What are my responsibilities as a Principal Investigator (PI)? 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
- File the appropriate Registration Document and an Annual Renewal form for each project and meet all the requirements of the NIH Guidelines For Research Involving Recombinant DNA MoleculesCDC/NIH Biosafety in Microbiological and Biomedical LaboratoriesOccupational Safety & Health Administration (OSHA) Standards for Bloodborne Pathogens. This registration will require that a) the PI proposes physical and biological containment levels inaccordance with the NIH Guidelines, and b) the PI proposes appropriate microbiological practices and laboratory techniquest to be used for the reserch
- Make available to laboratory staff and students copies of the registration documents and other protocols that describe potential biohazards 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;
- Report in writing to the IBC any significant problems pertaining to the operation and implementation of containment practices and procedures.
For which activities to I have to submit an IBC protocol? The College requires that investigative research as well as classroom and laboratory educational activities that require the use of recombinant DNA technology and 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 DNA Molecules the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories and the Occupational Safety & Health Administration (OSHA) Standards for Bloodborne Pathogens.
This policy is applicable to all research, teaching, and outreach activities involving recombinant DNA or infectious agents that are conducted at or sponsored by (or under the aegis of) Dickinson College. No activity involving the construction or handling of recombinant DNA 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.
What happens if I forget to submit a protocol?
Submit one to the Committee immediately. There are two critical things you need to know:
a) The IBC has the authority to investigate issues and reports of serious or continuing PI non-compliance with IBC policies, and may undertaken 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).
b) The College General Counsel has verified that in the event that a PI 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 PI 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 IRB and 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. General Counsel also verified that 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 IRB and IACUC? Maybe. Adherence to the policy shall not exempt investigators employing recombinant DNA 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 Institutional Review Board for the Protection of Human Subjects (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Radiation Safety Officer.
What are recombinant DNA molecules and what are infectious agents? Recombinant DNA 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.
Who are members of the IBC Committee? The Institutional Biosafety Committee is comprised of College faculty and staff appointed by the Provost plus at least two outside community members, also appointed by the Provost (see Committee Members)
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.
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.
How often do I have to renew my protocol? At the very least, an annual report (renewal) form (download under "Forms") must submitted each year for each approved registration.
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 via electronic mail 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 arrange a meeting of the committee to 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? E-mail the IBC Chair for questions and more information.