Understanding COMS and Recombinant DNA Regulations
The Committee on Microbiological Safety (COMS) was established in 1978 to address public concerns regarding safety, environment, and ethics of research involving hazardous biological agents. COMS oversees activities related to recombinant DNA and biological agents at Harvard, supporting all schools and affiliated hospitals/institutes. Researchers need a COMS registration for materials like recombinant nucleic acids, human/non-human primate samples, biological toxins, and various microorganisms. The COMS Office of Biological Safety provides expertise on NIH guidelines, administrative and technical support, reviews protocols, and establishes policies. The COMS review process involves protocol submission to the Biosafety Officer, followed by comprehensive evaluation during regular committee meetings where decisions are made on approval, modifications, rejection, or further information gathering.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
History of Recombinant DNA Regulations and COMS Beginnings
COMS History Public concern for safety, environment, ethics COMS was formed in the 1978 to meet the requirements of the NIH rDNA guidelines Voted by the President and Fellows of Harvard College in 1977 and 1978 as Policies and Procedures Governing the Use of Hazardous Biological Agents in Research or Instruction Under the Faculties of Arts and Sciences, Medicine and Public Health FAS and Longwood Committees joined into 1 committee responsible for overseeing all activities in rDNA and biological agents and to minimize the hazards connected with work in these areas COMS currently supports all Harvard schools and 2 affiliated hospitals/institutes Joslin Diabetes Center & The Wyss Institute
When does a PI need a COMS registration? COMS Regulated material(s) or CRM are defined as: Recombinant or synthetic nucleic acids as defined in the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines); Human or nonhuman primate blood, cells, tissues, fluids, and secretions; Biological toxins subject to the National Select Agent Registry Program; and Bacteria, viruses, fungi, parasites, and prions.
COMS Office of Biological Safety Committee expert on the NIH rDNA Guidelines Provides the administrative support for the COMS Provides technical support for BSOs on risk assessments and COMS Applications Reviews and approves administrative approvals Supports the COMS Chairs Provides training to BSOs and committee members Creates new policies and SOPs for committee review
COMS protocol submitted to Biosafety Officer (BSO) COMS Review Process BSO review for completeness, completes risk assessment, provides recommendations and submits to eCOMS COMS meets every 5 weeks on zoom. Complete, signed protocols must be submitted to the Office of COMS no later than 3 weeks prior to the COMS meeting to be considered at the meeting. Protocol is reviewed by COMS Coordinators & Director and assigned to additional reviewer(s), if necessary Protocol is added to agenda for next COMS meeting Protocol is 1) approved, 2) approved pending modifications, 3) declined or 4) tabled for further information PI is notified of decision by eCOMS
COMS Membership COMS CHAIR & VICE CHAIR COMS FACULTY EX OFFFICIOS Marissa Cardwell Rebecca R. Caruso Mary Corrigan Stanley Estime Eleanor Kuszmar Michelle Schatz Max Nibert COMS COMMUNITY MEMBERS Terry Kwan Donald Tipper Marissa Cardwell EXECUTIVE DIRECTOR, Harvard Center for Comparative Medicine Brian Corning COMS BIOSAFETY OFFICERS Seema Bhalchandra Marissa Cardwell Mike Melisi Beverly Neugeboren Rob Rasmussen Angela Reid Eric Rouse COMS STAFF Serena Jao (serena_jao@hms.harvard.edu) Matrida Neli (Matrida_neli@hms.harvard.edu) COMS office email (coms@harvard.edu) COMS Website
