IBC Resources

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IBC Resources2022-11-17T19:08:10+00:00

IBC Resources

Sitero’s experienced team provides comprehensive IBC coordination services to help researchers navigate Biosafety and NIH compliance.

Use these resources and links to help understand how Sitero can help your IBC succeed.

If you still have questions, feel free to contact us at ibc@sitero.com

Sitero Resources

Sitero IBC Requirements (Coming Soon)

Do I need to have IBC approval? (Coming Soon)

Outside Links & Resources

FAQs

Will the details of my research remain confidential?2022-11-07T16:58:36+00:00

Yes, all members of the IBC are required to sign non-disclosure agreements. However, it should be noted that the NIH does require that IBC meetings are open to the public and IBC meeting minutes are subject to FOIA.

Do I need a site/lab inspection?2022-11-07T16:58:11+00:00

Yes, this will be completed in the Sitero Mentor program. This may be conducted virtually or by Sitero staff on-site.

What training do we need for the IBC review?2022-11-07T16:57:45+00:00

Basic Biosafety (OSHA Bloodborne Pathogen training), spill response, and for staff that ship and receive IATA/DOT certification.  The PI will also need training on NIH/IBC basics.

What are the consequences of failure to comply with the NIH Guidelines?2022-11-07T16:57:19+00:00

Institutions that fail to comply with the NIH Guidelines risk suspension, loss, or termination of funding for the non-compliant study. They also potentially risk losing financial support for other NIH-funded other projects using r/sNAs or the requirement to obtain NIH approval before commencing future r/sNA research.

What should I do if there is an accidental spill, exposure, or non-compliance at my institution?2022-11-07T16:56:46+00:00

The first step is to attempt to correct the immediate problem and then contact your IBC chair or coordinator, who can help you with corrective action suggestions and assist with reporting steps. A complete report of an incident must be forwarded to the NIH within 30 days.

What is the definition of large-scale research?2022-11-07T16:56:18+00:00

Research or production that involves greater than 10-liter volumes.

Do I need a Biosafety Officer (BSO)?2022-11-07T16:55:55+00:00

In some circumstances, yes, a BSO must be appointed to comply with the NIH Guidelines if the research meets the large-scale or high-risk criteria. The BSO would also serve on the IBC. If you are not working at high-risk levels or large scale, no, a BSO is not required.

What documents are required to support my IBC review submission?2022-11-07T16:55:22+00:00

The required documents include a completed lab (site) inspection, training certificates for PI and study staff, PI’s Long CV, and SOPs for handling the Investigational Agent (IA), including spills and emergency response, shipping, and receiving. Additionally, information on the IA and typical study or sponsor documents such as a Scientific Abstract, Clinical Protocol, Preclinical Studies, Pharmacy Manual, and Investigators brochure. Additional documents specific to your research, such as Biological Safety Cabinet Certification, may be required.

How do we document PI experience?2022-11-07T16:55:15+00:00

The PI’s extended version CV documents PI experience. This should list any clinical trials worked on, clinical investigator and other biosafety training, and peer-reviewed publications.

Should the Principal Investigator (PI) attend IBC meetings?2022-11-07T16:54:16+00:00

While the PI cannot be a member of the IBC, they are free to join the IBC meeting to discuss the protocol(s). They would be asked to leave before an IBC vote could occur.

How do I manage my documentation for the IBC review?2022-11-07T16:53:19+00:00

A Sitero Mentor account will be created for your institution and documents can be uploaded to this site. IBC members can access documentation once a meeting has been scheduled. The PI will have access to review status and make changes as needed.

What happens if I make changes to my study?2022-11-07T16:52:57+00:00

Changes to the study are considered amendments and must be reviewed by the IBC. Initially, the IBC Chair will review any changes and then may administratively approve the amendments or recommend a convened IBC meeting, depending upon whether the changes affect the risk assessment.

