Registration/Approval Process for Biological Research

• Registration of Biological Agents
• Registration and Approval Process for Biological Research
• Key for Approval Process Table
• Federal Guidelines

Registration of Biological Agents
The Biosafety program evaluates and registers research involving recombinant DNA, infectious agents, biological agents, toxins, and select agents. Evaluation and registration include facilities inspection, proficiency of personnel, decontamination, and biocontainment measures, and registration with the Centers for Disease Control and Prevention(CDC);

Registration and Approval Process for Biological Research
As of July 27, 2005

Investigators at MIT are required to register all research projects that involve recombinant DNA (rDNA) technology. The MIT Biosafety Program (BSP) has developed a process for the oversight of rDNA research. This process was developed to meet the requirements of the NIH Recombinant DNA Guidelines and various local regulatory authorities. MIT and Whitehead Institute Principal Investigator's (PI's) must register all rDNA work, as defined by the NIH Guidelines, with BSP. BSP reports to the appropriate outside regulatory bodies including the NIH Office of Biotechnology Activities and the City of Cambridge Biosafety Committee on an annual basis regarding numbers and containment levels of recombinant DNA projects.

In order to clarify the project registration and approval process we have outlined the various steps. Projects have an active period of 3 years with annual review and approval. At the end of the 3 year active period, a new protocol form must be submitted. This will keep BSP and the MIT Committee on Assessment of Biohazards (CAB) up to date. PI's will be asked to review their protocol(s) annually and make minor changes as needed. Protocols may be amended within the 3 year period by submission of a letter to BSP for approval.

As the Table below indicates, regardless of the Biosafety Level, the project review process has certain common steps. A protocol will not be reviewed by BSP until a personnel list and a letter stating the technical proficiency of each person on the project is received. All laboratories where rDNA techniques are used are inspected at least once a year. All projects are reviewed by the CAB even though BL1 and BL2 projects can begin work after BSP review and administrative approval by the Biosafety Officer.

For projects with requirements for high levels of containment or require specialized work practices and facilities, the steps in the review process include the assessment of the need for vaccinations, and medical surveillance. At BL2+ and BL3, the investigator is required to document the laboratory procedures and techniques that will be used to prevent exposure/infection of personnel during the course of the project. These procedures and techniques must be worked out in conjunction with BSP. This written document will be used to train laboratory personnel in the appropriate safety procedures and techniques. Projects that require BL2+ or BL3 containment cannot begin without CAB approval.

Some of the intermediate steps may be done concurrently. Once all steps have been completed the CAB will review the project. It should be noted that MIT does not have a facility that meets the design requirements for BL3 containment. If an investigator is planning a project requiring BL3 containment, they should contact the Whitehead Institute to arrange for space in their BL3 laboratory.

Key Steps to the Approval Process Table:

1. Biosafety levels as defined by the CDC/NIH Guidelines

2. The list of personnel and letters attesting to their technical proficiency must accompany the protocol. Training in biosafety procedures and practices must be given by the PI or BSP for all rDNA research personnel.

3. The protocol is reviewed by BSP staff for clarity, completeness, assessment of appropriate biosafety level, and to detect any training needs. If questions arise, the principal investigator is contacted for further information.

4. All labs engaged in rDNA research are inspected for compliance with appropriate lab practice requirements, signs and labels. Laboratory facilities are expected to meet the design criteria commensurate with function and biosafety level.

5. BSP recommends and encourages the immunization of research personnel if a project involves the use of an agent for which an FDA approved vaccine is available. Vaccinations can be obtained through the Occupational Health Service in consultation with a physician. If immunization is declined, the offer and refusal must be documented. Medical surveillance, including physical exams, periodic serum sampling and banking may be needed when working with particular agents. Information is available from BSP and EHS on the hazards of various microbial agents.

6. BL2+ requires the use and documentation of BL3 work practices and procedures within a BL2 facility. Generic BL3 laboratory procedures are available from BSP for adaptation to individual projects. These written procedures become part of the protocol file and are used as a basis for the subsequent training and inspections. (see g. below)

7. At the higher containment levels (BL2+ and BL3) training is mandatory and conducted by members of BSP using the written laboratory procedures developed in step f. Records of training sessions are held with the protocol file. Training for personnel engaged in BL1 and BL2 work is the responsibility of the PI to provide or arrange, (see b.).

8. Projects at Biosafety Levels 1 & 2 require registration but can be administratively approved by the Biosafety Officer. This means that these projects may begin before CAB review and approval. A letter indicating administrative approval is sent to the principal investigator after Biosafety Officer approval. Projects that require higher biosafety containment, BL2+ and BL3, cannot be administratively approved. These will be reviewed by the CAB once all the necessary steps have been completed.

9. The CAB meets every other month to review all rDNA protocols. If questions arise about a protocol, approval may be delayed or made conditional upon further information. Projects at BL2+ and BL3 cannot begin without committee approval. Once the CAB has approved a BL2+ or BL3 rDNA protocol, the Biosafety Officer will sign the protocol and an approval letter will be sent to the PI.

Recombinant DNA Research
City of Cambridge Recombinant DNA Ordinance - copies can be obtained from BSP or contact the Office of the City Clerk in Cambridge.

Federal Regulations and Guidelines for Biological Research

City of Cambridge Recombinant DNA Ordinance - copies can be obtained from BSP or contact the Office of the City Clerk in Cambridge.

NIH Guidelines for Research Involving rDNA Molecules (NIH Guidelines, 2002)

Office of Biotechnology Activities (OBA)

Biosafety in Microbiological and Biomedical Laboratories (BMBL), 4th Edition

DHHS/CDC Select Agent Program

USDA/APHIS Select Agent Program

Biological Project Registration Form Word Doc Version

CAB website