SA国际传媒

All research laboratory protocols at SA国际传媒 must be submitted to the Office of Research Operations, Integrity & Compliance for initial review before the proposed research activities begin.

Complete the Research Laboratory Protocol Form. Provide information about the proposed research, personnel, locations, biological or other research materials, procedures, containment practices, personal protective equipment, and other safety considerations requested on the form.

Submit the completed form to research@marian.edu. Use the subject line “Research Laboratory Protocol.”

OROIC conducts an initial administrative review. OROIC determines the appropriate oversight pathway and identifies any additional institutional review, approval, registration, clearance, training, or safety requirements that apply.

Complete any required additional review. If the research is subject to the NIH Guidelines, the submission will be routed for the applicable IBC review. Other activities may be managed through administrative review or coordinated with other institutional committees, offices, or compliance programs as appropriate.

Wait for confirmation before beginning the work. Research activities may not begin until OROIC has completed its review and all applicable institutional approvals, registrations, clearances, administrative determinations, or required separate oversight submissions have been completed.

Formal IBC review and approval applies to research activities that are subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Depending on the activity, the NIH Guidelines may require IBC approval before initiation, IBC notification at the time the work begins, or another form of institutional handling specified by the Guidelines.

OROIC will determine whether a submitted research laboratory protocol falls within the IBC’s formal purview and will coordinate the appropriate review pathway. Investigators are not expected to determine the final oversight pathway on their own.

When appropriate, the IBC, IBC Chair, an IBC member, or other biosafety expertise may also be consulted on biosafety, biosecurity, containment, or research safety matters outside the NIH Guidelines. Consultation on these matters is advisory and does not constitute formal IBC review or approval unless the activity is determined to fall under the NIH Guidelines.

For research subject to the NIH Guidelines, the MU-IBC is authorized to review the proposed work for compliance with applicable NIH and institutional requirements and to approve, require modifications to, disapprove, suspend, or place conditions on covered research.

Within its formal purview, the IBC may:
- Review research subject to the NIH Guidelines for compliance with applicable NIH and institutional requirements;
- Assess appropriate containment levels, facilities, procedures, practices, training, and personnel expertise;
- Review proposed changes to previously approved covered research when required;
- Conduct periodic review of covered research as required by applicable institutional procedures;
- Address emergency planning related to accidental spills, personnel contamination, research-related illness, or loss of containment involving covered research;
- Report significant problems, violations of the NIH Guidelines, and significant research-related accidents or illnesses as required; and
- Provide guidance to investigators and institutional officials regarding applicability of and compliance with the NIH Guidelines.

IBC review does not replace other institutional reviews or approvals that may apply to a project, including review by the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), sponsored programs, conflict of interest processes, occupational health, environmental health and safety, or other research safety and compliance programs.

The MU-IBC is administratively located within the Office of Research Operations, Integrity & Compliance in Research & Scholarship Administration. The committee is led by an appointed Chairperson and is supported administratively by OROIC.

In accordance with the NIH Guidelines, the IBC includes no fewer than five voting members selected so that the committee collectively has appropriate experience and expertise in recombinant or synthetic nucleic acid molecule technology, biological safety, physical containment, and assessment of potential risks to public health and the environment. At least two voting members are not affiliated with SA国际传媒 and represent the interests of the surrounding community with respect to health and protection of the environment.

Additional expertise may be included or consulted when required by the NIH Guidelines or by the nature of the research under review.

All research laboratory activities must be conducted in accordance with applicable SA国际传媒 safety requirements and any federal, state, or local requirements that apply to the work. Safety and training requirements vary depending on the nature of the research, materials used, procedures performed, containment level, and research location.

As part of the protocol review process, OROIC will identify applicable training and safety requirements. These may include laboratory safety, chemical safety, bloodborne pathogens, biosafety/biosecurity, recombinant or synthetic nucleic acid molecule training, animal-related training, or other activity-specific requirements.

Principal Investigators are responsible for ensuring that personnel working under their protocols are appropriately trained, understand their responsibilities, have access to applicable procedures, and follow required laboratory safety and containment practices.

SA国际传媒 maintains an institutional subscription to the Collaborative Institutional Training Initiative (CITI) Program. Required CITI courses are assigned based on the nature of the research and the applicable oversight pathway rather than solely on the fact that an individual works in a laboratory.

