Approved February 18, 2013

Page 1 of 14

INDIANA UNIVERSITY - Bloomington

Institutional Biosafety Committee (IBC) Standard Operating Procedure

Approved February 18, 2013

Page 2 of 14

Our Mission

The Institutional Biosafety Committee (IBC) protects the health of laboratory scientists and the greater community by assuring that biological research at Indiana University is conducted in compliance with federal and state laws. The committee promotes research by guiding scientists through the complexities of regulatory requirements and helping them establish safe working conditions. In service of this mission, the IBC endeavors to:

Continue to inform researchers about the application of the federal regulations in an effort to keep researchers current with evolving standards,

Educate faculty, staff, and students who conduct research with recombinant or synthetic nucleic acid molecules, pathogenic microorganisms, and other infectious agents and toxins, and

Develop new approaches that better serve the overarching mission of the IBC and assessing the overall effectiveness of the program

Approved February 18, 2013

Page 3 of 14

Indiana University - Bloomington Institutional Biosafety Committee (IBC)

Standard Operating Procedure

Table of Contents

A. Charge of the Committee (IBC) ................................. ………………………………………………………………4 B. Membership ................................. …………………………………………………………………………………..4 C. Committee Meeting Process ............................................................................................................................ 5 D. Responsibilities ................................................................................................................................................. 5 E. Protocol/Amendment/Continuation Submission ............................................................................................... 7 F. IBC Review ................................................................................................................................................... 8 G. Monitoring Proceedings… .............................................................................................................................. 10 H. Specific IBC Policies ....................................................................................................................................... 11

Approved February 18, 2013

Page 4 of 14

A. Charge of the Committee

The Indiana University – Bloomington Institutional Biosafety Committee (IU-Bloomington IBC) is charged with the responsibility for review, approval and surveillance of all research and teaching at IU Bloomington involving the use of either recombinant or synthetic nucleic acid molecules or biohazards. Biohazards mean agents infectious to humans or vertebrate animals, and biological toxins or venom. Regardless of whether an activity has external financial support, all research and teaching activities with recombinant or synthetic nucleic acid molecules or any biohazards must be reviewed as set forth in this Policy and Procedure Manual. The IBC typically schedules meetings monthly.

The use of materials covered by the Bloodborne Pathogen Standard and animal tissues suspected to be contaminated with infectious agents also require IBC notification. Contact the IBC Administrator for assistance. Teaching or research activities involving recombinant or synthetic nucleic acid molecules, including NIH Exempt recombinant or synthetic nucleic acid molecules research, or biohazards, as defined above, will require an IBC protocol. For those instances where select agent toxins or infectious agents are in use, or BSL-3 conditions and precautions are indicated for research projects, IBC approval will also be required. Contact the IBC Administrator for assistance. IU-Bloomington lacks the facilities requiring BSL-3 Plant or BSL-4 Plant containment, or BSL-4 biological containment. Therefore, research requiring such containment cannot be performed at the IU-Bloomington campus.

B. Membership

1. Composition:

The Vice President for Research or designee, in consultation with the IBC Chair, has the authority to appoint members to the IBC. The committee must be comprised of no fewer than five members so selected that they collectively have experience and expertise in recombinant or synthetic nucleic acid molecule technology and the capability to assess the safety of recombinant or synthetic nucleic acid molecules research and to identify any potential risk to public health or the environment. At least two members shall not be affiliated with the institution. The committee shall also include at least one individual with expertise in plant, plant pathogen, or plant pest containment principles, at least one scientist with expertise in animal containment principles, and a designated staff member from the Biological Safety Office who shall serve as Biological Safety Officer. Membership reflects basic federal requirements for expertise and advocacy; additional members are added as necessary or appropriate. Membership may include non-voting members. A Vice-Chair of the IBC may be called upon to serve in the Chair’s absence.

