IBC Review Procedures

Protocol Submission: Researchers must submit protocols to the IBC for review before starting any research involving biological materials. Submissions should include a completed IBC application form, a detailed research description, risk assessments, and relevant supporting documents.

Submission Deadline: Protocols requiring Committee Review must be submitted at least 2 weeks before the scheduled IBC meeting to allow adequate time for review.

This review procedure begins when the RO and Chair receive a notification of new or revised registration. The Chair, BSO, and RO make a Biosafety Risk Assessment to:

• Assess submission completion by ensuring no materials are missing from the registration.
• Assess the risk group of agents, biosafety level, and investigator’s qualifications/training/experience.
• Identify any other concerns that will limit approval.
• Identify determinations for the IBC to review before the approval of the research.
• Determine if registration requires review by Non-Committee Review or Committee Review.

The Non-Committee Review procedure begins when the BSO or RO determine a registration, or minor revision presents may be reviewed and approved via a Non-Committee Review. The Non-Committee Review process applies to both the exempt review and expedited review processes.  The expedited review process is reserved for non-rDNA BSL 1 biohazardous materials and minor amendments which do not apply to changes in biosafety levels, biohazard management, or biocontainment measures.  After the BSO confirms the appropriateness of the Non-Committee Review designation and notifies the RO, the Chair or RO will assign the Non-Committee Review assignment to a Designated Reviewer to:

• Confirm there is no Conflict of Interest (COI). If a COI is identified, the Designated Reviewer must notify the Chair and RO to establish reassignment.
• Confirm sufficient review expertise or request reassignment from the Chair and RO if lacking:
  • Scientific or scholarly expertise.
  • Knowledge of biosafety practices.
  • Knowledge of NIH Guidelines.
  • Knowledge of institutional requirements.
• Confirm the Biosafety Risk Assessment is complete and accurate. If additional documents or information are necessary, the Designated Reviewer should notify the Chair and RO. The Designated Reviewer, Chair, BSO, or RO may reach out to the Principal Investigator and/or study team to obtain clarifications/documentation, may make recommendations to clarify processes or suggest improved handling procedures, and update Biosafety Risk Assessment if any additional information and documentation provided after the initial review.
• If no further information is required, the Designated Reviewer notifies the Chair, BSO, and RO of the review recommendation:
  • Approval: The submission meets the Criteria for Approval.
  • Conditional Approval: The submission requires minor to moderate changes before being granted approval. The Designated Reviewer provides the Chair, BSO, and RO with a list of concerns that require modifications and/or justification to be addressed before approval can be issued. Conditional Approval requires the resubmission to be re-reviewed by the assigned Designated Reviewer, RO, BSO, or Chair.
  • Return/Deny: The initial, continuing, modification, or report submission does not meet the criteria for approval and is found to have extensive deficiencies. The Designated Reviewer provides the Chair, BSO, and RO with a list of concerns that require modifications and/or justification to be addressed.
  • Rescind Approval: A prior approval of a document, site, investigator, procedure, use of a biologic agent, etc., was incorrectly provided, and therefore approval is rescinded. The research may not continue once approval is rescinded. The Designated Reviewer provides the Chair, BSO, and RO with a list of concerns that must be addressed before approval can be reissued.
  • Committee Review: The submission warrants review by the full board.

Documentation of the Non-Committee Review approval are recorded in the meeting minutes.

This review procedure begins when the Chair, BSO, RO, or Designated Reviewer determines a registration requires review via a Committee Review. New registrations that present hazards (to humans, animals, the environment), include BSL2 containment, involve the release of genetically modified organisms, or are deemed by the NIH to require convened review require Committee Review. Or a revised registration which includes a major amendment. Major Amendments involve significant changes to an approved protocol that may increase biosafety risks or require a higher level of containment. Major amendments require Committee Review and a discussion focused on ensuring appropriate risk containment and compliance with biosafety standards. Examples include:

• Introducing new biohazardous agents or recombinant DNA materials.
• Increasing the risk group classification of the biological agents.
• Substantial changes to the scope or design of the research that affect biosafety.
• Moving research to a new facility that requires reevaluation of containment measures.