Researchers should affiliate their CITI account with SA国际传媒 – Indianapolis. OROIC will communicate the specific courses required for a protocol during the review process. Investigators should not delay submission of a research laboratory protocol while attempting to determine the required CITI curriculum independently.

The Principal Investigator is responsible for ensuring that all personnel complete required training before beginning applicable research activities.

Approved or administratively cleared research is limited to the activities, materials, procedures, locations, containment practices, and other conditions reviewed through the applicable oversight pathway. Proposed changes that may affect the safety, compliance, or approved scope of a protocol must be submitted for review before implementation when required by institutional policy, protocol conditions, or the applicable oversight requirements.

Investigators should contact research@marian.edu before implementing changes if they are unsure whether additional review is required. OROIC will determine whether the change can be handled administratively or requires review by the IBC or another institutional oversight body.

Research-related incidents, safety concerns, protocol deviations, spills, exposures, injuries, illnesses, containment failures, unauthorized changes, or other events that may affect research safety or compliance should be reported promptly to the Office of Research Operations, Integrity & Compliance at research@marian.edu.

OROIC will coordinate the appropriate institutional response, documentation, and any required notification to applicable committees, offices, or external agencies. For research subject to the NIH Guidelines, significant problems, violations of the NIH Guidelines, and significant research-related accidents or illnesses will be reported in accordance with the NIH Guidelines and SA国际传媒 procedures.

Concerns involving biohazardous materials or recombinant or synthetic nucleic acid molecules may also be reported directly to the IBC at IBC@marian.edu or through SA国际传媒’s established anonymous reporting mechanism.

Does all laboratory research require IBC approval?

No. All research laboratory protocols must undergo initial administrative review by OROIC, but formal IBC review is limited to activities within the IBC’s formal purview under the NIH Guidelines. Other laboratory activities may be reviewed or managed administratively or through another applicable institutional process.

How do I know whether my research requires IBC review?

Submit the Research Laboratory Protocol Form to research@marian.edu. OROIC will review the proposed activities and determine whether formal IBC review or another institutional review pathway applies.

Can I begin research while my protocol is being reviewed?

No. Research activities may not begin until OROIC has completed its review and all applicable institutional approvals, registrations, clearances, administrative determinations, or required separate oversight submissions have been completed.

How long does protocol review take?

Review time depends on the nature and complexity of the proposed work and the oversight pathway required. Investigators are encouraged to submit protocols as early as possible before the anticipated start of research, particularly when committee review or coordination with other institutional oversight programs may be required.

What happens if my research requires IBC review?

OROIC will route the protocol through the applicable IBC review process and communicate any additional information, training, modifications, or other requirements needed before the covered research may begin.

Does IBC review replace IRB or IACUC review?

No. IBC review is separate from other institutional oversight requirements. A project may require review by more than one committee or office depending on the activities involved. OROIC will help coordinate applicable research compliance pathways.

Do I need CITI training before I submit my protocol?

You may submit the Research Laboratory Protocol Form before all training requirements have been determined. OROIC will identify the applicable training requirements during review. Required training must be completed before the applicable research activities begin.

What if I want to change an existing protocol?

Contact research@marian.edu before implementing a change that may affect the safety, compliance, or reviewed scope of the work. OROIC will determine whether the change can be handled administratively or requires additional committee or institutional review.

I am conducting research at another institution. What should I do?

Requirements depend on SA国际传媒’s role in the research, the activities being conducted, and the oversight provided by the collaborating institution. Contact research@marian.edu before beginning the work so OROIC can determine what SA国际传媒 review, documentation, or coordination is required.

A student, staff member, volunteer, or external collaborator is joining my laboratory. What should I do?

Contact research@marian.edu or follow the current Research & Scholarship Administration process for adding personnel to a research laboratory protocol. The Principal Investigator remains responsible for ensuring that all personnel complete required training and follow applicable protocol and safety requirements.

When does the IBC meet?

IBC review is coordinated as needed based on the research submitted and the type of review required. Investigators should submit research laboratory protocols as early as possible rather than waiting for a particular meeting date.

Who should I contact with questions?

For research laboratory protocol submissions, review pathways, training, or general research compliance questions, contact research@marian.edu. For questions specifically related to the Institutional Biosafety Committee or NIH Guidelines-covered research, contact IBC@marian.edu.