2. IBC Training:

The training of IBC members is an on-going process and begins for new members through training during a regularly convened meeting of the IBC or with an orientation session conducted by the staff of the Biosafety Office, IBC Administrator, or designee. This session includes an explanation of the NIH Guidelines and the institutional policies and procedures of the IBC. The training of new members continues when they attend the regularly scheduled meetings of the IBC where they observe how members review and present the submissions that they were responsible for reviewing. The training of members continues through the discussion, which takes place over substantive issues during the review of submissions and special topic presentations during convened IBC meetings.

Approved February 18, 2013

Page 5 of 14

3. Meeting Attendance:

Members are expected to attend the regularly scheduled meetings unless they have notified the IBC Administrator that they are unable to do so.

C. Committee Meeting Process

Convened meetings of the IBC typically occur monthly. Meetings must contain a quorum of members in order for the meeting to be held. A quorum is 50% of the voting membership plus one. In order for protocol submissions to be placed on the agenda for a convened meeting, the Principal Investigator (PI) should submit a protocol 4 weeks before the scheduled meeting and have satisfactorily addressed any issues raised during preliminary review by an IBC member or members prior to the meeting. IBC members responsible for preliminary review are expected to provide an overview of the submission at the convened meeting and provide any additional comments that they might have. Reviewers that are unable to attend a meeting should provide a written summary of their review and any additional concerns to the IBC Administrator for presentation at the meeting by another committee member. For information on limitations on members who may not be present during review of submissions, please consult the IBC Policy on Conflict of Interest found later in this document.

Meeting minutes will be taken in accordance with the Office of Biotechnology Activities (OBA) guidelines.

D. Responsibilities

1. The IBC is responsible for: Reviewing research and teaching conducted at the IU Bloomington and regional campuses

involving biohazards or recombinant or synthetic nucleic acid molecules for compliance with the NIH Guidelines, recommendations in the BMBL and the policies of the IU Bloomington IBC;

Notifying the Principal Investigator of the results of the IBC’s review and approval; Lowering containment levels for certain experiments as specified in Section III-D-2-a

Experiments in which DNA from Risk Group 2, Risk Group 3, or Restricted Agents are Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems;

Setting containment levels as specified in Sections III-D-4-b, Experiments Involving Whole Animals, and III-D-5, Experiments Involving Whole Plants;

Periodically reviewing recombinant or synthetic nucleic acid molecules research conducted at the institution to ensure compliance with the NIH Guidelines;

Reporting any significant problems with or violation of the NIH Guidelines and any significant research-related accidents or illnesses to the appropriate institutional official and NIH’s Office of Biotechnology Activities within 30 days, unless the IBC determines that a report has already been filed by the PI;

Immediately reporting any suspected BSL-3 or confirmed BSL-2 research-related illnesses, and any accidents or, significant problems with or violations of the NIH Guidelines to the appropriate institutional officials and NIH’s Office of Biotechnology Activities;

Reviewing any reports of spills or accidents that fall under the “IUB IBC Policy on Reporting Laboratory Incidents”, and

The IBC may not authorize initiation of experiments, which are not explicitly covered by the NIH Guidelines until NIH establishes the containment requirement.

2. IBC Chair:

Approved February 18, 2013

Page 6 of 14

The IBC Chair approves the agenda for the convened meetings of the IBC, approves attendees other than IBC members or staff, and directs the meeting deliberations of the committee. The Chair calls the meeting to order, requests motions and seconds, and closes the meeting once it has concluded its business. The Chair assigns subcommittees (i.e., a subset of IBC members) as needed to review an issue prior to official committee review at a convened IBC meeting. The Chair also signs all IBC protocols that include biohazards or non-exempt recombinant or synthetic nucleic acid molecules upon approval documenting official committee decisions made at a convened meeting and reviews the responses of the Principal Investigators to Pending-Conditions or Tabled Protocols. The Chair may request other committee members for assistance in reviewing the responses of Principal Investigators.

3. Principal Investigator:

On behalf of the institution, the Principal Investigator or the faculty member responsible for research and teaching activities that involve recombinant or synthetic nucleic acid molecules and biohazards is responsible for full compliance with the NIH Guidelines and for adherence to the policies and procedures of IU Bloomington IBC. While having said that, the PI should take particular note of the following responsibilities: The PI should make the initial determination of the required levels of physical and biological

containment in accordance with the NIH Guidelines and the most recent edition of the BMBL (Biosafety in Microbiological and Biomedical Laboratories).

