Recombinant DNA in Research

 


For Research Involving rDNA


Please note:  Research involving any other biological material(s) should be submitted to:

Michelle McConville
University at Albany Biological Safety Officer
Office of Environmental Health & Safety
mmcconville@albany.edu
CH B73 | 518-442-3495

IBC Protocol Submission

The principal investigator (PI) will submit the original IBC Registration Document for Recombinant DNA Research (protocol) or Exemption Request and related documents/forms with all required signatures, including:

PI and co-investigator (if applicable);
faculty advisor (if student);
dean or department chair.


 

The Document should be sent to:
The Office of Regulatory Research Compliance
Attn: Institutional Biosafety Committee
LCSB 28

Forms may be mailed or hand-delivered. Incomplete applications will be returned to the sender without review.

ORRC Administrative Review

ORRC staff will triage the protocol to ensure that the protocol submission is complete; i.e., that all required elements (e.g., training certificates, grant application, etc.) have been submitted. The protocol will then be referred to a research compliance administrator (RCA) for administrative review. The RCA will notify the PI when the protocol is accepted for IBC review.

The purpose of the administrative review is to identify issues that are either incomplete or unclear, thereby preventing or delaying approval by the IBC. Once issues are identified, the PI must respond to and/or revise the protocol before it can be referred on for IBC review. Protocols that require extensive revision or are missing a significant amount of information will take longer to review.

Although the administrative review process will materially improve the probability that the protocol will be approved, it does not guarantee approval. It is to the PI’s advantage to follow this submission format to avoid delaying the review process.

A protocol will be considered complete and accepted for review if it meets ALL the following criteria:

■   the protocol form and related documents/forms, signed by the appropriate parties, and the signed veterinarian checklist are received by ORRC. E-mail submissions are no longer accepted. The protocol will be returned to the PI if it is incomplete;
■   an administrative review by an RCA has determined that the PI has submitted all information necessary for the IACUC to adequately review the protocol;
■  a grant review has determined that the information presented in the proposed protocol is congruent with the research proposed in the grant application;
■   training requirements for the PI and all research personnel have been met.

 IBC Review

Protocols that are accepted for IBC review are placed on the agenda of the next scheduled meeting.

The PI will receive an e-mail from the RCA indicating the date of the meeting at which their protocol will be reviewed. PIs are invited to the meeting to address any IBC questions or concerns.

 

IBC Training

 

The IBC requires Primary Investigators to ensure that all laboratory personnel, including students, are trained in accepted procedures in laboratory safety procedures, accident techniques, and precautionary medical practices.

All individuals listed on an IBC protocol must provide their curriculum vitae as evidence that they are properly trained in microbiological and biosafety practices or complete the required training before approval will be granted.

For information on how to obtain this required training or to get information on other courses offered, please contact the Office of Environmental Health and Safety at (518)-442-3495.

Laboratory Safety for the Sciences (for graduates and new employees)
On-line presentations offered by the UAlbany Environment Health and Safety Office
General Safety Orientation for New Employees / Right to Know

 

Institutional Biosafety Committee Forms

Research Involving Recombinant DNA:
rDNA Registration Form | Word or RTF
rDNA Exemption Request | Word or RTF

NIH Guidelines for Research Involving Recombinant DNA Molecules:

http://oba.od.nih.gov/rdna/nih_guidelines_oba.html

Coming Soon.