What are my responsibilities as a Principal Investigator (PI)? See also the NIH-OBA Investigator Responsibilities brochure. The Principal Investigator is responsible for reviewing this policy and complying with its requirements. Specifically, he/she will:
- Determine if their classroom experiments or research are subject to Section II-A, III-B. III-C, III-D or III-E of the NIH Guidelines, or is exempt research.
- Ensure that the PI and any students involved in the research are appropriately trained in laboratory and biosafety procedures.
- File the appropriate Registration Document (Protocol) for each project and meet all the requirements of the NIH Guidelines For Research Involving Recombinant or Synthetic Nucleic Acid Molecules, CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, Occupational Safety & Health Administration (OSHA) Standards for Bloodborne Pathogens. This registration will require that a) the PI proposes physical and biological containment levels in accordance with the NIH Guidelines, and b) the PI proposes appropriate microbiological practices and laboratory techniques to be used for the research.
- Make available to laboratory staff and students copies of the registration documents and other protocols that describe potential biological hazards and the specific precautions to be taken.
- Provide appropriate instruction and training in practices and techniques necessary to ensure laboratory safety.
- Supervise the laboratory staff to ensure that appropriate safety techniques and procedures are employed.
- Submit to the committee an annual report on activities on each protocol.
- Report in writing to the IBC any significant problems pertaining to the operation and implementation of containment practices and procedures.
For which activities do I have to submit an IBC protocol? The College requires that investigative research as well as classroom and laboratory educational activities that make use recombinant or synthetic nucleic acid molecules and/or infectious agents be reviewed and approved by an Institutional Biosafety Committee (IBC) to ensure that they are conducted in a safe and appropriate manner, and in accordance with the current editions of the NIH Guidelines For Research Involving Recombinant or Synthetic Nucleic Acid Molecules, CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, Occupational Safety & Health Administration (OSHA) Standards for Bloodborne Pathogens.
This policy is applicable to all research, teaching, and outreach activities involving recombinant or synthetic nucleic acid molecules or infectious agents that are conducted at or sponsored by Dickinson College. No activity involving the construction or handling of recombinant or synthetic nucleic acid molecules or the use of infectious agents shall be initiated without the review and approval of the appropriate registration documents by the Dickinson College Institutional Biosafety Committee.
For which activities do I not have to submit an IBC Protocol? Here's what NIH-OBA says!
What happens if I forget to submit a protocol? Submit one to the Committee immediately. There are some critical things you need to know:
- The IBC has the authority to investigate issues and reports of serious or continuing Principal Investigator non-compliance with IBC policies, and may undertake a ranges of possible actions in response. These include, but are not limited to, suspension of protocols, termination of protocols, and consultation with institutional officials, including the Faculty Personnel Committee (FPC).
- The College General Counsel has verified that in the event that a Principal Investigator undertakes research/activities which are a) subject to the oversight of the IBC, and b) are not submitted for IBC review and approval, or are otherwise unapproved, the College will not feel obliged to support their legal defense in the event of any negative event which has legal ramifications. The Principal Investigator I would bear the full liability and responsibility on their own.
- According to Dickinson's insurance policy, all activities at the college are "covered" as long as approval has been secured from the appropriate committees: IBC, plus the Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC). The college has these and other committees in place for the specific purposes of abiding by federal and other regulations and officially overseeing their respective activities.
- Activities normally regulated by such committees but occurring without committee approval are in fact considered "willful and reckless" behavior and are not covered by the College's policies. General Counsel has also reiterated that ignorance of the regulations and College policies are no defense for negligence, as the policies are posted and faculty should be aware of them. Such issues are brought up at Department Chair's meetings, so there should be no questions among faculty on the issue.
Do I also need to submit protocols to the IRB and the IACUC? Maybe. Adherence to the IBC policy shall not exempt investigators employing recombinant or synthetic nucleic acid molecules or infectious agents in their research from compliance with other applicable laws, regulations or policies (e.g. research with human subjects, vertebrate animals, or radioactive materials). The appropriate paperwork must also be filed through the with the IRB and IACUC.
What are recombinant or synthetic nucleic acid molecules and what are infectious agents? Recombinant or synthetic nucleic acid molecules are defined as either (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate inside a living cell, or (ii) DNA molecules that result from the replication of those described in (i). Synthetic DNA segments likely to yield a potentially harmful polynucleotide or polypeptide (e.g. a toxin or pharmacologically active agent) shall be considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide of polypeptide product, it is exempt from this policy. Infectious agents are defined as those biological agents, both pathogenic and non-pathogenic, known to infect human as well as selected animal agents that may pose theoretical risks if inoculated into humans.
What forms do I have to fill out? Each investigator/instructor using recombinant DNA molecules or infectious organisms is required to submit the combined form as described below, and available as a download from the IBC Mentor system.
- Registration Document (Protocol) for Research/Teaching Involving Recombinant DNA: for those investigators/instructors employing recombinant or synthetic nucleic acid molecules and technology, including the construction and use of transgenic animals, and transfection of mammalian cell lines. Investigators conducting "exempt experiments" must still submit a registration form to the IBC. However, investigators completing this registration document need not complete an additional registration document for infectious agents for the same project.
- Registration Document (Protocol) for Research/Teaching Involving Infectious Agents: for those investigators/instructors employing infectious agents in their research and teaching, but not involving recombinant or synthetic nucleic acid molecules.
- Registration Document (Protocol) for Research/Teaching Involving Human Tissue or Body Fluid: for those investigators/instructors employing human tissue or body fluids, including saliva, urine, blood, or primary human cell cultures.
- Registration Document (Protocol) for Research/Teaching Involving Wild-Caught or Random Source Animals or Animal Tissues for those investigators/instructors employing animals that may carry zoonotic disease.
What about changes to protocols? Any substantive changes in procedures or type of recombinant DNA molecules/infectious agents should be reported immediately to the IBC via an amendment to the protocol.
How often do I have to renew my protocol? Every year.
When do I have to submit (or reregister) a new protocol? A new registration document must be completed every three years for research; every five years for classroom projects.
What are IBC’s procedures for protocol review? When a protocol is submitted, a copy will be sent to all committee members electronically for administrative pre-review. The committee chair, on behalf of the committee, will ask the Principal Investigator to responds to questions and requests for administrative revisions. The chair will then arrange a meeting of the committee to formally review the protocol. Once the committee is satisfied that the protocol is in compliance with the policies and guidelines, they will vote to approve the protocol. The chair, on behalf of the committee, sends the Principal Investigator official notification that she or he may begin the research described in the protocol.
How long does it take for IBC to review a protocol? Protocols are usually reviewed by IBC within 30 days of their submission.
Still have questions? Email the IBC Chair for questions and more information.