Tool for the Self-Assessment of the Institutional Biosafety Committee and Program of Oversight of Recombinant DNA Research

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1 IV- B-2-a-(1) IV-B-2-a-(3) IV-B-2-a-(1) IV-B-2-a-(1) OBA Comments Institution Comments/Notes How many members are The institution's must be comprised of no fewer currently on the institution's? than five members who collectively have experience expertise in recombinant DNA technology the capability to assess the safety of recombinant DNA research to identify any potential risk to public health or the environment. At least two of these individuals must be non-affiliated with the institution. Has the institution designated an Chair? Has the institution designated a BSO on the (if necessary)? Has the institution designated a plant, plant pathogen, or plant pest containment expert on the (if necessary)? The institution must file an annual report with OBA which includes a roster of all members of the clearly indicates who is serving as the Chair. A BSO must be appointed to the if the institution conducts research at BL3, BL4, or conducts Large Scale research (defined as greater than 10 liters). The must include at least one individual with expertise in plant, plant pathogen, or plant pest containment principles when experiments subject to Appendix P, Physical Biological for Recombinant DNA Involving Plants, are conducted at the institution IV-B-2-a-(1) IV-B-2-a-(1) IV-B-2-a-(3) Has the institution designated an animal containment expert on the (if necessary)? How many members are not affiliated with the institution but represent the interests of the surrounding community with respect to health protection of the environment? Has the institution designated an contact person on the? The must include at least one individual with expertise in animal containment principles when experiments subject to Appendix Q, Physical Biological for Recombinant DNA Involving Animals are conducted at the institution. The shall have at least two members who are not affiliated with the institution (apart from their membership on the ) who represent the interests of the surrounding community with respect to health protection of the environment. OBA requires institutions to designate a contact person on the roster whom OBA can contact with questions important information regarding the institution's. 1 of 15 Developed by the Office of Biotechnology Activities

2 IV-B-2-a-(3) IV-B-2-a-(3) OBA Comments Institution Comments/Notes Does the institution file a committee membership report annually with /OBA? Has the institution designated a human gene transfer expert on the (if necessary)? Are members appointed for a fixed term? How many staff members support the what are the lines of reporting for those staff? The institution must submit to /OBA at least annually (i) a roster of all members clearly indicating the Chair, contact person, biological safety officer (BSO - if applicable), plant, animal or human gene transfer experts (if applicable) nonaffiliated members; (ii) biographical sketches for all members. When the institution participates in or sponsors recombinant DNA research involving human subjects, the institution must ensure that there is an member who has adequate experience training in the field of human gene transfer. OBA recommends that members of the have a fixed term of appointment, thus allowing for fresh perspectives on the. Institutions should conduct a thorough assessment of the resources necessary for the to fulfill all of its responsibilities as articulated in Section IV-B of the, taking into account not only the protocol submission review process, but also training surveillance responsibilities as required under Sections IV-B-1-h IV-B-2-b-(5) of the respectively Does the institution formally appoint members? What does the institution do to recognize or promote service on the? OBA recommends that institutions have a written policy in place that addresses the appointment of members. This information could be contained in an charter or similar document. Appointments should be made formally by a senior institutional official. The ability to retain recruit qualified members is critically important for an program to succeed. Recognition of service on the is valuable not only for encouraging faculty to join the committee when invited to serve, but also for acknowledging institution-wide the value that the institution places on the s role. At many institutions, service counts toward service requirements that are a consideration for promotion tenure. 2 of 15 Developed by the Office of Biotechnology Activities

