FAQ

The following are frequently asked questions about IBC Servicepoint and IBCS. If your question is not here please email us at ibcs@wirb.com for more help.

FAQs for Sites
FAQs for Sponsors
FAQs for Committee Members

IBC FAQ FOR SITES

Where can I learn more about gene transfer and vectors?
Sponsor-supplied documents such as the protocol and brochure are usually the best sources. (Keep in mind though that the sponsor and the IBC may have different perspectives on a particular gene transfer product: the sponsor may view a product as safe and simple to administer, but the IBC may take a more conservative view about safety measures.) Professional societies such as the American Society of Gene Therapy (www.asgt.org) and the American Biological Safety Association (www.absa.org) also have informative websites.
Where can I learn more about biosafety?
The American Biological Safety Association (www.absa.org) is a very good resource. The most authoritative source is the CDC -- see Section Iv of the "BMBL" at http://www.cdc.gov/biosafety/publications/. Your state OSHA office should have a website describing state rules, and likely this will have useful links.
What are the sponsor’s responsibilities under the NIH Guidelines?
Sponsors are regulated mainly by the FDA, not the NIH, and the NIH Guidelines do not assign particular responsibilities to sponsors. The premise of the NIH Guidelines is that the researchers are responsible for biological safety, so the PI is the regulatory ‘touch point’ for the NIH.
Can we close a study with IBC when the last subject goes “off study”?
It depends on the protocol and the biology of the rDNA product. According to the NIH, the local IBC has the responsibility to decide when IBC oversight can end. Each local IBC will make its own determination about this. For the IBC, the study is certainly active as long as there is product at the site, or future dosing could occur. Even if the IBC allows the study to close before the end of long-term follow-up (LTFU), the study will still be under oversight by the IRB, the FDA, and the NIH.
Why is LTFU different from protocol to protocol?
In the US, gene transfer is considered experimental, with possible unknown or delayed long-term consequences. Therefore, long-term follow-up (LTFU) generally goes on for much longer than in drug or device studies—like years or life-long. Current FDA guidance calls for the duration of LTFU to relate to risk characteristics of the specific recombinant product; FDA CBER Guidance for Industry, Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events. Some older protocols have not been amended to shorten their LTFU.
What if my sponsor goes out of business during LTFU?
The Institution and PI remain responsible for conducting the research as specified in the protocol approved by the IRB and the IBC. This would include all tests or procedures (such as cancer screening or sample collection) included in the long-term follow-up. Although PIs are permitted to delegate to the sponsor the responsibility for annual reporting to the NIH, the PI remains ultimately responsible. Sites should fully understand the potential financial burdens of the LTFU at the time they agree to take on the research.
What are the implications of having our site visit be “BSL1” versus “BSL2”?
Practically any clinical site that handles body fluids should be able to provide Biosafety Level 2 (BSL2) containment using routine medical precautions, procedures and equipment. BSL2 controls offer additional protection to the agent, the site workers, and the environment. Compared to BSL1, the biggest differences are more attention to proper signage, decontamination, transport, and disposal of the gene transfer product. Also, many (but not all) BSL2 products require the use of a certified biologiacal safety cabinet (BSC, sometimes referred to as a "hood") to prepare the prodct, so this can be a challenge if the site does not already have a BSC.
If we are a BSL1 site, can we do BSL2 research?
Not unless the site upgrades to meet BSL2 requirements and is approved by the IBC. 
However, a site approved to provide BSL2 should be able to do research at BSL1 as long as the protocol and IBC requirements are met.
How can we find supplies such as eyewashes, spill kits, surface decontaminants, etc.?
Check with your usual medical supplies provider. Also, we will include at least one biosafety professional from your local area who will probably be able to suggest reliable suppliers in your area. The Scientific Specialists in the IBCS office may be able to share some resources, too.