The PI should select the appropriate microbiological practices and laboratory techniques to be used for the research.

The PI needs to ensure that all staff listed has access to the currently approved protocol and have read the protocol before beginning work.

The PI should ensure that the staff listed on the protocol have sufficient knowledge and are sufficiently trained to safely perform the responsibilities for which they have been assigned.

The PI ensures that the protocol participants fully understand the steps necessary following any spills or potential exposures with the agents described in the protocol.

The PI should immediately report any suspected BSL-3 or confirmed BSL-2 research-related illnesses as well as reporting any accidents, significant problems with or violation of the NIH Guidelines to the Biosafety Office immediately.

Report to the Biosafety Office spills or accidents that fall under the “IUB IBC Policy on Reporting Laboratory Incidents”.

4. Biological Safety Officer or Designee:

The responsibilities of the Biological Safety Officer include, but are not limited to:

Serving as a voting Member of Institutional Biosafety Committee;

Conducting periodic laboratory inspections to ensure that appropriate laboratory standards as determined by the IBC are rigorously followed;

Reporting to the IBC and the institution any significant problems, violations of the NIH Guidelines, and any significant research-related accidents or illnesses of which the Biological Safety Officer becomes aware unless the Biological Safety Officer determines that a report has already been filed by the PI;

Developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving recombinant or synthetic nucleic acid molecules or biohazards research;

Providing advice on laboratory security, providing technical advice to PI’s and the IBC on research safety procedures;

Developing, and implementing a comprehensive Biosafety program for the Indiana University Bloomington and regional campuses;

Approved February 18, 2013

Page 7 of 14

Together with the IBC, overseeing review of BSL-1, BSL-2 and BSL-3 research projects on campus and conducting all relevant inspections for these facilities;

Conducting Biosafety risk assessments and training to ensure the University is in compliance with all applicable federal biosafety laws and regulations;

Collaborating with investigators and staff in all matters related to biosafety;

Providing expertise for the design and management of containment facilities; and

Serving the University as a resource in all aspects of education and training in biosafety.

E. Protocol/Amendment/Continuation Submission

The IU-Bloomington IBC Protocol Registration Form is used to register, renew and approve research protocols and evaluate the Biosafety Level and Risk Group of the research organism(s).

1. Initial Registration

The IU IBC Protocol Registration Form must be submitted to the IBC and approval granted prior to initiating research for any BSL-2, BSL-3 and recombinant or synthetic nucleic acid molecule research covered by the NIH Guidelines, Sections III-A through III-D. The approval is valid for 5 years, with an annual review during this time. An amendment or new IU-Bloomington IBC Protocol Registration Form must be filed whenever there are room or personnel changes, or significant changes in the research such as the addition of biohazards or recombinant or synthetic nucleic acid molecules research in whole organisms.

As defined by the NIH Guidelines, BSL-1 recombinant or synthetic nucleic acid molecules research under Section III-E requires submission of IBC Protocol Application Forms at the time research is initiated.

BSL-1 and exempt recombinant or synthetic nucleic acid molecules research under Section III-F of the NIH Guidelines must be reported to the IBC using IU-Bloomington IBC Protocol Registration Form at the time research is initiated. BSL-1 labs are inspected annually by the Environmental Health & Safety Chemical Laboratory Safety group on behalf of the Biosafety Office.

Research conducted in BSL-1 or BSL-2 with pathogenic organisms or toxins must be reported to the IBC using IU-Bloomington IBC Protocol Registration Form, and must be approved prior to the initiation of the research.

o The Biosafety Office is authorized to approve non-recombinant or synthetic nucleic acid molecules research prior to the next regular IBC committee meeting.

o All research involving biological select agent organism and toxins, and research involving unique or novel safety or compliance concerns will be referred for full committee review.

o Approvals are reported at the next regular meeting of the IBC.