3 IV-B-2-a-(4) IV-B-2-a-(6) IV-B-2-a-(6) IV-B-2-a-(6) IV-B-2-a-(7) OBA Comments Institution Comments/Notes How does the identify No member of an may be involved (except to hle potential conflicts of provide information to the ) in the review or interest between members approval of a project in which he or she has been or the review or approval of a expects to be engaged or has a direct financial research project in which they interest. have a personal or financial OBA recommends institutions develop formal interest? Is there a written policy written Conflict of Interest policies, since this for conflicts of interest? promotes attention to this matter consistent approaches to dealing with it. Are members of the public (other When possible consistent with the protection of than non-institutional privacy proprietary interests, the institution is members) permitted to attend encouraged to open its meetings to the public. meetings? How would an interested Methods for advertising meetings are not member of the general public learn about future meetings dates, times location? proscribed by the but when possible consistent with the protection of privacy proprietary interests, the institution is encouraged to make information regarding meeting times locations available to also open its meetings to the public. The do not prescribe how s should be convened, but they do speak to the preparation of meeting minutes, they encourage institutions to accommodate public attendance at Is the conduct of official business (e.g., protocol review approval) done at a convened meeting (e.g., interactive/real-time/in-person)? meetings. Thus, s should be convened in a manner that allows for fulfillment of these two expectations. exchanges cannot fulfill these expectations thus are not an acceptable manner for the to conduct official business. For further information regarding the conduct of meetings, please visit: Interest%20to%20s.pdf 3 of 15 Developed by the Office of Biotechnology Activities

4 IV-B-2-a-(7) IV-B-2-a-(7) IV-B-2-a-(7) OBA Comments Institution Comments/Notes Has the ever received When public comments are made on the 's comments or questions from the actions, the institution must forward both the public general public about its comments the 's response to OBA. activities? Is there a policy for how such comments or questions would be hled? Has the institution forwarded any such comments to OBA? Does the record minutes for every meeting? Upon request, the institution shall make available to the public all meeting minutes. For information regarding OBA s expectations on content of meeting minutes please refer to: e_feb_23_2007.pdf Is any information pertaining to For information regarding OBA s expectations on the meeting routinely not the content of meeting minutes please refer to: captured in the meeting minutes (e.g., select agent information, PI names, research agent descriptors, location of agents)? e_feb_23_2007.pdf If so, please describe. 21 IV-B-2-a-(7) Are meeting minutes available to the public upon request? If so, how are they provided? Upon request, the institution shall make meeting minutes available to the public. OBA recommends the institution have a formal written policy for how it will distribute requested minutes With what frequency is the convened? Are PIs encouraged to attend meetings where their research is discussed? While the do not speak to the frequency that the should meet, OBA encourages institutions to look at the volume of their research determine an appropriate frequency for the to convene in order to ensure timely review of research. PI participation in the meeting can not only enrich the discussion of the research at h, but also raises the profile of the within the investigator community. 4 of 15 Developed by the Office of Biotechnology Activities

5 Review Review Review Review III-D IV-B-2-b-(1) IV-B-2-b-(1) IV-B-7-c-(3) IV-B-7-c-(3) OBA Comments Institution Comments/Notes Does the institution have written policies for the redaction of meeting minutes before they are released to the public? OBA recommends the institution have a formal written policy for redacting meeting minutes. Articulating the criteria for redaction in operating procedures can help ensure redaction is performed consistently for all requestors. Review Does the institution have a form The require that PIs submit a for registering protocols involving registration document to the with pertinent recombinant DNA with the? information regarding their protocols. This information includes, but is not limited to, the source of the DNA, the nature of the inserted DNA sequence, the host vector to be used, containment conditions. Does the use delegated or expedited reviews whereby any individual or subcommittee approves research on behalf of the? The is responsible for reviewing all recombinant DNA research conducted at or sponsored by the institution that is subject to the. Expedited reviews or approvals by a subgroup of the on behalf of the entire for research subject to the is not in keeping with the requirements of the. Such formal business should only be conducted when a quorum of the is present at a convened meeting. Do PIs determine whether their Recombinant DNA research that is exempt from the research is exempt from the under section III-F need not be? Is the registered with the, however the institution is determination verified by the responsible for ensuring PIs are correctly BSO or? Are PIs required to determining under which section of the register exempt work with the their research falls. This can be? accomplished in a number of ways, e.g. ensuring PIs are adequately trained to make the determination. Many institutions register all recombinant DNA research have the BSO or Chair verify that the PIs initial determination is correct. Do PIs register all research PIs must submit the initial research protocol subject to Section III-A though III- E of the? any subsequent changes if covered under Section III-A, III-B, III-C, III-D, or III-E to the for review approval or disapproval. 5 of 15 Developed by the Office of Biotechnology Activities