Official IBC business is reserved to occur at Committee Review meetings and must include a quorum of members for the meeting to be held (Quorum is established by the presence of at least 5 voting members). The Chair and RO determine the maximum number of items on the agenda to ensure reasonable workloads; limits are based on the complexity of agenda items, the time available to meet, and urgency of approval requirements. Limits are adjusted as needed by the RO. Full committee reviews occur during regularly scheduled IBC meetings. PIs are encouraged to attend these meetings to address any questions. PIs should allow 10-15 working days for the full review and approval process. All concerns raised by the IBC must be addressed before final approval.

Meeting Preparation

The RO prepares the IBC for a convened meeting by ensuring to:

• Confirm IBC members (regular, alternate, IBC chairs) availability to be present at the meeting. Ensure the meeting quorum will be appropriately met. If the meeting will not meet the quorum requirements, make arrangements to meet quorum requirements.
• Prepare an agenda.
• Assign IBC member(s) to present each agenda item.
• Ensure that the IBC has appropriate expertise to review registrations listed on the agenda. If the IBC does not have the relevant expertise available, a consultation may be requested from university employees or external consultants. If a consultant is requested, the RO will ensure there is no Conflict of Interest and document the agreement of the consultant to maintain confidentiality of information provided prior to Committee Review invitation. If the consultant provides a written report, the RO will provide the report to the IBC members for review.
• Ensure that all attendees are provided or have access to the materials at least one week before meetings.

Meeting Conduct

The Meeting Chair is responsible for oversight of meeting conduct at the IBC meeting and is expected to:

• Help IBC members meet their expectations and responsibility.
• Encourage IBC members to:
  • Ask questions.
  • Speak their minds at every protocol review.
  • Share information that has not been discussed.
  • Listen and learn from the group.
  • Respect dissenting opinions.
  • Think and vote independently.
• Mentor and guide IBC members to use the criteria for approval by:
  • Facilitating IBC members’ understanding of the research to apply the criteria for approval.
  • Having IBC members base concerns and recommended changes on the criteria for approval.
  • Framing difficult or controversial issues in terms of the criterion that is the basis of the controversy.
  • Taking votes on the criterion for approval that is the basis for a controversy if, after sufficient discussion, a controverted issue remains unresolved. Reminding IBC members who believe that one or more criteria for approval voted are not met that they should not vote for approval.
  • Removing issues from consideration when the Meeting Chair and IBC members determine they do not affect the criteria for approval.
  • Supporting and rewarding dissent based on the criteria for approval.
  • Obtaining assistance from the RO or BSO when IBC members are uncertain whether an issue affects the criteria for approval.
• Encourage IBC member engagement by:
  • Reinforcing IBC member expectations.
  • Encouraging IBC members to use their unique perspective to contribute to IBC deliberations.
  • Providing recognition and praise to IBC members.
  • Encouraging IBC members to develop their review skills.
  • Ensuring opinions of IBC members count.
• Ensure IBC members know the definition of and self-identify their Conflicting Interests. If there are individuals (either IBC members or consultants) with a Conflicting Interest related to an agenda item, neither should participate in the review (including discussion or voting), except to provide information requested by the IBC. Conflicted members may be present for discussion and to answer questions but will be asked to recuse themselves from the vote. If a committee member is unaware of any conflict of interest or potential conflict of interest at the time they sit in a meeting and later discovers the Conflict of Interest, the member should inform the Meeting Chair and RO immediately. If a committee member is in any doubt about whether or not they are in a potential conflict situation, they must state this to the committee members at the commencement of the meeting. Faculty members residing in the same Department are allowed to review protocols and registrations coming from the same Department as long as the committee member does not have a personal interest or stake in the research being proposed.
• Ensure all IBC members who are part of quorum vote, noting that consultants and guests may not vote. If quorum is lost, ensure no further action is taken until quorum is restored.
• Ensure notes and/or concerns provided by absent IBC members are included in the discussion. Absent IBC members may not vote.
• If alternate members are present, determine the voting status of the alternate IBC members by ensuring:
  • The number of IBC members with voting status is not greater than the number of regular IBC members on the IBC roster.
  • Notify the RO at the meeting of any change in IBC members’ voting status.
• If a guest/observer attends, ensure that they are aware that they may not participate in the deliberations unless invited to do so by the Meeting Chair. Neither can participate in the vote and must agree to main confidentiality of the IBC proceedings.
• If the study is eligible for Non-Committee Review, the Meeting Chair can make a motion for members to vote on taking no action and have the item reviewed via Non-Committee Review.
• After sufficient discussion of each agenda item, call for a vote from IBC members present at Committee Review as “For,” “Against,” or “Abstaining” in the motion for:
• “Approval”: When the IBC determines that the research meets or still meets the criteria for approval and more that 50% of the quorum votes in favor or protocol approval. For initial and continuing review, include in the motion, the level of risk (minimal risk or greater than minimal risk), and either that continuing review is not required, or the period of continuing review.
• “Conditional Approval”: When the IBC determines that the research will meet the criteria for approval with minor prescriptive changes or requirements that can be verified without considering the criteria for approval. Summarize the IBC required modifications and reasons. For initial and continuing review, include in the motion, the level of risk (minimal risk or greater than minimal risk), and either that continuing review is not required, or the period of continuing review. If after discussion the IBC members determine the protocol is ambiguous, resolve ambiguity by informing RO of request to obtain written information from the sponsor or investigator as an alternative to Conditional Approval. Alternative must be discussed and review by IBC members before the vote.
• “Table”: When the Committee Review determine further information is necessary to supplement the initial, continuing, or modification registration submission as its status does not meet the criteria for approval and require re-review by the Committee Review. Summarize the IBC reasons for motion and detail information Review of registrations may also be tabled when quorum is lost. A tie votes for and against “Approval” / “Conditional Approval” also results in the tabling of a registration review.
• “Return/Deny”: When the initial, continuing, or modification submission does not meet the criteria for approval and the IBC considers the research to have extensive deficiencies. Summarize the IBC reasons for motion and detail all information required to meet criteria.
• “Suspend”: When the IBC determines that based on new information the previously approved research no longer meets the criteria for approval or when only some research activities meet the criteria for approval or when the IBC has revision recommendations to make the research meet the criteria for approval. Summarize the IBC reasons and/or recommendation for the motion, include which research activities must stop or be modified, and detail all information required to meet criteria. The IBC may lift suspension when resubmission addresses concerns and meets criteria of approval via Non-Committee Review.
• “Terminate”: When the IBC determines that based on new information the previously approved research no longer meets the criteria for approval and the IBC has no recommendations to make the research approvable. Summarize the IBC reasons for the motion.