The Biosafety Office will request protocols described above be reviewed and approved by the IBC committee when research details contained within or special circumstances warrant committee review. The IU-Bloomington IBC Protocol Registration Form includes a Biosafety Level evaluation and solicits information about the PI's facilities, engineering controls, containment equipment, and safety procedures. This information must be completed in full when submitting the application.

o The Biosafety Office, will arrange for an inspection of the lab when the research will be conducted in BSL-2 or higher to assess whether engineering controls and containment facilities are appropriate for the designated Biosafety Level.

2. Continuing Review

Approved February 18, 2013

Page 8 of 14

Continuing reviews are required for all IU-Bloomington IBC protocols that are subject to the NIH Guidelines.

o Before the continuing review is due and with sufficient notice to complete the renewal, the IBC Administrator will remind the PI to submit a continuing review. Delinquent continuing review responses will be reported to the committee for appropriate action to be determined at their discretion. However, investigators must file a revised registration form when room or personnel changes occur or significant changes, such as the addition of biohazards or recombinant or synthetic nucleic acid molecules research in whole organisms, are made in the approved protocol.

3. Re-Registration

After 5 years, the PI must submit new IU-Bloomington IBC Protocol Registration Forms.

Before the end of the approval period and with sufficient notice to complete a re-registration, the IBC Administrator will remind the PI to submit new protocol forms.

F. IBC Review

1. Administrative Review

Upon receipt, the IBC protocol forms will undergo an administrative review by the IBC Administrator to ensure that the PI has signed the form, all the appropriate forms have been completed, and the forms contain sufficient detail and determine which type of committee review is required (i.e., Expedited Biosafety Office review or Full Committee Review). A complete initial submission must received for the protocol to move through the review process. The PI must only utilize the latest forms from the IBC website.

If the IBC submission involves the use of animals, the IBC Administrator will confirm if there is an associated approved Institutional Animal Care and Use Committee (IACUC) protocol. The Biosafety Office will confirm that the description of work on the IACUC protocol matches what is described in the IBC submission through the review process. If not, the PI is informed that IACUC approval is also required. If the IBC submission involves the administration of biohazards or recombinant or synthetic nucleic acid molecules to humans or the acquisition of materials covered under the Bloodborne Pathogens Standard, the IBC Administrator will confirm with the Institutional Review Board (IRB) if there is an associated approved IRB submission form. If not, the PI is informed that IRB approval is also required.

Upon receipt of amendment forms or new submissions, the Biosafety Office determines if the form describes the requested change and if the associated IBC submission forms are included and have been appropriately revised. If the associated IBC forms have not been included or revised, they will be requested prior to further IBC review of the amendment.

Minor amendments such as addition of new staff, or the use of new rooms under BSL 1 or BSL 2 conditions, are approved by the Director of Biological Safety or designee.

2. Expedited Review (Chair/Biosafety Office Review/Approval)

Expedited review for proposals involving non-exempt recombinant or synthetic nucleic acid molecules research is not permitted by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The Biosafety Office verifies the section(s) of the NIH Guidelines that apply to the research through the review process of any new protocol submission or major amendment. Protocols involving non-exempt recombinant or synthetic nucleic acid

Approved February 18, 2013

Page 9 of 14

molecules can only be approved at an official meeting of the full committee. Major amendments involving non-exempt recombinant or synthetic nucleic acid molecules research are approved by the Biosafety Office prior to regularly scheduled IBC meetings when the research described in the amendment does not change the safety, compliance, or risk assessment of the currently approved research. The Biosafety Office may request additional information from the PI with notification to the IBC Administrator. These Biosafety Office approved submissions are presented to the IBC at the next regularly scheduled meeting of the committee for final approval Amendment forms indicating a minor change that has no impact on biosafety level or on the classification of approved recombinant or synthetic nucleic acid molecules research are reviewed by the Biosafety Office. The Biosafety Office may request additional information from the PI with notification to the IBC Administrator, approve the amended submission without modifications, or send it to full committee when it is determined that such review is warranted.

