What's New

April 2013 - Update #1

Institutional Animal Care and Use Committee News

1. IACUC – Updated IACUC Policy and Procedure Manual
The IACUC Policy and Procedure Manual has been updated. A detailed summary of changes will be provided via email to all Principal Investigators and animal users. Please review the revised policies and begin adopting the changes immediately. Contact the Office of Research Affairs if you do not have the password to access the manual.

2. IACUC – Updated Form B
The IACUC Form B – Toxic Chemical Form has been revised and is currently available for use. Please begin using the new version of Form B with all submissions effective immediately.

Institutional Review Board Committee News

1. IRB – Updated IRB Policy and Procedure Manual
The IRB Policy and Procedure Manual has been updated and changes have been made to the to the following policies:

1. Educational Requirements (Part 1, Policy I) – Updated for consistency with current IRB training requirements.
2. Noncompliance (Part 1, Policy XXV) - Replaces previous policy (Responding to Allegations of Noncompliance in a Clinical Investigation) and now includes all aspects of non-compliance in clinical research including failure to comply with the laws, regulations, IRB policies and procedures or the requirements or determinations of the IRB. Describes the process for reporting and handling of differing severity levels of non-compliance. Incorporates references to applicable MLH Compliance Office policies.
3. Jurisdiction Over Clinical Research (Part 5, Policy III) - Clarified that all research in which funding is received or administered by LIMR must be reviewed by Main Line Hospitals IRB (MLH IRB). Formalized existing process for MLH IRB fees and Institutional Department Review of research projects. Included requirement that use of non-public information (i.e., Protected Health Information) into a research project requires review by the MLH IRB and may require review by MLH Privacy Officer. Clarified that any type of research conducted by an employee, including residents and fellows, requires MLH IRB review. Formalized existing process to permit the use of an IRB authorization agreement to rely on the use of an external IRB in limited circumstances. Deleted category involving “recruitment of hospital patients” to minimize redundancy and confusion regarding protocols which “require hospital involvement”. Described the MLH IRB criteria to conduct collaborative research projects by individuals not affiliated with the Main Line Health System. Identified the categories of individuals that are considered to be affiliated with the Main Line Health System. Clarified that research conducted by private physicians may not be covered under the Main Line Hospitals Federal-wide Assurance.

In addition, the document on pages 1-3 of the manual entitled Institutional Review Board Procedures For Compliance With Federal Regulations Governing The Protection Of Human Research Subjects has been revised.

Institutional Biosafety Committee News

1. Biosafety - Update to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
The NIH Guidelines have been revised to include synthetic nucleic acid molecules. The Guidelines have been modified to cover explicitly certain types of basic and clinical research with nucleic acid molecules created solely by synthetic means. Certain classes of basic and clinical research with synthetic nucleic acids will be exempt. The updated Guidelines as well as an FAQ about the update can be found on the ORA website.

2. Biosafety – Updated New Protocol Form

The New Protocol Form has been revised and is currently available for use. Please begin using the new version of the form with all submissions effective immediately. The updated form is located on the ORA website.

What's New Update Archive