Research Protocol Registration at WUStL Institutional Biological and Chemical Safety Committee/ Environmental Health and Safety Joe Kanabrocki Biological Safety Officer

Research Protocol Registration at WUStL Why this request? What does “research protocol registration” mean? What types of research protocols must be registered? Who should register their research? With whom is the research registered? How does a PI register his/her protocol? When and how often are protocols registered?

Why this request? Federal response to terror attacks. FBI, CDC, DOJ, (USDA-coming soon!) Regulatory compliance. NIH (recombinant DNA) OSHA (BBP and Lab Standard) The “right” thing to do. Facilitate research activities

Federal response to terror attacks Federal agencies have requested that research institutions develop an inventory describing the nature & use of research materials associated with research activities. Centers for Disease Control and Prevention (CDC) Federal Bureau of Investigation (FBI) Department of Justice-Office of Inspector General (DOJ-OIG) Mandate is forthcoming (see handout)

Regulatory Compliance: Response to terror threats & attacks Select Agent Transfer (SAT) Rule (see handout) Rule pertains to select bacteria, viruses, fungi and toxins with potential for use as WMD (see handout). Purpose of SAT Rule is to ensure that: select infectious agents & toxins shipped only to institutions/individuals equipped to handle appropriately. transfer of these agents is to those who have legitimate reasons to use them. system is implemented whereby scientists and researchers involved with legitimate research may continue transferring these agents without undue burden.

Regulatory Compliance: Response to terror threats & attacks U.S. PATRIOT Act ( Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism-2001) Extends limitations of the SAT Rule to use and possession of select agents. Prohibits certain personnel from access to select agents. Criminal records. Foreign nationals from certain countries. Drug abusers.

Regulatory Compliance: Response to terror threats & attacks Additional legislation is pending (see handout). Uncertain outcome. Requirement for development of an inventory of research materials is an absolute certainty.

Regulatory Compliance: Long-established requirements National Institutes of Health: Guidelines for Research Involving Recombinant DNA Molecules (1976). Guide for the Care and Use of Research Animals (Occupational Health and Safety requirements) OSHA: Laboratory Standard (1990) Bloodborne Pathogens Standard (1991) Other funding agency requirements: (e.g. American Heart Association, etc.)

The “Right” Thing To Do Provides basis for assessment of research associated risks: Primary function of Institutional Biological and Chemical Safety Committee (IBC). Allows for determination of appropriateness of facilities and lab work practices. Provides basis for staff training needs. Provides EH&S with info on hazardous waste disposal needs.

The “Right” Thing To Do Provides mechanism for institutional and PI accountability. Public outcry for accountability. St. Louis Fire Department requirements include the establishment of inventories of research materials. Security

Inventory of Biohazardous Materials Inventory to be maintained in Biohazardous Materials Database. Access database. Tracks research reagents, research locations, personnel, training, grants supporting research, lab audit data, fume hood test data Component of Environmental Management System (EPA initiative)

Biohazardous Materials Database Occupational & public health info for exposure prophylaxis. Info for support personnel (e.g. maintenance, custodial, etc.) Info for lab decommissioning. Regulatory compliance records. Provides registry of WUStL research resources for campus investigators.

What does “research protocol registration” mean? Completion of a registration form describing research program elements and protocols. Program-based research protocol description, not grant-based. Graded approach-emphasis on risk The greater the risk, the greater the required detail.

Who should register their research? Investigators should register their research if: they have Principal Investigator status; their research involves regulated or hazardous biological agents and/or materials or select chemical agents.

With whom is the research registered? Registration Program administered through the Office of Biological and Chemical Safety on behalf of the Institutional Biological and Chemical Safety Committee (IBC). Program of the Environmental Health and Safety Department, FMD, School of Medicine.

Institutional Biological and Chemical Safety Committee Representation from Medical School and Hilltop campuses. Membership to reflect required expertise (see roster). Charge.

IBC Charge “In addition to providing scrutiny of recombinant DNA research protocols in accordance with the Guidelines, the University instructs the IBC and OBCS, on its behalf, to assist all faculty and staff in observing safe laboratory practices. Furthermore, the IBC endeavors to provide institutional assurance, via research protocol review and risk assessment, that research involving potentially etiological materials, including either biological or chemical agents, is carried out in appropriate and secure facilities in compliance with all applicable regulations.”

Draft IBC Policy: Research Registration The Institutional Biological and Chemical Safety Committee (IBC) endorses registration with the IBC of all research activities (in vitro and in vivo) involving regulated and/or potentially hazardous biological or select chemical research materials. The bases for this endorsement include regulatory compliance documentation, inventory assessment, security and establishment of a registry of research resources for the WUStL research community (24 April 2002).

What types of research protocols must be registered? Recombinant DNA molecules and recombinant DNA-containing organisms or cell cultures which are subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules, including human gene therapy trials. Pathogenic microorganisms or agents potentially infectious to humans and/or animals. Human blood, tissues, and cell lines as well as potentially infectious animal blood, tissues and cell lines.

What types of research protocols must be registered? Carcinogens, mutagens, teratogens, drugs, and toxins when administered in vivo to animals or in vitro to cell or tissue cultures to induce a biological outcome. Animals for which a reasonable potential for transmission of zoonotic agents exists, e.g., wild- trapped animals, sheep, & rhesus macaques. Exotic plants, animals or microbes (e.g., non- indigenous plant or insect pathogen, or biological control agent).

How does a PI register his/her protocol? Complete Recombinant DNA and Hazardous Research Materials Protocol form (see handout). Available at: Can be filed as attachment. Requires printing of cover page only for signatory purposes.

When and how often are protocols registered? Protocols are considered active for five years. Amendments can be made in the interim when novel (relative to the protocol) risks or regulated materials are added to the protocol.

Handouts Select Agent Lists SAT Rule summary Proposed legislation IBC Roster Registration form