IBC protocols or amendments involving exempt recombinant or synthetic nucleic acid molecules research including exempt transgenic vertebrate and invertebrate animals, materials covered by the Bloodborne Pathogen Standard, non-select agent toxins, and culturing non-select agent Risk Group 2 organisms, are recorded by the IBC Administrator, then sent to the Biosafety Office for initial review. Following satisfactory resolution of any issues raised by this review, the submission is considered to be “registered” and the Principal Investigator may proceed with the generation or manipulation of vertebrate animals, unless IACUC approval is required. These Biosafety Office approved submissions are presented to the IBC at the next regularly scheduled meeting of the committee for final approval. The full committee is informed in scheduled meetings of all new protocol submissions and amendments that have been approved by the Biological Safety Office.

3. Convened Committee Review

All protocols that require, or that are recommended, for full IBC review are pre-reviewed by the Chair, the Biosafety Office, and by additional members or ad hoc experts as is deemed necessary to assure reviewer expertise. The PI should respond to questions or concerns raised during preliminary review prior to placing the submission on the agenda of the next convened meeting of the IBC. IBC submissions on the agenda are presented by the IBC member(s) who performed the initial review. At this time the committee determines if there are remaining issues or concerns that must be satisfactorily addressed by the PI prior to approval. At the conclusion of the committee review, the committee has the following decision options: Approved: The protocol submission satisfactorily addresses all issues and the submission is

fully approved, no further modification by the PI is necessary.

Pending-Conditions: Issues remain that must be addressed by the Principal Investigator prior to approval. The revised protocol submission is reviewed by the pre-reviewers, Biosafety Office, and Chair and may be approved outside full committee when a satisfactory assessment of the risk was possible and the Section III-D of the NIH Guidelines was checked appropriately on the initial submission. The revised protocol submission is reviewed by the full committee when satisfactory risk assessment was not possible, or additional information may bring the protocol under Section III-D of the NIH Guidelines. The Chair or any of the committee members are authorized to bring back any submission to a convened meeting of the IBC if he/she is not satisfied with the Principal Investigator’s response to Conditions approved by the IBC. The Chair may also bring back any submission in response to concerns raised by another member of the IBC.

Tabled: Significant issues remain requiring the full committee to review the PI response.

Approved February 18, 2013

Page 10 of 14

Rejected: The protocol submission is not approved and has been not recommended for further consideration by the committee.

The PI will receive written communication and comments as a basis for discussion and a guide for any decisions made by the committee. The communications will be sent to the investigator via e-mail.

4. Continuing Review

The Continuing Reviews are recorded by the IBC Administrator. Continuing Reviews that do not contain changes are reviewed and approved by the IBC Administrator. Continuing Reviews that contain minor amendments, and major amendments that do not change the risk assessment .are reviewed and approved by the Biosafety Office Continuing Reviews that describe changes that affect the risk assessment are reviewed and approved by the IBC.

5. Delinquent PI Responses to IBC Review Letters

Failure to respond to IBC review letters (e.g., IBC questions or comments provided to the PI before or after a convened meeting) within 30 days will result in a Final Notice letter from the IBC Administrator. If the PI fails to respond to the Final Notice in 30 days, this may result in withdrawal of the original submission. The PI needs to contact the IBC Administrator if the PI is unable to respond to the review letters on a timely basis.

G. Monitoring Proceedings 1. Annual Review

The Annual Review process confirms the staff members who are working on the project, the

location of the work, and reminds the PI to review the approved protocol and to make any appropriate revisions and acquire approval from the IBC for major amendments.

2. Lab Inspections

Biosafety Office

o At the request of the IBC, the Biosafety Office conducts BSL-2, ABSL-2, BSL-3 and ABSL-3 inspections based upon the standards set forth in most current edition of the BMBL, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the select agent regulation 42 CFR 73. BSL-2 and ABSL-2 labs are inspected annually; BSL-3 and ABSL-3 labs are inspected semi-annually.

o At each IBC meeting, a Biosafety Office representative will present a summary of each

inspection that was conducted since the last meeting. These reports will include any inspections conducted for initial purposes, the annual scheduled inspections, or close out inspections.

