writing as a Report of Contact. Notifications must specify what is to be delivered, where it is to be brought, and a deadline that includes the date and time for compliance. All medical and research records are the property of the VA and must be surrendered upon request.

iii. Failure to respond to 3 notifications, without written documentation of an extension from the Chair of the Convening Authority, is serious non-compliance.

iv. If the PI still fails to respond, then the AO/Research will request that the records will be secured by the VA Police.

v. Unless otherwise specified, the PI is responsible for arranging for transportation of the requested material.

vi. The PI may request a receipt for the surrendered material. If such a request is made then the PI is responsible for providing an inventory of what has been surrendered. The receipt will be signed by the AO/Research, or designee.

vii. The AO/Research will be responsible for maintaining the chain of custody and the integrity of the surrendered material. Such materials will be sequestered in a secure location with limited and monitored access.

viii. The Convening authority may elect not to impound evidence if it is deemed that the integrity of the evidence is not in question.

(8) review the findings of the Board and will determine if the facts constitute Non-Compliance, Serious Non-Compliance, or Continuing Non-Compliance. The definitions and criteria for these decisions are described in the SOP of the Convening Authority. See also section b(4) below.

(9) determining if a Serious or Continuing Non-Compliance has occurred. If this is the case, then the Convening Authority is responsible for reporting this to appropriate authorities and agencies as described in the Reporting SOP. Additional requirements may apply as described in the SOP of the Convening Authority.

• Investigative Board.• Qualifications.

• One or more members will be selected from the membership of the Convening Authority. In general there will be an odd number of members in order to minimize the likelihood of tie votes. In determining the size of the Board, the Convening Authority will consider the volume of material to be reviewed, the seriousness of the potential outcome, and the complexity of the questions to be determined.

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• The Convening Authority will evaluate the potential for conflicts of interest of prospective members. Members must be objective and impartial, both in appearance and in actuality.• All members must fulfill the requirements noted in the Managing Conflicts of

Interest SOP.• Members should have no personal interest or other bias with respect to the

investigation.• Individuals should be excluded who had access to protected medical quality

assurance information such as in a focused review or root cause analysis.• At least one member must be senior or equal in academic or administrative

standing to any individual whose conduct is being investigated.• Members should be excluded who had direct administrative authority over

the subject of an investigation. Direct administrative authority means the person who completes the subject’s performance reviews.

• Members should be excluded who have a significant current, or recent, collaborative arrangement with the subject of the investigation. Significant means more than 1 coauthored publication or submitted proposal within the past 2 years.

• If adequate membership cannot be found, then the Convening Authority may request members from the R&D Committee or may ask that the R&D Committee request equivalent members from another VA.

• The RCO will serve as a procedural consultant to the Board but will not otherwise participate in the investigative process.

• The identities of the members of the Board will remain confidential during the course of the investigation. Attempts to identify, coerce, or otherwise influence Board members will be reported to the AO/Research or the RCO who will convey these to the Convening Authority for possible action. The identities of Board members may be released after completion of the investigation. Board members should be aware that the emails that contain exchanges of information concerning deliberations may be released as a consequence of Freedom of Information Act (FOIA) requests.

• Preliminary Meeting. The Board will conduct a preliminary meeting. At this meeting the Board will:

• Review the Charge from the Convening Authority and seek clarification of any points that remain unclear.

• Review the qualifications of the Board members including any potential conflicts of interest.

• Define what facts need to be determined.• Determine an Investigative Plan. In making such a plan, the Board should

consider first examining questions that may be answered based upon physical evidence, e.g., records, and then questions that may only be answered by interviews or testimony. The subjects of an investigation should generally be interviewed last.

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• VA employees and others may generally not be compelled to testify. If the Board is unable to obtain cooperation, then this should be reported to the Convening Authority. The Convening Authority may solicit the Director to compel VA employees to cooperate. Non-VA employees are under no obligation.