Meeting Review Process

The review of any registration at a Committee Review involves a discussion led by the Primary Reviewer (typically the Designated Reviewer) in collaboration with the Meeting Chair and IBC members who collectively share the responsibility of:

• Having the appropriate expertise to discuss scientific/scholarly review of:
  • Agent or Material’s characteristics (e.g. virulence, pathogenicity, environmental stability).
  • Types of manipulations planned.
  • Source(s) of the inserted DNA sequences (e.g., species).
  • Nature of the inserted DNA sequences (e.g., structural gene, oncogene).
  • Host(s) and vector(s) to be used.
  • Containment conditions to be implemented.
  • Animal or plant containment methodologies and practices
  • Occupational health concerns
  • Whether expression of a foreign gene will be attempted, and if so, the protein that will be produced.
  • The NIH Guidelines (e.g., Section II-D-1. Section III-E-1, etc.).
• Review all submitted materials for consistency. Then review the findings/concerns identified via the Biosafety Review. Identify any additional findings/concerns. Notify the Meeting Chair, BSO, and RO if additional information is necessary to answer questions about the submitted materials.
• Assess if the criteria of approval are met, if one or more criteria are not met, consider what specific and directive changes would make the protocol approvable.
• For a reviews related to an Unanticipated Problem Involving Risks to Researchers or Others, General Noncompliance, Serious Noncompliance, Continuing Noncompliance, Suspension of IBC Approval, Termination of IBC Approval or new information is provided determine whether additional information is necessary, or if the registration, approval interval, biosafety SOP, corrective action plan, or monitoring plan requires modification.
• The Designated Reviewer and Meeting Chair summarize the IBC’s consensus and provide notes to the RO for the generation of minutes and correspondence.

The RO is responsible for administrative oversight of the IBC review process. The RO schedules meetings, creates the meeting agenda, disseminates registration forms and relevant meeting materials electronically, records minutes, and then distributes the minutes for IBC members to review.

Schedule and Distribution

The IBC meets on the first Thursday of every month. If there are no registrations requiring Committee Review, the meeting is canceled by the Chair or RO. If there is a time-sensitive matter requiring Committee Review, such as registrations with specific funding timelines, noncompliance, or serious and/or unexpected events, an emergency ad hoc meeting can be called by the Chair or RO as necessary. Meetings may be conducted by teleconferencing, and a written record of the meeting is created by the RO to document committee actions and requirements. Email is used to distribute registrations, conduct designated reviews, pre-meeting discussions, and to poll members as necessary.

