The Institutional Biological Safety Committee (IBC) provides review and oversight of the College’s Biosafety Program in accordance with all local, state, and federal regulations and guidelines. The Dartmouth College IBC reviews all biological research on campus to ensure labs have proper containment for various types of biohazards, including recombinant DNA, infectious agents, toxins, human source materials, etc., and that all PIs and lab personnel are properly trained in biosafety. As such, the IBC serves as an advisory board to the research community on all aspects of biological safety.
Yes. All biological research at Dartmouth needs IBC review and approval before commencement.
The NIH requires all institutions receiving research funds to have its research reviewed by an IBC (regardless of whether that research is directly supported by the NIH), as stipulated by the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules. If research is conducted without approval, the NIH has the authority to withdrawal research support from that lab or institution.
Section IV-B-7 of the NIH Guidelines states, "on behalf of the institution, the Principal Investigator is responsible for full compliance with the NIH Guidelines". Here are the details of the NIH Guidelines Principal Investigator Responsibilities.
Since it's a little like reading tax code, the salient points pertaining to most Dartmouth Researchers are outlined below in 3 categories:
The research review process by the IBC is conducted in the step-wise fashion above, starting with the submission of research information by the PI.
1. Submit your research to the IBC: Online submission to the IBC is achieved using the BioRAFT online registration system (see below for submission instructions). All information pertaining to biological agent usage (rDNA technology - including viral vectors, animal research, human source material, infectious agents, biotoxins, etc.) and the personnel involved with the research will be queried in this system. This information is maintained in BioRAFT and you can update or revise it any time there is a change in your research program.
2. EHS Pre-Review The Biological Safety Officer will review your research information and conduct a risk assessment based upon the information submitted. A biosafety audit of the lab will be conducted as part of the risk assessment. Any questions/problems/concerns will be directed back to the PI for clarification. Once all aspects of the risk assessment have been satisfied by EHS, your research will be reviewed by the IBC committee.
3. IBC Review The IBC will review the research information submitted through BioRAFT and discuss the safety and regulatory aspects of the research project. Discussion topics include: the nature of experimentation, location, rDNA aspects, training requirements fulfilled by research staff, past laboratory inspection record, etc. If it is warranted, researchers can be invited to present their research protocols to the IBC committee.
4. Decision Letter Sent to PI Once the IBC has made a decision regarding the research project reviewed, a decision letter will be sent to the PI from the Biological Safety Officer and the Chair of the IBC. This decision letter should be retained for your records.
5. Conduct Research Once an approval letter has been received from the IBC, only then can the proposed research begin.
At Dartmouth, we use BioRAFT as the online application mechanism for IBC approval. To submit your research to the IBC, you need to enter all relevant information into the BioRAFT "Bio Summary" (aka "Live Usage Summary" or "Bio Registration"). The BioRAFT Bio Summary is designed to communicate the biohazardous aspects of your research to the IBC so that it can properly review and approve your work. The registration of your lab in BioRAFT is conveniently setup to ask you specific questions ("surveys") about your research to make this process easier. As the PI, you will be required to complete a series of surveys in BioRAFT that are aimed to identify the biohazards involved in your research program (rDNA, cells, animals, toxins, human source materials/cells, pathogenic microbes, viruses, etc). If you have already have a Bio Live Usage Summary and need to update it, you can edit any of these surveys to make the necessary modifications. This allows you to have a "live" snapshot of current research in your lab - how nice!
Once this information has been inputted, BioRAFT will then prompt you to "certify" that your Bio Summary (registration) is complete and correct. IMPORTANT NOTE: The information will only be sent to the Biological Safety Officer for pre-review after it has been certified by the PI.
The Biological Safety Officer (BSO) will then review your BioRAFT Bio Summary, discuss any questions or concerns with you during a risk assessment (which may include a lab safety audit). The BSO then creates a Summary Report of your submitted research and presents it to the IBC on your behalf. Thus, it is in your best interest that the information you provide in BioRAFT is complete and accurate so that the BSO can justly present your research to the IBC. Lacking or incorrect information may delay your approval process. Any PI is welcome to present his/her work directly to the IBC if he/she would like. Click here to view a blank Summary Report.
BioRAFT DETAILED INSTRUCTIONS (pdf) link coming soon
The Dartmouth College IBC bylaws cover all of the working procedures for review of biological research and oversight authorities of the committee. A copy of the IBC bylaws can be downloaded here.
The IBC meets quarterly, or more frequently as needed, and meetings are open to the public.
The Dartmouth College Subcommittee for Clinical Gene Transfer (IBC-SCGT) is a multidisciplinary committee charged with the review of clinical protocols involving gene related therapies. Please click here for info on how to submit a human gene transfer protocol to the IBC-SCGT.
Deborah A. Hogan, Ph.D., IBC Chair; Microbiology and Immunology
Brenda L. Petrella, Ph.D., Biological Safety Officer, Environmental Health & Safety
Elizabeth Bankert, MA, Assistant Provost, Human Subjects Protection Official
Brent Berwin, Ph.D., Microbiology and Immunology
Géza Fejes-Tóth, D.M.D., Physiology
Dianne M. Ferris, MS, CIP, Human Research Analyst
Bert Hennessy, Hanover Fire Department; Community Representative
Alexandra Howell, Ph.D., Department of Veterans Affairs, Microbiology and Immunology
Karen Huyck Ph.D, MD, MPH, Medicine/Occupational Medicine
Thomas Jack, Ph.D., Biological Sciences
Kirk, J. Maurer, DVM, Attending Veterinarian, Center for Comparative Medicine and Research
Robin Oertel, IACUC Post-Approval Compliance, Center for Comparative Medicine and Research
Maureen O'Leary, Ph.D., MBA, CBSP, Director, Environmental Health & Safety
Sherrie Read, Office of Sponsored Projects
R. Mako Saito, PH.D., Genetics
Kimberly A. Smith, Hypertherm; Community Representative
Last Updated: 8/27/14