• If charged to obtain testimony, the Board should determine if a court stenographer will be required. In making such determinations the Board should consult the relevant section of VHA Handbook 0700, the Human Resources Office, or Regional Counsel.

• Fact Finding.• The Board will conduct meetings to review evidence and to collect sufficient

information to determine if facts are supported or not supported.• This process may involve an interview of the PI or others if this is deemed

necessary to determine a fact. Such individuals may not be represented by a third party, but may be accompanied by a legal advisor if this is requested of, and permitted in writing by, the Convening Authority. Legal advisors may not address the Board.

• The Investigative Board is not a jury and the PI is not entitled to a hearing before the Board. The PI may challenge Board findings in an Appeal to the Convening Authority as is described in section b(9) below.

• Final Report. The board will submit a final report to the Convening Authority. The report will contain:

• A summary of the Charge.• Background and Procedural Information.• Statements of each question that was addressed.• Reviews of the evidence concerning each question that was addressed.• A determination of fact for each question that was addressed that is based

upon a preponderance of the evidence. A fact is determined by a majority vote of those in attendance. If a majority cannot be obtained that either supports or rejects a fact then the fact is not determined. In such a case the Board will consider if additional evidence may be obtained that would enable determination of the fact. In determining facts, the Board will record the finding but will not record the vote tally.

• The final report should be signed and dated by all Board members.• If any Board member who was not in attendance disagrees with the Board

findings, then the Board will reconvene and a new vote will be taken.

• Discovery of Matters Outside of the Scope of Investigation. If the Board discovers significant matters that are outside of the Scope of the

investigation then it should promptly provide this information to the Convening Authority for appropriate action, such as expanding the Scope of the investigation, convening a separate investigation, or referring the matter to another authority.

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• Final Determinations.• The Convening Authority will:

• Review the findings of the Board and determine if each factual finding constitutes Non-Compliance, Serious Non-compliance, or Continuing Non-compliance.

• review the overall findings and make an overall determination that is based upon the aggregate findings. In making such a determination it is possible that multiple determinations that are not in themselves Serious or Continuing may in aggregate be Serious or Continuing. The overall determination will be decided by a recorded vote tally at a properly convened meeting, i.e. quorum as defined by the SOP of the Convening Authority.

• send an initial report to the Medical Center Director within 5 working days if there is a finding of Serious or Continuing Non-Compliance. The Director must forward the report to the VISN Director, the ORO Central Office and ORD within 5 working days of being notified. These notifications must be made regardless of whether or not the matter has been fully resolved at the time of the determination. Additional details are contained in the IRB SOP section QA 903 and the Reporting SOP.

• will be responsible for insuring that the content of the meeting minutes provide an adequate and accurate account of the findings and actions and especially those that represent controverted issues. The Chair of the Convening Authority will be responsible for verifying that the minutes have been reviewed prior to approval.

• The RCO will review the approved minutes and will verify that the vote has been properly documented and that any controverted issues have been adequately described. Any deficiencies will be reported to the Chair of the Convening Authority within 5 working days of being identified and will be documented in the following Quarterly Report.

• Should it be necessary to make corrections or additions to approved minutes, then the corrections or additions will be clarified in an addendum and the original minutes will be retained. The addendum must be subsequently reviewed and approved in the same manner as the original minutes.

• Notification of Actions.• The PI will be notified by telephone within 24 hours, and in writing within 5

working days of the meeting at which the action was finalized. The notification will include a description of any restrictions, required actions, and deadlines for required actions. The written notification will include a copy of the findings of the Investigative Board if an Investigative Board was convened. The Board findings should be reviewed by the Privacy Officer and

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redacted if appropriate. Additional details are provided in the IRB SOP section RA 602.

• The Convening Authority may elect to make a preliminary determination and defer action pending review by the R&D Committee. The R&D Committee may add additional findings and/or restrictions but may not contravene those of the Convening Authority. All such actions will be returned to the Convening Authority for final action.