Agenda

The agenda is provided to IBC members with sufficient time in advance to review and includes:

• New registration applications.
• Identification of conflicts of interest.
• Listings of registrations approved, conditionally approved, and withdrawn via Non-Committee Review since the last meeting.
• Previous committee review meeting minutes for review and approval.
• Administrative updates relating to IBC announcements and/or educational materials.

Minutes

Meeting minutes are drafted and distributed to all IBC members by the RO before the next meeting for review and approval. Committee Review minutes include the meeting date, time of start and finish, attendance, conflicts of interest, and discussion of agenda items. The minutes section of each registration includes:

• Registration Information:Lists the IBC Number, Project Title, PI, Sponsor Name, Grant Number, NIH Category (e.g., III-D vs III-E), and whether IRB/IACUC committee approvals are required/available.
• Material Information:Lists the Material, Agents, Hosts, Vectors, Methodology, Risk Group, and Biosafety Containment Level.
• Discussion Summary:Includes a brief summary of previous actions, consultation reports, and identified issues or concerns regarding agent/host/vector characteristics, types of manipulations, and the nature or source of materials, along with proposed resolutions. This section also mentions controverted issues—topics where committee members have differing opinions or unresolved disagreements, such as ethical dilemmas related to specific materials or methods, differing interpretations of regulatory guidelines, or debates on risk assessment thresholds.
• Motion:Each motion requires specific information to be captured:
  • For a motion of “Approval,” no other information needs to be recorded.
  • For a motion of “Conditional Approval,” the reasons and required modifications must be recorded.
  • For a motion of “Table” and “Return/Deny,” the IBC’s reasons and recommendations must be documented.
  • For a motion of “Suspend,” the specific activities suspended, reason for suspension, and the IBC’s recommendations must be noted.
  • For a motion of “Lift Suspension,” no other information needs to be recorded.
  • For a motion of “Terminate,” the IBC’s reasons must be documented.
• Vote:Each vote must be captured for each voting member’s vote as:
  • “For”: Voting for the motion.
  • “Against”: Voting against the motion.
  • “Abstain”: Present for the vote but not voting “For” or “Against.”
  • “Absent”: Present for the meeting but not present for the vote.
  • “Recused”: Present for the meeting but not present for discussion and vote due to a conflict of interest.

Correspondence

The RO is responsible for drafting all IBC correspondence (determination letters, notices, and memos) for review and approval by the Chair prior to distribution.

Education and Training

The RO is responsible for educating IBC members and faculty on IBC procedures, training requirements, and conflict of interest policies. Training is available through citiprogram.org.

Documentation and Record-Keeping

The RO is responsible for maintaining up-to-date records of all official IBC business. This includes:

• Meeting Minutes:Detailed records of IBC meetings, including attendance, discussions, motions, and voting outcomes.
• Registration Forms:Copies of all submitted registration forms for research projects, including new registrations, amendments, and renewals.
• Approval Correspondence:Documentation of all correspondence related to approvals, conditional approvals, and disapprovals, including determination letters and notices sent to PIs.
• Conflict of Interest Disclosures:Records of any disclosed conflicts of interest by IBC members, along with the management plan for such conflicts.
• Educational Materials:Copies of training materials and resources provided to IBC members and faculty regarding biosafety practices, IBC procedures, and ethical considerations.
• Audit Reports:Documentation of lab audits conducted by the BSO, including findings, recommendations, and follow-up actions taken in response to audit results.
• Policy Documents:Up-to-date versions of IBC policies and procedures, including any revisions or amendments made over time.
• Compliance Documentation:Records of compliance-related activities, including reports of noncompliance, corrective actions taken, and communications with PIs regarding compliance issues.
• Historical Records:Archived records of past IBC activities, decisions, and correspondence to ensure transparency and continuity in governance.

The RO must ensure all records are securely stored in an electronic system with appropriate data backup procedures and are easily accessible for review by IBC members, regulatory agencies, and institutional officials as needed. Regular audits of documentation practices may also be conducted to ensure compliance with institutional and regulatory requirements.