6 Review Review Review Review Review Review Review IV-B-7-c-(3) IV-B-7-a-(2) OBA Comments Institution Comments/Notes Does the registration document require PIs to identify what section of the their research is subject to? How does the institution assess the 's performance compliance with the? How do PIs go about submitting new recombinant DNA research projects to the? How are PIs informed of the procedures for submitting new research to the? What systems does the institution have in place to ensure that all recombinant DNA research that requires review is being captured? Is the empowered with the authority to enforce the ensure that approved conditions are adhered to? Do the ever grant approvals dependent upon certain conditions being met? If so, how does the verify that those conditions are met? How are PIs informed of the outcome of the 's review of their submitted research protocols involving recombinant DNA? PIs must submit the initial research protocol any subsequent changes if covered under Section III-A, III-B, III-C, III-D, or III-E to the for review. Thus it is incumbent upon PIs to be able to identify the appropriate section of the their research falls under. OBA recommends that institutions have mechanisms in place that allow senior administration to assess the performance of the. For example, annual reports to the Institution's Responsible Official. OBA finds that a good practice is to have a formalized written policy that communicates the process of how PIs submit their registrations to the for review approval. Furthermore, the Institution should develop training for PIs in order to communicate these requirements. Various strategies can be employed to ensure that all research requiring review approval is being captured. These include coordination sharing of information between the, IACUC, the IRB. Coordination with the grants contracts office surveying relevant academic departments. The should be granted the appropriate authority to fully investigate potential violations or compliance problems. The s authority should be articulated in an charter or similar document. If the grants approvals based on specific conditions being met then there should be a formal mechanism for verifying the conditions are indeed fulfilled. Section IV-B-2-b-(2) requires the to notify PIs of the results of the 's review approval. For example, sending a formal letter stating the approval conditions, protocol expiration date other pertinent information. 6 of 15 Developed by the Office of Biotechnology Activities

7 Review Review Policies Procedures Policies Procedures Policies Procedures IV-B-1-A 41 Training IV-B-7-d-(2) OBA Comments Institution Comments/Notes Do registrations have an expiration date? How long is approval granted for? Does the require periodic (annual) updates? How are PIs made aware of these requirements? Does the institution encourage communication coordination between the other institutional oversight committees (such as the IRB IACUC)? What policies are in place to ensure that the institution is in compliance with the? Has the institution developed a charter or other document defining member roles responsibilities, policies procedures for the general implementation of the? What review activities, if any, beyond those described in the have been delegated to the by the institution? Does the institution provide resources to investigators to assist them in conducting training for laboratory staff regarding laboratory safety the implementation of the? Because research is typically dynamic, OBA recommends that protocol registrations have an expiration date, after which time a new registration document must be submitted. Many institutions also have a periodic (annual) update form or an amendment form for registering any changes to the protocol. Communication between the, the IRB, the IACUC can be one of an array of mechanisms for institutions to ensure that they are capturing all recombinant DNA research subject to the. Policies Procedures The require that institutions establish implement policies that provide for the safe conduct of recombinant DNA research ensure compliance with the. OBA recommends that institutions develop an charter or similar document which clearly articulates the responsibilities the. The charter is also an ideal mechanism for documenting policies procedures, such as conflict of interest, minute taking etc, Although not required by the, many s review non-recombinant DNA research that may pose a biohazard. Training Education The require that institutions ensure appropriate training for laboratory staff regarding laboratory safety implementation of the. Many institutions offer a stard general biosafety course (including material addressing requirements under the ) to assist investigators with the training requirements. 7 of 15 Developed by the Office of Biotechnology Activities