• The Convening Authority will advise the PI of the outcome of Investigator Appeals. The PI will be notified in writing within 40 working days of a meeting at which there was a final action. If the Appeal is not granted, then the notification will provide a detailed description of why this was the case.

• Investigator Appeals. The PI may appeal the decisions of the Convening Authority. An appeal is a request from the PI to the Convening Authority to reconsider a prior decision. Appeals are not “Appeals” in the legal sense and do not solicit a “higher authority” to over-turn the finding of the Convening Authority. Decisions of the Convening Authority are final.

• Appeals must be submitted by the PI only and not by a representative, • Appeals must be submitted in writing within 30 days of the meeting at

which action was taken by the Convening Authority. Appeals should be submitted to the AO/Research who will convey them to the Convening Authority.

• The PI may submit clarifications, dispute facts, provide additional references, consultants’ reports or other material that may support his/her case.

• The PI may describe mitigating circumstances that might dispose the Convening Authority to be more lenient.

• Appeals should not contain procedural objections unless such objections might alter the findings of facts. Procedural objections should be submitted separately as complaints to the R&D Committee.

• The PI may request a hearing before the Convening Authority but may not be present during deliberations or voting.

• The Convening Authority may, at its discretion, permit the PI to be accompanied by a legal advisor. The legal advisor, if permitted, may not represent the PI or address the Convening Authority.

• The Convening Authority will be responsible for reporting amendments or reversals of decisions to Officials and Agencies that had previously been notified.

• Reinstatement. If the Convening Authority has decided to suspend or permanently withhold approval for all human, animal, or basic research, then the PI may solicit the Convening Authority to reinstate approval at a later date. If approval is reinstated then the Convening Authority must consider if limitations should be imposed. These may include but are not limited to:

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• Limiting the number of human or animal subjects that may be included.• Limiting the number of approved projects.• Limiting the risk of approved projects.• Providing for supervision of the research by another investigator.• Limiting the period of approval.• Requiring more frequent auditing by the Convening Authority or the RCO. If

more frequent auditing is required then the focus of the audits should be defined and reassessed on an annual basis. In considering this focus, the Convening Authority should give special consideration to any areas of previous non-compliance.

20. ADDITIONAL REPORTINGR&D Committee reporting requirements include:

• Providing written notification of the results of R&D Committee review to the Research Office, and the PI.

• Reporting operational problems or violations of directives to the Research Office within 30 days of occurrence or detection, unless R&D Committee determines that a report has been previously filed by the PI.

• Reporting confirmation of Serious or Continuing Non-compliance to the ACOS R&D within 2 working days of the determination.

• Reporting confirmation of Serious or Continuing Non-compliance to the ORO within 5 working days of the determination.

• Forwarding minutes of R&D Committee through the Research Office to the medical Director.

• Ensuring that timely reports are submitted to external Offices and Officials, e.g. VISN22, ORO, NIH, etc. as is described in the SOP for Reporting of Research Events to Institutional Officials and External Oversight Offices.

21. REFERENCES

a. Title 38 CFR §16.

b. VHA Handbook 1200.05.

c. VHA Handbook 1200.06.

d. VHA Handbook 1200.7.

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e. VHA Handbook 1200.8.

f. VA Directive 6500 and its implementing handbooks in the 6500 series.

g. VHA Handbook 1605.1.

h. VA Directive and Handbook 6102.

i. VA Directive 6502.

j. VA Handbook 6502.1.

k. VA Handbook 6502.2.

l. VHA Directive 6300.

m VHA policy concerning Research Financial Conflict of Interest Statement.

n. VHA Handbook 1200.13.

o. VHA Handbook 1100.19.

p. VHA policies concerning Credentialing of Health Care Professionals.

q. VHA Handbook 1058.06

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Appendix 1


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Appendix 2

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