Monitoring Compliance and Audits

The BSO conducts regular lab audits to monitor compliance with approved protocols and ensure adherence to biosafety standards. The BSO reports lab audit results to the RO for IBC review and consideration, establishing if any additional registrations are required or if existing registrations require revision through an amendment. The frequency of audits and criteria for selecting which labs to audit will be specified, along with how findings are communicated to PIs and any follow-up actions that are required.

Review of Policies and Procedures

The RO conducts regular audits of existing policies and procedures to determine which require revisions. Noncompliance and lab audit reports are taken into account when deciding whether new policies or procedures must be established or if new educational guidance is necessary.

Approval Criteria

To meet the criteria for approval, the Institutional Biosafety Committee (IBC) must ensure the following conditions are satisfied:

1. Appropriate Expertise: The IBC members and any external consultants involved in the review must have the necessary expertise to understand and evaluate the scientific, biosafety, and ethical aspects of the research. This includes, but is not limited to, knowledge in characteristics of biological agents (e.g., virulence, pathogenicity, environmental stability), genetic manipulations involved in the study, source, nature, and function of inserted genetic material, host/vector systems, biosafety containment measures appropriate for the risk group, occupational health and environmental safety concerns, NIH Guidelines, relevant biosafety protocols, and containment methodologies for animals and plants. If the IBC lacks the necessary expertise for a specific protocol, it may seek input from external experts, ensuring there is no conflict of interest.
2. Appropriate Biosafety Containment and Risk Assessment: The containment level for the research must be appropriate for the risk group of the study agents. A thorough risk assessment must be conducted to ensure that risks to personnel, co-occupants, and the public environment are reasonable, including consideration of the nature of the study agent, the risk group, and any genetic modifications introduced. Risk to personnel, students or visitors, and environment is reasonable in relation to the threats and hazards associated with use of the materials.
3. Effective Safety Procedures: Safety procedures are developed and monitored for hazards and risks associated with the project or activity. Safety procedures must be developed in collaboration with Environmental Health and Safety (EHS) staff and the BSO to address associated hazards and risks. The BSO is available to assist Principal Investigators (PIs) in the development of individual BioHazardous Material Standard Operating Procedures (BHMSOPs) tailored to each study and lab. Risks to personnel, students, or visitors must be reasonable compared to the threats posed by the materials. Additionally, risks to community health and the environment must be adequately mitigated, and necessary medical measures, such as occupational health consultations, must be in place to minimize risks. EHS staff may conduct routine monitoring of facilities to ensure compliance. Where appropriate, preventative medical measures are taken to minimize risks associated with breeches in safety procedures (including any required occupational health consultations).
4. Adequate Emergency Response Plans and Facilities: Adequate emergency plans must be in place to handle accidental spills, exposures, or other unforeseen incidents, including protocols for responding to researcher or personnel contamination. The research facilities and operational procedures are sufficient to protect against the risks posed by the research, including proper use of containment equipment, safety protocols, and regular safety training programs.
5. Compliance with Guidelines: The proposed research must comply with the NIH Guidelines, the Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual, and any other applicable institutional or federal biosafety regulations.
6. Completion and Consistency of Registration Materials: All registration documents must be complete, consistent, and compliant with the NIH Guidelines, the BMBL, and the IBC’s Charter. Incomplete or inconsistent applications may result in the delay or denial of approval. All necessary documents have been provided with review (reference publications, Material Data Safety Sheets, vector maps, training certificates, and external agreements and permits, etc).
7. Proper Assessment and Monitoring of Risks and Noncompliance: Any previous instances of unanticipated risks, noncompliance, or new information must be considered during the review process. Ongoing monitoring of the research process must be conducted to identify any emerging risks or issues, with clear requirements for reporting to the IBC. If required, modifications to protocols, corrective action plans, or enhanced monitoring may be mandated.

These criteria ensure that the research is conducted safely, ethically, and in compliance with all relevant regulations, while also addressing potential gaps in expertise and preparedness.

IBC PROCEDURES

The IBC receives an annual report from the BSO regarding the annual inspections of all UMassD biosafety facilities (including laboratories and satellite facilities). The BSO may delegate this function to an appropriate Biosafety official.

In order to approve proposed activities or changes in ongoing biohazardous activities, the IBC reviews components related to biosafety and may make recommendations to clarify processes or suggest improved handling procedures.

Meetings

Minority views are recorded in the minutes.

The vote will show the total number of members present, the total votes (yes and no), and one member absent from room during vote because recused. This verifies that a quorum is present, even though the vote was one less than that necessary for a quorum.