If an inspection reveals major, unacceptable deficiencies in laboratory

biosafety conditions or practices, the Biosafety Office representative will immediately contact the Director of Biosafety, IBC Administrator, and IBC Chair to discuss appropriate action which may include an order of cessation of all laboratory work until biosafety conditions are met.

Any action of this matter by the Biosafety Office, IBC Chair, or IBC Administrator, when acting at the request of the Biosafety Office, IBC Chair, or full committee, will be reported at the next scheduled IBC meeting.

In case of major biosafety hazards or violation of NIH Guidelines, an ad-hoc IBC meeting will be called as quickly as feasible, to discuss and act,

Approved February 18, 2013

Page 11 of 14

including confirming or amending any actions taken by the Biosafety Office, IBC Office, and IBC Chair.

3. Training

Biosafety training is provided by the Biosafety Office. BSL-2/ABSL-2 and Viral Vector training

is required prior to working on research that uses these criteria and annually thereafter for all persons working with Risk Group 2 infectious agents and genetically modified human cell lines. Additional training is provided to all Select Agent investigators, researchers and CDC-registered IU staff at initiation, after policy revision, and annually, and includes Biosafety, Security, and Incident Response in accordance with IU Bloomington Select Agent Program policy. Specific training is also provided by the Biosafety Office as requested.

H. Specific IBC Policies

1. Conflict of Interest No member of the IBC may be involved in the IBC's deliberation, review or approval of a submission in which he or she, or his/her spouse or domestic partner, is listed as an investigator, otherwise expects to be engaged, or has a financial interest, except to provide information requested by the IBC (including information requested during a convened IBC meeting). IBC members are obligated to report their conflict of interest to the IBC Chair prior to discussion of the protocol in question, and to leave the meeting room during discussion and voting on that protocol, unless requested by the IBC Chair to remain to answer questions or provide additional information.

2. Antibiotic Sensitivity

Research involving organisms with known human biosafety concerns (Risk Group 2 and above) which may be partially or fully resistant to clinical treatment in humans, animals or plants by such agents as antibiotics, antivirals and antifungals, must be described in detail, providing human safety health risks, available treatments, proposed containment measures and, if appropriate, specialized testing procedures.

3. Accidents Involving Biohazards or Recombinant or Synthetic Nucleic Acid Molecule Material

Spills

Any spill involving a biohazardous agent or recombinant or synthetic nucleic acid molecules material must be reported to the Biosafety Office in accordance with “IUB IBC Policy on Reporting Laboratory Incidents”.

Exposures

All exposures (inhalation, inoculation, ingestion or skin contact) involving biohazardous material or recombinant or synthetic nucleic acid molecules must be immediately reported to the IUB Biosafety Office.

NIH Reporting Requirements

Significant problems with or any violations of the NIH Guidelines including all accidents and exposures involving recombinant or synthetic nucleic acid molecules, must be reported to the Director of Biosafety as soon as possible, certainly well within the specified deadlines for NIH’s Office of Biotechnology Activities reporting. The Director of Biosafety will prepare a report and will notify NIH and appropriate institutional officials.

The Biosafety Office reports to the IBC any injury or exposure involving biohazardous material,

Approved February 18, 2013

Page 12 of 14

genetically modified materials or organisms manipulated in BSL-2. Also reported are any injuries or exposures in BSL-1 involving research described on an approved IBC protocol, or that should be covered by an IBC protocol which is in review or for which submission has been or will be requested.

4. Non-Compliance with the NIH Guidelines or other regulations - Procedure for Reporting

Concerns:

The IBC investigates all concerns brought to its attention. Reports of suspected non-compliance with NIH Guidelines, Select Agent Regulations, or any other regulatory agency concerns can be made to any IBC member or through internal audit’s anonymous reporting hotline. Reports should indicate, times, dates, place and procedures of concern. The more specific information provided, the more effective will be the IBC evaluations.

Initial Evaluation and Actions:

Whoever receives an allegation of non-compliance or other concern will immediately notify the IBC Chair, Director of Biosafety or Executive Director of Research Compliance, and other appropriate Institutional Officials.