How often does my study have to be reviewed2022-11-07T16:42:16+00:00

After initial IBC approval has been obtained, the committee reviews functional studies annually until the study meets close-out criteria. An IBC meeting may be required sooner than one year if any of the following modifications are made; (i) change to the overseeing PI, (ii) the manner the Investigational agent is handled, (iii) modifications to the dosing strategy, or (iv) the location(s) of IA handling.

Do I have to have Institutional Review Board (IRB) approval before the IBC can review my study?2022-11-07T16:41:40+00:00

IBC review and approval can occur before or after IRB approval. However, clinical research studies involving HGT require approval from both IRB and IBC before the study can commence.

Are IBC meetings closed?2022-11-07T16:41:08+00:00

The NIH Guidelines require that IBC meetings are open to the public. You will be asked to post a sign (public posting) that details the date and time of your upcoming IBC meeting. It should also include contact information for someone at your site, typically the study coordinator, whom members of the public can reach if they would like to attend an IBC meeting.

How do I find IBC members?2022-11-07T16:40:45+00:00

Sitero’s IBC Coordinator will assign an IBC Chair (this is an experienced biosafety professional who has expert knowledge in NIH Guidelines) and other subject matter experts from their staff. The IBC coordinator will also identify local unaffiliated members. You will be asked to identify one-two people who work at your institution to serve on your IBC. They will represent your safety staff, lab staff, and others involved in the study.

How long does IBC oversight last?2022-11-07T16:40:20+00:00

Sitero close-out criteria for concluding IBC oversight are that (i) the study must be complete, (ii) the final dosing of the last human subject has been conducted, and (iii) Investigational Agent (IA) is off-site (either destroyed or returned to the sponsor).

Does the IBC only review HGT clinical studies?2022-11-07T16:39:57+00:00

While the IBC is required to review all research involving recombinant r/sNAs, it can also oversee any hazardous research if the Institution chooses. This may include research that is not in human subjects, but in animals or in vitro.

When do I need to obtain IBC approval?2022-11-07T16:39:26+00:00

For any work that involves work with r/sNAs in human subjects (Section III-C NIH Guidelines), IBC approval must be obtained before research/study is initiated.

How do I register my IBC?2022-11-07T16:38:58+00:00

Sitero’s IBC coordinator will register your IBC with the NIH Office of Science Policy.

What is the definition of an unaffiliated committee member?2022-11-07T16:38:27+00:00

To serve as a local unaffiliated member, the individual cannot have any financial interest in or other association with the Institution. They represent the local community concerning health and environmental safety and must reside within a 50-mile radius of the institution whose study is being reviewed.

How many members do I need for an IBC committee?2022-11-07T16:38:03+00:00

The NIH requires a minimum of five members with expertise to review the research. At Sitero, the committee will include at least one biosafety professional, one representative from the institution, and two local unaffiliated members. The committee will also have an expert in Human Gene Therapy, animal containment, and plant research (including plant pathogens and containment), depending on the nature of the research being reviewed. Guests may also be invited to IBC meetings to provide additional expertise or context for the study.

What is an Institutional Biosafety Committee (IBC), and what does it do?2022-11-07T16:37:20+00:00

An IBC is a panel of experts that review and oversee work with recombinant or synthetic nucleic acids (r/sNAs). The IBC functions to mitigate risks to workers and the surrounding community. This is achieved by reviewing Standard Operating Procedures (SOPs), ensuring proper use of PPE, reviewing the facility, and advising on other applicable local, state, or federal regulations. All research activities involving r/sNA at a covered entity must be registered and approved by the IBC.

Why do I need an IBC review?2022-11-07T16:34:52+00:00

To comply with the NIH Guidelines, any institutions or sites with studies involving recombinant or synthetic nucleic acids (r/sNAs), funded by the NIH or conducted in an institution that receives NIH funding, are required to form an IBC. The IBC is responsible for reviewing research at a local level and overseeing this research until its conclusion.

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