8 42 Training IV-B-7-d-(2) OBA Comments Institution Comments/Notes How do PIs instruct train PIs are required to train their laboratory staff in the laboratory staff in the procedures practices techniques required to ensure safety for dealing with research-related the procedures for dealing with accidents. approved written policies for dealing with accidents accidents/ illnesses in the laboratory? involving recombinant DNA in the laboratory should be available to all applicable personnel. 43 Training IV-B-1-h 44 Training IV-B-1-h 45 Training 46 Surveillance, Emergency Planning, Response IV-B-1-i Does the institution conduct training with respect to the (e.g. content, format, timing, requirements) for PIs laboratory staff? How are animal hlers informed of the risks associated with research involving recombinant DNA-modified microorganisms used with animals? Are there postings in the rooms/cages? Does the institution keep records documenting the training individual personnel have undergone relative to the? The require that the institution ensure appropriate training for PIs laboratory staff regarding laboratory safety implementation of the. Furthermore, institutions should provide training to PIs regarding the responsibilities expectations of PIs under the. OBA has an information brochure available that institutions can use to instruct their investigators in the requirements of the. It is the responsibility of the PI to ensure that laboratory staff others involved in recombinant DNA research are sufficiently trained regarding laboratory safety the. Training programs should be in place that fulfill these expectations OBA recommends keeping records of training that individual personnel have undergone relative to the. This includes laboratory specific training given by the PI. Surveillance, Emergency Planning, Response Does the institution have a The institution shall determine the necessity for health surveillance program for health surveillance of personnel involved in laboratory workers conducting connection with recombinant DNA projects; if recombinant DNA research? appropriate, conduct a health surveillance program for such projects. The institution must establish maintain a health surveillance program for personnel engaged in large-scale research or production activities involving viable organisms containing recombinant DNA molecules which require BL3 containment. 8 of 15 Developed by the Office of Biotechnology Activities

9 47 Surveillance, Emergency Planning, Response IV-B-1-i OBA Comments Institution Comments/Notes Does the institution have a The institution must establish maintain a health health surveillance program for surveillance program for personnel engaged in animal care workers involved animal research involving viable recombinant DNA with recombinant DNA research? containing microorganisms that require BL3 or higher laboratory containment. 48 Surveillance, Emergency Planning, Response IV-B-1-j The require that Detailed information about incident reporting significant incidents, violations requirements may be found in a set of FAQ's at: research-related accidents illnesses be reported to OBA Interest%20to%20s.pdf within thirty days or immediately depending on the nature of the incident. Have any such incidents occurred? If so, were any reported to the / OBA? What criteria are used when determining what a reportable event is? Review Surveillance, Emergency Planning, Response IV-B-2-b-(5) IV-B-2-b-(6) B-7-a-(6) Does the keep track of currently registered protocols falling under the? Does the institution have plans or policies for the following if recombinant DNA is involved: A) Personnel contamination, B) -related illnesses, C) Accidental spills, D) Loss of containment, E) Violations? Have these plans been reviewed approved by the? Section IV-B-2-b-(5) of the requires s to periodically review recombinant DNA research conducted at the institution. By having mechanisms for tracking currently registered protocols, the institution can ensure compliance with this requirement. On behalf of the institution, the must adopt emergency plans covering accidental spills personnel contamination resulting from recombinant DNA research. 9 of 15 Developed by the Office of Biotechnology Activities

10 51 Surveillance, Emergency Planning, Response IV-B-2-b-(7) OBA Comments Institution Comments/Notes What procedures are followed to report any significant violations of the, or significant research-related accidents / illnesses to the appropriate institutional official to OBA? How has this policy been conveyed to the lab personnel? Significant problems with, or violations of, the any significant research related accidents or illnesses must be reported to OBA within 30 days (or immediately depending on the nature of the incident). The most effective way to ensure this provision is met is to have a formalized institutional policy describing how these incidents will be reported to OBA by whom. Also, this policy should be widely disseminated to PIs laboratory staff. 52 Surveillance, Emergency Planning, Response IV-B-3-c-(1) Are periodic inspections conducted to ensure that laboratory stards containment conditions required by the are rigorously followed? If so, how often by whom? Are problems communicated to the? The Biological Safety Officer is charged with performing periodic inspections to ensure that laboratory stards are rigorously followed. Any significant problems that are encountered as a result of these inspections should be promptly reported to the. 53 Surveillance, Emergency Planning, Response Does the institution have a laboratory inspection checklist? Section IV-B-3-c-(1) requires periodic inspections to ensure that laboratory stards are rigorously followed. Having an inspection checklist can help ensure stardized inspection practices Safety Safety IV-B-7-e-(1) Appendix G IV-B-7-e-(4) Who determines the minimum required Personal Protective Equipment (PPE) for laboratory staff working with recombinant DNA? Who trains personnel in the proper use of PPE? How is compliance monitored? Does the institution ensure that laboratory equipment (cabinets, HEPA filters) are properly maintained functioning properly? Physical - Environment Determining the minimum PPE required for laboratory staff is a responsibility of the PI. Training for the proper use of PPE should also be conducted by the PI. The PI is also responsible for supervising the safety performance of the laboratory staff. This would include monitoring PPE compliance. The PI is responsible for ensuring the integrity of the physical containment (e.g. biosafety cabinets) the biological containment (e.g. purity genotypic phenotypic characteristics). The institution should consider a policy of periodic certification maintenance of laboratory equipment. 10 of 15 Developed by the Office of Biotechnology Activities