Unless involved in the alleged non-compliance, the Director of Biological Safety will conduct the initial review and submit a report to the IBC Chair, or to the Vice Chair if the Chair is not available, or if the Chair is involved with the protocol to which the concern is related. If appropriate to the particular concern, or if the Chair and Co-Chair are both not available, other IBC members will be notified and charged with acting on behalf of the Chair in implementing this procedure. The Chair, Co-Chair, or other IBC member acting on behalf of the Chair, will promptly initiate an investigation of the circumstances underlying the concern.

Investigation:

A subcommittee appointed by the Chair should conduct the investigation of the circumstances underlying the concern and report findings to the IBC. It is important to avoid actual or perceived conflicts of interest in this process and to protect the identity of the complainant. The IBC should charge the subcommittee to gather information and should impose a deadline for reporting to the IBC. The time allowed will depend on the initial determination of whether immediate action may be required.

The nature and sources of the information required will vary depending on the circumstances, but may involve:

Interviewing complainants (if known), any persons against whom allegations were directed, and pertinent program officials;

Observing the environment; and Reviewing any pertinent records, (e.g. protocol and other documents).

The subcommittee investigator(s) should provide a report to the IBC that summarizes:

the concern(s) as reported to the IBC, the results of interviews, the condition of the environment, the results of records and other document reviews, any supporting documentation such as correspondence, reports, and animal records, conclusions regarding the substance of the concerns vis-à-vis requirements of the NIH,

and institutional policies, procedures, and protocols; and recommended corrective actions and deadlines, if appropriate.

Approved February 18, 2013

Page 13 of 14

IBC consideration of the concern and determination of corrective actions: The report of the subcommittee investigation should be provided to all IBC members, The IBC may vote electronically to accept the recommendations of the investigating

subcommittee, offer further suggestions or comments, or request convened meeting to discuss the concern and/or the report; and

Any member request for a convened meeting to consider a concern must result in a convened meeting.

Based upon the report of investigation the IBC will determine required actions, if any. IBC determinations may include, but are not limited to:

investigation did not reveal an issue of non-compliance, investigation revealed non-compliance, related aspects of the program require further review; and other related institutional programs may require review.

For any noncompliance with standards accepted by the IBC, the IBC must prescribe corrective actions along with appropriate deadlines and reporting requirements. The IBC must also determine whether the noncompliance meets the criteria “serious or continuing noncompliance” or “serious deviation” so as to require reporting to NIH as discussed below. Notification in Writing:

IBC Chair will communicate, in writing, the results of the IBC evaluation of a reported concern to the person(s) responsible for the situation reported, the Institutional Official (IO), the Executive Director of Research Compliance, and the person reporting the concern if they wish to be notified of the outcome. The communication will contain a summary of the concern, the findings of the investigation, determinations of the IBC, and the recommended corrective actions/sanctions. The letter will also inform the person(s) responsible for the situation reported of his/her option to appeal the decision by writing the IBC Chair, within 10 days of receipt of this letter detailing the basis of the appeal and requesting a meeting with the IBC.

Examples of IBC actions that may be appropriate in response to situations that constitute non-compliance are:

terminate approval of the respective research study, suspend approval of the respective research study pending completion and acceptance

by the IBC of an independent audit of the study and/or the submission, by the principal investigator, of a written plan for the correction and/or prevention of the problem,

institute an IBC-mandated corrective action plan and independent audit of the study; and take such other action as the IBC deems appropriate.

The IBC is obligated to report, through the IO, any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH’s Office of Biotechnology Activities within thirty days; unless the institution determines that a report has already been filed by the Principal Investigator, Biosafety Officer, or Director of Biosafety.

Appeals

Disputes regarding interpretation of this policy or decisions made by the IBC are referred to the Institutional Official for adjudication.

Approved February 18, 2013

Page 14 of 14

Version 1: adopted 2010

Version 2: Reflects amendments to 2010 version were approved February 14, 2011.

Version 3: Reflects amendment to 2012 version due to March, 2013 NIH Guidelines