IBC FAQ FOR SPONSORS AND CROs

Do you offer "central IBC" services?
No. There is no such thing. Unlike IRB regulations, the NIH Guidelines do not provide for central IBC review, so one IBC cannot review for a multi-center trial. To assure the interests of the community are represented, each institution must set up its own separate IBC, and IBC Services does this. A local IBC can serve multiple units of an institution (such as satellite offices) in the same local area. NIH Guidelines require each IBC to have at least two unaffiliated local members, and recommend including at least one member representing the people who actually handle the rDNA product (“laboratory technical staff”).
How long does it take for research to be approved?
For a site we are already working with, the review meeting will typically occur within a few weeks, or less in urgent circumstances. For a new site starting gene transfer research for the first time, once we receive complete information about the protocol and identify who at the site will work with us to prepare for the review, it generally takes about 8 weeks to hold the first meeting of a new IBC. Depending on local circumstanced, it can be shorter or longer. The steps that tend to be the most time consuming are: 

  • recruiting local members--the site can help with this by suggesting possible contacts who are unaffiliated with the site. IBC Services will make the contact and train the local members. Under the NIH Guidelines, local members "represent the interest of the surrounding community with respect to health and protection of the environment (e.g., officials of state or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health, or environmental concerns in the community)". We seek members who have the interest and willingness to prepare for the meetings by reading all the meeting materials, and the flexibility to be able to schedule teleconferences during work hours.
  • recruiting a site visitor--we arrange for local biosafety professionals (such as biosafety officers, infection control nurses, etc.) to inspect the sites, and inform the IBC about the facility. So suggestions can be very helpful in speeding up the process. Again, IBC Services provides the training.
  • arranging the site visits--sometimes Study Coordinators are over-committed. It takes time to prepare for a successful site inspection. The PI can speed things up by providing enough time for the Coordinator to make the necessary preparations, or designating other staff to work with the site visitor.
  • site SOPs, installing equipment, etc--IBC Services can provide templates, but only the research team can customize them to fit local conditions. Sometimes equipment such as eyewashes must be installed. How long this takes depends on local efforts.
  • surprises--sometimes the protocol-related documents include requirements that are difficult for a particular site to implement (examples: product must be stored or prepared “in a pharmacy”, or staff who could become pregnant may not handle the product). These restrictions are not always recognized during site qualification discussions, and can be a source of delay when IBC Services checks on implementation plans.
    • The IBC review process moves fastest when the PI stays involved, provides adequate resources to the Study Coordinator, makes it clear to the study team that arranging for the site visit and IBC review are work priorities.

    What can a sponsor do to speed the process?
    Site selection makes a big difference. Sites that already have an NIH-registered IBC and experience with gene transfer obviously have a head start. Some sites may lack appropriate space (such as space for a new freezer, or a room with impervious flooring to allow spill clean up), a key piece of equipment (such as a biosafety cabinet or locking freezer) or a capability (such as an on-site pharmacist for agent storage and preparation if required by protocol)

    Be sure the protocol, investigator brochure, and any special handling instructions are reviewed so they are complete, up to date, and consistent between documents. Contradictory statements in the brochure, the protocol, can result in delay of approval.


    IBC FAQ FOR COMMITTEE MEMBERS

    What is an IBC, what does it do?
    IBCs are required by the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local biological safety oversight. The NIH Office of Biotechnology Activities has a great FAQ Concerning IBCs.
    How do I become a committee member?
    Members are appointed by IBC Services. We include members of the local community as well as professionals in related fields (biosafety, genetics, virology, pharmacology, etc.). If you are interested in participating on an IBC, coordinated by IBC Services (WIRB, Inc.), please contact us at (360) 252-2850 or ibcs@wirb.com to introduce yourself as a prospective member.
    How do I review my meeting documents?
    The review documents for IBC meetings are posted on IBC Services secured website, IBC Servicepoint. As a Committee Member you will be provided a username and password to access Servicepoint. Online video instructions for navigating in Servicepoint can be viewed at Training. If you have any difficulties with the website please contact us at (360) 252-2850 or ibcs@wirb.com. The website is designed to support Internet Explorer, Firefox, and Safari.

    Here is a link to the IBC Servicepoint Members page