11 56 57 Safety Safety IV-B-2-b-(1) Appendix G OBA Comments Institution Comments/Notes Does the review s are responsible for assessments of facilities approve plans for the renovation contemplating research. The s review of or construction of laboratories construction plans can help ensure that new other facilities where facilities comport with the conditions recombinant DNA research is containment measures described in the conducted?. How does the institution dispose of liquid solid waste containing recombinant DNA? Are there written Stard Operating Procedures (SOP) for waste disposal? As part of stard microbiological practice, all liquid solid laboratory waste containing recombinant DNA must be decontaminated before disposal Safety Safety Safety t Safety Appendix G-II-C Appendix G-II-D Appendix G Does the institution engage in recombinant DNA research at BL3? If so, has a BSO been appointed? Does the institution engage in recombinant DNA research at BL4? If so, has a BSO been appointed? Does the institution have policies procedures regarding the disposal of recombinant DNA containing animal waste? Does the institution have any autoclave verification program? Appendix G-II-C discusses the stard microbiological practices, the special practices, containment equipment laboratory facilities requirements for research being conducted at BL3. A BSO must be appointed when conducting research at BL3 or higher. Appendix G-II-D discusses the stard microbiological practices, the special practices, containment equipment laboratory facilities requirements for research being conducted at BL4. A BSO must be appointed when conducting research at BL3 or higher. Appendix G-II-B-2-I Appendix G-II-C-2-n require that all recombinant DNA containing wastes (including transgenic animal carcasses) from laboratories animal rooms are appropriately decontaminated before disposal. OBA strongly recommends the institution have formalized written policies for how animal waste containing recombinant DNA is disposed. Autoclave verification programs should be employed in order to ensure that autoclaves are working properly effectively. The institution should consider having a written SOP detailing the methodology frequency of testing. 11 of 15 Developed by the Office of Biotechnology Activities

12 Physical (Large Scale) OBA Comments Institution Comments/Notes Physical - Large Scale Uses of Organisms Containing Recombinant DNA Molecules Does the institution engage in Appendix K specifies physical containment large-scale research or guidelines for large scale (greater than 10 liters of production activities involving culture) research or production involving viable organisms containing organisms containing recombinant DNA molecules. Appendix K recombinant DNA molecules? Appendix K applies to large scale research or What is the largest volume? production activities as specified in Section III-D-6 What BL is used? If the of the. If the institution is institution does engage in Large performing large scale research, a BSO must be Scale has a BSO been appointed. appointed? Appendix M Appendix M Appendix M Does the institution participate in or sponsor recombinant DNA research involving human subjects? The requirements of Appendix M apply to human gene transfer research conducted at or sponsored by an institution that receives any support for recombinant DNA research from. Has a PI at the institution ever proposals involving the deliberate transfer submitted a human gene transfer of recombinant DNA, or DNA or RNA derived from protocol to OBA for recombinant DNA, into human subjects will be Director s Recombinant DNA considered through a review process involving both Advisory Committee (RAC) OBA the RAC. s requiring RAC review review? Was the protocol cannot be approved by the until the RAC review selected for in-depth public is completed. review at one of the RAC meetings? Does the institution have written policies for reporting serious adverse events on human gene transfer trials to the? PIs must submit a written report on: (1) any serious adverse event that is both unexpected associated with the use of a gene transfer product; (2) any finding from tests in laboratory animals that suggest a significant risk for human research participants. Appendix M-I-C-4-a Appendix M-I- C-4-b describe the content format time frame for reporting, respectively. OBA recommends written policies procedures be in place for reporting serious adverse events to the. 12 of 15 Developed by the Office of Biotechnology Activities