The IBC defines a “quorum” as more than half the regular voting members.

A protocol is approved only if a quorum is present, and if more that 50% of the quorum votes in favor or protocol approval. For reasons other than conflict of interest, abstentions from voting do not alter the quorum or change the number of votes required.

Meeting schedules are typically set six months in advance and posted on the IBC website.

All registrations (exempt, expedited, and approved) are recorded in meeting minutes.

Meeting Protocol

Call the meeting to order and follow an agenda prepared prior to the meeting. The typical order of the agenda is as follows:

• Call to order.
• Chair’s reminder to members of conflict of interest requirements.
• Approval of the previous month’s meeting minutes.
• IBC related announcements.
• Educational items for discussion.
• Next meeting announcement.
• Protocol Review.
• Meeting adjournment.

Meeting Documentation

set the meeting agenda, disseminating materials, scheduling meeting locations, and recording and distributing minutes and submitted registration forms. The agenda must include time to review and approve the previous meeting minutes, summarize activities reviewed or exempted since the last meeting, and provide administrative updates. Minutes include the meeting date, attendance, general registration form information (number, project title, PI, type of material, and recombinant methodology, containment level), motions, voting results, and a summary of discussions and actions.

All forms are kept on file with the Director of Institutional Compliance and EHS (or BSO).

Every effort will be made to determine exemption status within 3 business days of receipt of the completed application. Projects that are exempt from full committee review will be reported to the full IBC at regularly scheduled meetings.

Approval Information

The approval memo will contain any elements that the IBC requested to be modified or clarified during the full review. Approval memos will also include the identifying registration number, list the materials registered, note the highest biosafety level required for carrying out the work, and include a note about the supporting documentation such as training certificates, product descriptions, and exposure control plans.  The letter will clearly state the changes requested before final approval is granted. Official copies of approval letters will be kept on file in the Institutional Compliance Office.  Approvals from the IBC are for a maximum of three years. IBC records and a database of approved protocols are maintained by the Office of Institutional Compliance in accordance with federal standards. Laboratory inspection records, training records, and inventory are maintained by the EHS Office in accordance with applicable municipal, state, and federal regulations.

Post Review

The post-review process begins when a Designated Reviewer or Committee Review determines whether a submission requires revision to secure approval or cannot be approved.

Communication of Findings and Actions:

• The IBC communicates its findings and actions to the investigator.
• The IBC reports its findings and actions to the institution, the NIH Office of Science Policy, or other relevant agencies as required under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, OSHA, or local/state biosafety regulations.
• When the IBC disapproves research, it provides the investigator with a statement of the reasons for the decision and offers the opportunity to respond in person or in writing.

Timeliness of Communications:

• Communication of review results to investigators is completed within 7 business days of the IBC meeting or receipt of completed review.
• Reporting of noncompliance, containment breaches, termination of IBC approval, and incidents related to the use of biohazardous materials to outside agencies, as applicable, must occur within 30 days of the determination of a reportable event.

Appeal of IBC Decisions

• If an investigator disagrees with an IBC decision, they may submit a written appeal to the IBC Chair or the Office of Institutional Ethics and Compliance (OIEC) within 30 days of receiving notification of the decision.
  • The appeal should include information supporting the disagreement.
  • For appeals involving research reviewed by a Designated Reviewer, the appeal is reviewed by the Designated Reviewer, IBC Chair, and OIEC.
  • For appeals involving research reviewed by the convened board, the appeal is reviewed by the convened board. The investigator may request to address the board to provide clarification or additional information.
  • The investigator will be notified in writing of the decision.
• The Institutional Official (IO) may override the IBC’s decision to approve research; however, the IO or institution cannot approve research that has not been approved by the IBC or overrule other IBC decisions.

IBC Follow-Up

• Check in with investigators who have not resubmitted within 14 days of a request for revisions.
• Remind investigators whose study involves biohazardous agents within 30 days of the anniversary of approval that their study will continue to be considered open unless a closure report is submitted.
• Notify investigators whose approval has lapsed due to lack of continuing review.
  • When possible, contact the investigator to determine if enrolled subjects or ongoing experiments should continue in the research because it is in their best interest or in compliance with containment standards.
  • Inform the investigator:
    • Which research procedures may continue
    • The continuing review progress report must be submitted as soon as possible.