13 66 Appendix M OBA Comments Institution Comments/Notes Does the institution have written policies for reporting serious of adverse events that are associated with the use of human gene transfer products to OBA? What is the required time frame for reporting serious adverse events as well as the threshold for determining what is a reportable event to OBA? PIs must submit a written report on: (1) any serious adverse event that is both unexpected associated with the use of a gene transfer product; (2) any finding from tests in laboratory animals that suggest a significant risk for human research participants. Appendix M-I-C-4-a Appendix M-I- C-4-b describe the content format time frame for reporting, respectively. OBA recommends institutions have written policies procedures in place for reporting serious adverse events to OBA other required entities Plant Appendix M Appendix M Appendix M Does the review informed consent documents to ensure that human subjects are adequately informed of the possible risks, discomforts, side effects that are associated with the use of gene transfer agents? Does the institution utilize the guidance on informed consent for human gene transfer research on OBA's website? Appendix M-1-C-1 of the requires that the approve human gene transfer protocols prior to their initiation. As part of this approval process s should review the informed consent documentation from the perspective of risks associated with the use of recombinant DNA. For more information visit ml If the institution has ever If the protocol requires RAC review, the must submitted a protocol to OBA that await the RAC's recommendations before approving warranted RAC review, did the the protocol. take into account the RAC s recommendations in their final approval? Does the institution encourage the use of the GeMCRIS database for reporting adverse events on human gene transfer trials to OBA? For more information regarding GeMCRIS please visit: Physical Biological for Recombinant DNA Involving Plants Does the institution engage in Appendix P of the specifies the recombinant DNA research physical biological containment conditions Appendix P involving plants subject to practices suitable to the greenhouse conduct of Appendix P of the plant experiments involving recombinant DNA.? 13 of 15 Developed by the Office of Biotechnology Activities

14 Plant Plant Animal Appendix P Appendix P Appendix Q OBA Comments Institution Comments/Notes Does the institution have policies procedures regarding the proper disposal of transgenic plants? Has the institution ever allowed the field release of a transgenic plant? If so, was authorization obtained from the proper agency? Transgenic plants associated organisms must be decontaminated in accordance with the requirements of Appendix P of the. OBA recommends having formalized written policies describing procedures to be followed when disposing of transgenic plants. These plans should be approved by the. The address contained research only. Experimental field releases require proper authorization from a responsible federal agency. In terms of transgenic plants the appropriate agency would be USDA APHIS. Physical Biological for Recombinant Involving Animals Does the institution engage in If the institution engages in recombinant DNA recombinant DNA involving large experiments involving large animals then the animals subject to Appendix Q of institution is required to follow the procedures of the? (Large Appendix Q of the. Appendix Q animals subject to Appendix Q pertains to research involving animals of a size or include transgenic animals having growth requirements that preclude the use of animals into which viable containment for laboratory animals. recombinant DNA-modified microorganisms have been introduced) Animal Animal Appendix Q-1-B-2 Appendix Q Does the institution inventory track large animals subject to Appendix Q to ensure proper disposal? Does the institution have policies procedures regarding the proper disposal of transgenic animals covered under Appendix Q? The r equire that institutions keep a permanent record of the experimental use disposal of animals covered under Appendix Q. Large animals must be disposed of in accordance with the procedures of Appendix Q of the. OBA recommends that the institution have formalized, approved polices describing how large animals are to be disposed. 77 Animal Appendix Q Does the institution have policies procedures regarding the disposal of infectious animal waste covered under Appendix Q? Infectious animal wastes must be disposed of in accordance with Appendix Q of the. OBA recommends that the institution have formalized, approved polices describing how infectious animal wastes containing recombinant DNA will be disposed. 14 of 15 Developed by the Office of Biotechnology Activities

15 78 Animal 79 Resources 80 Resources Appendix Q OBA Comments Institution Comments/Notes Has the institution conducted the field release of a transgenic animal covered under Appendix Q? From what agency was authorization obtained? Has the institution developed any tools for communicating recombinant DNA research requirements? Does the institution encourage attendance at professional development conferences, or scientific symposia related to biosafety or the? The address contained research only. Experimental field releases require proper authorization from the appropriate federal agency. Resources OBA recommends that the institution develop a method for disseminating information regarding the to those faculty staff in need of such information. Effective methods include newsletters, blasts FAQ's. OBA encourages support of professional development particularly for members staff. 15 of 15 Developed by the Office of Biotechnology Activities