Consultant Review

The IBC utilizes consultants to enhance IBC reviews when a project requires specialized expertise beyond the scope of IBC membership. Consultants may be needed for:

• Expertise related to a particular biohazardous agent, intervention, or containment practice.
• Understanding of biosafety levels (BSL1-4) and the necessary laboratory containment practices.
• Knowledge of risk assessments related to Dual Use Research of Concern (DURC) or biohazardous materials that may present significant risks to public health or safety.
• Experience with the research population, including considerations of community safety or exposure.
• Knowledge of environmental impact and safety requirements for research involving genetically modified organisms (GMOs) or other materials with ecological risks.
• Expertise related to protecting participants, including informed consent, privacy, and data confidentiality, especially in research involving human subjects and biospecimen collection.

During the initial review of a submission, if the Designated Reviewer identifies the need for additional expertise, they must notify the OIEC or IBC Chair. Once identified, the OIEC, IBC Chair, or IO will consult with IBC members, University, or affiliate administrators and faculty to identify suitable experts.

The convened IBC may also determine that additional expertise is required:

• If the IBC decides that additional expertise is necessary before approval, the review and approval are deferred until the consultant’s review is completed and presented at a subsequent meeting.
• If the IBC approves the submission with conditions but deems consultation necessary for finalizing changes, the consultant will work with the Designated Reviewer and OIEC to confirm the necessary information from the PI.

Consultants are not appointed members of the IBC and do not have voting rights. Their role is limited to providing expertise for specific submissions. Once an appropriate consultant is identified, the OIEC ensures:

• The consultant has no conflicts of interest that might affect the review before engaging in the review process. Consultants with conflicts may only participate under these conditions:
  • They restrict their input to the information requested by the IBC, or
  • They disclose their conflict to the IBC before presenting their comments if no alternative expert is available.
• Consultants receive relevant materials and must provide written comments and recommendations. These documents are attached to the agenda.
• Consultant reviews, which summarize findings, considerations, and recommendations, are presented to the Designated Reviewer via email or at the IBC meeting by the consultant or IBC Chair.

IBC Record Requirements

The IBC prepares and maintains adequate documentation of IBC activities within the Office of Sponsored Programs, including the following:

1. Research Proposals and Biosafety Protocols:
   • Copies of all research proposals and registrations reviewed and approved.
   • Reports submitted by investigators, including lab inspections and safety audits.
2. Minutes of IBC Meetings:
   • Members present (any consultants/guests/others shown separately).
   • Results of discussions on biosafety concerns and record of IBC decisions.
   • Record of voting (showing votes for, against, and abstentions).
3. Continuing Review Activities:
   • Records of continuing review activities.
   • Updated biosafety protocols and summaries of ongoing project activities.
4. Correspondence:
   • Copies of all correspondence between the IBC and the investigators, including communication with the Environmental Health and Safety (EHS) Office regarding lab inspections or containment audits.
   • Copies of all correspondence between federal agencies and the IBC.
5. Incident Reports and Safety Concerns:
   • Any statements of significant findings (e.g., unanticipated risks, adverse reactions, or containment breaches) were provided to the investigator and IBC.
6. Adverse Event Reports:
   • Adverse event reports and documentation that the IBC reviews such reports.
7. Emergency Use Reports:
   • Emergency use reports of biohazardous agents or containment breaches.
8. General Project Information:
   • General project information provided to subjects or personnel (e.g., biosafety manuals, training requirements).

These documents and records shall be retained for at least three (3) years after the research is completed. The records shall be accessible for inspection and copying by authorized representatives of the NIH Office of Science Policy, the Centers for Disease Control (CDC), and other federal regulatory agencies at reasonable times and in a reasonable manner.

Annual Review and OSP Reports

IBC SOP will be reviewed on an annual basis and updated, as necessary.  Issues that arise during the year will be noted and addressed during the annual review of the guidelines.

EHS staff (or BSO) are responsible for annual inspections or may delegate responsibility for inspection of facilities where rDNA and activities using hazardous agents occur. The annual audit and review of facilities report assesses the overall biosafety at UMassD, ensures ongoing projects meet all regulatory requirements, and identifies areas of deficit and noncompliance.

Committee composition documentation is compiled by the Office of Institutional Ethics & Compliance and submitted to the National Institutes of Health, Office of Science & Policy. Annual reports must include a committee roster indicating the role and a biosketch of each member with a cover letter should indicate the information submitted is for the annual report.